{"id":2601,"date":"2025-10-27T13:01:09","date_gmt":"2025-10-27T13:01:09","guid":{"rendered":"https:\/\/network.rvrising.com\/?p=2601"},"modified":"2025-10-27T13:01:09","modified_gmt":"2025-10-27T13:01:09","slug":"bimzelx-bimekizumab-bkzx-three-year-rheumatology-data-at-acr-2025-demonstrated-sustained-inflammation-control-in-psoriatic-arthritis-and-axial-spondyloarthritis","status":"publish","type":"post","link":"https:\/\/www.rvrising.com\/news\/business\/bimzelx-bimekizumab-bkzx-three-year-rheumatology-data-at-acr-2025-demonstrated-sustained-inflammation-control-in-psoriatic-arthritis-and-axial-spondyloarthritis\/","title":{"rendered":"BIMZELX\u00ae (bimekizumab-bkzx) Three-Year Rheumatology Data at ACR 2025 Demonstrated Sustained Inflammation Control in Psoriatic Arthritis and Axial Spondyloarthritis"},"content":{"rendered":"<ul>\n<li><b>Sustained improvements across stringent measures of disease in patients with psoriatic arthritis (PsA): <\/b>One-year improvements were sustained to three years across measures of peripheral arthritis, dactylitis, enthesitis, skin psoriasis, and nail psoriasis \u2013 indicating sustained inflammation control<\/li>\n<\/ul>\n<div>\n<ul type=\"disc\">\n<li><b>Sustained clinical response to stringent endpoints in half of patients with axial spondyloarthritis (nr-axSpA and AS): <\/b>From Week 16 to three years, 50% of patients never lost ASDAS low disease activity (LDA) (&lt;2.1) status at any assessed visit \u2013 indicating sustained inflammation control<\/li>\n<li><b>First real-world findings demonstrate rapid quality of life (HRQoL) improvements in patients with PsA, nr-axSpA, and AS: <\/b>Improvements in outcomes in routine clinical practice were reported at 24 weeks, with benefits as early as Week 2 in some patients<\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">ATLANTA<\/span>, <span class=\"legendSpanClass\">Oct. 25, 2025<\/span> \/PRNewswire\/ &#8212; UCB, a global biopharmaceutical company,\u00a0today\u00a0announced\u00a0new\u00a0three-year\u00a0data\u00a0from\u00a0Phase\u00a03\u00a0trials, and\u00a0their\u00a0open-label\u00a0extensions, investigating BIMZELX<sup>\u00ae<\/sup>\u00a0(bimekizumab-bkzx) in adults with active psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and ankylosing spondylitis (AS). BIMZELX, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),<sup>1<\/sup>\u00a0continued to demonstrate sustained control of inflammation and deep efficacy in patients living with PsA, nr-axSpA, and AS.<sup>2-6<\/sup><\/p>\n<p><b>Sustained\u00a0improvements\u00a0across\u00a0stringent\u00a0measures of\u00a0disease\u00a0in\u00a0patients\u00a0with\u00a0PsA<sup>2<\/sup><\/b><\/p>\n<p>&#8220;The diverse, multi-faceted nature of PsA can make it challenging to treat, as therapy should ideally address multiple disease domains,&#8221; said Professor Laura Coates, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford, United Kingdom. &#8220;These compelling data show sustained improvements over three years across key PsA disease domains. This demonstrates that bimekizumab has potential to benefit a broad range of patients, and may improve long-term inflammation control and prevent structural damage.&#8221;<\/p>\n<p>In patients with PsA, one-year improvements were sustained to three years across the following GRAPPA domains:* peripheral arthritis, dactylitis, enthesitis, skin psoriasis and nail psoriasis.<sup>2<\/sup> Individual domain responses were consistent between bDMARD\u2011na\u00efve\u00a0and\u00a0TNFi-IR\u00a0patients.<sup>2<\/sup>\u00a0Further, exposure-adjusted incidence rates per 100 patient years for uveitis and definite or probable adjudicated inflammatory bowel disease (IBD) to Week 156 were 0.2 (95% confidence interval 0.1, 0.6) and 0.3 (0.1, 0.7) in\u00a0BE OPTIMAL and 0 and 0.1 (0.0, 0.6) in BE COMPLETE, respectively.<sup>2<\/sup> (See Appendix for further details).<\/p>\n<p><b>Sustained\u00a0clinical response\u00a0to\u00a0stringent endpoints\u00a0in\u00a0half\u00a0of\u00a0patients with\u00a0nr-axSpA and AS<\/b><\/p>\n<p>&#8220;In\u00a0clinical\u00a0practice, ASDAS\u00a0LDA\u00a0is\u00a0an\u00a0important\u00a0treatment\u00a0target\u00a0for\u00a0disease\u00a0control for\u00a0people\u00a0living with axSpA, as it is a highly stringent measure of low disease activity,&#8221; said Professor Fabian Proft, Universit\u00e4tsmedizin Berlin, Germany. &#8220;It is therefore meaningful that in this study of bimekizumab, half\u00a0of\u00a0the\u00a0patients\u00a0never lost\u00a0their\u00a0ASDAS\u00a0LDA\u00a0response at\u00a0any\u00a0assessed\u00a0visit over\u00a0three years,\u00a0while\u00a0over\u00a0three\u00a0quarters of\u00a0patients maintained\u00a0this\u00a0response\u00a0over\u00a0three\u00a0years. This suggests long-term disease control, which is paramount in treating both nr-axSpA and AS.&#8221;<\/p>\n<p>A high proportion of BIMZELX-randomized patients who achieved clinical responses at Week\u00a016\u00a0maintained\u00a0these\u00a0to\u00a0Week\u00a0164\u00a0across the\u00a0full\u00a0disease spectrum\u00a0of\u00a0axSpA, including nr-axSpA and AS.<sup>4<\/sup>\u00a0From\u00a0Week\u00a016 through to Week 164, 50% of patients never lost their ASDAS LDA (&lt;2.1) status at any assessed visit (MI), with a further 22.4% only losing their ASDAS LDA status at one visit, and 6.1% at two visits, respectively (MI).<sup>4<\/sup>\u00a0Of the 152 patients (43.6%; NRI) who achieved ASDAS LDA at Week 16, 78.8% still achieved ASDAS LDA at Week 164 (MI).*<sup>4<\/sup><\/p>\n<p><i>*Proportion of patients who achieved ASDAS LDA at Week 16 and Week 164 in patients randomized to BIMZELX 160 mg every four weeks (Q4W) at baseline.<\/i> <sup> <i>4<\/i> <\/sup><\/p>\n<p><b>Real-world\u00a0findings demonstrate\u00a0rapid\u00a0HRQoL\u00a0improvements\u00a0in\u00a0patients\u00a0with\u00a0PsA, nr-axSpA, and AS<sup>5,6<\/sup><\/b><\/p>\n<p>Interim, post-hoc data analysis\u00a0(observed\u00a0case,\u00a0OC)\u00a0of\u00a0patient-reported\u00a0outcomes from\u00a0the\u00a0SPEAK\u00a0study\u00a0in\u00a0routine clinical practice showed that:<sup>5,6<\/sup><\/p>\n<p>For <b>BIMZELX-treated patients with PsA<\/b>, improvements in PsAID-12 total score were\u00a0observed to\u00a024\u00a0weeks, with mean\u00a0(SD) change from baseline (CfB)\u00a0at Week 24\u00a0of \u22121.9 (2.0).<sup>5<\/sup> SF-36 PCS scores improved to Week 24 (mean [SD] CfB: +4.6 [7.9]), as did PGADA scores\u00a0(mean\u00a0[SD]\u00a0CfB:\u00a0\u221217.5\u00a0[23.8]).<sup>5<\/sup>\u00a0At\u00a0Week\u00a02,\u00a0mean\u00a0(SD)\u00a0CfB\u00a0in PsAID-12 total score and PGADA score were -0.8 (1.6) and -7.1 (19.3), respectively.<sup>5<\/sup><\/p>\n<p>For\u00a0<b>BIMZELX<\/b><b>-treated\u00a0patients with nr-axSpA and AS<\/b>,\u00a0improvements\u00a0in\u00a0ASAS\u00a0HI\u00a0score\u00a0were observed to 24 weeks, with mean (SD) CfB at Week 24 of \u20131.6 (3.0).<sup>6<\/sup>\u00a0SF-36 PCS scores improved to Week 24 (mean [SD] CfB: +5.7 [7.3]), as did PGADA scores (mean [SD] CfB:\u00a0\u20131.0 [2.5].<sup>6<\/sup> At Week 2, mean (SD) change from baseline (CfB)\u00a0in\u00a0ASAS\u00a0HI\u00a0score\u00a0and\u00a0PGADA score were \u20130.7 (2.3) and \u20130.8 (2.1), respectively.<sup>6<\/sup><\/p>\n<p>&#8220;This data presented at ACR shows that bimekizumab continues to demonstrate long-term improvement in inflammation control and deep efficacy in patients living with PsA and axSpA, and emphasizes\u00a0that\u00a0this\u00a0effect\u00a0is\u00a0consistent\u00a0across a spectrum\u00a0of\u00a0patients with\u00a0these\u00a0diseases,&#8221; said Donatello Crocetta, Chief Medical Officer, UCB.<\/p>\n<p>UCB\u00a0will\u00a0present 16\u00a0abstracts on BIMZELX\u00a0at ACR\u00a02025\u00a0in Chicago, October 24-29, across\u00a0nr-axSpA, AS, PsA,\u00a0and\u00a0psoriasis.\u00a0These\u00a0will\u00a0complement\u00a0seven\u00a0other\u00a0presentations\u00a0from\u00a0UCB\u00a0across their rheumatology portfolio. This data underscores UCB&#8217;s ambition to be a leader in rheumatology, commitment to advancing clinical research and innovation, and focus on developing meaningful solutions across the spectrum of rheumatic diseases.<\/p>\n<p>*Core\u00a0domains\u00a0of\u00a0PsA\u00a0according to\u00a0GRAPPA\u00a0(Group for\u00a0Research\u00a0and\u00a0Assessment\u00a0of\u00a0Psoriasis\u00a0and Psoriatic Arthritis) recommendations.<sup>7<\/sup><\/p>\n<p><b>Study\u00a0methodology<\/b><\/p>\n<p><u>PsA abstract<\/u>:<sup>2<\/sup>\u00a0Included patients who were randomized to subcutaneous BIMZELX\u00a0160 mg or placebo every 4 weeks (Q4W) in BE OPTIMAL (biologic DMARD [bDMARD]\u2011na\u00efve patients with PsA), BE COMPLETE (patients with PsA with inadequate response or intolerance to TNF inhibitors [TNFi\u2011IR]),\u00a0BE\u00a0MOBILE 1\u00a0(nr-axSpA)\u00a0and BE MOBILE 2\u00a0(AS, i.e., radiographic axSpA).<sup>2<\/sup> From Week 16, all placebo-randomized patients received BIMZELX\u00a0160 mg Q4W.<sup>2<\/sup>\u00a0Week 52\/16\u00a0BE\u00a0OPTIMAL\/BE\u00a0COMPLETE\u00a0completers\u00a0were\u00a0eligible\u00a0for\u00a0BE\u00a0VITAL\u00a0open-label\u00a0extension;\u00a0BE MOBILE 1 and 2 Week 52 completers could enter BE MOVING OLE.<sup>2<\/sup><\/p>\n<p><u>AxSpA abstract<\/u>:<sup>4<\/sup> BE MOBILE 1 (nr-axSpA) and 2 (AS) from Week 16, all patients received subcutaneous BIMZELX 160 mg Q4W. At Week 52, eligible patients could enroll in the OLE (BE MOVING).<sup>4<\/sup><\/p>\n<p><u>Real-world study<\/u>:<sup>5,6<\/sup>\u00a0SPEAK is an ongoing 52-week, multi-country, observational study in Belgium, Czechia,\u00a0France,\u00a0Germany,\u00a0Greece, Spain\u00a0and\u00a0the\u00a0United\u00a0Kingdom.<sup>5,6<\/sup>\u00a0This\u00a0planned interim\u00a0analysis reports data to April 2, 2025 (approx. 50% enrollment).<sup>5,6<\/sup>\u00a0Adult patients with active PsA, nr-axSpA, or AS who initiated\u00a0BIMZELX\u00a0in\u00a0routine\u00a0clinical practice\u00a0could be\u00a0included if\u00a0receiving treatment per label (BIMZELX 160 mg Q4W).<sup>5,6<\/sup><\/p>\n<p><b>Notes\u00a0to Editors<\/b><\/p>\n<ul type=\"disc\">\n<li>ASAS40 responder rate: Assessment in SpondyloArthritis international Society \u226540% improvement<sup>4<\/sup><\/li>\n<li>ASAS HI: Assessment of SpondyloArthritis international Society Health Index<sup>6<\/sup><\/li>\n<li>ASDAS LDA: axSpA Disease Activity Score (ASDAS) low disease activity (LDA; &lt;2.1)<sup>4,8<\/sup><\/li>\n<li>Dactylitis: Inflammation of a finger or toe<sup>9<\/sup><\/li>\n<li>Enthesitis: Inflammation where the tendons and ligaments insert into bones<sup>10<\/sup><\/li>\n<li>GRAPPA domains: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-based treatment recommendations focus on six core domains and the PsA-related conditions, uveitis and IBD. The six core domains are: peripheral arthritis, axial disease, enthesitis, dactylitis, skin psoriasis and nail psoriasis<sup>2,7<\/sup><\/li>\n<li>IBD: Inflammatory Bowel Disease<\/li>\n<li>LDI: Leeds Dactylitis Index<\/li>\n<li>LEI: Leeds Enthesitis Index<\/li>\n<li>MI: Multiple imputation<sup>2<\/sup><\/li>\n<li>mNAPSI: Modified nail psoriasis severity index<sup>2<\/sup><\/li>\n<li>mNRI: Modified NRI<sup>2<\/sup><\/li>\n<li>NRI: Non-responder imputation<sup>2<\/sup><\/li>\n<li>PASI 100: 100% improvement from baseline in Psoriasis Area and Severity Index<sup>2<\/sup><\/li>\n<li>PGADA: Patient Global Assessment of Disease Activity<sup>5,6<\/sup><\/li>\n<li>PsAID-12: 12-item PsA Impact of Disease questionnaire<sup>5<\/sup><\/li>\n<li>SF-36 PCS: Short Form 36-item Health Survey Physical Component Summary<sup>5,6<\/sup><\/li>\n<li>SJC: Swollen joint count<sup>2<\/sup><\/li>\n<li>TNFi-IR: Inadequate response or intolerance to tumor necrosis factor inhibitors<sup>2<\/sup><\/li>\n<li>Uveitis: Inflammation of the middle layer of the eyeball called the uvea<sup>11<\/sup><\/li>\n<\/ul>\n<p><b>Appendix<\/b><\/p>\n<p>Further\u00a0detail\u00a0from\u00a03-year\u00a0PsA\u00a0data\u00a0across GRAPPA\u00a0domains<sup>2<\/sup><\/p>\n<p>For\u00a0the\u00a0majority of\u00a0GRAPPA domains, 1-year improvements were sustained to 3 years across all studies.<sup>2<\/sup>\u00a0These include stringent measures of disease within the disease domains, for example, complete resolution of the following:<sup>2<\/sup><\/p>\n<div>\n<div class=\"divOverflow\">\n<div class=\"table-responsive\">\n<table class=\"prnbcc\" border=\"0\" width=\"\" cellspacing=\"0\" cellpadding=\"1\">\n<tbody>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\"> <b>Complete resolution criteria\u00a0within domains<span class=\"prnews_span\"><sup>2<\/sup><\/span><\/b> <\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">Data extracted from abstract table for nail psoriasis, peripheral\u00a0arthritis,\u00a0enthesitis, dactylitis, skin psoriasis<\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"2\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"> <b>BE\u00a0OPTIMAL <\/b>(bDMARD\u2011na\u00efve)<\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">BIMZELX (BKZ)\u00a0Total\u00a0(n=712)<\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"2\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\"> <b>BE\u00a0COMPLETE\u00a0<\/b>(TNFi-IR)<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">BKZ\u00a0Total (n=400)<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"2\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen5\" colspan=\"4\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\"> <i>BKZ<\/i>\u00a0<i>160<\/i>\u00a0<i>mg<\/i>\u00a0<i>Q4W<\/i>\u00a0<i>Total<\/i>\u00a0<i>includes<\/i>\u00a0<i>patients<\/i>\u00a0<i>who<\/i>\u00a0<i>switched<\/i>\u00a0<i>from<\/i>\u00a0<i>placebo<\/i>\u00a0<i>to <\/i><i>BKZ at Week 16<\/i><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"> <b>Year\u00a01<\/b> <\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"> <b>Year\u00a03<\/b> <\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\"> <b>Year\u00a01<\/b> <\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\"> <b>Year\u00a03<\/b> <\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\"> <b>Peripheral<\/b>\u00a0<b>arthritis<span class=\"prnews_span\"><sup>2<\/sup><\/span><\/b><\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">Swollen\u00a0joint\u00a0count (SJC)=0 (mNRI)<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">61.8<\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">(58.2\u221265.5)<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">59.5<\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">(55.7\u201363.3)<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">58.2<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">(53.2\u221263.1)<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">59.1<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">(54.0\u221264.2)<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen8\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">%\u00a0(95%\u00a0CI)<\/span><\/p>\n<\/td>\n<td class=\"prngen9\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen9\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen9\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen9\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n<div>\n<div class=\"divOverflow\">\n<div class=\"table-responsive\">\n<table class=\"prnbcc\" border=\"0\" width=\"\" cellspacing=\"0\" cellpadding=\"1\">\n<tbody>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\"> <b>Enthesitis<\/b> <sup>2<\/sup> <\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">Complete resolution of enthesitis,\u00a0LEI=0 (mNRI)\u00a0in patients with enthesitis at baseline (LEI &gt;0; BE OPTIMAL: n=213;<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">BE\u00a0COMPLETE:\u00a0n=142)<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">%\u00a0(95%\u00a0CI)<\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">63.1<\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">(56.5\u221269.7)<\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">59.6<\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">(52.7\u221266.5)<\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">58.9<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">(50.6\u221267.2)<\/span><\/p>\n<\/td>\n<td class=\"prngen3\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">59.9<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">(51.4\u221268.4)<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\"> <b>Dactylitis<span class=\"prnews_span\"><sup>2<\/sup><\/span><\/b> <\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">Complete resolution of dactylitis,\u00a0LDI=0 (NRI),\u00a0in patients with dactylitis at baseline (LDI &gt;0; BE OPTIMAL: n=89;<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">BE COMPLETE:\u00a0n=48);\u00a0missing data imputed using NRI as MI was not estimable as it would<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">not\u00a0converge<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">83.1<\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">(75.4\u221290.9)<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">66.3<\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">(56.5\u221276.1)<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">85.4<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">(75.4\u221295.4)<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">70.8<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">(58.0\u221283.7)<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen8\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">%\u00a0(95%\u00a0CI)<\/span><\/p>\n<\/td>\n<td class=\"prngen9\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen9\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen9\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen9\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<\/tr>\n<tr>\n<td class=\"prngen8\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\"> <b>Skin\u00a0psoriasis<span class=\"prnews_span\"><sup>2<\/sup><\/span><\/b> <\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">Complete\u00a0skin\u00a0clearance\u00a0(PASI 100) (mNRI), in patients with<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">\u22653% body surface area affected by psoriasis at baseline\u00a0(BE\u00a0OPTIMAL:\u00a0n=357; BE COMPLETE: n=264)<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">64.7<\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">(59.6\u221269.8)<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">61.9<\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">(56.6\u221267.3)<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">66.2<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">(60.3\u221272.1)<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">67.5<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">61.6\u221273.4)<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n<div>\n<div class=\"divOverflow\">\n<div class=\"table-responsive\">\n<table class=\"prnbcc\" border=\"0\" width=\"\" cellspacing=\"0\" cellpadding=\"1\">\n<tbody>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">%\u00a0(95%\u00a0CI)<\/span><\/p>\n<\/td>\n<td class=\"prngen10\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen10\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen10\" colspan=\"2\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen10\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<\/tr>\n<tr>\n<td class=\"prngen6\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\"> <b>Nail\u00a0psoriasis<span class=\"prnews_span\"><sup>2<\/sup><\/span><\/b> <\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">Complete resolution of nail psoriasis, mNAPSI=0 (mNRI), in patients with nail psoriasis\u00a0at\u00a0baseline\u00a0(mNAPSI<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">&gt;0;\u00a0BE\u00a0OPTIMAL:\u00a0n=400;<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">BE\u00a0COMPLETE:\u00a0n=242)<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">68.7<\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">(64.1\u221273.3)<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">65.6<\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">(60.5\u221270.6)<\/span><\/p>\n<\/td>\n<td class=\"prngen7\" colspan=\"2\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">67.0<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">(61.0\u221273.0)<\/span><\/p>\n<\/td>\n<td class=\"prnpr2 prnpl2 prnvat prntac prnsbtb1 prnbrbrs prnsbbb1 prnsblb1\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">67.1<\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">60.9\u221273.4)<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen8\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">%\u00a0(95%\u00a0CI)<\/span><\/p>\n<\/td>\n<td class=\"prngen9\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen9\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen9\" colspan=\"2\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen9\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen9\" colspan=\"5\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<\/tr>\n<tr>\n<td class=\"prngen8\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\"> <b>Axial\u00a0disease<span class=\"prnews_span\"><sup>2<\/sup><\/span><\/b> <\/span><\/p>\n<\/td>\n<td class=\"prngen12\" colspan=\"5\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"> <b>Pooled BE MOBILE 1 and 2\u00a0<br class=\"dnr\" \/>nr-axSpA and AS<\/b> <\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">Data were pooled for all randomized patients with nr-axSpA\u00a0and\u00a0AS\u00a0in BE MOBILE 1 and 2<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen12\" colspan=\"5\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"> <b>Any\u00a0BKZ\u00a0160 mg\u00a0Q4W<\/b> <\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">Includes\u00a0patients\u00a0who\u00a0switched\u00a0from placebo\u00a0to\u00a0BKZ\u00a0at\u00a0Week 16<\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"> <b>n=586<\/b> <\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen5\" colspan=\"2\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"> <b>Year\u00a01<\/b> <\/span><\/p>\n<\/td>\n<td class=\"prngen12\" colspan=\"3\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\"> <b>Year\u00a03<\/b> <\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen8\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">ASAS40\u00a0responder\u00a0rate (MI),<\/span><\/p>\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">%\u00a0(95%\u00a0CI)<\/span><\/p>\n<\/td>\n<td class=\"prngen5\" colspan=\"2\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml60 dnr\"><span class=\"prnews_span\">62.4\u00a0(58.4,\u00a066.4)<\/span><\/p>\n<\/td>\n<td class=\"prnpr2 prnpl2 prnvab prnsbtb1 prnrbrb1 prnbbbs prnsblb1\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml8 dnr\"><span class=\"prnews_span\">60.2<\/span><\/p>\n<\/td>\n<td class=\"prnpr2 prnpl2 prnvat prntal prnsbtb1 prnrbrb1 prnbbbs prnsblb1\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\">(56.0,\u00a064.5)<\/span><\/p>\n<\/td>\n<td class=\"prngen9\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<\/tr>\n<tr>\n<td class=\"prngen15\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen15\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen15\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prnpr2 prnpl2 prnvab prnsbtb1 prnrbrb1 prnsbbb1 prnsblb1\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen15\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen15\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n<p>Table\u00a0adapted from\u00a0data\u00a0extracted\u00a0from\u00a0abstract\u00a0table for\u00a0nail\u00a0psoriasis,\u00a0peripheral\u00a0arthritis,\u00a0enthesitis, dactylitis, skin psoriasis, axial disease.<\/p>\n<p><b>About\u00a0Psoriatic Arthritis<\/b><\/p>\n<p>Psoriatic arthritis is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin with a prevalence of 0.02 percent to 0.25 percent of the population.<sup>12<\/sup>\u00a0Psoriatic arthritis affects approximately 30 percent of people living with psoriasis.<sup>13<\/sup>\u00a0It manifests as joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis) and inflammation\u00a0of\u00a0the\u00a0sites\u00a0where\u00a0tendons\u00a0or\u00a0ligaments\u00a0insert into\u00a0the\u00a0bone\u00a0(enthesitis).<sup>14<\/sup>\u00a0The\u00a0burden on those living with PsA extends beyond physical discomfort to reduced quality of life, with\u00a0comorbidities\u00a0including\u00a0hypertension,\u00a0cardiovascular\u00a0disease,\u00a0anxiety, and\u00a0depression.<sup>15<\/sup>\u00a0In\u00a0PsA, uncontrolled active disease can lead to long-term, irreversible structural damage.<sup>16<\/sup><\/p>\n<p><b>About\u00a0BE\u00a0OPTIMAL and\u00a0BE\u00a0COMPLETE<\/b><\/p>\n<p>BE OPTIMAL and BE COMPLETE were two Phase 3 studies evaluating the efficacy and safety of BIMZELX in the treatment of psoriatic arthritis.<sup>17,18 <\/sup>The primary endpoint in both studies was the proportion of patients reaching 50% or greater improvement in American College of Rheumatology criteria (ACR50) at Week 16.<sup>17,18 <\/sup>BE OPTIMAL (bDMARD-na\u00efve) and BE COMPLETE (TNFi-IR) assessed subcutaneous BIMZELX 160 mg every four weeks (Q4W) in patients with\u00a0PsA;\u00a0both\u00a0studies\u00a0were\u00a0placebo-controlled\u00a0to\u00a0Week\u00a016,\u00a0after\u00a0which\u00a0placebo\u00a0patients switched\u00a0to BIMZELX.<sup>17,18<\/sup><\/p>\n<p>BE\u00a0OPTIMAL\u00a0Week\u00a052\u00a0and\u00a0BE\u00a0COMPLETE Week\u00a016\u00a0completers\u00a0were\u00a0eligible\u00a0for\u00a0BE\u00a0VITAL\u00a0open-label extension.<sup>17,18<\/sup><\/p>\n<p><b>About\u00a0Axial Spondyloarthritis<\/b><\/p>\n<p>Axial spondyloarthritis (axSpA), which includes both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), is a chronic, immune-mediated, inflammatory disease.<sup>19<\/sup> nr-axSpA is defined clinically by the absence of definitive x-ray evidence of structural damage to the sacroiliac joints.<sup>19<\/sup>\u00a0axSpA\u00a0is\u00a0a\u00a0painful condition\u00a0that\u00a0primarily\u00a0affects\u00a0the\u00a0spine and\u00a0the\u00a0joints\u00a0linking\u00a0the\u00a0pelvis and lower spine (sacroiliac joints).<sup>19<\/sup>\u00a0The leading symptom of axSpA in a majority of patients is inflammatory back pain that improves with exercise, but not with rest.<sup>19<\/sup>\u00a0Other common clinical features frequently include anterior uveitis, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel disease, and dactylitis.<sup>19<\/sup>\u00a0The overall prevalence of axSpA is 0.3 percent to 1.4 percent of adults.<sup>20,21<\/sup> Approximately half of all patients with axSpA are patients with nr-axSpA.<sup>19<\/sup>\u00a0axSpA onset usually occurs before the age of 45.<sup>19\u00a0<\/sup>Approximately 10 to 40 percent of patients with nr-axSpA progress to ankylosing spondylitis over 2 to 10 years.<sup>19<\/sup><\/p>\n<p><b>About\u00a0BE\u00a0MOBILE\u00a01\u00a0and\u00a0BE\u00a0MOBILE\u00a02<\/b><\/p>\n<p>BE MOBILE 1 and BE MOBILE 2 were two Phase 3 studies evaluating the efficacy and safety of BIMZELX in\u00a0the\u00a0treatment of\u00a0nr-axSpA and AS,\u00a0respectively.<sup>22<\/sup>\u00a0The\u00a0primary\u00a0endpoint\u00a0in both studies was the Assessment of SpondyloArthritis international Society 40 percent (ASAS40) response at Week 16.<sup>22<\/sup> BE MOBILE 1 and BE MOBILE 2 comprised a 16-week double-blind treatment period followed by a 36-week maintenance period.<sup>22<\/sup> In BE MOBILE 1 and BE MOBILE 2, patients were randomized to BIMZELX (160 mg Q4W; N=128 for BE MOBILE 1 and N=221 for BE MOBILE 2) or to placebo (N=126 for BE MOBILE 1 and N=111 for BE MOBILE 2). Patients initially randomized to placebo were switched to\u00a0BIMZELX (160 mg Q4W) at Week 16.<sup>22\u00a0<\/sup>BE MOBILE 1 and BE MOBILE 2 Week 52 completers were eligible for BE MOVING open-label extension.<sup>22<\/sup><\/p>\n<p><b>About\u00a0BIMZELX<sup>\u00ae<\/sup> (bimekizumab-bkzx)<br class=\"dnr\" \/><\/b>BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.<sup>1<\/sup> IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.<sup>1,23-25<\/sup> IL-17F is over-expressed in skin and highly elevated in the serum of patients with psoriasis (PSO), psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), ankylosing spondylitis (AS), and hidradenitis suppurativa (HS).<sup>1,23-26<\/sup><\/p>\n<p>The\u00a0approved\u00a0indications\u00a0for\u00a0BIMZELX\u00a0in\u00a0the\u00a0U.S.\u00a0are:<sup>1<\/sup><\/p>\n<ul type=\"disc\">\n<li><b>Plaque psoriasis: <\/b>BIMZELX is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy<\/li>\n<li><b>Psoriatic arthritis: <\/b>BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis<\/li>\n<li><b>Non-radiographic axial spondyloarthritis: <\/b>BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation<\/li>\n<li><b>Ankylosing spondylitis: <\/b>BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis<\/li>\n<li><b>Hidradenitis suppurativa: <\/b>BIMZELX is indicated for the treatment of adults with moderate- to-severe hidradenitis suppurativa<\/li>\n<\/ul>\n<p><b>BIMZELX\u00a0U.S.\u00a0IMPORTANT\u00a0SAFETY INFORMATION <\/b><\/p>\n<p><b>IMPORTANT SAFETY INFORMATION<\/b><\/p>\n<p><b>Suicidal Ideation and Behavior<br class=\"dnr\" \/><\/b>BIMZELX\u00a0(bimekizumab-bkzx)\u00a0may\u00a0increase\u00a0the\u00a0risk\u00a0of\u00a0suicidal\u00a0ideation and\u00a0behavior\u00a0(SI\/B). A\u00a0causal association between treatment with BIMZELX and increased risk of SI\/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI\/B. Advise monitoring for the emergence or worsening of depression,\u00a0suicidal\u00a0ideation, or\u00a0other\u00a0mood\u00a0changes.\u00a0If\u00a0such\u00a0changes occur,\u00a0instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re- evaluate the risks and benefits of continuing treatment.<\/p>\n<p><b>Infections<br class=\"dnr\" \/><\/b>BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is\u00a0adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or\u00a0symptoms\u00a0suggestive\u00a0of\u00a0clinically\u00a0important infection\u00a0occur.\u00a0If\u00a0a\u00a0patient develops\u00a0such\u00a0an\u00a0infection or is not\u00a0responding to standard therapy,\u00a0monitor\u00a0the patient closely\u00a0and\u00a0do not administer BIMZELX until the infection resolves.<\/p>\n<p><b>Tuberculosis<br class=\"dnr\" \/><\/b>Evaluate\u00a0patients for\u00a0tuberculosis\u00a0(TB)\u00a0infection\u00a0prior\u00a0to\u00a0initiating\u00a0treatment\u00a0with\u00a0BIMZELX. Avoid\u00a0the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely\u00a0monitor patients\u00a0for\u00a0signs\u00a0and\u00a0symptoms of\u00a0active\u00a0TB\u00a0during\u00a0and\u00a0after\u00a0treatment.<\/p>\n<p><b>Liver Biochemical Abnormalities<br class=\"dnr\" \/><\/b>Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine\u00a0patient management. If\u00a0treatment-related increases in liver enzymes occur and drug-induced liver injury\u00a0is\u00a0suspected, interrupt\u00a0BIMZELX\u00a0until a\u00a0diagnosis\u00a0of\u00a0liver\u00a0injury is\u00a0excluded. Permanently\u00a0discontinue\u00a0use\u00a0of\u00a0BIMZELX in\u00a0patients\u00a0with\u00a0causally\u00a0associated\u00a0combined\u00a0elevations\u00a0of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis.<\/p>\n<p><b>Inflammatory Bowel Disease<br class=\"dnr\" \/><\/b>Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD\u00a0and\u00a0discontinue\u00a0treatment\u00a0if\u00a0new\u00a0onset or worsening of signs and symptoms occurs.<\/p>\n<p><b>Immunizations<br class=\"dnr\" \/><\/b>Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.<\/p>\n<p><b>Most Common Adverse Reactions<br class=\"dnr\" \/><\/b>Most common (\u2265 1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis,\u00a0headache,\u00a0injection\u00a0site\u00a0reactions,\u00a0tinea\u00a0infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other <i>candida <\/i>infections, and fatigue.<\/p>\n<p>Most\u00a0common (\u2265\u00a02%)\u00a0adverse reactions\u00a0in\u00a0psoriatic arthritis\u00a0include\u00a0upper respiratory\u00a0tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections.<\/p>\n<p>Most\u00a0common (\u2265\u00a02%)\u00a0adverse reactions\u00a0in\u00a0non-radiographic\u00a0axial\u00a0spondyloarthritis\u00a0include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain,\u00a0myalgia,\u00a0tonsillitis,\u00a0transaminase\u00a0increase,\u00a0and\u00a0urinary tract\u00a0infections.<\/p>\n<p>Most common (\u2265 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections,\u00a0oral\u00a0candidiasis,\u00a0headache,\u00a0diarrhea,\u00a0injection site\u00a0pain,\u00a0rash,\u00a0and\u00a0vulvovaginal\u00a0mycotic infection.<\/p>\n<p>Please\u00a0see\u00a0Important\u00a0Safety\u00a0Information\u00a0below and\u00a0full\u00a0U.S.\u00a0Prescribing\u00a0Information\u00a0at <u><a href=\"https:\/\/edge.prnewswire.com\/c\/link\/?t=0&amp;l=en&amp;o=4540891-1&amp;h=1372028608&amp;u=http%3A%2F%2Fwww.ucb-usa.com%2FInnovation%2FProducts%2FBIMZELX&amp;a=www.UCB-\" target=\"_blank\" rel=\"nofollow noopener\">www.UCB-<\/a><\/u>\u00a0<u><a href=\"https:\/\/edge.prnewswire.com\/c\/link\/?t=0&amp;l=en&amp;o=4540891-1&amp;h=2761777119&amp;u=http%3A%2F%2Fwww.ucb-usa.com%2FInnovation%2FProducts%2FBIMZELX&amp;a=USA.com%2FInnovation%2FProducts%2FBIMZELX\" target=\"_blank\" rel=\"nofollow noopener\">USA.com\/Innovation\/Products\/BIMZELX<\/a><\/u>.<\/p>\n<p><b>For further information, contact\u00a0UCB: <\/b><\/p>\n<p><b>Investor Relations<br class=\"dnr\" \/><\/b>Antje Witte<br class=\"dnr\" \/>T +32.2.559.94.14<br class=\"dnr\" \/>email <u><a href=\"http:\/\/www.prnewswire.com\/cdn-cgi\/l\/email-protection#1b7a756f717e356c726f6f7e5b6e787935787476\" target=\"_blank\" rel=\"nofollow noopener\"><span class=\"__cf_email__\" data-cfemail=\"85e4ebf1efe0abf2ecf1f1e0c5f0e6e7abe6eae8\">[email\u00a0protected]<\/span><\/a><\/u><\/p>\n<p><b>Brand Communications<br class=\"dnr\" \/><\/b>Nicole Herga\u00a0<br class=\"dnr\" \/>T +1.773.960.5349\u00a0<br class=\"dnr\" \/>email: <a href=\"http:\/\/www.prnewswire.com\/cdn-cgi\/l\/email-protection#f896919b97949dd6909d8a9f99b88d9b9ad69b9795\" target=\"_blank\" rel=\"nofollow noopener\"><span class=\"__cf_email__\" data-cfemail=\"5b35323834373e75333e293c3a1b2e383975383436\">[email\u00a0protected]<\/span><\/a><\/p>\n<p><b>About\u00a0UCB<br class=\"dnr\" \/><\/b>UCB,\u00a0Brussels,\u00a0Belgium\u00a0(<a href=\"https:\/\/edge.prnewswire.com\/c\/link\/?t=0&amp;l=en&amp;o=4540891-1&amp;h=4147203310&amp;u=http%3A%2F%2Fwww.ucb.com%2F&amp;a=www.ucb.com)\" target=\"_blank\" rel=\"nofollow noopener\">www.ucb.com)<\/a> is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of \u20ac6.1 billion in 2024. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter:@UCBUSA.<\/p>\n<p><b>Forward looking statements<br class=\"dnr\" \/><\/b>This document contains forward-looking statements, including, without limitation, statements containing the words &#8220;potential&#8221;, &#8220;believes&#8221;, &#8220;anticipates&#8221;, &#8220;expects&#8221;, &#8220;intends&#8221;, &#8220;plans&#8221;, &#8220;seeks&#8221;, &#8220;estimates&#8221;, &#8220;may&#8221;, &#8220;will&#8221;, &#8220;continue&#8221; and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guaranteeing future performance and are subject to known and unknown\u00a0risks,\u00a0uncertainties,\u00a0and assumptions\u00a0which\u00a0might cause\u00a0the\u00a0actual results,\u00a0financial\u00a0condition,\u00a0performance\u00a0or\u00a0achievements\u00a0of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document.<\/p>\n<p>Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of UCB&#8217;s information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars\u00a0or\u00a0disruptive\u00a0technologies\/business\u00a0models,\u00a0changes in\u00a0laws\u00a0or\u00a0regulations,\u00a0exchange rate\u00a0fluctuations,\u00a0changes or\u00a0uncertainties in laws and\/or rules pertaining to tax and duties or the administration of such laws and\/or rules, and hiring, retention and compliance of employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are\u00a0the\u00a0subject of\u00a0partnerships,\u00a0joint ventures or licensing collaborations may\u00a0be\u00a0subject\u00a0to\u00a0disputes between\u00a0the\u00a0partners or may\u00a0prove\u00a0to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB&#8217;s efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and\/or devices after they are marketed. The discovery of significant problems with a product similar to\u00a0one of UCB&#8217;s products that\u00a0implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may\u00a0be\u00a0impacted by\u00a0international and domestic trends toward managed care\u00a0and health\u00a0care cost\u00a0containment,\u00a0including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB&#8217;s data and systems.<\/p>\n<p>Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward- looking\u00a0statements\u00a0are\u00a0made\u00a0only as\u00a0of\u00a0the\u00a0date\u00a0of\u00a0this\u00a0document, and\u00a0do\u00a0not\u00a0reflect\u00a0any\u00a0potential\u00a0impacts from\u00a0the\u00a0evolving event\u00a0or\u00a0risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB.<\/p>\n<p>UCB expressly disclaims any obligation to update any forward-looking statements in\u00a0this document, either to confirm the actual results or to\u00a0report\u00a0or\u00a0reflect\u00a0any\u00a0change\u00a0in\u00a0its\u00a0forward-looking\u00a0statements\u00a0with\u00a0regard thereto\u00a0or\u00a0any\u00a0change\u00a0in\u00a0events,\u00a0conditions\u00a0or\u00a0circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.<\/p>\n<p><b>References<\/b><\/p>\n<ol type=\"1\">\n<li>BIMZELX<sup>\u00ae<\/sup>\u00a0(bimekizumab-bkzx)\u00a0U.S.\u00a0Prescribing Information.\u00a0<u><a href=\"https:\/\/edge.prnewswire.com\/c\/link\/?t=0&amp;l=en&amp;o=4540891-1&amp;h=396428983&amp;u=https%3A%2F%2Fwww.ucb-usa.com%2FInnovation%2FProducts%2FBIMZELX&amp;a=https%3A%2F%2Fwww.ucb-usa.com%2FInnovation%2FProducts%2FBIMZELX\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/www.ucb-usa.com\/Innovation\/Products\/BIMZELX<\/a><\/u>.<\/li>\n<li>Merola J. Sustained Efficacy up to 3 Years with\u00a0Bimekizumab\u00a0Treatment\u00a0Across\u00a0GRAPPA\u00a0Core\u00a0Domains\u00a0in\u00a0Patients\u00a0with Psoriatic Arthritis: Long-Term Results from Two Phase 3 Trials [abstract]. ACR 2025. #2129566.<\/li>\n<li>Rudwaleit\u00a0M. Long-Term\u00a0Uveitis\u00a0Rates\u00a0with\u00a0Bimekizumab\u00a0Treatment\u00a0Across\u00a0Pooled Phase\u00a02b\u00a0and\u00a0Phase\u00a03\u00a0Studies\u00a0in Patients with Axial Spondyloarthritis or Psoriatic Arthritis: 3-Year Update [abstract]. ACR 2025. #2129301.<\/li>\n<li>Proft\u00a0F. Bimekizumab\u00a0Treatment\u00a0Resulted in\u00a0Patients\u00a0with\u00a0Axial\u00a0Spondyloarthritis\u00a0Maintaining\u00a0Their\u00a0Clinical Responses Over 3 Years: Results from Two Phase 3 Studies and Their Open-Label Extension [abstract].ACR 2025. #2129239.<\/li>\n<li>Baraliakos X. An Interim Analysis of Health-Related Quality of Life Outcomes from an International Multicentre Observational\u00a0Study\u00a0in\u00a0Patients with\u00a0Psoriatic\u00a0Arthritis\u00a0Initiating\u00a0Bimekizumab\u00a0in\u00a0Real-World\u00a0Clinical Practice\u00a0[abstract].\u00a0ACR 2025. #2127676.<\/li>\n<li>Baraliakos X. An Interim\u00a0Analysis of Health-Related\u00a0Quality of Life Outcomes from an International\u00a0Multicentre Observational\u00a0Study\u00a0in\u00a0Patients\u00a0with\u00a0Axial\u00a0Spondyloarthritis\u00a0Initiating\u00a0Bimekizumab\u00a0in\u00a0Real-World\u00a0Clinical Practice. [abstract]. ACR 2025. #2127714.<\/li>\n<li>Coates\u00a0LC,\u00a0et\u00a0al.\u00a0Group\u00a0for\u00a0Research and\u00a0Assessment of\u00a0Psoriasis\u00a0and\u00a0Psoriatic\u00a0Arthritis (GRAPPA):\u00a0Updated treatment recommendations for psoriatic arthritis 2021. <i>Nat Rev Rheumatol<\/i>. 2022;18(8):465\u201379.<\/li>\n<li>Garcia-Magall\u00f3n\u00a0B\u00a0et\u00a0al.\u00a0Is\u00a0the\u00a0new\u00a0ASDAS\u00a0nomenclature\u00a0in\u00a0agreement\u00a0with\u00a0therapeutic\u00a0decision making\u00a0in\u00a0patients with axial spondyloarthritis? <i>Semin Arthritis and Rheum<\/i>. 2020;50(5):854-57.<\/li>\n<li>Hamard A, Burns R, Miquel A, et al. Dactylitis: A pictorial review of key symptoms. <i>Diagn Interv Imaging<\/i>. 2020;101(4):193-207.<\/li>\n<li>Sudo\u0142-Szopi\u0144ska I, Kwiatkowska B, Prochorec-Sobieszek M, et al. Enthesopathies and enthesitis. Part 1. Etiopathogenesis. <i>J Ultrason<\/i>. 2015;15(60):72-84.<\/li>\n<li>Maghsoudlou P, Epps SJ, Guly CM, et al. Uveitis in adults: a review. <i>JAMA<\/i>. 2025;334(5):419-434.<\/li>\n<li>Ogdie\u00a0A,\u00a0Weiss\u00a0P.\u00a0The\u00a0Epidemiology\u00a0of\u00a0Psoriatic\u00a0Arthritis.\u00a0<i>Rheum\u00a0Dis\u00a0Clin\u00a0North\u00a0Am<\/i>. 2015;41(4):545\u201368.<\/li>\n<li>Mease PJ, Gladman DD, Papp KA, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis\u00a0in European\/North American dermatology clinics. <i>J Am Acad Dermatol<\/i>. 2013;69(5):729-735.<\/li>\n<li>Mease\u00a0PJ,\u00a0Armstrong\u00a0A.\u00a0Managing\u00a0patients with\u00a0psoriatic\u00a0disease: the\u00a0diagnosis\u00a0and\u00a0pharmacologic\u00a0treatment\u00a0of psoriatic arthritis in patients with psoriasis. <i>Drugs<\/i>. 2014;74(4):423\u201341.<\/li>\n<li>Lee S, Mendelsohn A, Sarnes E. The burden of psoriatic arthritis: A literature review from a global health systems perspective. <i>P T<\/i>. 2010;35(12):680\u201389.<\/li>\n<li>Kwok T, Sutton M, Cook R, et al. Musculoskeletal Surgery in Psoriatic Arthritis: Prevalence and Risk Factors. <i>J Rheumatol. <\/i>2023;50(4):497\u2013503.<\/li>\n<li>Ritchlin C, Coates L, McInnes I, et al. Bimekizumab treatment in biologic DMARD-na\u00efve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. <i>Ann Rheum Dis<\/i>. 2023;82(11);1404\u201314.<\/li>\n<li>Coates L, Landew\u00e9 R, McInnes I, et al. Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL. <i>RMD Open<\/i>. 2024;10(1):e003855.<\/li>\n<li>Deodhar A. Understanding Axial Spondyloarthritis: A Primer for Managed Care. Am J Manag Care. 2019;25(1):S319\u201330.<\/li>\n<li>Reveille J, Witter J, Weisman M. Prevalence of axial spondyloarthritis in the United States: estimates from a cross- sectional survey. <i>Arthritis Care Res (Hoboken)<\/i>. 2012;64(6):905\u201310.<\/li>\n<li>Hamilton L, Macgregor A, Toms A, et al. The prevalence of axial spondyloarthritis in the UK: a cross-sectional cohort study. <i>BMC Musculoskelet Disord<\/i>. 2015;16:392.<\/li>\n<li>Baraliakos X, Deodhar A, van der Heijde D, et al. Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. <i>Ann Rheum Dis<\/i>. 2024;83(2):199\u2013213.<\/li>\n<li>Glatt S, Baeten D, Baker T et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. <i>Ann Rheum Dis<\/i>. 2018;77:523\u201332.<\/li>\n<li>Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate-to-severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. <i>Lancet<\/i>. 2021;397(10273):475-486.<\/li>\n<li>Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate-to-severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. <i>Lancet<\/i>. 2021;397(10273):487-498.<\/li>\n<li>Rumberger BE, Boarder EL, Owens SL, et al. Transcriptomic analysis of hidradenitis suppurativa skin suggests roles for multiple inflammatory pathways in disease pathogenesis. <i>Inflamm Res<\/i>. 2020;69(10):967-973.<\/li>\n<\/ol>\n<p>US-BK-2501221\u00a0<br class=\"dnr\" \/>Date of preparation: October 2025<br class=\"dnr\" \/>BIMZELX<sup>\u00ae<\/sup> is a registered trademark of the UCB Group of Companies.\u00a0<br class=\"dnr\" \/>\u00a92025 UCB, Inc., Smyrna, GA 30080. All rights reserved<\/p>\n<p>SOURCE UCB<\/p>\n<\/div>\n<p><b>This release is auto-published via PR Newswire; our journal is not responsible for the content.<\/b><\/p>\n<p><a href=\"https:\/\/www.prnewswire.com\/news-releases\/bimzelx-bimekizumab-bkzx-three-year-rheumatology-data-at-acr-2025-demonstrated-sustained-inflammation-control-in-psoriatic-arthritis-and-axial-spondyloarthritis-302594241.html\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sustained improvements across stringent measures of disease in patients with psoriatic arthritis (PsA): One-year improvements were sustained to<\/p>\n","protected":false},"author":1,"featured_media":2602,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[8,92],"tags":[710],"class_list":["post-2601","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business","category-pr-newswire","tag-ucb"],"_links":{"self":[{"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/posts\/2601","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/comments?post=2601"}],"version-history":[{"count":1,"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/posts\/2601\/revisions"}],"predecessor-version":[{"id":2693,"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/posts\/2601\/revisions\/2693"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/media\/2602"}],"wp:attachment":[{"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/media?parent=2601"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/categories?post=2601"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/tags?post=2601"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}