Deucravacitinib

Brussels-based UCB announced topline results from BE BOLD, a Phase IIIb trial comparing bimekizumab (Bimzelx) with risankizumab (SKYRIZI) in adults with active psoriatic arthritis. Bimekizumab achieved statistically significant superiority over risankizumab on the primary ACR50 endpoint at Week 16, making this the first head-to-head study in psoriatic arthritis where a licensed biologic has demonstrated superiority over another IL-23 inhibitor using this measure. The result extends bimekizumab’s run of head-to-head wins to four across psoriatic disease indications. Trial specifics BE BOLD is a multicenter, randomized, double-blind, parallel-group study that enrolled 553 adults with active psoriatic arthritis. Participants were either biologic-naïve or had prior exposure to one tumor necrosis factor inhibitor (TNFi) with an inadequate or intolerant response. They were randomized 1:1 to receive bimekizumab or risankizumab, with double-blinding maintained through Week 24. The primary endpoint, ACR50 at Week 16, requires at least a 50% improvement from baseline in tender and swollen joint counts along with 50% improvement in three of five additional criteria. UCB reported that bimekizumab met this endpoint with statistical significance, though exact response rates and p-values were not disclosed in the topline release. Treatment with bimekizumab was generally well tolerated, with no new safety signals through Week 16. UCB plans to submit full BE BOLD results at a forthcoming international congress. Emmanuel Caeymaex, Executive Vice President and Head of Patient Evidence at UCB, stated that the data “reinforce bimekizumab’s potential to deliver clinically meaningful improvements using the stringent ACR50 measure of disease activity, indicating more complete control of joint inflammation”. Bimekizumab is already approved in the EU and the US across multiple indications: plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), and hidradenitis suppurativa. No new regulatory filing timelines were disclosed in connection with the BE BOLD data. Research context Bimekizumab is a humanized IgG1 monoclonal antibody that selectively neutralizes both IL-17A and IL-17F. Both cytokines drive inflammation in psoriatic arthritis through overlapping but non-redundant pathways, promoting synovial hyperplasia and joint damage. Preclinical work has shown that dual inhibition of IL-17A and IL-17F reduces synovial tissue inflammation beyond what IL-17A blockade alone achieves. Risankizumab, by contrast, targets the p19 subunit of IL-23, acting upstream in the Th17 axis. The BE BOLD result suggests that direct cytokine neutralization at the IL-17 level may yield greater joint-level efficacy than upstream IL-23 blockade, at least on the ACR50 measure at 16 weeks. Psoriatic arthritis affects an estimated 0.02% to 0.25% of the general population, with roughly 30% of psoriasis patients progressing to joint involvement. Uncontrolled disease leads to structural joint damage, and treatment options span TNF inhibitors, IL-17 inhibitors, IL-23 inhibitors, and JAK inhibitors. Despite this, no prior head-to-head trial in psoriatic arthritis had demonstrated superiority of one biologic class over another on ACR50. Key approved competitors in the PsA treatment landscape include Novartis’s Cosentyx (secukinumab) and Eli Lilly’s Taltz (ixekizumab), both IL-17A inhibitors; Janssen’s Tremfya (guselkumab), an IL-23p19 inhibitor; and Bristol Myers Squibb’s Sotyktu (deucravacitinib), an oral TYK2 inhibitor approved in the US for active psoriatic arthritis in March 2026. MorphoSys-partnered sonelokimab, a nanobody targeting IL-17A and IL-17F, is in Phase III and represents the closest mechanistic competitor to bimekizumab. The BE BOLD data give UCB a differentiation argument against both IL-17A-only and IL-23 inhibitors in psoriatic arthritis, though longer-term comparative data beyond Week 24 and detailed secondary endpoint results remain pending. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Four years after blessing BMS's Sotyktu for plaque psoriasis, the FDA has expanded the label of the selective allosteric tyrosine kinase 2 (TYK2) inhibitor to treat psoriatic arthritis. In a dizzying span of seven months in 2022, Bristol Myers Squibb gained FDA approval for three new products, touting each with the potential to achieve $4 billion in peak sales. While multiple myeloma drug Opdualag and cardiomyopathy treatment Camzyos became blockbusters last year, psoriasis med Sotyktu wasn’t close.With a new FDA nod in hand for Sotyktu, however, BMS can reach more patients with the oral med, which was acquired in the drugmaker’s 2019 buyout of Celgene for $74 billion.The U.S. regulator has endorsed Sotyktu as a treatment for adults with active psoriatic arthritis. It becomes the first drug in its class as a selective allosteric tyrosine kinase 2 (TYK2) inhibitor to be approved in the indication. The thumbs up comes on top of Sotyktu’s original FDA approval for moderate-to-severe plaque psoriasis.“This latest approval of Sotyktu confirms its important role in managing both skin and joint symptoms of psoriatic disease and is a key milestone as we continue to explore its development in diseases that have limited or no treatment options,” Al Reba, the company’s commercial lead in cardiovascular and immunology, said in a release. The blessing is backed by data from two trials showing that 54% of patients on a daily 6 mg dose of Sotyktu achieved a 20% improvement in disease activity at Week 16, compared with 39% on placebo in one study and 34% on placebo in the other trial. When the measurement was 50% improvement in disease symptoms, 24% and 29% of those on Sotyktu made the grade, compared to 14% and 16% of those on placebo. “Psoriatic arthritis is a chronic, progressive autoimmune condition that often involves both the joints and skin. Patients often have trouble moving and staying active and can experience pain in the joints, and tendons, or ligaments,” Philip Mease, M.D., the director of rheumatology research at Providence Swedish Medical Center, added in a release. “New oral, effective first-line treatments are needed.” A new oral competition is on its way from Takeda, with its TYK2 inhibitor zasocitinib. The Japanese company paid $4 billion to Nimbus Therapeutics to acquire the compound, which has achieved success in two phase 3 trials in plaque psoriasis and is lined up for regulatory filings this year. Another competitor is on its way with Johnson & Johnson’s IL-23 inhibitor icotrokinra, which has topped Sotkytu as secondary endpoints in two psoriasis phase 3 studies. J&J’s partner, Protagonist Therapeutics, originally developed the oral peptide.  In 2019, BMS made a big bet on Sotyktu by deciding to keep the then-pipeline asset despite its pending acquisition of Celgene. Based on that decision, BMS sold its mega-blockbuster Otezla to Amgen for $13.4 billion to resolve antitrust concerns surrounding the Celgene merger. After five straight years of Otezla sales between $2.1 billion and $2.3 billion, Amgen said that they dropped to $1.8 billion in 2025. Otezla will be subject to IRA Medicare pricing at the start of next year.BMS reported sales of $291 million for Sotyktu last year compared to $246 million in 2024. Meanwhile, Opdualag generated $1.2 billion in sales and Camzyos achieved $1.1 billion in 2025. Camzyos was gained by BMS in a $13.1 buyout of MyoKardia in 2020.