Questions about the BE OPTIMAL trial

Abstract

In their study on the effects of bimekizumab in patients with psoriatic arthritis who are naive to biologicals, Iain B McInnes and colleagues showed that bimekizumab had greater improvement in American College of Rheumatology criteria (ACR50) compared with placebo and adalimumab.1McInnes IB Asahina A Coates LC et al.Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL).Lancet. 2023; 401: 25-37Summary Full Text Full Text PDF PubMed Scopus (0) Google Scholar Although the results are encouraging, clarification is needed for better generalisability. Although adalimumab is highly effective in the treatment of psoriatic arthritis, the SPIRIT-H2H trial revealed that another first-line biological, ixekizumab, was superior to adalimumab in achieving joint improvement (ACR50) in biological-naive patients with psoriatic arthritis.2Mease PJ Smolen JS Behrens F et al.A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naive patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial.Ann Rheum Dis. 2019; 79: 123-131Crossref Scopus (160) Google Scholar Therefore, comparing bimekizumab with adalimumab in the BE OPTIMAL trial might have produced more favourable and statistically significant results than if bimekizumab were compared with a more effective biological such as ixekizumab. Studies have suggested that oestrogen might downregulate Th-17 cytokines and treatment with high-dose oestrogen oral contraceptives improves psoriatic arthritis.3Danesh M Murase JE The immunologic effects of estrogen on psoriasis: a comprehensive review.Int J Womens Dermatol. 2015; 1: 104-107Crossref Google Scholar Over 50% of the participants in the BE OPTIMAL trial were female; however, it is unclear whether any of these female participants were using hormonal contraceptives, as use of oestrogen contraceptives can confound the results. Finally, this study consists of a racially homogeneous population of mostly White individuals (over 95%). Minority racial groups are often not included in clinical trials investigating psoriatic arthritis treatments.4Shwe S Nguyen C Bhutani T Racial disparities in clinical trials of biologic treatments for psoriatic arthritis.J Am Acad Dermatol. 2022; 87: 910-912Summary Full Text Full Text PDF Scopus (0) Google Scholar Although psoriatic arthritis occurs less frequently among minority racial groups, patients have lower rates of biological treatment use, while also carrying a higher disease burden.5Kerr GS Qaiyumi S Richards J et al.Psoriasis and psoriatic arthritis in African-American patients–the need to measure disease burden.Clin Rheumatol. 2015; 34: 1753-1759Crossref PubMed Scopus (0) Google Scholar By working collectively to make clinical trials more representative of the general population, researchers help to close gaps in treatment disparities, starting at the clinical trial level. JJW is or has been an investigator for AbbVie, Amgen, Eli Lilly, Incyte, Janssen, Novartis, and Pfizer; a consultant for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy's Laboratories, Eli Lilly, EPI Health, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, and Zerigo Health; and a speaker for AbbVie, Amgen, Bausch Health, EPI Health, Novartis, Regeneron, Sanofi Genzyme, Sun Pharmaceutical, and UCB. All other authors declare no competing interests. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL)Bimekizumab treatment had superior improvements in joint, skin, and radiographic efficacy outcomes at week 16 compared with placebo in patients with psoriatic arthritis who were naive to biologic DMARDs. The safety profile of bimekizumab, including the occurrence of fungal infections, was consistent with previous phase 3 studies in patients with plaque psoriasis, and with IL-17A inhibitors. Full-Text PDF Open AccessQuestions about the BE OPTIMAL trial – Authors' replyWe thank Sogol Stephanie Javadi and colleagues for their interest in the phase 3 BE OPTIMAL study, which demonstrated the efficacy and tolerability of bimekizumab in biologic-naive patients with psoriatic arthritis.1 Full-Text PDF