Questions about the BE COMPLETE trial Reply

Joseph F Merola and colleagues1Merola JF Landewé R McInnes IB et al.Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE).Lancet. 2023; 401: 38-48Summary Full Text Full Text PDF PubMed Scopus (18) Google Scholar investigated the safety and efficacy of bimekizumab among individuals aged 18 years or older with active psoriatic arthritis and previous intolerance or inadequate response to a tumour necrosis factor-α inhibitor. Their findings revealed that bimekizumab was more efficacious compared with placebo in improving joint and skin disease. Although the results are promising, there are a few limitations and points that remain unknown. The low number of participants from minority racial groups serves as a crucial limitation, as 96% of individuals from both placebo and treatment groups were White.1Merola JF Landewé R McInnes IB et al.Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE).Lancet. 2023; 401: 38-48Summary Full Text Full Text PDF PubMed Scopus (18) Google Scholar The racial breakdown in this study does not represent the overall prevalence of psoriasis, impairing the generalisability of the study findings.2Alexis AF Blackcloud P Psoriasis in skin of color: epidemiology, genetics, clinical presentation, and treatment nuances.J Clin Aesthet Dermatol. 2014; 7: 16-24PubMed Google Scholar Moreover, the prevalence of coexisting comorbidities and contraindications to biologicals varies on the basis of race, making it crucial to have a well represented study cohort.3Hodges WT Bhat T Raval NS et al.Biologics utilization for psoriasis is lower in black compared with white patients.Br J Dermatol. 2021; 185: 207-209Crossref PubMed Scopus (7) Google Scholar Although minimal side-effects of bimekizumab were reported, it will be important to observe adverse events, specifically oral candidiasis, over a longer monitoring period. Reich and colleagues4Reich K Warren RB Lebwohl M et al.Bimekizumab versus secukinumab in plaque psoriasis.N Engl J Med. 2021; 385: 142-152Crossref PubMed Scopus (100) Google Scholar reported substantially higher rates of oral candidiasis over a 48-week period among individuals receiving bimekizumab compared with secukinumab. In addition, Merola and colleagues1Merola JF Landewé R McInnes IB et al.Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE).Lancet. 2023; 401: 38-48Summary Full Text Full Text PDF PubMed Scopus (18) Google Scholar did not mention the potential development of immunogenicity among bimekizumab users. The development of antidrug antibodies is of concern as many patients who are given bimekizumab have previously attempted treatment with another biological, including currently approved IL-17 inhibitors. Immunogenicity might alter the long-term efficacy, pharmacodynamics, and pharmacokinetics of bimekizumab.5Valenzuela F Flores R Immunogenicity to biological drugs in psoriasis and psoriatic arthritis.Clinics. 2021; 76e3015Crossref PubMed Scopus (4) Google Scholar 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 active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE)Bimekizumab treatment led to superior improvements in joint and skin efficacy outcomes at week 16 compared with placebo in patients with psoriatic arthritis and inadequate response or intolerance to TNFα inhibitors. The safety profile of bimekizumab was consistent with previous phase 3 studies in patients with plaque psoriasis, and studies of IL-17A inhibitors. Full-Text PDF Open AccessQuestions about the BE COMPLETE trial – Authors' replyWe thank Chirag Rajkumar Kopp and Anupam Wakhlu, and Brandon Smith and colleagues for their interest in the phase 3 BE COMPLETE study,1 which showed the efficacy and tolerability of bimekizumab in people with psoriatic arthritis with previous inadequate response or intolerance to tumour necrosis factor-α inhibitors. Full-Text PDF