Questions about the BE COMPLETE trial – Authors' reply

Abstract

We thank Chirag Rajkumar Kopp and Anupam Wakhlu, and Brandon Smith and colleagues for their interest in the phase 3 BE COMPLETE study,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 (0) Google Scholar 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. The correspondents raise the issue of adverse events. In both BE COMPLETE and its sister study BE OPTIMAL,2McInnes 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 we describe increased rates of fungal infection compared with placebo, commensurate with previously reported rates in psoriatic arthritis trials of bimekizumab and indeed lower than those reported in psoriasis trials of bimekizumab.3Coates LC McInnes IB Merola JF et al.Safety and efficacy of bimekizumab in patients with active psoriatic arthritis: three-year results from a phase IIb randomized controlled trial and its open-label extension study.Arthritis Rheumatol. 2022; 74: 1959-1970Crossref Scopus (4) Google Scholar, 4Thaçi D Vender R de Rie MA et al.Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial.Br J Dermatol. 2023; 188: 22-31Crossref Scopus (1) Google Scholar We continue to monitor fungal infection rates and severity closely in ongoing extension studies. Although it will be important to assess the effect of comorbidities on fungal infections, we highlight that neither well controlled cardiometabolic syndrome nor diabetes were excluded from these trials.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 (0) Google Scholar, 2McInnes 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 Regarding immunogenicity, assays for antidrug antibodies and neutralising antibodies were conducted in both studies to consider pharmacokinetics, safety, and efficacy by subgroups, and by methotrexate use. We agree on the importance of increased diversity in psoriatic clinical trials and acknowledge that minoritised racial groups are underrepresented in these trials. Going forward, it will be important to confirm the efficacy and tolerability of bimekizumab across more diverse, representative patient populations, in clinical trials and in real-world studies. JFM is a consultant or investigator for AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, LEO Pharma, Pfizer, Novartis, Regeneron, Sanofi, Sun Pharma, and UCB Pharma. IBM has received consulting fees and honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Cabaletta, Causeway Therapeutics, Celgene, Evelo, Janssen, Eli Lilly, MoonLake, Novartis, and UCB Pharma; and research support from BMS, Boehringer Ingelheim, Celgene, Janssen, Novartis, and UCB Pharma. 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 trialJoseph F Merola and colleagues1 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. Full-Text PDF Questions about the BE COMPLETE trialWe thank Iain B McInnes and colleagues for conducting two well designed trials—BE COMPLETE1 and BE OPTIMAL2—and helping to expand the therapeutic armamentarium of psoriatic arthritis. In the BE COMPLETE trial, the stringent use and balance of concomitant conventional synthetic disease-modifying antirheumatic drugs during a trial period homogenises the baseline treatment of the study population. Providing the mean baseline dose of methotrexate and post-hoc efficacy analysis on the basis of methotrexate dose stratification would present valuable insights regarding combination therapy versus monotherapy. Full-Text PDF