Questions about the BE COMPLETE trial

Abstract

We thank Iain B McInnes and colleagues for conducting two well designed trials—BE COMPLETE1Merola 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 and BE OPTIMAL2McInnes 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—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. As with tumour necrosis factor inhibitors, the formation of antibodies and immunogenicity against them is hindered by methotrexate; therefore, it would be prudent to measure the antibodies against bimekizumab, and the effect of concomitant methotrexate dosing. The average duration or the cumulative period of TNF inhibitor exposure (in addition to the number of previous TNF inhibitors used) before making a switch to bimekizumab would be more accurate and provide useful data as done in previous studies.3Cannon GW Erickson AR Teng C-C et al.Tumour necrosis factor inhibitor exposure and radiographic outcomes in veterans with rheumatoid arthritis: a longitudinal cohort study.Rheumatol Adv Pract. 2019; 3rkz015Google Scholar Fungal infections are commonly seen in patients using anti-IL-17 agents, and a higher prevalence of comorbidities in psoriatic arthritis in the real world, especially diabetes (prevalence from 6·1% to 20·2%), would further add to the infection burden.4Davidson L van den Reek JMPA Bruno M et al.Risk of candidiasis associated with interleukin-17 inhibitors: a real-world observational study of multiple independent sources.Lancet Reg Health Eur. 2022; 13100266PubMed Google Scholar, 5Dal Bello G Gisondi P Idolazzi L Girolomoni G Psoriatic arthritis and diabetes mellitus: a narrative review.Rheumatol Ther. 2020; 7: 271-285Crossref PubMed Scopus (10) Google Scholar The exclusion of these important subsets in this study cautions the use of such treatments in these populations. We 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