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)

Merola, Joseph F.; Landewé, Robert; McInnes, Iain B.; Mease, Philip J.; Ritchlin, Christopher T.; Tanaka, Yoshiya; Asahina, Akihiko; Behrens, Frank; Gladman, Dafna D.; Gossec, Laure; Gottlieb, Alice B.; Thaçi, Diamant; Warren, Richard B.; Ink, B.; Assudani, Deepak; Bajracharya, R.; Shende, Vishvesh; Coarse, Jason; Coates, Laura C.

doi:10.1016/s0140-6736(22)02303-0

Cited by 100 publications

(70 citation statements)

References 33 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Despite limited patient numbers, efficacy assessed by ASAS40 response was similar across TNFi-naïve and TNFi-IR patients, consistent with findings of comparable efficacy from recent phase 3 studies of bimekizumab in biologic-naïve and TNFi-IR patients with psoriatic arthritis. 29 30 Biomarker analysis in psoriatic arthritis has demonstrated an IL-17F signal in biologic-IR patients, 31 providing a possible explanation for the similar efficacy in this subgroup and further highlighting the potential of dual IL-17A/IL-17F inhibition with bimekizumab.…”

Section: Discussionmentioning

confidence: 95%

See 1 more Smart Citation

Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials

et al. 2023

View full text Add to dashboard Cite

ObjectivesAxial spondyloarthritis (axSpA) is a complex disease with diverse manifestations, for which new treatment options are warranted. BE MOBILE 1 (non-radiographic (nr)-axSpA) and BE MOBILE 2 (radiographic axSpA (r-axSpA)) are double-blind, phase 3 trials designed to evaluate efficacy and safety of bimekizumab, a novel dual interleukin (IL)-17A and IL-17F inhibitor, across the axSpA spectrum.MethodsIn parallel 52-week trials, patients with active disease were randomised 1:1 (nr-axSpA) or 2:1 (r-axSpA) to bimekizumab 160 mg every 4 weeks:placebo. From week 16, all patients received bimekizumab 160 mg every 4 weeks. Primary (Assessment of SpondyloArthritis international Society ≥40% improvement (ASAS40)) and secondary endpoints were assessed at week 16. Here, efficacy and treatment-emergent adverse events (TEAEs) are reported up to week 24.Results254 patients with nr-axSpA and 332 with r-axSpA were randomised. At week 16, primary (ASAS40, nr-axSpA: 47.7% bimekizumab vs 21.4% placebo; r-axSpA: 44.8% vs 22.5%; p<0.001) and all ranked secondary endpoints were met in both trials. ASAS40 responses were similar across TNFi-naïve and TNFi-inadequate responder patients. Improvements were observed in Ankylosing Spondylitis Disease Activity Score (ASDAS) states and objective measures of inflammation, including high-sensitivity C-reactive protein (hs-CRP) and MRI of the sacroiliac joints and spine. Most frequent TEAEs with bimekizumab (>3%) included nasopharyngitis, upper respiratory tract infection, pharyngitis, diarrhoea, headache and oral candidiasis. More fungal infections (all localised) were observed with bimekizumab vs placebo; no major adverse cardiovascular events (MACE) or active tuberculosis were reported. Incidence of uveitis and adjudicated inflammatory bowel disease was low.ConclusionsDual inhibition of IL-17A and IL-17F with bimekizumab resulted in significant and rapid improvements in efficacy outcomes vs placebo and was well tolerated in patients with nr-axSpA and r-axSpA.

show abstract

Section: Discussionmentioning

confidence: 95%

“…They add to a growing evidence base demonstrating the efficacy of bimekizumab in spondyloarthritis, including the BE OPTIMAL and BE COMPLETE phase 3 trials in patients with psoriatic arthritis. 29 30 …”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials

et al. 2023

View full text Add to dashboard Cite

show abstract

“…Bimekizumab, a humanized monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, has recently demonstrated efficacy and tolerability in patients with PsA up to weeks 24 and 52 of the BE OPTIMAL phase III trial, and up to week 16 of the BE COMPLETE phase III trial. [5][6][7] As a result of the increase in therapeutic options for PsA, clinicians have been prompted to consider the most complete picture of patients' disease in order to make treatment decisions. 3,4 However, direct comparative evidence from head-to-head (H2H) trials in PsA is limited, making comparisons difficult.…”

Section: How Might This Change Clinical Pharma-cology or Translationa...mentioning

confidence: 99%

“…Other effective treatments include targeted synthetic DMARDs, such as Janus kinase (JAK) and phosphodiesterase type 4 (PDE4) inhibitors. Bimekizumab, a humanized monoclonal IgG1 antibody that selectively inhibits IL‐17F in addition to IL‐17A, has recently demonstrated efficacy and tolerability in patients with PsA up to weeks 24 and 52 of the BE OPTIMAL phase III trial, and up to week 16 of the BE COMPLETE phase III trial 5–7 …”

mentioning

confidence: 99%

Comparative Effectiveness of Bimekizumab in Psoriatic Arthritis: A Model‐Based Meta‐Analysis of American College of Rheumatology Response Criteria

Maloney,

Dua,

Ahmed

2024

Clin Pharma and Therapeutics

View full text Add to dashboard Cite

A model‐based meta‐analysis (MBMA) was conducted to compare the efficacy of bimekizumab with other psoriatic arthritis (PsA) treatment regimens using ≥20%/50%/70% improvements in American College of Rheumatology (ACR) criteria (ACR20/50/70) for patients with PsA. Forty‐nine trials of 16 drugs were identified in the literature, comprising 21,340 patients. Trial‐level covariates including prior biologic use, concomitant methotrexate use, time since diagnosis, trial completion year, and active comparator were considered for exploratory models. The final model was selected using leave‐one‐out cross‐validation (LOO CV) to assess predictive performance based on prespecified criteria. LOO CV was conducted for 15 trials; the final model demonstrated that 91.5% (952/1,040) of the observed treatment differences, and 96.1% of the observed ACR20/50/70 response rates were within the 95% prediction interval (PI). Median ACR50 response rates (95% PI) at Week 16 in biologic‐naïve patients were predicted to be 44% (40–49%) for bimekizumab 160 mg, amongst the highest of all treatments analyzed. Response rates for secukinumab 150 mg and risankizumab 150 mg were 28% (25–32%) and 27% (24–‍31%), respectively. The MBMA was also used to predict the probability of success (PoS) of potential head‐to‐head trials using ACR50 response as the endpoint with varying sample sizes: versus secukinumab 150 mg, the PoS for bimekizumab 160 mg was 62% (N=200) and 90% (N=400). Versus risankizumab 150 mg, the PoS for bimekizumab 160 mg was 68% (N=200) and 94% (N=400). In summary, a predictive MBMA described ACR20/50/70 outcomes in PsA, allowing accurate and precise treatment comparisons and robust PoS calculations.

show abstract

“…Bimekizumab was superior to the placebo in achieving an ACR50 response at 16 weeks (43% versus 7%, respectively). Moreover, bimekizumab demonstrated rapid improvements in clinical manifestations of PsA, with separation from the placebo as early as week 4 [ 114 ].…”

Section: Il17mentioning

confidence: 99%

Targeted Therapies in Psoriatic Arthritis—An Update

Sundanum

Orr

Veale

2023

IJMS

View full text Add to dashboard Cite

Psoriatic arthritis (PsA) is a systemic inflammatory condition characterised by multiple clinical manifestations. Over the last decade, significant progress has been made in understanding the pathobiology of the disease. An expanded set of targeted therapies have emerged and have shown efficacy in PsA. Nevertheless, there is still a substantial subset of patients who experience no response or only a partial response to currently licensed therapies. The heterogeneous nature of the disease, together with a varying level of severity at presentation and disease activity during follow-up, brings tremendous challenges to devising management strategies. While there are certain pathophysiological similarities between PsA and rheumatoid arthritis (RA), it has become clear that there are discriminating features between these two conditions at the clinical, cellular, and molecular levels. However, there is a degree of overlap in the clinical approach when treating both PsA and RA, given that many biological and targeted therapies have proven efficacy for both pathologies. With an increasing understanding of the relevance of the IL-23/IL-17 axis in PsA, pharmacological agents blocking this pathway have provided promising possibilities for patients with PsA.

show abstract

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)

Cited by 100 publications

References 33 publications

Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials

Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials

Comparative Effectiveness of Bimekizumab in Psoriatic Arthritis: A Model‐Based Meta‐Analysis of American College of Rheumatology Response Criteria

Targeted Therapies in Psoriatic Arthritis—An Update

Contact Info

Product

Resources

About