Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL)

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

doi:10.1016/s0140-6736(22)02302-9

Cited by 65 publications

(87 citation statements)

References 20 publications

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“…Radiographic outcomes were not evaluated in this trial; however, interim results from the BE OPTIMAL study report the inhibition of structural progression in patients with psoriatic arthritis who are naive to biologics treated with bimekizumab, compared with placebo, at week 16. 15 The overall safety profile of bimekizumab in BE COMPLETE was similar to previous studies in psoriatic arthritis and consistent with its known safety profile. 13,14 Of note, more mild-to-moderate fungal infections occurred in the bimekizumab group than in the placebo group, which is consistent with the known role of IL-17A and IL-17F in mucosal host defences against fungal infections.…”

Section: Discussionsupporting

confidence: 84%

“…This speed of response across the signs and symptoms of psoriatic arthritis is of value to patients, who have reported that symptom alleviation is a priority to reduce the impact of disease on daily life. 23 Although BE OPTIMAL and BE COMPLETE are independent studies, the magnitude of efficacy measured in this study was similar to that measured in the population of patients who were naive to biologic DMARDs in the BE OPTIMAL study, 15 suggesting that bimekizumab treatment might lead to a similar magnitude of clinically meaningful improve ments in psoriatic arthritis, irrespective of previous TNFα inhibitor treatment.…”

Section: Discussionsupporting

confidence: 71%

“…Pooled data for these endpoints are reported in the associated full publication. 15 Safety outcomes included the number of treatmentemergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to withdrawal. Prespecified safety topics of interest included infections (serious, opportunistic [as defined in the appendix p 7], fungal [including Candida], and active tuberculosis), neutropenia, hypersensitivity (including anaphylaxis), suicidal ideation and behaviour, major adverse cardiovascular events, liver function test changes or enzyme elevations, malignancies, and inflammatory bowel diseases.…”

Section: Discussionmentioning

confidence: 99%

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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)

et al. 2023

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Section: Discussionsupporting

confidence: 84%

Section: Discussionsupporting

confidence: 71%

Section: Discussionmentioning

confidence: 99%

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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)

et al. 2023

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“…The study achieved its primary endpoint, with a significantly larger proportion of patients experiencing an ACR50 at 16 weeks in the bimekizumab-treated group (44%) versus the placebo group (10%). Active treatment also inhibited radiographic progression in patients in both the overall population (a subgroup with elevated CRP) and in those with at least one bone erosion at baseline [ 113 ].…”

Section: Il17mentioning

confidence: 99%

Targeted Therapies in Psoriatic Arthritis—An Update

Sundanum

Orr

Veale

2023

IJMS

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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.

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“…5 Bimekizumab is an anti-IL-17A and anti-IL-17F antibody therapy that has been useful for treating psoriasis and psoriatic arthritis. 6,7 Some preliminary data suggest that bimekizumab reduces IL-36 levels in the serum by simultaneously blocking IL-17A and IL-17F. 8 These data suggest that bimekizumab could be an appealing option for treating PPP and palmoplantar plaque psoriasis with pustules through the inhibition of various pathways.…”

mentioning

confidence: 99%

Treatment of Severe Palmoplantar Pustular Psoriasis With Bimekizumab

Passeron,

Perrot,

Jullien

et al. 2024

JAMA Dermatol

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ImportancePalmoplantar pustulosis (PPP) and palmoplantar plaque psoriasis with pustules remain challenging to treat. Studies suggest that an interleukin 17 or interleukin 36 loop acts synergistically in these diseases to induce palmoplantar pustules.ObjectiveTo assess the effectiveness of bimekizumab in treating PPP and palmoplantar plaque psoriasis with pustules.Design, Setting, and ParticipantsThis case series involved 21 adults with PPP (11 patients) or palmoplantar plaque psoriasis with pustules (10 patients) treated at 1 of 7 tertiary dermatological centers in France from September 2022 through June 2023. All patients treated with bimekizumab for at least 3 months were included in the analyses.Main Outcomes and MeasuresThe main outcome was the posttreatment Investigator Global Assessment (IGA), scored as 0 (complete clearance), 1 (almost clear), 2 (mild), 3 (moderate), or 4 (severe). When relevant, evolution of joint pain and nail involvement was reported. Tolerance and potential adverse events were noted.ResultsA total of 21 patients (mean [range] age, 46 [24-68] years; 19 females) were included. Eleven patients had isolated PPP, and 10 had palmoplantar plaque psoriasis with pustules. All of them, except 2 who received bimekizumab as first systemic therapy, had not responded to at least 1 systemic treatment (median [range], 3 [1-7] treatments), and/or had adverse events leading to the discontinuation of the treatment. Complete clearance (IGA score, 0) was achieved by 17 patients in 1 to 4 months. Three patients achieved an IGA score of 1, and 1 achieved an IGA score of 2. Three patients with PPP also presented with acrodermatitis continua of Hallopeau. Nail involvement showed 50% to 70% improvement after 4 to 6 months of bimekizumab treatment for these 3 patients. Two patients had SAPHO (synovitis, acne, pustulosis, hyperostosis, osteitis) syndrome; both had complete clearance of skin lesions associated with joint pain improvement. Four patients (19%) with candidiasis were successfully treated with oral antifungal agents. None of the patients had to stop bimekizumab treatment due to adverse events.Conclusions and RelevanceThe findings of this case series suggest that bimekizumab could be an appealing approach for treating PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome. Prospective randomized placebo-controlled clinical trials are needed to confirm these encouraging initial results.

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Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL)

Cited by 65 publications

References 20 publications

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 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)

Targeted Therapies in Psoriatic Arthritis—An Update

Treatment of Severe Palmoplantar Pustular Psoriasis With Bimekizumab

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