Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial

Ritchlin, Christopher T.; Kavanaugh, Arthur; Merola, Joseph F.; Schett, Georg; Scher, Jose U.; Warren, Richard B; Gottlieb, Alice B.; Assudani, Deepak; Bedford-Rice, Kathy; Coarse, Jason; Ink, B.; McInnes, Iain B.

doi:10.1016/s0140-6736(19)33161-7

Cited by 123 publications

(127 citation statements)

References 21 publications

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“…The BE ACTIVE randomized, double-blind, placebo-controlled phase IIb study showed that BMK was associated with significant improvement in joint involvement compared with placebo, with an acceptable safety profile. 95 Although the results are promising, larger studies are required to better characterize the efficacy and safety profile of both BRD and BMK in the treatment of PsA. 95 The safety profile of BMK was consistent with previous reports, with no apparent relationship between dose and treatment-emergent adverse events.…”

Section: Biological Dmards Other Than Tnfisupporting

confidence: 79%

<p>An Update for the Clinician on Biologics for the Treatment of Psoriatic Arthritis</p>

Chimenti¹,

D’Antonio²,

Conigliaro³

et al. 2020

BTT

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Psoriatic arthritis (PsA) is a chronic inflammatory arthropathy typically associated with psoriasis (PsO). The pathogenesis is strictly related to the association among the presence of genetic risk alleles and innate and acquired immune response with dramatic consequences on bone remodeling. Clinically, PsA patients may present heterogenicity of articular and periarticular manifestations that may be associated with the presence of comorbidities making treatment decision challenging in patients management. The identification of patient-targeted therapies is still a critical issue. Actually, several biological and synthetic drugs are promising in terms of efficacy and safety profile. National and international treatment recommendations support clinicians in the decision of the best treatment, although they may have limits basically related to updates and different outcomes included in the clinical studies evaluated. The aim of this narrative review is therefore to give guidance for clinicians for PsA patients treatment. For this purpose, we evaluated evidence on biological therapies efficacy used for PsA treatment. Specifically, we reviewed data on biological therapies, Janus kinases (JAK) inhibitors, and drugs with a new mechanism of action that are part of the treatment pipeline. The concept of "switching" and "swapping" is also described, as well as data concerning special populations such as pregnant women and elderly patients.

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Section: Biological Dmards Other Than Tnfisupporting

confidence: 79%

<p>An Update for the Clinician on Biologics for the Treatment of Psoriatic Arthritis</p>

Chimenti¹,

D’Antonio²,

Conigliaro³

et al. 2020

BTT

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“…To inform the taskforce conducting the 2019 update of the EULAR recommendations for pharmacologic management of PsA, this SLR was conducted and included results of 56 publications from January 2015 to December 2018. The field is emerging quickly and several new compounds, not captured in the timeframe of this update are currently under investigation [58,59]. Efficacy of TNF inhibition across various disease domains was confirmed, as well as the bioequivalenceof biosimilars compared to their biooriginators.…”

mentioning

confidence: 92%

Pharmacological treatment of psoriatic arthritis: a systematic literature research for the 2019 update of the EULAR recommendations for the management of psoriatic arthritis

et al. 2020

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ObjectiveTo perform an update of a review of the efficacy and safety of disease-modifying antirheumatic drugs (DMARDs) in psoriatic arthritis (PsA).MethodsThis is a systematic literature research of 2015–2018 publications on all DMARDs in patients with PsA, searching Medline, Embase and the Cochrane Library. Efficacy was assessed in randomised controlled trials. For safety, cohort studies, case–control studies and long-term extensions (LTEs) were analysed.Results56 publications (efficacy: n=33; safety n=23) were analysed. The articles were on tumour necrosis factor (TNF) inhibitors (n=6; golimumab, etanercept and biosimilars), interleukin (IL)-17A inhibitors (n=10; ixekizumab, secukinumab), IL-23-p19 inhibitors (n=2; guselkumab, risankizumab), clazakizumab (IL-6 inhibitor), abatacept (CD80/86 inhibitor) and ABT-122 (anti-TNF/IL-17A), respectively. One study compared ustekinumab (IL-12/23i) with TNF inhibitor therapy in patients with entheseal disease. Three articles investigated DMARD tapering. Trials on targeted synthetic DMARDs investigated apremilast (phosphodiesterase-4 inhibitor) and Janus kinase inhibitors (JAKi; tofacitinib, filgotinib). Biosimilar comparison with bio-originator showed non-inferiority. Safety was evaluated in 13 LTEs, 9 cohort studies and 1 case–control study investigating malignancies, infections, infusion reactions, multiple sclerosis and major cardiovascular events, as well as efficacy and safety of vaccination. No new safety signals were identified; however, warnings on the risk of venous thromboembolic events including pulmonary embolism when using JAKi were issued by regulators based on other studies.ConclusionMany drugs in PsA are available and have demonstrated efficacy against placebo. Efficacy varies across PsA manifestations. Safety must also be taken into account. This review informed the development of the European League Against Rheumatism 2019 updated PsA management recommendations.

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“…BE ACTIVE trial is a phase IIb dose RCT ( n = 206) investigating the efficacy and safety of bimekizumab, a selective monoclonal antibody targeting both IL-17A and IL-17F receptors. 69 The results suggested that bimekizumab is efficacious across all clinical domains in PsA without new safety concerns. 69 Phase III trials are ongoing in PsA comparing bimekizumab with placebo [BE COMPLETE, ClinicalTrials.gov identifier: NCT03896581] and with placebo as well as adalimumab as comparators [BE OPTIMAL, ClinicalTrials.gov identifier: NCT03895203].…”

Section: Therapeutic Optionsmentioning

confidence: 96%

Choosing the right treatment for patients with psoriatic arthritis

Noviani

Feletar²,

Nash

et al. 2020

Therapeutic Advances in Musculoskeletal

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Psoriatic arthritis (PsA) is a chronic inflammatory condition with articular and extra-articular manifestations: peripheral arthritis, axial disease, enthesitis, dactylitis, psoriasis, inflammatory bowel disease and uveitis. Anti-tumour necrosis factors (anti-TNFs) have demonstrated clinical efficacies exceeding those of conventional disease-modifying antirheumatic drugs (DMARDs). New understanding in pathogenic pathways have led to novel therapeutic targets. The current treatment paradigms emphasize early diagnosis and treatment, and treating towards remission and low disease activity status, particularly in long-standing disease. This review addresses the evidence of current treatment options for each of the domains of PsA. We present a simple guide that weighs on clinical efficacies for each PsA domain to aid clinicians in choosing the most appropriate treatment for patients. We highlight the unmet need for biomarkers of treatment response, and future perspectives with precision medicine in PsA.

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Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial

Cited by 123 publications

References 21 publications

<p>An Update for the Clinician on Biologics for the Treatment of Psoriatic Arthritis</p>

<p>An Update for the Clinician on Biologics for the Treatment of Psoriatic Arthritis</p>

Pharmacological treatment of psoriatic arthritis: a systematic literature research for the 2019 update of the EULAR recommendations for the management of psoriatic arthritis

Choosing the right treatment for patients with psoriatic arthritis

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