Skip to main content
Top

04-05-2024 | Psoriatic Arthritis | Adis Drug Evaluation

Bimekizumab: A Review in Psoriatic Arthritis

Authors: Tina Nie, Matt Shirley

Published in: Drugs

Login to get access

Abstract

Although several biological disease-modifying antirheumatic drugs (bDMARDs), including interleukin (IL)-17A inhibitors, are approved for psoriatic arthritis, the treatment of this disease remains suboptimal. Bimekizumab (Bimzelx®), a dual IL-17A and IL-17F inhibitor, is approved in the EU, Great Britain and Japan for the treatment of psoriatic arthritis. In pivotal phase 3 clinical trials in patients who were bDMARD-naïve or previously had an inadequate response or intolerance to tumour necrosis factor (TNF) α inhibitors, bimekizumab improved the signs and symptoms of psoriatic arthritis across a range of joint, skin, radiographic and patient-reported outcomes compared with placebo, including the proportion of patients achieving a ≥ 50% response in the American College of Rheumatology criteria. Phase 2 clinical trial data have shown that responses are maintained up to 3 years. Bimekizumab was generally well tolerated in patients with psoriatic arthritis, with a safety profile consistent with that in other approved indications. The most common adverse events included nasopharyngitis, upper respiratory tract infection, oral candidiasis, headache and diarrhoea. In conclusion, bimekizumab extends the treatment options available to patients with psoriatic arthritis.
Appendix
Available only for authorised users
Literature
1.
go back to reference Mease PJ, Gladman DD, Papp KA, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013;69(5):729–35.CrossRefPubMed Mease PJ, Gladman DD, Papp KA, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013;69(5):729–35.CrossRefPubMed
2.
go back to reference Coates LC, Soriano ER, Corp N, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol. 2022;18(8):465–79.CrossRefPubMedPubMedCentral Coates LC, Soriano ER, Corp N, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol. 2022;18(8):465–79.CrossRefPubMedPubMedCentral
3.
go back to reference Mahmood F, Coates LC, Helliwell PS. Current concepts and unmet needs in psoriatic arthritis. Clin Rheumatol. 2018;37(2):297–305.CrossRefPubMed Mahmood F, Coates LC, Helliwell PS. Current concepts and unmet needs in psoriatic arthritis. Clin Rheumatol. 2018;37(2):297–305.CrossRefPubMed
4.
go back to reference Gossec L, Baraliakos X, Kerschbaumer A, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020;79(6):700–12.CrossRefPubMed Gossec L, Baraliakos X, Kerschbaumer A, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020;79(6):700–12.CrossRefPubMed
5.
go back to reference Reis J, Vender R, Torres T. Bimekizumab: the first dual inhibitor of interleukin (IL)-17A and IL-17F for the treatment of psoriatic disease and ankylosing spondylitis. BioDrugs. 2019;33(4):391–9.CrossRefPubMed Reis J, Vender R, Torres T. Bimekizumab: the first dual inhibitor of interleukin (IL)-17A and IL-17F for the treatment of psoriatic disease and ankylosing spondylitis. BioDrugs. 2019;33(4):391–9.CrossRefPubMed
6.
go back to reference Costa L, Perricone C, Chimenti MS, et al. Switching between biological treatments in psoriatic arthritis: a review of the evidence. Drugs R D. 2017;17(4):509–22.CrossRefPubMedPubMedCentral Costa L, Perricone C, Chimenti MS, et al. Switching between biological treatments in psoriatic arthritis: a review of the evidence. Drugs R D. 2017;17(4):509–22.CrossRefPubMedPubMedCentral
7.
8.
go back to reference Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523–32.CrossRefPubMed Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523–32.CrossRefPubMed
9.
go back to reference Cole S, Manghera A, Burns L, et al. Differential regulation of IL-17A and IL-17F via STAT5 contributes to psoriatic disease. J Allergy Clin Immunol. 2023;152(3):783–98.CrossRefPubMed Cole S, Manghera A, Burns L, et al. Differential regulation of IL-17A and IL-17F via STAT5 contributes to psoriatic disease. J Allergy Clin Immunol. 2023;152(3):783–98.CrossRefPubMed
14.
go back to reference Rodríguez-Cerdeira C, González-Cespón JL, Martínez-Herrera E, et al. Candida infections in patients with psoriasis and psoriatic arthritis treated with interleukin-17 inhibitors and their practical management. Ital J Dermatol Venerol. 2021;156(5):545–57.PubMed Rodríguez-Cerdeira C, González-Cespón JL, Martínez-Herrera E, et al. Candida infections in patients with psoriasis and psoriatic arthritis treated with interleukin-17 inhibitors and their practical management. Ital J Dermatol Venerol. 2021;156(5):545–57.PubMed
15.
go back to reference Oliver R, Krueger JG, Glatt S, et al. Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double-blind multicentre study. Br J Dermatol. 2022;186(4):652–63.CrossRefPubMed Oliver R, Krueger JG, Glatt S, et al. Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double-blind multicentre study. Br J Dermatol. 2022;186(4):652–63.CrossRefPubMed
16.
go back to reference McInnes 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(10370):25–37.CrossRefPubMed McInnes 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(10370):25–37.CrossRefPubMed
17.
go back to reference Merola 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(10370):38–48.CrossRefPubMed Merola 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(10370):38–48.CrossRefPubMed
18.
go back to reference Ritchlin CT, Kavanaugh A, Merola JF, et al. Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2020;395(10222):427–40.CrossRefPubMed Ritchlin CT, Kavanaugh A, Merola JF, et al. Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2020;395(10222):427–40.CrossRefPubMed
19.
go back to reference Coates LC, Landewe R, McInnes IB, et al. Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL. RMD Open. 2024;10(1):e003855.CrossRefPubMedPubMedCentral Coates LC, Landewe R, McInnes IB, et al. Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL. RMD Open. 2024;10(1):e003855.CrossRefPubMedPubMedCentral
20.
go back to reference Ritchlin CT, Coates LC, McInnes IB, et al. Bimekizumab treatment in biologic DMARD-naive patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. 2023;82(11):1404–14.CrossRefPubMed Ritchlin CT, Coates LC, McInnes IB, et al. Bimekizumab treatment in biologic DMARD-naive patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. 2023;82(11):1404–14.CrossRefPubMed
21.
go back to reference Merola J, Mease P, Deodhar A, et al. Bimekizumab impact on core Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) domains for patients with psoriatic arthritis: 52-week results from four phase 3 studies [abstract no. 1433]. Arthritis Rheumatol. 2023;75(Suppl 9). Merola J, Mease P, Deodhar A, et al. Bimekizumab impact on core Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) domains for patients with psoriatic arthritis: 52-week results from four phase 3 studies [abstract no. 1433]. Arthritis Rheumatol. 2023;75(Suppl 9).
22.
go back to reference McInnes I, Mease P, Tanaka Y, et al. Bimekizumab efficacy and safety in biologic DMARD-naïve patients with psoriatic arthritis was consistent with or without methotrexate: 52-week results from the phase 3 active‑reference study BE OPTIMAL [abstract no. POS1537 plus poster]. Ann Rheum Dis. 2023;82(Suppl 1):1133–4. McInnes I, Mease P, Tanaka Y, et al. Bimekizumab efficacy and safety in biologic DMARD-naïve patients with psoriatic arthritis was consistent with or without methotrexate: 52-week results from the phase 3 active‑reference study BE OPTIMAL [abstract no. POS1537 plus poster]. Ann Rheum Dis. 2023;82(Suppl 1):1133–4.
23.
go back to reference Gottlieb AB, Asahina A, Merola JF, et al. Bimekizumab improves joint measures in patients with active psoriatic arthritis and moderate or severe psoriasis: pooled 16-week results from phase 3 randomized, placebo-controlled studies BE OPTIMAL and BE COMPLETE [abstract no. 43024]. J Am Acad Dermatol. 2023;89(3 Suppl):AB128. Gottlieb AB, Asahina A, Merola JF, et al. Bimekizumab improves joint measures in patients with active psoriatic arthritis and moderate or severe psoriasis: pooled 16-week results from phase 3 randomized, placebo-controlled studies BE OPTIMAL and BE COMPLETE [abstract no. 43024]. J Am Acad Dermatol. 2023;89(3 Suppl):AB128.
24.
go back to reference Tillett W, Merola J, Tanaka Y, et al. Bimekizumab maintained efficacy responses through 52 weeks in biologic disease-modifying antirheumatic drug-naive patients with psoriatic arthritis who were responders at week 16: results from BE OPTIMAL, a phase 3, active-reference study [abstract no. POS1534 plus poster]. Ann Rheum Dis. 2023;82(Suppl 1):1130–1. Tillett W, Merola J, Tanaka Y, et al. Bimekizumab maintained efficacy responses through 52 weeks in biologic disease-modifying antirheumatic drug-naive patients with psoriatic arthritis who were responders at week 16: results from BE OPTIMAL, a phase 3, active-reference study [abstract no. POS1534 plus poster]. Ann Rheum Dis. 2023;82(Suppl 1):1130–1.
25.
go back to reference Coates 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(12):1959–70.CrossRefPubMedPubMedCentral Coates 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(12):1959–70.CrossRefPubMedPubMedCentral
27.
go back to reference Tanaka Y, Shaw S. Bimekizumab for the treatment of psoriatic arthritis. Expert Rev Clin Immunol. 2024;20(2):155–68.CrossRefPubMed Tanaka Y, Shaw S. Bimekizumab for the treatment of psoriatic arthritis. Expert Rev Clin Immunol. 2024;20(2):155–68.CrossRefPubMed
28.
go back to reference Reich K, Warren RB, Lebwohl M, et al. Bimekizumab versus secukinumab in plaque psoriasis. N Engl J Med. 2021;385(2):142–52.CrossRefPubMed Reich K, Warren RB, Lebwohl M, et al. Bimekizumab versus secukinumab in plaque psoriasis. N Engl J Med. 2021;385(2):142–52.CrossRefPubMed
29.
go back to reference Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus adalimumab in plaque psoriasis. N Engl J Med. 2021;385(2):130–41.CrossRefPubMed Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus adalimumab in plaque psoriasis. N Engl J Med. 2021;385(2):130–41.CrossRefPubMed
30.
go back to reference Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021;397(10273):487–98.CrossRefPubMed Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021;397(10273):487–98.CrossRefPubMed
Metadata
Title
Bimekizumab: A Review in Psoriatic Arthritis
Authors
Tina Nie
Matt Shirley
Publication date
04-05-2024
Publisher
Springer International Publishing
Published in
Drugs
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-024-02026-3