February 2024

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 Feb 22;10(1):e003855 doi: 10.1136/rmdopen-2023-003855

Bimekizumab was well tolerated in patients with PsA and TNFi-IR up to 52 weeks, with a safety profile consistent with that observed in prior studies. This study aimed to assess 52-week safety and efficacy of bimekizumab in patients with active PsA and prior IR/intolerance to TNFi.

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Long term safety of ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: A post hoc analysis of final safety data from 25 randomized clinical trials

Arthritis Res Ther 2024;26(1):49 doi: 10.1186/s13075-023-03257-7

Incident rates of TEAEs were comparable for patients with PsO, PsA, and axSpA and did not increase with prolonged ixekizumab (IXE) treatment. Deodhar, et al. presented the final update on the long-term safety of IXE up to 6 years in PsO patients and up to 3 years in PsA and axSpA patients. Exposure-adjusted incident rates were calculated using patient data (TEAEs, SAEs, selected AEs) from 25 clinical trials.

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September 2023

Bimekizumab Treatment in Biologic DMARD-Naïve 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):1404–1414 doi: 10.1136/ard-2023-224431

Data from this phase 3 RCT demonstrated that the efficacy of bimekizumab observed at 16 weeks remained consistent through to 52 weeks in the treatment of bDMARD-naïve patients with PsA. Patients who started the trial on placebo and switched to bimekizumab at week 16 showed similar improvements to those patients who were randomised to receive bimekizumab at the start of the trail. No new safety signals were identified.

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March 2023

Low Rates of Radiographic Progression Associated with Clinical Efficacy Following up to 2 Years of Treatment with Guselkumab: Results From a Phase 3, Randomised, Double-blind, Placebo-controlled Study of Biologic-naïve Patients with Active Psoriatic Arthritis

RMD Open. 2023 doi: 10.1136/rmdopen-2022-002789

Data from this paper provides a robust analysis of radiographic progression through 2 years in a phase 3 study of guselkumab in patients with PsA. This study sought to evaluate the relationship between radiographic progression and clinical outcomes in post hoc analyses of patients with PsA receiving up to 2 years of guselkumab therapy in DISCOVER-2.

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January 2023

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 doi: 10.1002/art.42280

This study highlighted that the safety of bimekizumab in patients with PsA over 3 years of treatment was consistent with the previous 48-week results, as well as other recently published studies of IL-17 inhibitors in PsA patients.

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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

Lancet. 2023 doi: 10.1016/S0140-6736(22)02303-0

This study showed rapid and clinically meaningful improvements with bimekizumab treatment in patients experiencing active PsA and showing an inadequate response or intolerance to TNFα inhibitors. Its chief aim was to evaluate the efficacy and safety of bimekizumab in patients with an inadequate response or intolerance to TNFα inhibitors.

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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)

Lancet. 2023 doi: 10.1016/S0140-6736(22)02302-9

This study showed that bimekizumab treatment resulted in clinically meaningful and consistent improvements across multiple measures in bDMARD-naïve patients with active PsA. It aimed to assess the efficacy and safety of bimekizumab in patients with active PsA who were naive to bDMARDs.

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August 2022

Safety and Efficacy of Bimekizumab in Patients with Active Psoriatic Arthritis: 3-Year Results from a Phase 2b Randomized Controlled Trial and its Open-Label Extension Study

Arthritis Rheumatol 2022 doi: 10.1002/art.42280

In this investigation bimekizumab was associated with a sustained ACR50 improvement. This was highlighted following the attempt to describe the long-term safety, tolerability, and efficacy of up to three years of bimekizumab treatment in PsA patients

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Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks from 2 Phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2)

J Am Acad Dermatol 2018;79:302–14. doi: 10.1016/j.jaad.2018.04.012

Treatment of moderate-to-severe chronic plaque PsO with either CZP 400 mg or 200 mg Q2W was associated with significant, clinically meaningful improvements in efficacy and quality of life that were maintained over time compared with placebo. Safety findings were in line with those expected of the therapy.

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July 2015

Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two, randomised, placebo-controlled, Phase 3 trials

British Journal of Dermatology. 7 July 2015 DOI: 10.1111/bjd.14018. [Epub ahead of print]

The management of moderate to severe chronic plaque psoriasis has benefited from the introduction of biological therapies, but unmet needs still remain, especially for oral therapies. Tofacitinib is an orally active agent that blocks signalling of key cytokines implicated in the immune response and inflammatory pathways of psoriasis. The Phase III studies presented in this paper analysed efficacy and safety endpoints.Both studies demonstrated that tofacitinib in both 5 mg and 10 mg twice daily d...

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