November 2029

Persistent patient-level effect of guselkumab at consecutive 8-week dosing visits and over time in patients with active psoriatic arthritis: post hoc analysis of a 2-year, Phase 3, randomized, controlled study

ACR Open Rheumatol. 2024 doi 10.1002/acr2.11732 Epub ahead of print

Mease et al. conducted a post-hoc analysis of the phase 3 DISCOVER-2 trial to assess the persistence of clinically relevant improvements with guselkumab in biologic-naïve patients with PsA. The analysis showed that guselkumab maintained clinical improvements in joint and skin domains at consecutive dosing visits (Q8W) and over time.

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July 2024

Mental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of Phase 2/3 randomized trials

J Am Acad Dermatol 2024;91:72–81 doi: 10.1016/j.jaad.2024.02.039

Results of this analysis by Blauvelt, et al. showed a low adjudicated suicidal ideation and behaviour (SIB) rate of 0.13/100 patient-years for bimekizumab, consistent with general psoriasis population ranges. Bimekizumab did not increase the risk of SIB compared to other anti-IL-17A/anti-IL-23 therapies.

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Durable Control of Psoriatic Arthritis with Guselkumab Across Domains and Patient Characteristics: Post Hoc Analysis of a Phase 3 study

Clin Rheumatol 2024 doi: 10.1007/s10067-024-06991-8 Epub ahead of print

Ritchlin et al. conducted a post hoc analysis of the DISCOVER-2 trial, evaluating the efficacy of guselkumab in biologic-naïve patients with PsA. Guselkumab provided durable disease control across key PsA domains and PROs over 2 years, regardless of baseline characteristics. A significant proportion of patients achieved stringent endpoints such as ACR50/70, complete skin clearance, and resolution of dactylitis/enthesitis.

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April 2024

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;397:487–98. doi: 10.1016/S0140-6736(21)00125-2

Bimekizumab was more efficacious than ustekinumab and placebo in the treatment of moderate to severe plaque psoriasis. Previous bimekizumab Phase 2 clinical studies have shown both rapid and durable clinical improvements in skin clearance, as well as a safety profile in line with expectations from this MoA. This study aimed to evaluate the efficacy and safety of bimekizumab in moderate to severe plaque PsO over 1 year compared with both placebo and ustekinumab.

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Deucravacitinib, a selective, allosteric tyrosine kinase 2 inhibitor, in scalp psoriasis: A subset analysis of two Phase 3 randomized trials in plaque psoriasis

Am Acad Dermatol 2023. doi: 10.1016/j.jaad.2023.11.060

This pooled analysis of the Phase 3 PSO-1 and PSO-2 trials shows that deucravacitinib has greater efficacy in treating scalp PsO than placebo and apremilast. At week 16, response rates were greater with deucravacitinib versus placebo or apremilast for scalp-specific Physician Global Assessment 0/1 and Psoriasis Scalp Severity Index. Efficacy was maintained through 52 weeks in patients who received continuous deucravacitinib treatment.

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March 2024

Association of the clinical components in the distal interphalangeal joint synovio-entheseal complex and subsequent response to ixekizumab or adalimumab in psoriatic arthritis

Rheumatology 2024 doi 10.1093/rheumatology/keae060 Epub ahead of print

This post hoc analysis of the SPIRIT-H2H study showed that patients with PsA that were treated with ixekizumab had significantly higher rates of symptom resolution versus adalimumab at Weeks 12 and 52 in distal interphalangeal joint disease and nail PsO.

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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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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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October 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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January 2023

Sicurezza ed efficacia del bimekizumab nei pazienti con artrite psoriasica attiva: risultati a tre anni di uno studio controllato randomizzato di fase IIb e del relativo studio di estensione in aperto

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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