Long-term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
Drug Saf. 2023 doi:10.1007/s40264-023-01361-w. Epub ahead of print
Data gathered from 11 phase 2 and phase 3 trials have shown that guselkumab has a favourable safety profile in treating psoriatic disease. The data were gathered from 4399 patients over 10787 patient years. In the placebo-controlled periods, guselkumab showed a similar safety profile to placebo, and this remained consistent and stable in the non-placebo controlled preiods.
Bimekizumab Treatment in Patients With Active Axial Spondyloarthritis: 52-week Efficacy and Safety from the Randomised Parallel Phase 3 BE MOBILE 1 and BE MOBILE 2 Studies
Ann Rheum Dis. 2023 doi 10.1136/ard-2023-224803 Epub ahead of print
Baraliakos, et al. present data from two Phase 3 studies, BE MOBILE 1 and BE MOBILE 2, that investigated the clinical efficacy and safety of bimekizumab in axSpA patients. They found that bimekizumab had sustained and consistent efficacy in patients with nr-axSpA and r-axSpA.
Gender-specific Differences in Patients with Psoriatic Arthritis Receiving Ustekinumab or Tumour Necrosis Factor Inhibitor: Real-world Data
Rheumatology (Oxford) doi:10.1093/rheumatology/kead089.
Real-world data from the PsABio study indicated that females with PsA had more severe disease than males before the initiation of treatment. While both genders experienced treatment related improvements, fewer females than males were able to achieve a favourable disease state within 12 months. Treatment discontinuation and switching were also higher in females than males, due to lower efficacy and adverse events.
Tofacitinib Efficacy and Safety in Patients With Ankylosing Spondylitis by Prior Biologic Disease-Modifying Antirheumatic Drug Use: A Post Hoc Analysis
ACR Open Rheumatol. 2023 Sep 29 doi 10.1002/acr2.11601 Epub ahead of print
In this post hoc analysis by Deoodhar, et al., the authors found that tofacitinib demonstrated greater efficacy than placebo in bDMARD-naïve and TNFi-IR AS patients. They also found that safety event rates for tofacitinib therapy were numerically higher in the TNFi-IR subgroup than the bDMARD-naïve subgroup.
Efficacy and Safety of Upadacitinib in Patients with Ankylosing Spondylitis Refractory to Biologic Therapy: 1-year Results From the Open-label Extension of a Phase III Study
Arthritis Res Ther 2023; 2023;18;25(1):172 doi 10.1186/s13075-023-03128-1
The efficacy and safety of updacitinib in bDMARD-IR patients with AS were sustained through to one year in an open-label extension of the SELECT-AXIS 2 study.
Anti-GM-CSF Otilimab Versus Tofacitinib or Placebo in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Conventional or Biologic DMARDs: Two Phase 3 Randomised Trials (contRAst 1 and contRAst 2)
Ann Rheum Dis 2023;0:1–11 doi 10.1136/ard-2023-224482
Fleischmann, et al investigated the safety and efficacy of otilimab versus tofacitinib and placebo in RA patients treated with MTX (contRAst 1) or csDMARDs (contRAst 2). They found that while otilimab achieved the primary endpoint of ACR20 versus placebo in Week 12, it did not demonstrate non-inferiority to tofacitinib.
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 doi: 10.1136/ard-2023-224431. Epub ahead of print
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.
Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice
Rheumatol Ther. 2023 doi: 10.1007/s40744-023-00589-3. Epub ahead of print
In the UPJOINT open label study, the proportion of patients with PsA, and an inadequate response to csDMARDs or bDMARDs, who achieved minimal disease activity with upadacitinib was in line with the results of previous studies at 24 weeks. No new safety signals were identified.
A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Tildrakizumab Efficacy and Safety in Patients with Active Ankylosing Spondylitis
J Clin Rheumatol. 2023;29(5):223–229 doi: 10.1097/RHU.0000000000001973
Phase 2a study assessing the efficacy and safety of tildrakizumab in patients with active AS fails to meet the primary endpoint.
The effect of ixekizumab on axial manifestations in patients with psoriatic arthritis from two phase III clinical trials: SPIRIT-P1 and SPIRIT-P2
Ther Adv Musculoskelet Dis. 2023;15:1759720X231189005 doi: 10.1177/1759720X231189005
Post-hoc analysis of SPIRIT-P1 and SPIRIT-P2 concludes that ixekizumab (IXE) is effective in improving axial symptoms in patients with active PsA presenting with axial manifestations.