Author: Bayram Farisogullari
Kivitz et al. (0776) investigated the long-term efficacy, safety, and tolerability of intravenous (IV) secukinumab (SEC) in patients with active PsA through 52 weeks in a randomised, double-blind, placebo (PBO)-controlled, parallel-group, phase 3 study (INVIGORATE-2; NCT04209205). Patients were randomized 1:1 to receive IV SEC (6 mg/kg at baseline followed by 3 mg/kg q4w) or PBO. A higher proportion of patients receiving SEC than PBO achieved ACR50 (primary endpoint) at week 16 using nonresponder imputation (60/191 [31.4%] vs 12/190 [6.3%]; P< .0001). Patients receiving SEC had greater improvements in secondary efficacy outcomes (ACR20, minimal disease activity, PASI90, dactylitis resolution, and enthesitis resolution) compared with PBO at week 16, and both SEC and PBO/SEC groups had comparable efficacy outcomes by week 52. Through week 16, the incidences of adverse events (AEs; 37.7% vs 38.4%), serious AEs (1.6% vs 2.1%), and AEs leading to treatment discontinuation (0.5% vs 1.6%) were similar for patients receiving SEC or PBO.
Østergaard et al (1690) assessed the efficacy of apremilast (APR) 30 mg BID (as monotherapy or in combination with stable methotrexate) on inflammation measured by a dedicated MRI of the hand in a phase 4 MOSAIC (NCT03783026) study. Patients with PsA treated with APR had improvements in both clinical indices and objective MRI indices of inflammation assessed by PsA MRI Score in the target hand at week 24 and week 48, confirming an effect of APR on clinical and inflammatory manifestations of PsA. No significant structural progression was observed.
Yang et al (2550) assessed the efficacy of apremilast (APR) 30 mg BID (as monotherapy or in combination with stable methotrexate) on inflammation measured by a dedicated MRI of the hand in a phase 4 MOSAIC (NCT03783026) study. Patients with PsA treated with APR had improvements in both clinical indices and objective MRI indices of inflammation assessed by PsA MRI Score in the target hand at week 24 and week 48, confirming an effect of APR on clinical and inflammatory manifestations of PsA. No significant structural progression was observed.
Mease et al (0510) reported the impact of bimekizumab (BKZ) in patients with axSpA on key patient-reported symptoms (spinal pain, stiffness, and fatigue) through BE MOBILE 1 (nr-axSpA) and 2 (r-axSpA) RCTs. At week 16, BKZ-randomized patients achieved greater improvements in mean nocturnal and total spinal pain (nominal), and BASDAI morning stiffness (nominal) vs PBO (all p< 0.001). Mean scores were further improved to week 52 among BKZ-randomized patients and patients who switched from PBO to BKZ at week 16 (PBO/BKZ). At week 52, these improvements were similar across BKZ-randomized and PBO/BKZ patients. At week 16, BKZ-randomized pts achieved greater improvements in FACIT-F scores vs PBO (mean CfB [nominal p value]: nr-axSpA: 8.5 vs 3.9 [< 0.001]; r-axSpA: 8.4 vs 5.0 [0.015]; LSMD: nr-axSpA: 4.2; r-axSpA: 2.2) with similar improvements at week 52 among BKZ-randomized and PBO/BKZ pts (mean CfB: nr-axSpA: 10.9 vs 9.2; r-axSpA: 9.9 vs 9.5)..
Harroon et al (0524) evaluated acute anterior uveitis (AAU) flares rate in patients with axSpA who are at high risk of recurrent uveitis (≥2 AAU flares in total; ≥1 in the year before baseline) when treated with certolizumab pegol (CZP; 89 patients) compared with standard non-biologic care (66 patients) in an open-label, multicenter study (C-VIEW study; NCT03020992) during the 48-week follow-up period. The mean number of AAU flares (mean ± standard deviation) was significantly lower (p< 0.001) with CZP (0.42±0.81) than in the matched comparator population (1.3±1.47). In the final model after inverse probability weighting (IPW), there was an 87% reduction in AAU flares (p≤0.001) associated with CZP treatment. This matched control study supports the benefit of CZP over standard non-biologic treatment in reducing anterior uveitis flares among high-risk patients with axSpA, highlighting its potential as a promising therapeutic option in managing this debilitating ocular manifestation in axSpA.
ABOUT THE AUTHOR
Bayram Farisogullari
Bayram is a consultant rheumatologist in Turkey. He is currently doing a clinical research fellowship at University College London in London, UK.
Bayram’s major interests are spondyloarthritis, myositis, patient-reported outcomes, particularly fatigue and musculoskeletal ultrasound.
Bayram is a member of the Social Media Sub-Committee.