In the treatment of rheumatic and musculoskeletal diseases (RMDs), there is a need for feasible measures of patient-reported bother (impact on life and cumulative burden) from side effects and the benefit-harm-balance. Berthelsen et al. evaluated what with RMDs considered important to know about symptomatic side effects they may experience from a new prescription drug.

June 2024

Goldman, et al. conducted a pharmacovigilance study to evaluate the cardiovascular safety of JAK inhibitors in RA patients. The study demonstrated an increase in the reporting of VTE, stroke, and ischemic heart disease in patients treated with JAK inhibitor compared to bDMARDs, especially within the first year of treatment. This suggests a class effect of JAK inhibitors on cardiovascular risk, emphasising the need for ongoing surveillance and proactive cardiovascular risk management.

FitzGerald, et al. found that Deucravacitinib significantly impacted biomarkers associated with TYK2 signalling pathways of key inflammatory cytokines, including IL-23 and Type I IFN, and those related to collagen matrix turnover.

May 2024

Efficacy and safety of bimekizumab in the treatment of psoriatic arthritis: A systematic review and meta-analysis

Expert Opin Drug Saf 2024;23:1–9 doi: 10.1080/14740338.2024.2343017 Epub ahead of print

Bimekizumab was superior to placebo in achieving ACR, MDA, and PASI outcomes and had an acceptable safety profile. This meta-analysis also showed that 160mg and 320mg doses of bimekizumab were both superior to placebo in achieving these outcome measures.

The 5-year benefit-risk profile for upadacitinib in RA remains favourable, with clinical outcomes improved or maintained through Week 260. No new safety findings were identified during the LTE. Results remained consistent with earlier analyses of SELECT-NEXT.

Risk of composite CV endpoints combining all ischaemic CV events and heart failure were similar for individual and combined TOF doses versus TNFi. The totality of CV risk (MACE-8 plus VTE) was higher with TOF 10mg twice daily versus TNFi. Buch et al conducted a post-hoc analysis on the ORAL Surveillance trial to assess risk across extended MACE endpoints in RA patients treated with either TOF 5mg, TOF 10mg, or TNFi.

April 2024

Risankizumab therapy was associated with significant and sustained improvement in multiple disease domains from Week 52 through Week 100, compared with placebo. Kristensen et al. investigated the safety, efficacy and tolerability of 100-week risankizumab therapy in PsA patients with previous inadequate response to ≥1 csDMARD, using data from KEEPsAKE 1 trial.

Risk of venous thromboembolism with tofacitinib versus tumor necrosis factor inhibitors in cardiovascular risk-enriched rheumatoid arthritis patients

Arthritis Rheumatol 2024 doi: 10.1002/art.42846 Epub ahead of print https://pubmed.ncbi.nlm.nih.gov/38481002/

This post hoc analysis of ORAL Surveillance showed that incidence of venous thromboembolism (VTE) events was higher in patients with RA treated with tofacitinib (10>5mg BID) versus TNFi. Across treatments, VTE risk factors (age, BMI, and VTE history) were aligned with previous studies in the general RA population.

The results of the meta-analysis show that TNFi, IL-17i, and JAK inhibitor treatments significantly improved sacroiliac joint SPARCC scores in patients with axSpA or AS at Weeks 12–16. However, there were no significant differences in mean improvement between the treatment groups.

March 2024

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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