December 2022 to March 2023
Authors: Juan C Sarmiento-Monroy
Petri M et al (doi: 10.1016/S0140-6736(22)02546-6) assessed the efficacy and safety of baricitinib (BARI) in 775 adult patients with active SLE in a phase 3 study (SLE-BRAVE-II). The primary endpoint was the proportion of patients with an SRI-4 response at week 52 in the BARI 4 mg treatment group compared with placebo. There was no difference in the primary efficacy outcome of the proportion of SRI-4 responders at week 52 between participants who received BARI 4mg (121 [47%]; OR 1·07 [95% CI 0·75 to 1·53]), 2 mg (120 [46%]; 1·05 [0·73 to 1·50]; 0·8 [–7·9 to 9·4]) and placebo (116 [46%]). No new safety signals were observed.
Solomon JJ et al (doi: 10.1016/S2213-2600(22)00260-0) reported the results of the TRAIL1 study, a randomised, double-blind, placebo-controlled, phase 2 trial which evaluated the efficacy and safety of pirfenidone in 123 patients with RA-ILD. The primary endpoint was the incidence of the composite endpoint of a decline from baseline in FVC% of 10% or more or death during the 52-week treatment period. The trial was stopped early due to slow recruitment and the COVID-19 pandemic and did not meet the composite primary endpoint. Compared with the placebo group, patients in the pirfenidone group had a slower rate of decline in lung function, measured by estimated annual change in absolute FVC (-66 vs. -146; p=0·0082) and FVC% (-1.02 vs. -3.21; p=0·0028).
Santos Hoff L et al (doi: 10.1007/s00296-022-05229-7) in the COVAD Study (a self-reported online global survey, n=10,900) found that patients with idiopathic inflammatory myopathies (IIMs) reported fewer COVID-19 cases than healthy controls (HCs) and other systemic autoimmune and inflammatory diseases, but had higher odds of all-cause hospitalization from COVID-19 than HCs ([23 (30%) vs. 59 (8%), OR 2.5, 95% CI 1.2-5.1 before vaccination, and 3 (18%) vs. 9 (5%), OR 2.6, 95% CI 1.3-5.3 in vaccine breakthrough infections]).
Merola JF et al (doi: 10.1016/S0140-6736(22)02303-0) assessed the efficacy and safety of bimekizumab (a monoclonal IgG1 antibody that selectively inhibits interleukin 17F and IL-17A) in 400 adult-onset psoriatic arthritis patients at BE COMPLETE trial (phase 3, multicentre, randomised, double-blind, placebo-controlled). 116 (43%) of 267 patients receiving bimekizumab reached ACR50, compared with 9 (7%) of 133 patients receiving placebo (aOR=11·1 [95% CI 5·4-23·0], p<0·0001). Bimekizumab treatment led to superior improvements in joint and skin efficacy outcomes at week 16 compared with placebo in patients with psoriatic arthritis and inadequate response or intolerance to TNFα inhibitors. The safety profile of bimekizumab was consistent with previous studies.
Pombo-Suárez M et al (doi: 10.1002/msc.1684) evaluated the golimumab retention rate during up to 8 years of follow up in a retrospective analysis of the BIOBADASER (Spanish registry of biological drugs) database. Among 885 patients (RA 267, axial SpA 370, PsA 248) receiving 944 cycles of golimumab, the retention rate of golimumab was 71.1% (95% CI: 68.0-73.9) at one year, and 37.7% (95% CI: 33.3-42.1) at year 8. In Cox regression analysis, factors associated with golimumab retention included use as first-line therapy (HR for discontinuation 1.52 for second- and 1.79 for third/later-line vs. first-line), use in axial SpA or PsA rather than RA (HR for axial SpA vs. RA 0.59, for PsA vs. RA 0.67), and treatment with concomitant methotrexate (HR 0.67).
Juan C Sarmiento-Monroy
Juan C. is a Rheumatologist and clinical research fellow at the Hospital Clinic of Barcelona. His main research interests include the validation of biomarkers in RA-ILD and the development of digital tools for patients with SLE. Juan C. is a member of the EMEUNET Newsletter Sub-Committee.