Laure Gossec

The aim of the study was to assess the contemporary frequency of adverse pregnancy outcomes in women with rheumatoid arthritis (RA) and to identify associated factors. This French prospective multicentre cohort included pregnant women with RA between 2015 and 2021. Maternal characteristics, disease activity, treatments and pregnancy outcomes were analysed. Outcomes of pregnancies in women with RA were compared in univariable analysis with those of matched general population women from the 2016 and 2021 French perinatal surveys assessing maternal and neonatal health. Multivariable logistic regressions were performed to identify factors associated with adverse outcomes. A total of 100 pregnancies in 90 women with RA were analysed. Mean maternal age was 33.7±5.0 years and 57.6% were nulliparous. During pregnancy, 46% received glucocorticoids and 39% biologic disease-modifying antirheumatic drugs. Compared with the 359 controls from the general population, preterm birth (OR 2.08, 95% CI 1.04 to 4.09) and small for gestational age (SGA) (OR_{SGA 10th percentile} 2.11, 95% CI 1.12 to 3.94; OR_{SGA 3rd percentile} 3.21, 95% CI 1.13 to 9.44) rates were higher in RA pregnancies. SGA was associated with nulliparity (adjusted OR (aOR) 4.38, 95% CI 1.12 to 9.78), whereas preterm birth was associated with maternal age (aOR 1.14, 95% CI 1.01 to 1.30) and exposure to glucocorticoids at doses ≥10 mg/day during pregnancy (aOR 4.91, 95% CI 1.30 to 10.59). In this contemporary cohort mostly followed in tertiary care centres, pregnancies in women with RA remained at increased risk of preterm birth and SGA. Exposure to systemic glucocorticoids at doses ≥10 mg/day emerged as a risk factor for preterm birth, although a contribution of maternal disease activity cannot be entirely excluded.

Objective: To assess the 3-year effect of bimekizumab on health status, work productivity, and productivity-related costs in patients with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA). Methods: BE MOBILE 1 ( ClinicalTrials.gov : NCT03928704 ) and BE MOBILE 2 ( NCT03928743 ), phase III trials in axSpA, and BE OPTIMAL ( NCT03895203 ) and BE COMPLETE ( NCT03896581 ), phase III trials in PsA, evaluated subcutaneous bimekizumab 160 mg every 4 weeks. Patients who completed these studies were eligible to enter the open-label extension studies BE MOVING ( NCT04436640 ; axSpA) or BE VITAL ( NCT04009499 ; PsA). Outcomes are reported by indication for observed cases among patients originally randomized to placebo or bimekizumab through year 3. These included changes in health status (EQ-5D-3L and the EQ visual analog scale [VAS; 0-100]), work productivity (Work Productivity and Activity Impairment Questionnaire–Specific Health Problem v2.0 [WPAI-SHP]), and annualized productivity cost savings associated with improvements in work impairment. Results: Among 586 patients with axSpA and 1112 patients with PsA, mean EQ VAS scores improved by 20.2-21.3 points in axSpA and 17.1-17.3 points in PsA from baseline to year 3. At year 3, most patients reported clinically meaningful improvements in work impairment (axSpA: 74.2-81.1%; PsA: 71.2-71.3%) and achieved an acceptable work state, defined by WPAI-SHP presenteeism < 40% (axSpA: 83.7-84.2%; PsA: 84.1-87.2%). In the US, productivity cost savings (in US dollars) were sustained to year 3 ($22,012.14-22,549.32 in axSpA, and $13,327.60-16,428.25 in PsA); similar trends were observed in Europe and Japan. Conclusion: Bimekizumab demonstrated sustained improvements in health status and work productivity to year 3 across axSpA and PsA. Health status was comparable to population norms at year 3. Productivity cost savings from reduced work impairment were observed, reflecting a reduced economic and social burden of axSpA and PsA.

Objectives: Data regarding progression from oligoarticular to polyarticular psoriatic arthritis (PsA) are sparse. Using FOREMOST, we identify progression predictors and evaluate apremilast’s treatment effect in early PsA. Methods: FOREMOST (NCT03747939) randomised N = 308 patients with early (mean duration, 9.9 months) PsA and limited joint involvement (>1 to ≤ 4 swollen and >1 to ≤ 4 tender joints; not confirmed by imaging) to apremilast or placebo for 24 weeks, followed by open-label apremilast through week 48. Multivariable logistic regression modelled predictors of progression from oligoarticular (≤4 active [swollen and/or tender] joints) to polyarticular (>4 active joints) PsA at week 16 and the effect of apremilast. Disease progression, disease activity, clinical signs/symptoms, and tolerability were summarized through week 48 for N = 291 patients receiving ≥1 apremilast dose (from randomization or switched from placebo). Results: Most (268/308 [87.0%]) patients had oligoarticular PsA at baseline; 25.1% (59/235) progressed to polyarticular PsA by week 16 (data as observed). Apremilast reduced odds of progression vs placebo by 58% (Odds Ratio [OR; 95% CI]: 0.42 [0.22, 0.77]). In placebo-treated patients, being female, being csDMARD-naïve, and having dactylitis significantly increased odds of progression (OR: 3.35 [1.20, 9.34], 3.42 [1.18, 9.93], and 9.26 [1.32, 65.09], respectively). Apremilast treatment for up to 48 weeks maintained low rates of disease progression and improvements in disease activity/clinical signs and symptoms, with no new safety signals. Conclusion: Initiating apremilast treatment during the early, oligoarticular phase of PsA reduced disease activity and delayed progression to polyarticular disease, with benefits maintained with up to 48 weeks of treatment. Trial Registration: ClinicalTrials.gov; NCT03747939