Although splenectomy is still considered the most effective curative treatment for immune thrombocytopenia (ITP), its use has significantly declined in the last decade, especially since the approval of thrombopoietin receptor agonists (TPO-RAs).The main objective of the study was to determine whether splenectomy was still as effective nowadays, particularly for patients with failure to respond to TPO-RAs.Our secondary objective was to assess, among patients who relapsed after

We saw an increase in this condition related to emergence of Streptococcus pneumoniae serotype 23B.

Introduction Published data on the safety of biologics other than tumor necrosis factor (TNF) inhibitors during pregnancy are limited. Objective The aim was to detect pharmacovigilance signals for fetal and neonatal adverse drug reactions (ADRs) to biologics taken by pregnant women with autoimmune diseases. Methods We performed a disproportionality analysis of the World Health Organization’s VigiBase ® pharmacovigilance database from 1968 to June 1, 2021. Data were collected in June 2021. By using terms for different hierarchical levels of the Medical Dictionary for Regulatory Activities, we selected the following fetal or neonatal ADRs: stillbirth, premature birth, low birth weight, small for gestational age, and congenital malformations. The frequency of all identified ADRs for biologics of interest (adalimumab, infliximab, golimumab, certolizumab, etanercept, anakinra, canakinumab, tocilizumab, sarilumab, ustekinumab, guselkumab, secukinumab, ixekizumab, belimumab, abatacept, and rituximab) was compared with that of all other reports for all other drugs and quoted as the reporting odds ratio (ROR) [95% confidence interval]. Reports with known concomitant use of teratogenic drugs were excluded from the main analysis. Other analyses included ROR stratifications by therapeutic indication in the periods 1968–2021 and 2001–2021, and an analysis after excluding reports with steroids. Results In the main analysis, the RORs were particularly high for musculoskeletal malformations with anakinra (7.18 [3.50–14.73]), canakinumab (19.54 [12.82–29.79]), and abatacept (5.09 [2.77–9.33]), and for immune system disorders with canakinumab (347.88 [217.9–555.50]) and rituximab (9.27 [2.95–29.15]). After the exclusion of reports with steroids, the ROR was significant for neonatal infections with belimumab (28.49 [5.75–141.25]). Conclusion We identified possible associations with some adverse fetal and neonatal outcomes, suggesting that vigilance is required when prescribing certain biologics during pregnancy. Supplementary Information The online version contains supplementary material available at 10.1007/s40259-022-00564-4.

Background To determine whether the use of disease‐modifying antirheumatic drugs (DMARDs) is linked to the risk of COVID‐19 among patients with inflammatory rheumatic diseases (IRDs). Methods We performed a disproportionality analysis of the World Health Organization pharmacovigilance database between January 1, 2020, and June 10, 2020. The frequency of COVID‐19 reports for all DMARD classes identified was compared with that for all other reports for all other drugs and quoted as the reporting odds ratio (ROR) (95% confidence interval [CI]). Results Among 980,446 individual case‐safety reports voluntarily recorded in the database, 398 identified COVID‐19 in DMARD‐treated patients with IRDs. There were 177 (44.5%) patients with rheumatoid arthritis (RA), 120 (30.1%) with ankylosing spondylitis (AS), 93 (23.4%) with psoriatic arthritis (PsA), and 8 (2.0%) with juvenile idiopathic arthritis. Most of the cases of COVID‐19 occurred in patients taking anti‐TNF agents (84.2%), resulting in a significant disproportionality signal (ROR [95% CI]: 8.31 [7.48–9.23]) – particularly in patients with RA, AS or PsA. A significant inverse disproportionality was found for the anti‐IL‐6 agent tocilizumab (ROR [95% CI]: 0.12 [0.02–0.88]) and JAK inhibitors (ROR [95% CI]: 0.33 [0.19–0.58]) in patients with RA – suggesting that these two drug classes are safer in the context of RA. Conclusion Our results are in line with the literature on a potentially better safety profile for anti‐IL‐6 agents and JAK inhibitors. The WHO pharmacovigilance data suggest that COVID‐19 is significantly more frequent in patients with IRDs treated with TNF inhibitors.

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