Frequency of real-world reported adverse drug reactions in rheumatoid arthritis patients

Abstract

Objectives: To describe the cumulative incidences of adverse drug reactions (ADRs) associated with disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients from real-world data (RWD), using the DREAM-RA registry, and to compare these with incidence frequencies mentioned in the Summary of Product Characteristics (SmPC). Methods: All ADRs in patients with recorded use of adalimumab, etanercept, hydroxychloroquine, leflunomide, oral and subcutaneous methotrexate, and sulfasalazine from a single center participating in the DREAM-RA registry (n = 1,098 patients) that were directly sent to the Netherlands Pharmacovigilance Center Lareb were assessed. Cumulative incidences were calculated, described and compared to the most recently revised SmPCs. Results: In total, 14 ADRs (≥5 case reports) associated with the use of one of the included DMARDs were reported with a higher estimated cumulative incidence compared to the SmPC. For hydroxychloroquine and sulfasalazine, 5 ADRs (≥5 case reports) mentioned with an 'unknown' incidence in the SmPC were reported as 'common' in this study. Conclusions: Although ADR data in the DREAM-RA registry were partly comparable with data in the SmPCs, RWD from this patient registry provided an added value to the currently available information on the incidences of ADRs associated with DMARDs in RA patients as described in SmPCs.

Off‐Label Use of Hydroxychloroquine in COVID‐19: Analysis of Reports of Suspected Adverse Reactions From the Italian National Network of Pharmacovigilance

“…Although there was no difference in patients’ mean age, in the 2 periods studied, a sex difference was identified. In line with literature, 48,49 in a COVID‐19 setting, ADRs were reported more frequently in men, consistent with the higher risk of severe disease and death in men than in women 50 but during HCQ label use, more frequently in women, in agreement with female predominance of autoimmune diseases 51,52 …”

“…In line with literature, 48,49 in a COVID-19 setting, ADRs were reported more frequently in men, consistent with the higher risk of severe disease and death in men than in women 50 but during HCQ label use, more frequently in women, in agreement with female predominance of autoimmune diseases. 51,52 The percentage of serious and nonserious reports in the 2 periods analyzed was comparable, and no differences in outcomes were appreciated, except for pandemic ADRs that resolved with sequelae or were fatal.…”

Gastrointestinal Adverse Drug Reaction Profile of Etanercept: Real-world Data From Patients and Healthcare Professionals

“…In addition, all ADRs that had been registered between 2003 and 2015 were retrospectively forwarded to Lareb. 18 All patients had given written consent before inclusion in the registries, including data assessments by Lareb. In the DREAM registries, no additional data, other than data collection in routine development of SpA-Net registry; and received consulting fees and speaker fees from Novartis.…”

“…The DREAM-RA and SpA-Net registries collect real-world data in participating hospitals on quality of care, including both clinical aspects and patient-reported outcomes, with the aim to monitor and evaluate safety and effectiveness of rheumatic treatment in daily clinical practice. 16,17,18 All clinically verified ADRs that are captured in these registries are forwarded directly to Lareb. 19 Because little is known about the frequency and characteristics of GI-ADRs with ETN treatment, we aimed to describe the profile of GI-ADRs associated with ETN using the systematically collected patient-reported data from the Dutch Biologic Monitor and the HCP-registered and clinically verified data from the DREAM-RA and SpA-Net registries.…”

Traditional Chinese Medicine Qingre Huoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis: A Multicenter, Double-Blind, Randomized Controlled Trial

“…Methotrexate (MTX) is the anchor drug ( Pincus et al, 2003 ) while hydroxychloroquine (HCQ) is mainly used in combination treatment regimens (95%) ( Zhang et al, 2013 ); the utilization rates of these drugs are 55.9 and 30.4%, respectively, ( Jin et al, 2017 ). However, MTX and HCQ have adverse effects such as gastrointestinal discomfort (e.g., nausea and diarrhea) ( Giraud et al, 2020 ), hepatitis, interstitial pneumonitis, cytopenias, and retinopathy ( Abbasi et al, 2019 ); as such, the vast majority of RA patients in China are willing to receive TCM treatment ( Lu et al, 2019 ).…”