biostudies-literatureMalm EParker Institute, Bispebjerg and Frederiksberg HospitalOak Foundatione049850https://www.ebi.ac.uk/biostudies/studies/S-EPMC8422485biostudies-literatureUnknown11(9)<h4>Introduction</h4>Inflammatory arthritis (IA) conditions, including rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, are characterised by inflammatory infiltration of the joints. Biological disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), respectively, reduce the effects of proinflammatory cytokines and immune cells to ameliorate disease. However, immunosuppression can be associated with high rates of serious adverse events (SAEs), including serious infections, and maybe an increased risk of malignancies and cardiovascular events. Currently, there is no empirical evidence on the extent to which contextual factors and risk of bias (RoB) domains may modify these harm signals in randomised trials.BMJ openRisk of harm in synthetic and biological intervention trials in patients with inflammatory arthritis: protocol for a metaepidemiological study focusing on contextual factors.PMC8422485OCAY-18-774-OFILMalm ETaylor PCBerg JIoannidis JPAKristensen LENielsen SMSmolen JSChristensen RTarp SEllingsen TFurst DfalseRisk of harm in synthetic and biological intervention trials in patients with inflammatory arthritis: protocol for a metaepidemiological study focusing on contextual factors.<h4>Introduction</h4>Inflammatory arthritis (IA) conditions, including rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, are characterised by inflammatory infiltration of the joints. Biological disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), respectively, reduce the effects of proinflammatory cytokines and immune cells to ameliorate disease. However, immunosuppression can be associated with high rates of serious adverse events (SAEs), including serious infections, and maybe an increased risk of malignancies and cardiovascular events. Currently, there is no empirical evidence on the extent to which contextual factors and risk of bias (RoB) domains may modify these harm signals in randomised trials.2021-01-01T00:00:00Z2021 Sep2026-05-08T12:53:04.813Z2025-06-01T00:11:32.468ZS-EPMC84224853448928610.1136/bmjopen-2021-049850