PMID- 31196653 OWN - NLM STAT- MEDLINE DCOM- 20200514 LR - 20200514 IS - 1879-114X (Electronic) IS - 0149-2918 (Linking) VI - 41 IP - 7 DP - 2019 Jul TI - Impact of Adverse Events Associated With Medications in the Treatment and Prevention of Rheumatoid Arthritis. PG - 1376-1396 LID - S0149-2918(19)30197-3 [pii] LID - 10.1016/j.clinthera.2019.04.030 [doi] AB - PURPOSE: Treatments for rheumatoid arthritis (RA) over the last few decades have transformed the future outlook of the disease. Although patients with clinically apparent RA have a number of therapeutic options, all are associated with the risk of adverse events (AEs). Such therapeutics, facilitated by the identification of novel biomarkers and environmental and genetic factors to predict RA, may allow early detection, prompt treatment, and prevention before the future development of clinically apparent disease. Before choosing such treatments to make informed decisions in this context, however, accurate quantification of benefits and harms of such treatments is vital for participants without symptoms. This review summarizes the AEs reported in trials in preclinical or very early RA, the frequency and risk of primary AEs of concern associated with disease-modifying antirheumatic drugs (conventional, biologic, and targeted), glucocorticoids, and analgesia in clinically apparent RA. Also summarized is the evidence to date to support the quantification of benefit and harms incorporating patient preferences. METHODS: This analysis is a narrative review in which individual searches were performed in PubMed and EMBASE for each drug and topic outlined in the review. FINDINGS: Current therapies in RA can result in a considerable burden of AEs (serious and nonserious) depending on the individual's baseline risk. The absolute risk of serious AEs to treatments reported in individuals at risk of RA, undifferentiated, or very early inflammatory arthritis trials was low; however, nonserious AEs were not consistently reported. If such therapies prove effective at preventing the onset of RA in high-risk patients, incorporating patient preferences as well as robust quantification of benefits and harms to inform decisions is imperative. Patients' perceptions about treatment in this context may be risk averse or benefit driven. The risk of AEs that may not reverse after drug cessation, such as serious infection and malignancy, seem to be important AEs in such decision-making. IMPLICATIONS: The impact of AEs in response to potentially preventative treatment is an important consideration for individuals at high risk of developing RA with minimal symptoms. Robust quantification of treatment effect given baseline risk versus the risks of developing all AEs (including those that may affect quality of life), while incorporating participants' views, will be necessary for future informed decision-making. CI - Copyright (c) 2019. Published by Elsevier Inc. FAU - Costello, Ruth AU - Costello R AD - Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester, United Kingdom. FAU - David, Trixy AU - David T AD - Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester, United Kingdom. FAU - Jani, Meghna AU - Jani M AD - Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester, United Kingdom; Department of Rheumatology, Salford Royal NHS Foundation Trust, Salford, United Kingdom. Electronic address: meghna.jani@manchester.ac.uk. LA - eng GR - 21755/VAC_/Versus Arthritis/United Kingdom GR - DH_/Department of Health/United Kingdom PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Review DEP - 20190610 PL - United States TA - Clin Ther JT - Clinical therapeutics JID - 7706726 RN - 0 (Antirheumatic Agents) SB - IM MH - Antirheumatic Agents/*adverse effects/pharmacology/therapeutic use MH - Arthritis, Rheumatoid/*drug therapy/prevention & control MH - Drug-Related Side Effects and Adverse Reactions MH - Humans MH - Quality of Life MH - Randomized Controlled Trials as Topic OTO - NOTNLM OT - NSAIDs OT - adverse events OT - biologics OT - disease-modifying antirheumatic drug OT - glucocorticoids OT - rheumatoid arthritis EDAT- 2019/06/15 06:00 MHDA- 2020/05/15 06:00 CRDT- 2019/06/15 06:00 PHST- 2019/02/07 00:00 [received] PHST- 2019/03/28 00:00 [revised] PHST- 2019/04/10 00:00 [accepted] PHST- 2019/06/15 06:00 [pubmed] PHST- 2020/05/15 06:00 [medline] PHST- 2019/06/15 06:00 [entrez] AID - S0149-2918(19)30197-3 [pii] AID - 10.1016/j.clinthera.2019.04.030 [doi] PST - ppublish SO - Clin Ther. 2019 Jul;41(7):1376-1396. doi: 10.1016/j.clinthera.2019.04.030. Epub 2019 Jun 10.