PMID- 26663412 OWN - NLM STAT- MEDLINE DCOM- 20170719 LR - 20220409 IS - 2151-4658 (Electronic) IS - 2151-464X (Linking) VI - 68 IP - 8 DP - 2016 Aug TI - Comparative Risk of Harm Associated With the Use of Targeted Immunomodulators: A Systematic Review. PG - 1078-88 LID - 10.1002/acr.22815 [doi] AB - OBJECTIVE: To systematically compare the risk of adverse events (AEs) for 13 targeted immunomodulators (TIMs) indicated for ankylosing spondylitis (AS), inflammatory bowel diseases, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis (PsA), or rheumatoid arthritis (RA). METHODS: We searched electronic databases through July 2015 to retrieve randomized controlled trials (RCTs) and observational studies comparing AEs between 2 or more TIMs head-to-head. We reported on the following outcomes: number of AEs, discontinuation due to AEs, serious AEs, mortality, serious infections, tuberculosis, herpes zoster, and malignancies. We qualitatively synthesized the literature and conducted random-effects meta-analyses if 3 or more studies provided data for an outcome. RESULTS: Ten head-to-head RCTs and 51 observational studies were included in this systematic review. A majority of the studies (70%) were conducted in RA patients. Risk of treatment discontinuation due to AEs was higher with infliximab than with adalimumab or etanercept in RA, PsA, and AS. A higher risk for serious infections was noted with infliximab than with abatacept, adalimumab, or etanercept in RA. Risk for treatment discontinuation due to AEs, serious infections, and tuberculosis was lower with etanercept than with adalimumab in RA. Limited evidence suggested no comparative differences in risk for mortality, malignancies, and herpes zoster for adalimumab, etanercept, and infliximab in RA. CONCLUSION: Important differences were noted in the safety profile of TIMs in RA, generally favoring abatacept, adalimumab, and etanercept over infliximab. Head-to-head comparative evidence for other TIMs and non-RA populations was insufficient to draw conclusions for most of the safety outcomes. CI - (c) 2016, American College of Rheumatology. FAU - Desai, Rishi J AU - Desai RJ AD - Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. FAU - Thaler, Kylie J AU - Thaler KJ AD - Danube University, Krems, Austria. FAU - Mahlknecht, Peter AU - Mahlknecht P AD - Danube University, Krems, Austria. FAU - Gartlehner, Gerald AU - Gartlehner G AD - Danube University, Krems, Austria, and RTI International, Research Triangle Park, North Carolina. FAU - McDonagh, Marian S AU - McDonagh MS AD - Pacific Northwest Evidence-Based Practice Center, Oregon Health & Science University, Portland, Oregon. FAU - Mesgarpour, Bita AU - Mesgarpour B AD - Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran. FAU - Mazinanian, Alireza AU - Mazinanian A AD - Danube University, Krems, Austria. FAU - Glechner, Anna AU - Glechner A AD - Danube University, Krems, Austria. FAU - Gopalakrishnan, Chandrasekar AU - Gopalakrishnan C AD - Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. FAU - Hansen, Richard A AU - Hansen RA AD - Harrison School of Pharmacy, Auburn University, Auburn, Alabama. LA - eng PT - Comparative Study PT - Journal Article PT - Review PT - Systematic Review PL - United States TA - Arthritis Care Res (Hoboken) JT - Arthritis care & research JID - 101518086 RN - 0 (Immunologic Factors) SB - IM MH - Arthritis, Juvenile/drug therapy MH - Arthritis, Psoriatic/drug therapy MH - Arthritis, Rheumatoid/drug therapy MH - Humans MH - Immune System Diseases/*drug therapy MH - Immunologic Factors/*adverse effects MH - Inflammatory Bowel Diseases/drug therapy MH - Observational Studies as Topic MH - Psoriasis/drug therapy MH - Randomized Controlled Trials as Topic MH - Spondylitis, Ankylosing/drug therapy EDAT- 2015/12/15 06:00 MHDA- 2017/07/20 06:00 CRDT- 2015/12/15 06:00 PHST- 2015/03/27 00:00 [received] PHST- 2015/12/07 00:00 [revised] PHST- 2015/12/08 00:00 [accepted] PHST- 2015/12/15 06:00 [entrez] PHST- 2015/12/15 06:00 [pubmed] PHST- 2017/07/20 06:00 [medline] AID - 10.1002/acr.22815 [doi] PST - ppublish SO - Arthritis Care Res (Hoboken). 2016 Aug;68(8):1078-88. doi: 10.1002/acr.22815.