PMID- 27338778 OWN - NLM STAT- MEDLINE DCOM- 20170531 LR - 20220316 IS - 1468-2060 (Electronic) IS - 0003-4967 (Print) IS - 0003-4967 (Linking) VI - 76 IP - 2 DP - 2017 Feb TI - Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. PG - 414-417 LID - 10.1136/annrheumdis-2016-209322 [doi] AB - BACKGROUND: Adalimumab has been used in patients with moderately to severely active rheumatoid arthritis (RA) for over 10 years and has a well-established safety profile across multiple indications. OBJECTIVE: To update adverse events (AEs) of special interest from global adalimumab clinical trials in patients with RA. METHODS: This analysis includes 15 132 patients exposed to adalimumab in global RA clinical trials. AEs of interest included overall infections, laboratory abnormalities and AEs associated with influenza vaccination. Pregnancy outcome data were collected from the Adalimumab Pregnancy Registry. RESULTS: Serious infections and tuberculosis occurred at a rate of 4.7 and 0.3 events/100 patient-years, respectively. Two patients experienced hepatitis B reactivation. No significant laboratory abnormalities were reported with adalimumab-plus-methotrexate compared with placebo-plus-methotrexate. Influenza-related AEs occurred in 5% of vaccinated patients compared with 14% of patients not vaccinated during the study. Relative risk of major birth defects and spontaneous abortions in adalimumab-exposed women were similar between that of unexposed women with RA and healthy women. CONCLUSIONS: This analysis confirms and expands the known safety profile of adalimumab and reports no additional safety risk of laboratory abnormalities, hepatitis B reactivation and pregnancy outcomes, including spontaneous abortions and birth defects. The benefits of influenza vaccination are reinforced. TRIAL REGISTRATION NUMBERS: NCT00195663, NCT00195702, NCT00448383, NCT00049751, NCT00234845, NCT00650390, NCT00235859, NCT00647920, NCT00649545, NCT00647491, NCT00649922, NCT00538902, NCT00420927, NCT00870467, NCT00650156, NCT00647270, NCT01185288, NCT01185301. CI - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/. FAU - Burmester, Gerd R AU - Burmester GR AD - Department of Rheumatology and Clinical Immunology, Charite-University Medicine Berlin, Free University and Humboldt University of Berlin, Berlin, Germany. FAU - Landewe, Robert AU - Landewe R AD - Clinical Immunology and Rheumatology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands. FAU - Genovese, Mark C AU - Genovese MC AD - Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA. FAU - Friedman, Alan W AU - Friedman AW AD - Immunology Clinical Development, AbbVie, North Chicago, Illinois, USA. FAU - Pfeifer, Nathan D AU - Pfeifer ND AD - Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, Illinois, USA. FAU - Varothai, Nupun A AU - Varothai NA AD - Data and Statistical Sciences, AbbVie, North Chicago, Illinois, USA. FAU - Lacerda, Ana P AU - Lacerda AP AD - Immunology Clinical Development, AbbVie, North Chicago, Illinois, USA. LA - eng SI - ClinicalTrials.gov/NCT00538902 SI - ClinicalTrials.gov/NCT00234845 SI - ClinicalTrials.gov/NCT00650156 SI - ClinicalTrials.gov/NCT00650390 SI - ClinicalTrials.gov/NCT00195663 SI - ClinicalTrials.gov/NCT00649545 SI - ClinicalTrials.gov/NCT00649922 SI - ClinicalTrials.gov/NCT00049751 SI - ClinicalTrials.gov/NCT00235859 SI - ClinicalTrials.gov/NCT01185301 SI - ClinicalTrials.gov/NCT00195702 SI - ClinicalTrials.gov/NCT01185288 SI - ClinicalTrials.gov/NCT00420927 SI - ClinicalTrials.gov/NCT00870467 SI - ClinicalTrials.gov/NCT00647491 SI - ClinicalTrials.gov/NCT00647270 SI - ClinicalTrials.gov/NCT00647920 SI - ClinicalTrials.gov/NCT00448383 PT - Journal Article DEP - 20160623 PL - England TA - Ann Rheum Dis JT - Annals of the rheumatic diseases JID - 0372355 RN - 0 (Antirheumatic Agents) RN - 0 (Influenza Vaccines) RN - FYS6T7F842 (Adalimumab) SB - IM CIN - Ann Rheum Dis. 2020 Dec;79(12):e166. PMID: 30787005 MH - Abortion, Spontaneous/*epidemiology MH - Adalimumab/*administration & dosage MH - Adult MH - Aged MH - Antirheumatic Agents/*adverse effects MH - Arthritis, Rheumatoid/*drug therapy/epidemiology MH - Clinical Trials as Topic MH - Congenital Abnormalities/*epidemiology MH - Female MH - Hepatitis B/*epidemiology/etiology/immunology MH - Herpes Zoster/epidemiology/etiology/immunology MH - Humans MH - Immunocompromised Host/immunology MH - Incidence MH - Influenza Vaccines/therapeutic use MH - Influenza, Human/*epidemiology/etiology/immunology/prevention & control MH - Male MH - Middle Aged MH - Opportunistic Infections/epidemiology/etiology/immunology MH - Pregnancy MH - Pregnancy Outcome/epidemiology MH - Tuberculosis/*epidemiology/etiology/immunology MH - Virus Activation/immunology PMC - PMC5284339 OTO - NOTNLM OT - *Anti-TNF OT - *Rheumatoid Arthritis OT - *Vaccination COIS- GRB has received research grants, consulting fees and speaker's fees from AbbVie, BMS, Merck, Pfizer, Roche and UCB. RL has received consulting fees from AbbVie, Amgen, BMS, Centocor, GSK, Merck, Novartis, Pfizer, Roche, Schering-Plough, UCB and Wyeth and is owner of Rheumatology Consultancy BV. MCG has received research grants and consulting fees from AbbVie. AWF, NDP and APL are employees of AbbVie and may hold stock and/or options. NV is a former employee of AbbVie and may hold stock and/or options. EDAT- 2016/06/25 06:00 MHDA- 2017/06/01 06:00 PMCR- 2017/01/31 CRDT- 2016/06/25 06:00 PHST- 2016/02/02 00:00 [received] PHST- 2016/04/25 00:00 [revised] PHST- 2016/05/27 00:00 [accepted] PHST- 2016/06/25 06:00 [pubmed] PHST- 2017/06/01 06:00 [medline] PHST- 2016/06/25 06:00 [entrez] PHST- 2017/01/31 00:00 [pmc-release] AID - annrheumdis-2016-209322 [pii] AID - 10.1136/annrheumdis-2016-209322 [doi] PST - ppublish SO - Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.