Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis
Open Access
- 23 June 2016
- journal article
- research article
- Published by BMJ in Annals Of The Rheumatic Diseases
- Vol. 76 (2), 414-417
- https://doi.org/10.1136/annrheumdis-2016-209322
Abstract
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.Funding Information
- AbbVie
This publication has 21 references indexed in Scilit:
- Clinical, Functional, and Radiographic Benefits of Longterm Adalimumab Plus Methotrexate: Final 10-year Data in Longstanding Rheumatoid ArthritisThe Journal of Rheumatology, 2013
- Clinical, functional and radiographic consequences of achieving stable low disease activity and remission with adalimumab plus methotrexate or methotrexate alone in early rheumatoid arthritis: 26-week results from the randomised, controlled OPTIMA studyAnnals Of The Rheumatic Diseases, 2012
- Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn's diseaseAnnals Of The Rheumatic Diseases, 2012
- Risk of skin and soft tissue infections (including shingles) in patients exposed to anti-tumour necrosis factor therapy: results from the British Society for Rheumatology Biologics RegisterAnnals Of The Rheumatic Diseases, 2012
- Teratogen update: MethotrexateBirth Defects Research Part A: Clinical and Molecular Teratology, 2012
- Altered expression of microRNA‐203 in rheumatoid arthritis synovial fibroblasts and its role in fibroblast activationArthritis & Rheumatism, 2010
- Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritisArthritis Care & Research, 2010
- Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid arthritis especially in the first 6 months of treatment: updated results from the British Society for Rheumatology Biologics Register with special emphasis on risks in the elderlyRheumatology, 2010
- Better data needed from pregnancy registriesBirth Defects Research Part A: Clinical and Molecular Teratology, 2009
- Pregnancy in rheumatology patients exposed to anti-tumour necrosis factor (TNF)- therapyRheumatology, 2006