Adalimumab long-term safety: Infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis

Annals of the Rheumatic Diseases

Volumn 76, Issue 2, 2017, Pages 414-417

  Burmester, Gerd R ^a   Landewé, Robert ^b   Genovese, Mark C ^c   Friedman, Alan W ^d   Pfeifer, Nathan D ^d   Varothai, Nupun A ^d   Lacerda, Ana P ^d  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b UNIVERSITY OF AMSTERDAM   (Netherlands)

^c STANFORD UNIVERSITY   (United States)

^d ABBVIE INC   (United States)

Author keywords

Anti TNF; Rheumatoid Arthritis; Vaccination

Indexed keywords

ADALIMUMAB; APOLIPOPROTEIN A1; APOLIPOPROTEIN B; CHOLESTEROL; HEMOGLOBIN; HIGH DENSITY LIPOPROTEIN; INFLUENZA VACCINE; LIPOPROTEIN; LOW DENSITY LIPOPROTEIN; ANTIRHEUMATIC AGENT;

ABNORMAL LABORATORY RESULT; ANEMIA; ARTICLE; ATYPICAL MYCOBACTERIOSIS; BACTERIAL ARTHRITIS; CELLULITIS; COCCIDIOIDOMYCOSIS; COHORT ANALYSIS; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; DRUG SAFETY; ESOPHAGUS CANDIDIASIS; FEMALE; HEPATITIS B; HUMAN; INFECTION; INFLUENZA; INFLUENZA VACCINATION; MAJOR CLINICAL STUDY; OPPORTUNISTIC INFECTION; PNEUMONIA; PREGNANCY OUTCOME; RHEUMATOID ARTHRITIS; SEPSIS; SIDE EFFECT; TUBERCULOSIS; ABORTION, SPONTANEOUS; ADULT; AGED; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL (TOPIC); CONGENITAL ABNORMALITIES; HERPES ZOSTER; IMMUNOCOMPROMISED PATIENT; IMMUNOLOGY; INCIDENCE; INFLUENZA, HUMAN; MALE; MIDDLE AGED; OPPORTUNISTIC INFECTIONS; PREGNANCY; VIRUS ACTIVATION;

ABORTION, SPONTANEOUS; ADALIMUMAB; ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; CLINICAL TRIALS AS TOPIC; CONGENITAL ABNORMALITIES; FEMALE; HEPATITIS B; HERPES ZOSTER; HUMANS; IMMUNOCOMPROMISED HOST; INCIDENCE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; OPPORTUNISTIC INFECTIONS; PREGNANCY; PREGNANCY OUTCOME; TUBERCULOSIS; VIRUS ACTIVATION;

EID: 84979080260     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2016-209322     Document Type: Article

References (21)

1. National Center for, Immunization Respiratory, Diseases. General recommendations on immunization-recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2011;60:1-64.
2. Schiff MH, Burmester GR, Kent JD, et al. Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. Ann Rheum Dis 2006;65:889-94.
3. Briggs GG, Polifka J, Research Committee, Organization of Teratology Information Specialists. Better data needed from pregnancy registries. Birth Defects Res Part A Clin Mol Teratol 2009;85:109-11.
4. Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum 2006;54:26-37.
5. Kavanaugh A, Fleischmann RM, Emery P, et al. 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 study. Ann Rheum Dis 2013;72:64-71.
6. Keystone EC, Kavanaugh AF, Sharp JT, et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum 2004;50:1400-11.
7. Keystone EC, van der Heijde D, Kavanaugh A, et al. Clinical, functional, and radiographic benefits of longterm adalimumab plus methotrexate: final 10-year data in longstanding rheumatoid arthritis. J Rheumatol 2013;40:1487-97.
8. Hyoun SC, Običan SG, Scialli AR. Teratogen update: methotrexate. Birth Defects Res Part A Clin Mol Teratol 2012;94:187-207.
9. Galloway JB, Hyrich KL, Mercer LK, et al. 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 elderly. Rheumatology (Oxford) 2011;50:124-31.
10. Kay J, Fleischmann R, Keystone E, et al. Golimumab 3-year safety update: an analysis of pooled data from the long-term extensions of randomised, double-blind, placebo-controlled trials conducted in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis. Ann Rheum Dis 2015;74:538-46.
11. Listing J, Strangfeld A, Kary S, et al. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum 2005;52:3403-12.
12. Weinblatt ME, Bathon JM, Kremer JM, et al. Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis. Arthritis Care Res (Hoboken) 2011;63:373-82.
13. Burmester GR, Panaccione R, Gordon KB, et al. 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 disease. Ann Rheum Dis 2013;72:517-24.
14. Winthrop KL, Baddley JW, Chen L, et al. Association between the initiation of anti-tumor necrosis factor therapy and the risk of herpes zoster. JAMA 2013;309:887-95.
15. Galloway JB, Mercer LK, Moseley A, et al. 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 Register. Ann Rheum Dis 2013;72:229-34.
16. Zisman D, Bitterman H, Shalom G, et al. Psoriatic arthritis treatment and the risk of herpes zoster. Ann Rheum Dis 2016;75:131-5.
17. Burmester GR, Kivitz AJ, Kupper H, et al. Efficacy and safety of ascending methotrexate dose in combination with adalimumab: the randomised CONCERTO trial. Ann Rheum Dis 2015;74:1037-44.
18. Humira [package insert]. North Chicago, IL, USA: AbbVie, 2014.
19. Berthelot JM, De Bandt M, Goupille P, et al. Exposition to anti-TNF drugs during pregnancy: outcome of 15 cases and review of the literature. Joint Bone Spine 2009;76:28-34.
20. Diav-Citrin O, Otcheretianski-Volodarsky A, Shechtman S, et al. Pregnancy outcome following gestational exposure to TNF-alpha-inhibitors: a prospective, comparative, observational study. Reprod Toxicol 2014;43:78-84.
21. Roux CH, Brocq O, Breuil V, et al. Pregnancy in rheumatology patients exposed to anti-tumour necrosis factor (TNF)-alpha therapy. Rheumatology (Oxford) 2007;46:695-8.