Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
Authors
Kay, JonathanFleischmann, Roy
Keystone, Edward
Hsia, Elizabeth C.
Hsu, Benjamin
Zhou, Yiying
Goldstein, Neil
Braun, Jurgen
UMass Chan Affiliations
Division of Rheumatology, Department of MedicineDocument Type
Journal ArticlePublication Date
2016-12-01Keywords
ADVERSE EVENTSANTITUMOR NECROSIS FACTOR
CLINICAL TRIAL
LYMPHOMA
MALIGNANCY
TUBERCULOSIS
Amino Acids, Peptides, and Proteins
Clinical Trials
Immune System Diseases
Musculoskeletal Diseases
Pharmaceutical Preparations
Rheumatology
Skin and Connective Tissue Diseases
Therapeutics
Metadata
Show full item recordAbstract
OBJECTIVE: Assess 5-year golimumab (GOL) safety in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). METHODS: Subcutaneous (SC) GOL (50 mg or 100 mg every 4 weeks) was evaluated in phase 3 trials of patients with active RA, PsA, and AS. Safety data through Year 5 were pooled across 3 RA trials [1 each evaluating methotrexate (MTX)-naive, MTX-experienced, and antitumor necrosis factor (TNF)-experienced patients], 1 PsA trial, and 1 AS trial. Data summarized was derived from both placebo-controlled (through weeks 24-52) and uncontrolled study periods. For adverse events (AE) of special interest [serious infections (SI), opportunistic infections (OI), deaths, malignancies, demyelination, tuberculosis (TB)], incidence per 100 patient-years (pt-yrs) was determined. RESULTS: Across all trials, 639 patients received placebo and 2228 received SC GOL 50 mg only (n = 671), 50 mg and 100 mg (n = 765), or 100 mg only (n = 792). Safety followup extended for averages of 28.5 and 203.2 weeks for placebo and GOL, respectively. Respective placebo and GOL AE incidence/100 pt-yrs (95% CI) through Year 5 were 4.86 (2.83-7.78) and 3.29 (2.92-3.69) for SI, 0.00 (0.00-0.86) and 0.23 (0.14-0.35) for TB, 0.00 (0.00-0.86) and 0.22 (0.13-0.34) for OI, 0.00 (0.00-0.86) and 0.10 (0.05-0.20) for lymphoma, 0.00 (0.00-0.86) and 0.08 (0.03-0.17) for demyelination, and 0.29 (0.01-1.59) and 0.41 (0.29-0.57) for death. TB, OI, lymphoma, and demyelination incidence appeared to be higher among patients receiving GOL 100 mg only. CONCLUSION: SC GOL safety through Year 5 remained consistent with previously reported Year 3 findings and with other TNF antagonists. Numerically higher incidences of TB, OI, lymphoma, and demyelination were observed with 100 mg versus 50 mg. Clinicaltrials.gov identifiers: NCT00264537 (GO-BEFORE), NCT00264550 (GO-FORWARD), NCT00299546 (GO-AFTER), NCT00265096 (GO-REVEAL), and NCT00265083 (GO-RAISE).Source
J Rheumatol. 2016 Dec;43(12):2120-2130. Epub 2016 Nov 1. Link to article on publisher's site
DOI
10.3899/jrheum.160420Permanent Link to this Item
http://hdl.handle.net/20.500.14038/40178PubMed ID
27803138Related Resources
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Free online via JRheum Full Release option.ae974a485f413a2113503eed53cd6c53
10.3899/jrheum.160420