@article {Kay2120, author = {Jonathan Kay and Roy Fleischmann and Edward Keystone and Elizabeth C. Hsia and Benjamin Hsu and Yiying Zhou and Neil Goldstein and J{\"u}rgen Braun}, title = {Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis}, volume = {43}, number = {12}, pages = {2120--2130}, year = {2016}, doi = {10.3899/jrheum.160420}, publisher = {The Journal of Rheumatology}, abstract = {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{\textendash}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{\textendash}7.78) and 3.29 (2.92{\textendash}3.69) for SI, 0.00 (0.00{\textendash}0.86) and 0.23 (0.14{\textendash}0.35) for TB, 0.00 (0.00{\textendash}0.86) and 0.22 (0.13{\textendash}0.34) for OI, 0.00 (0.00{\textendash}0.86) and 0.10 (0.05{\textendash}0.20) for lymphoma, 0.00 (0.00{\textendash}0.86) and 0.08 (0.03{\textendash}0.17) for demyelination, and 0.29 (0.01{\textendash}1.59) and 0.41 (0.29{\textendash}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).}, issn = {0315-162X}, URL = {https://www.jrheum.org/content/43/12/2120}, eprint = {https://www.jrheum.org/content/43/12/2120.full.pdf}, journal = {The Journal of Rheumatology} }