For patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis, the 5-year safety data of 50-mg and 100-mg golimumab remained consistent with its 3-year results, according to a recently published study.
Jonathan Kay, MD, in the Division of Rheumatology at the University of Massachusetts Medical School and a Healio Rheumatology Board member, and colleagues evaluated the safety of 50-mg or 100-mg subcutaneous golimumab (Simponi, Janssen) per 4 weeks across three rheumatoid arthritis (RA) trials, one psoriatic arthritis trial and one ankylosing spondylitis trial. For the three RA trials, one each evaluated patients who were methotrexate-naïve, methotrexate-experienced or anti-tumor necrosis factor-experienced. Overall, 639 patients received placebo; 671 patients received 50-mg golimumab; 792 patients received 100-mg golimumab; and 765 patients received both. The average follow-up was 28.5 weeks for placebo — which the researchers cited as a limitation — and 203.2 weeks for golimumab. Researchers determined 100-year incidence rates for death, malignancy, demyelination, tuberculosis, serious infection and opportunistic infection.
Compared with placebo, golimumab overall had lower 100-year incidence rates for serious infection (4.86 vs. 3.29). However, it had slightly higher incidence rates for death (0.29 vs. 0.41), malignancy (0 vs. 0.1), demyelination (0 vs. 0.08), tuberculosis (0 vs 0.23) and opportunistic infection (0 vs 0.22). When split between dose, the higher incidence of malignancy, demyelination, tuberculosis and opportunistic infection was only present in the 100-mg group. When adjusting for follow-up duration, investigators found none of these higher incidences remained significant.
In the 100-mg group, there was a higher incidence of malignancy through 5 years, as well as an increase in malignancy duration (12.7 vs. 7.6 years) and DAS28 (6.2 vs. 5.7), compared with other patients with RA.
These safety results remained consistent with the 3-year findings, as well as with other anti-tumor necrosis factor antagonists, the researchers wrote. However, they noted the malignancy rate needs to continue to be monitored.
“While lymphoma is a known, albeit infrequent, [adverse event] AE that was observed in these studies that were not powered to detect statistical significance of the differential rates of rare AE across dose groups, the potential development of lymphoma with higher doses of [golimumab] GOL requires continued pharmacovigilance,” the researchers wrote. – by Will Offit
Disclosure: The researchers report no relevant financial disclosures.