In patients with rheumatoid arthritis (RA) who are being treated with a biologic disease-modifying antirheumatic drug (bDMARD) with and without denosumab, serious and opportunistic infections are uncommon, according to the results of a retrospective cohort study recently published in The Journal of Rheumatology.
In this study, researchers sought to compare the incidence of infections in patients with RA (n=308) treated between July 2010 and July 2014 with denosumab plus a bDMARD (concurrent group; n=102) vs denosumab alone (biologic-alone group; n=206). All study participants were followed from the time of drug initiation (index date) until the conclusion of the study or loss to follow-up; cases of serious or opportunistic infections were noted.
The primary study outcome was the occurrence of serious infections during the follow-up period. A serious infection was described as either hospitalization for ≥24 hours associated with a primary diagnosis of infection or an emergency department visit associated with a primary diagnosis of infection and treatment with ≥1 courses of intravenous antibiotics. The secondary outcome was the occurrence of opportunistic infections.
In the concurrent and biologic-alone groups, 3 and 4 serious infections were recorded, respectively, with 1 opportunistic infection recorded in the latter group. The rates of serious or opportunistic infections were 1.22 per 100 patient-years (95% CI, 0.25-3.56) in the concurrent group vs 0.98 per 100 patient-years (95% CI, 0.32-2.29) in the biologic-alone group (rate difference, 0.24; P =.77).
Pneumonia was the most common type of infection reported. All participants with serious or opportunistic infections in both groups recovered; no deaths were reported.
These findings are consistent with findings reported in prior cohort studies and offer further evidence on the safety of concurrent bDMARD and denosumab therapy. Additional studies with larger cohorts are warranted. The researchers concluded that showed that this study indicates that “in a real-world setting, the occurrence of serious infections was low in patients with RA treated concurrently with a bDMARD and denosumab, and in patients treated with a bDMARD alone.”
Lau AN, Wong-Pack M, Rodjanapiches R, et al. Occurrence of serious infection in patients with rheumatoid arthritis treated with biologics and denosumab observed in a clinical setting [published online November 15, 2017]. J Rheumatol. doi:10.3899/jrheum.161270