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| Biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs) are well-known for increasing the risk of serious infections (SI). Few studies conducted in real-world setting directly compared the incidence rate (IR) of serious bacterial, viral or opportunistic infection in rheumatoid arthritis (RA) patients with tofacitinib (TOF) versus other biologic DMARDs: abatacept (ABA), adalimumab (ADA), certolizumab (CER), etanercept (ETA), golimumab (GOL), infliximab (INF) and tocilizumab (TCZ). The results indicated that TOF had a higher risk for the composite endpoint of SIs as compared to the other biologics. Results were presented at the 2019 American College of Rheumatology (ACR) / The Association of Rheumatology Professionals (ARP) Annual Meeting held in Atlanta, Georgia. | ||||||||||||||||
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| Data was analyzed from 3 U.S. healthcare claims databases: Medicare (2012-2015), Optum (2012-2017) and MarketScan (2012-2017). This analysis included RA patients aged ≥18 years who initiated TOF or another biologic DMARD without any prior use of biologics or Janus kinase (JAK) inhibitors. Based on the inpatient principal diagnosis code, the primary outcome was a composite endpoint of SIs that included bacterial, viral or opportunistic infection and secondary outcomes were specific subtypes of SIs. Through propensity score (PS)-based inverse probability treatment weighting, >70 potential confounders in each database were adjusted, including demographics, prior DMARD and antibiotic use, comorbidities, other medications and healthcare utilization. The as-treated analysis measured follow-up time from the day after entry until the earliest of treatment discontinuation, switching to any biologic other than index therapy, nursing home admission, death, disenrollment or the end of study period. Using an inverse variance-weighted, fixed-effects meta-analysis, the combined estimates from 3 databases were derived. A total of 123,960 biologic initiators were identified across 3 databases, of which 4.5% were TOF initiators. | ||||||||||||||||
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| The median follow-up time (days) ranged from 164 (Optum) to 182 (MarketScan) with a total occurrence of 2,958 SI events. The IR for SIs per 100 person-years (PYs) ranged from 2.80 (MarketScan) to 7.89 (Medicare) in the TOF group and adjusted hazard ratios (HRs) showed a higher risk of composite SIs in TOF compared to ABA (HR 1.20), ETA (1.27), GOL (1.35) and TCZ (1.46). However, a similar risk was shown when compared to ADA, CER and INF. When comparing serious bacterial infections, the risk was higher in TOF than ABA, CER, ETA and GOL. Moreover, secondary analyses showed consistent findings. Risk of incidence serious infection associated with initiating TOF vs other biologics |
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SI risk of TOF when compared with different biologics
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In this multi-database cohort study of RA patients, initiating TOF as the first biologic or targeted synthetic DMARD therapy, resulted in a higher risk for the composite endpoint of SIs when compared to ABA, ETA, GOL and TCZ. A higher risk of serious bacterial infection, pneumonia, herpes zoster and skin and soft tissue infections was also observed in TOF when compared to several other biologics. |
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