Baricitinib remains safe, effective in RA at 8.4 years
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A long-term safety study of baricitinib for rheumatoid arthritis, with more than 13,000 patient-years of exposure, found no increase in safety issues for up to 8.4 years, according to a speaker at ACR Convergence.
“This [study] added to prior integrated safety analyses of baricitinib by reporting on additional years of exposure,” Kevin Winthrop, MD, MPH, of the Oregon Health & Science University, in Portland, told Healio Rheumatology. “The highlight was that event rates are staying stable or going down over time, including the important stuff like venous thromboembolism and serious infection events.”
To provide an update on the safety profile of baricitinib (Olumiant, Eli Lilly & Co.) among patients with RA for up to 8.4 years of treatment, Winthrop and colleagues assessed data from nine randomized trials. These included one phase 1, three phase 2 and five phase 3 trials — all completed — and one ongoing long-term extension study. The researchers calculated incidence rates per 100 patients-years of exposure for all participants treated with at least one dose of baricitinib through Sept. 1, 2019. This group was identified as the “all-bari-RA analysis set.”
Winthrop and colleagues also determined incidence rates for deep vein thrombosis and pulmonary embolism, as well as both conditions together, for groups of participants receiving 2 mg or 4 mg of baricitinib within the all-bari-RA set. Meanwhile, major adverse cardiovascular events were assessed in the phase 3 trials and in the long-term extension. Incidence rates for serious infections were analyzed by age group through week 24 for patients who received either placebo or 4 mg of baricitinib in seven phase 2 or 3 trials —identified as the “bari-RA-PC analysis set” — as well as within the all-bari-RA set.
Events of interest within all-bari-RA were assessed over time in 48-month intervals. To account for aging within the cohort, incidence rates for death and malignancy — excluding non-melanoma skin cancer — were directly standardized to the WHO world population 2000-2025 within each time interval.
In all, Winthrop and colleagues analyzed data on 3,770 patients treated with baricitinib, representing 13,148 patient-years of exposure, with a median and maximum exposure of 4.2 and 8.4 years, respectively.
According to the researchers, overall incidence rates per 100 patient-years of exposure were 25.8 for any treatment-emergent adverse event and 7.2 for serious adverse events — including death. Within the all-bari-RA set, incidence rates for the participants while receiving 2 mg or 4 mg of baricitinib, respectively, were 0.4 (95% CI, 0.2-0.7) and 0.3 (95% CI, 0.2-0.4) for deep vein thrombosis, 0.3 (95% CI, 0.1-0.6) and 0.3 (95% CI, 0.2-0.4) for pulmonary embolism, and 0.5 (95% CI, 0.2-0.8) and 0.5 (95% CI, 0.3-0.6) for both conditions.
The all-bari-RA set also demonstrated serious-infection incidence rates of 2.1 (95% CI, 1.9-2.4) for those aged younger than 65 years and 4.8 (95% CI, 4-5.7) for those aged 65 years and older.
Meanwhile, in the bari-RA-PC set, serious-infection incidence rates for the placebo and 4 mg baricitinib groups, respectively, were 3.1 (95% CI, 1.6-5.4) and 3.3 (95% CI, 1.8-5.6) among those younger than 65 years, and 9.9 (95% CI, 4-20.4) and 7 (95% CI, 2.6-15.2) in those aged 65 years or older.
Incidence rates for major adverse cardiovascular events, deep vein thrombosis and pulmonary embolism, and non-melanoma skin cancer (NMSC) remained stable over time, according to the researchers. In addition, Winthrop and colleagues observed no increases in the rates of death or non-NMSC malignancy, after adjusting for aging. Incidence rates cross safety topics were consistent with previous analyses, they wrote.
“Of most interest to me was the evaluation of serious infection events in those older than 65 years versus those younger,” Winthrop said. “No big surprise here, as the incidence was roughly double for the elderly. We see higher rates among elderly RA patients as compared to younger RA patients in general, as well as with all therapies. This highlights the importance of age as a risk factor for serious infection events. This is life.”
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Winthrop K. Abstract 0202. Presented at: ACR Convergence 2020; November 5-9, 2020 (virtual meeting).
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