Elderly With UC Are Likely to Experience Adverse Events from Treatment

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Elderly patients with ulcerative colitis (UC) are more likely to experience an adverse event from tofacitinib treatment than their younger counterparts, according to a new study presented at the Advances in Inflammatory Bowel Diseases Annual Meeting.

This analysis is indicative of the safety and efficacy of tofacitinib demonstrated in previous phase 2 and 3 induction studies and a 52-week phase 3 maintenance study. There is also an ongoing, open-label, long-term extension study.

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For the study, the researchers measured the occurrence of adverse events within both a maintenance cohort—participants who received 5 mg or 10 mg tofacitinib twice daily or placebo—and overall cohort—all participants treated with tofacitinib in the phase 2 and 3 studies as well as the ongoing study, as of December 2016.

Among the elderly in the placebo group, 83.3% had experienced an adverse event compared with 74.4% of the younger participants. Among the elderly participants in the tofacitinib-treated group, 80% had experienced an adverse event compared with 75.5% of the younger participants.

Elderly participants had higher rates of serious and severe adverse events, as well as discontinuation rates due to adverse events.

Multivariate analyses showed that older age was associated with increased opportunistic infections and herpes zoster risk. However, no significant difference was found in the rate of serious infections or non-melanoma skin cancer.

“Although this is consistent with the general population, due to the small number of patients aged 65 years or older (fewer than 10% of the total), these findings should be interpreted with caution,” the researchers concluded.

—Colleen Murphy

Reference:

Lichtenstein G, Bressler B, Chan G, et al. Assessment of age as a risk factor for adverse events in patients from the tofacitinib ulcerative colitis clinical program. Paper presented at: Advances in Inflammatory Bowel Diseases; December 13-15, 2018; Orlando, FL. https://www.consultant360.com/meeting-materials/assessment-age-risk-factor-adverse-events-patients-tofacitinib-ulcerative-colitis. Accessed November 27, 2018.