Older age a risk factor for AEs during ulcerative colitis treatment
Older patients receiving treatment for ulcerative colitis (UC) were more likely to experience adverse events (AEs) compared with their younger counterparts, according to a study presented at AIBD 2018.
“In the tofacitinib UC [clinical] program, AE rates were higher among patients aged ≥65 years vs those aged <65 years, regardless of whether they received tofacitinib or placebo,” said lead author Dr Gary Lichtenstein from the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, Pennsylvania, US.
Two cohorts from the tofacitinib UC clinical program were analysed in this study, which consisted of patients with UC, stratified by age (≥65 vs <65 years), who were given tofacitinib 5 or 10 mg twice/day or placebo in a phase III study (maintenance cohort) or tofacitinib 10 mg twice/day for 8 weeks in phase II/III induction and maintenance studies and tofacitinib 5 or 10 mg twice/day for ≥12 months in an OLE* study (overall cohort). AEs including serious infections, opportunistic infections, herpes zoster, malignancies (excluding NMSC**), NMSC, MACE***, and gastrointestinal perforations were assessed. [AIBD 2018, abstract P034]
In the maintenance cohort, tofacitinib-treated patients aged ≥65 years showed a higher rate of AEs than those aged <65 years (80.0 percent vs 75.5 percent), specifically serious AEs (16.7 percent vs 4.4 percent) and severe AEs (10.0 percent vs 7.1 percent), and treatment discontinuation due to AEs (16.7 percent vs 8.8 percent).
Similarly, placebo-treated patients aged ≥65 years in the maintenance cohort had a higher rate of AEs than those aged <65 years (83.3 percent vs 74.4 percent), serious AEs (11.1 percent vs 6.1 percent), severe AEs (11.1 percent vs 9.4 percent), and AE-related treatment discontinuation (22.2 percent vs 18.3 percent).
In the overall cohort, the rates of AEs, serious AEs, and severe AEs were also higher among tofacitinib recipients aged ≥65 vs <65 years (88.3 percent vs 81.7 percent, 19.5 percent vs 14.3 percent, and 15.6 percent vs 12.2 percent, respectively).
In addition, compared with those aged <65 years, patients aged ≥65 years in the overall cohort had a higher rate of opportunistic infections (3.9 percent vs 1.7 percent), herpes zoster (14.3 percent vs 5.0 percent), malignancies (2.6 percent vs 0.6 percent), NMSC (5.3 percent vs 0.7 percent), and MACE (2.6 percent vs 0.2 percent).
There was no difference between those aged ≥65 and <65 years in the overall cohort with regard to serious infections (2.6 percent vs 2.9 percent) or gastrointestinal perforation (0.0 percent vs 0.4 percent).
The increased risk for opportunistic infections and herpes zoster with increasing age (hazard ratio [HR], 1.53 and HR, 1.58 for every 10 years of age, respectively), “was consistent with the general population,” Lichtenstein noted.
He highlighted that caution is warranted in interpreting the results of this study, primarily due to a relatively small number of patients aged ≥65 years, which was only more than 10 percent of the total study population.
*OLE: Open-label, long-term extension study
**NMSC: Nonmelanoma skin cancer
***MACE: Major adverse cardiovascular events