Anti-TNF safe in older patients with ulcerative colitis

SAN DIEGO — Despite having a higher frequency of infections and adverse events, older patients with ulcerative colitis are not at increased risk for anti-TNF treatment-related complications, according to research presented at Digestive Disease Week.

Kelly Cushing, MD, of the University of Michigan, said that older and younger patients with IBD tend to experience similar complications, but they are not always treated the same way.

“Older patients are much less likely to be prescribed anti-TNF therapy,” she said in her presentation. “This hesitation may be secondary to fear of increased adverse events, such as infection and malignancy, or relative contra-indications, such as recent malignancy or high-comorbidity.”

Researchers used pooled data from four randomized controlled trials to determine the comparative safety and efficacy of anti-TNF (Remicade [infliximab, Janssen], or Simponi [golimumab, Janssen]) in older patients compared with younger patients with UC. Of 2,257 patients in the four studies, 231 were aged at least 60 years.

The primary outcome of the study was adverse events, including death, life-threatening event, hospitalization, infection or neoplasm during follow-up. Efficacy outcomes included clinical remission — defined as total Mayo score 2 or less or partial Mayo score of 2 or less with no sub-score greater than 1 — during induction and maintenance arms.

Cushing and colleagues found that a higher percentage of older patients experienced serious adverse events, hospitalizations and infections compared with younger patients. However, fewer older patients treated with anti-TNF experienced events in these categories compared with older patients who received placebo. Older patients treated with anti-TNF did, however, have a higher risk for developing neoplasm compared with younger patients and older patients who received placebo.

After accounting for this interaction, researchers found that age greater than 60 years was not associated with an incremental increase in likelihood of adverse events or treatment-related complications.

In their efficacy analysis, investigators determined that older patients had a reduced treatment effect vs. placebo after induction (relative OR = 0.69; 95% CI, 0.53–0.89) not after maintenance.

“Baseline risk of serious adverse events are higher in older patients compared to younger patients with UC,” Cushing concluded. “However, the incremental risks of anti-TNF therapy with infliximab or golimumab were similar between older and younger patients.” – by Alex Young

Reference:

Nemer KC, et al. Abstract 208. Presented at: Digestive Disease Week; May 18-21, 2019; San Diego.

Disclosures: Cushing reports no relevant financial disclosures. Please see the meeting disclosure index for all other authors’ relevant financial disclosures.