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Anti-TNF persistence lower among women with IBD
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Higher rates of side effects lead to lower drug persistence of anti-TNF therapy among women with inflammatory bowel disease, according to study results.
Herma H. Fidder, of the department of gastroenterology and hepatology at University Medical Centre Utrecht, in the Netherlands, and colleagues wrote that patient-specific factors, like the ones they identified, can help physicians make important clinical decisions.
“Female sex has been associated with lower persistence of TNF alpha inhibitor therapy in psoriasis, psoriatic arthritis and rheumatoid arthritis,” they wrote. “In [Crohn’s disease] an association between female sex and discontinuation of [Humira (adalimumab, AbbVie)] has been reported. However, it is presently not clear whether female sex is also associated with earlier discontinuation of TNF alpha inhibitor therapy in general, and if this association exists among all IBD patients, ie, CD as well as [ulcerative colitis].”
Researchers performed a retrospective analysis using data from 539 patients with IBD (49.9% men) who underwent anti-TNF therapy and had at least 12 months of follow-up. They used patient and clinical data, as well as reasons for anti-TNF discontinuation to evaluate factors associated with discontinuation.
The patients in the study had 631 treatment episodes (2,280 anti-TNF treatment years), and 289 discontinuations of therapy. Investigators determined that female sex (adjusted HR = 1.42; 95% CI, 1.16–1.74), greater age at start of therapy per decade (aHR = 1.15; 95% CI, 1.04–1.27) and dose escalation (aHR = 3.74; 95% CI, 2.78–5.02) were associated with anti-TNF discontinuation.
Female sex was also associated with side effects (aHR = 4.05; 95% CI, 2.36–6.98) but no other reasons for discontinuation. Fidder and colleagues wrote that previous trials of anti-TNF therapy have not identified sex-related differences in efficacy or side effects.
“However, follow-up in these trials was relatively short, potentially leading to an underestimation of side effects, especially the long-term immune-mediated side effects,” they wrote.
Additionally, researchers found that adalimumab and Simponi (golimumab, Janssen) use were associated with increased risk for discontinuation (HR = 1.7; 95% CI, 1.11–2.6 and HR = 4.97; 95% CI, 2.3–10.74, respectively) compared with Remicade (infliximab, Janssen). Dose escalation was associated with secondary loss of response (HR = 7.71; 95% CI, 5.28–11.26) but no other reasons for discontinuation.
Fidder and colleagues wrote that their findings could help clinicians take a more personalized approach to treating women with IBD.
“Increasing awareness in doctors and educating female patients about the side effects could potentially contribute to a reduction in drug discontinuation, although this remains to be shown in prospective studies,” they wrote. “Additionally, we would recommend future clinical trials and post-clinical marketing studies to give special attention to possible sex-based differences in treatment outcomes.” – by Alex Young
Disclosures: Fidder reports consulting for AbbVie, Ferring, Janssen and Takeda. Please see the full study for all other authors’ relevant financial disclosures.
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