Some indicators of suboptimal response included discontinuation of anti-TNF therapy for patients with ulcerative colitis and IBD-related hospitalization for patients with Crohn’s disease.
While anti-tumor necrosis factor (anti-TNF) treatments do show efficacy in treating patients with inflammatory bowel disease (IBD), but many patients do not have an adequate response.
A team, led by Ji Li, Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, evaluated the incidence and indicators of suboptimal responses to first-line anti-TNF treatment in patients with either ulcerative colitis or Crohn’s disease in a subgroup of mainland China residents.
IBD rates have increased in China in recent years.
In the retrospective chart review of the EXPLORE study, the investigators examined 287 adult patients with IBD at 10 centers who initiated anti-TNF therapy between March 2010 and March 2015. Of the patient population, 72% were male, 35 had ulcerative colitis and 252 had Crohn’s disease. The median observational period was 27.6 months for patients with ulcerative colitis and 40 months for patients with Crohn’s disease.
The team assessed the cumulative incidence of suboptimal responses to first-line anti-TNF therapy over 24 months using the Kaplan-Meier method.
Some of the indicators of suboptimal responses were dose escalation, discontinuation, augmentation with non-biologic therapy, or IBD-related surgery or hospitalization. They also conducted a survey with participating physicians at site initiation to identify some of the barriers to anti-TNF use.
The investigators found 45.7% (n = 16) of patients with ulcerative colitis and 48.8% (n = 123) of patients with Crohn’s disease experienced a suboptimal response to first-line anti-TNF therapy at any point during the observation period.
At the 1 and 2 year mark following anti-TNF initiation, the cumulative incidence of suboptimal response was 51.4% and 75.7% for patients with ulcerative colitis and 45.4% and 57% for patients with Crohn’s disease.
The median time to first suboptimal response was 7.2 months for patients with ulcerative colitis and 14.3 months for patients with Crohn’s disease.
There were various indicators identified for suboptimal response, including discontinuation of anti-TNF therapy for patients with ulcerative colitis (56.3%; n = 9) and IBD-related hospitalization for patients with Crohn’s disease (56.1%; n = 69) followed by augmentation with non-biologic therapy for both cohorts (ulcerative colitis: 31.3%; n = 5; Crohn’s disease: 22.8%; n = 28).
On the other hand, dose escalation was the least frequent indicator of suboptimal response to anti-TNF therapy for Crohn’s disease (3.3%; n = 4). However, it was not found to be an indicator for ulcerative colitis.
The cumulative incidence of suboptimal response within 4 months of first-line anti-TNF therapy was over 30%, regardless of IBD type.
In the physician surveys, the investigators found financial reasons and reimbursement were the most common barriers to prescribing an anti-TNF therapy.
“Over one-half of patients with IBD are at risk of experiencing a suboptimal response to first-line anti-TNF therapy at 2 years post-initiation in China,” the authors wrote. “This study highlights a substantial unmet need associated with anti-TNF therapies in China.”
The study, “Indicators of suboptimal response to anti-tumor necrosis factor therapy in patients from China with inflammatory bowel disease: results from the EXPLORE study,” was published online in BMC Gastroenterology.