SAN DIEGO — A combination of infliximab and oral methotrexate effectively treated patients with IBD, according to data presented at the 2012 Digestive Disease Week Annual Meeting.
Researchers reviewed data from 706 patients at the IBD clinic at the University of Washington in Seattle who were on either infliximab monotherapy (n=323), infliximab combined with other immunosuppressants (n=323) or infliximab and 7.5 mg oral methotrexate (n=60) administered weekly. The participants’ Harvey-Bradshaw Index (HBI) and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores were collected to measure disease severity, and tests for Human Anti-Chimeric Antibody (HACA) and serum infliximab levels were performed if patients reported symptoms that indicated poor or no response to treatment.
In the group receiving infliximab, 2.8% were tested for HACA and infliximab serum levels, compared with 3.0% in both the methotrexate and other immunosuppressant concomitant therapy groups. One of every nine patients in the monotherapy group had a positive HACA test compared with zero patients in the dual therapy groups. Average serum levels were 26.8 mcg/mL for the infliximab monotherapy group, 26.6 mcg/mL for the immunosuppressant group and 20.0 mcg/mL for the oral methotrexate group. All serum levels in the methotrexate group were in therapeutic range, and no patients developed antibodies.
The mean HBI score was lowest for the methotrexate group (2.5) compared with the immunosuppressant (4.8) and monotherapy (4.6) groups, and the mean SIBDQ score was highest in the methotrexate group (54.0) compared with the monotherapy (49.7) and immunosuppressant (51.3) groups.
“We were able to previously demonstrate that oral methotrexate is safe and tolerable, and now we are able to demonstrate that it also has good efficacy compared to other concomitant therapy,” Anita Afzali, MD, MPH, University of Washington in Seattle, told Healio.com. “It has minimal adverse effects, and even at a low dose of 7.5 mg weekly it’s able to do its job along with the biologic agents.” Afzali added that ongoing study is being conducted with a larger sample size to further evaluate the efficacy, safety and tolerability of the treatment.
For more information:
- Afzali A. #Tu1309: Assessment of the Efficacy of Oral Methotrexate in Conjunction with Infliximab Therapy for the Treatment of Inflammatory Bowel Disease (IBD). Presented at: the 2012 Digestive Disease Week Annual Meeting; May 19-22, San Diego.