Combination Biologics or Small Molecules vs Biologic Monotherapy in IBD

The following article is a part of conference coverage from the 2019 Advances in Inflammatory Bowel Diseases (AIBD) Meeting, being held in Orlando, Florida. The team at MPR will be reporting on the latest news and research conducted by leading experts gastroenterology. Check back for more from the 2019 AIBD Meeting.

Combination biologic therapy may be an effective treatment option for patients with inflammatory bowel disease (IBD) who are refractory or have a concomitant autoimmune disease that is inadequately controlled by biologic monotherapy, according to a retrospective cohort study presented at the AIBD 2019 Annual Meeting in Orlando, FL.

To understand the efficacy and safety of combining 2 biologics or a biologic with a small molecule, researchers retrospectively analyzed 50 IBD patients seen at the Houston Methodist Hospital who received biologic combinations from 2015 to 2019 and had persistent disease activity, or concomitant rheumatologic or dermatologic disease. The combinations included vedolizumab with either ustekinumab, adalimumab, certolizumab, golimumab, or tofacitinib; or tofacitinib with either infliximab, golimumab, certolizumab, or ustekinumab; or adalimumab and apremilast. The primary end point was effectiveness based on laboratory parameters, clinical and endoscopic scoring; secondary end point included safety.

Findings from the study demonstrated that patients treated with biologic combinations had a significantly greater clinical (50% vs 14%; 95% CI 0.13-0.53; P =.0018) and endoscopic remission (34% vs 6%; 95% CI 0.09-0.47; P =.0039), compared with biologic monotherapy at 2-month follow up. Additionally, combination biologic therapy decreased the median erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) as well as improved mean hemoglobin and albumin.

With regard to safety, researchers identified 8 serious adverse events which were determined to be associated with immune modulator use. The frequency of serious adverse events was greater for patients with an immune modulator as part of their drug regimen compared to those without (57% vs 17.4%, respectively; P =.019). The risk of serious infection could be averted by discontinuing the immune modulator prior to starting combination therapy.

Researchers concluded that combination biologic therapy may be a potential treatment option for these particular IBD patients but “larger prospective studies are needed to confirm these findings.”

Reference

Glassner K, Oglat A, Duran A, et al. The Use of Combination Biologics or Small Molecule Therapy in Inflammatory Bowel Disease: A Retrospective Cohort Study. Presented at: 2019 AIBD Annual Meeting; December 12-14 in Orlando, FL.