Combination Biologic Therapy May Be Effective in Previously Treated Patients With IBD
Combination biologic therapy may be an effective treatment option for patients with inflammatory bowel disease (IBD) with refractory disease or concomitant autoimmune disease that is inadequately controlled by biologic monotherapy, according to new research presented at the 2019 Advances in Inflammatory Bowel Diseases (AIBD) Meeting.
Data on combination biologic or small molecule therapy in IBD is limited. To determine the effectiveness and safety of combining two or more biologics, or a biologic and small molecule, in patients with IBD, the researchers performed a retrospective observational cohort study using data from 50 patients who received such treatment from 2015 to 2019 for persistent disease activity or concomitant rheumatologic or dermatologic disease. All patients had previously failed a median of two biologic medications.
The patients received one of the following therapy combinations:
- Vedolizumab with ustekinumab, adalimumab, certolizumab, golimumab, or tofacitinib
- Tofacitinib with infliximab, golimumab, certolizumab, or ustekinumab
- Adalimumab and apremilast
Compared with 1 month prior to starting combination therapy (baseline), significantly more patients were in clinical remission after at least 2 months on combination therapy (14% vs 50%). A similar trend was present for endoscopic remission when endoscopic data collected within 6 months prior to initiation of combination therapy was compared with follow-up after at least 2 months on combination therapy (6% vs 34%).
Furthermore, median erythrocyte sedimentation rate and C-reactive protein levels significantly decreased, and mean levels of hemoglobin and albumin significantly increased.
A total of 8 serious adverse events (AEs) were reported, none of which included death. Multivariate analysis indicated that immune modulator use was a risk factor for serious AEs. Of the patients who experienced a serious AE, 57% were on an immune modulator, compared with 17.4% of patients without a serious AE who were on an immune modulator.
“There appears to be an increased risk of serious infection compared [with] biologic monotherapy; however, this risk could be minimized by discontinuing [immune modulator] prior to initiation of combination therapy,” the researchers wrote.
The authors concluded that larger prospective studies are needed to confirm these findings.
—Colleen Murphy
Reference:
Glassner K, Oglat A, Duran A, et al. The use of combination biologic or small molecule therapy in inflammatory bowel disease: a retrospective cohort study [poster 028]. Presented at: 2019 AIBD Meeting; December 12-14, 2019; Orlando, FL. https://www.consultant360.com/meeting-materials/use-combination-biologic-or-small-molecule-therapy-inflammatory-bowel-disease. Accessed December 12, 2019.