P054  Utilization of Biologic Therapy in Patients with Microscopic Colitis not Responding to Standard Therapy

P054  Utilization of Biologic Therapy in Patients with Microscopic Colitis not Responding to Standard Therapy

Gupta Sanchit1, Hurtado Jonathan1, Marcus Jenna1, McClure Emma1, Pruce Jordan1, Allegretti Jessica1
1 Brigham and Women's Hospital, Boston, United States

BACKGROUND: Microscopic colitis (MC), consisting of collagenous colitis (CC) and lymphocytic colitis (LC), is a notable and often under-recognized cause of diarrheal disease. Standard of care treatment includes the use of anti-diarrheal agents and steroids. However, patients with refractory disease not responding to standard therapy will require escalation of therapy, often to a biologic agent. Data on this population are limited.

METHODS: We performed a retrospective, multicenter study of patients diagnosed with MC refractory to steroids requiring treatment initiation with an anti-TNF, anti-integrin, or anti-IL-12/23 from 7/2006 to 6/2020. Patients with comorbid, rheumatologic, dermatologic, or oncologic disease requiring a biologic agent were excluded. Data regarding disease history and prior and current treatment characteristics were collected. The primary outcome was steroid-free response to biologic therapy defined as cessation of steroids after biologic initiation without further use for a minimum of 90 days. The secondary outcome was duration of steroid-free response, defined as the time to re-initiation of steroids. Patients with CC and LC were compared, and statistical analyses were conducted using the Mann-Whitney U test and Fisher’s exact test.

RESULTS: 32 patients with MC were identified, of whom 19 had CC and 13 had LC. The patients had a median age of 60.5 years, and 93.8% were female. Treatments prior to biologics included budesonide (100%), prednisone (50%), cholestyramine (68.8%), bismuth (37.5%), methotrexate (25.0%), thiopurine (21.9%), and 5-ASA (37.5%). Median (IQR) calprotectin and CRP within 3 months of biologic treatment initiation were 61.5 mcg/g (15.6-109.6) and 1.6 mg/L (1.0-2.6), respectively. The median time from diagnosis of MC to biologic initiation was 1,095 days overall, with 1,642 days for those with CC and 851 days for those with LC (p = 0.03). No additional significant differences in clinical characteristics or prior treatments were found among those with CC versus LC.  All patients were started on a biologic: vedolizumab (n = 16), adalimumab (n = 10), infliximab (n = 6). Overall, steroid-free response was observed in 71.2% of patients. Steroid-free response was observed in 75.0% of patients on vedolizumab (n = 16), 70.0% of patients on adalimumab (n = 10), and 66.7% of patients on infliximab (n = 6). The overall duration of steroid-free response had a median days (IQR) of 391 (120-741): vedolizumab 400.5 (260-533), adalimumab 120 (82-491), and infliximab 1,475 (759.5-1625). There was no significant difference in steroid free response between patients with LC versus CC (61.5% vs. 79.0%, p = 0.25), though steroid-free response with vedolizumab was observed in 88.9% of patients with CC and 57.1% of patients with LC (p = 0.26). Patients with CC experienced a shorter median days (IQR) duration of steroid-free response compared to patients with LC: 131 (81-508) vs. 524.5 (389-1101), p = 0.07). Additionally, the duration of steroid-free response with adalimumab was median (IQR) 120 days (82-120) for patients with CC versus 616 days (491-741) for patients with LC (p = 0.05).

CONCLUSION(S): Anti-TNFs and anti-integrins may be treatment options for patients with MC not responding to standard therapy.