DHW Little et al. Am J Gastroenterol 2020;115:1768–1774. Effectiveness of Dose De-escalation of Biologic Therapy in Inflammatory Bowel Disease: A Systematic Review (Thanks to Ben Gold for this reference)
In this systematic review, a total of 995 adult patients were included from 18 observational studies (4 prospective and 14 retrospective), 1 nonrandomized controlled trial, and 1 subgroup analysis of a randomized controlled trial.
- Biologic dose de-escalation was associated with relapse rates as high as 50% at 1 year. Overall, clinical relapse occurred in 0%–54% of patients who dose de-escalated biologic therapy (17 studies).
- Lower rates of relapse (10%–25%) were reported in studies involving patients with endoscopic and/or histologic remission
- These results are in agreement with a previous meta-analysis, which found a 1-year risk of relapse after discontinuation of anti-TNF therapy of 36% in CD and 28% in UC ( Gisbert JP, et al.. Am J Gastroenterol 2016;111:632–47).
My take: This study shows that dose de-escalation of biologic therapy in IBD
seems to be associated with high rates of clinical relapse
C Chapuis-Biron et al. Am J Gastroenterol 2020;115:1812–1820. Ustekinumab for Perianal Crohn’s Disease: The BioLAP Multicenter Study From the GETAID (Thanks to Ben Gold for this reference too)
In this national multicenter retrospective cohort study in 207 adult patients with either active or inactive perianal Crohn’s disease (pCD) who received ustekinumab (2017-2018). The majority had received multiple biologics (~85% had at least 2 anti-TNF agents, 28% had received vedolizumab) and prior anal surgeries (mean 2.8).
Methods: Success of ustekinumab was defined by (i) clinical success at 6 months of treatment assessed by the physicians’ judgment, with (ii) no need for dedicated medical treatment for perianal lesions (antibiotics and/or topics) nor (iii) unscheduled surgical treatment. For perianal disease evaluation, clinical success was defined in the study protocol, by the absence of draining pus for fistulas, and no anal ulcers
- In patients with active pCD, success was reached in 57/148 (38.5%) patients.
- Among patients with setons at initiation, 29/88 (33%) had a successful removal.
- In patients with inactive pCD at initiation, the probability of recurrence-free survival was 86.2% and 75.1% at weeks 26 and 52, respectively.
- The absence of ustekinumab optimization was associated with upper odds of success (OR 2.74). “We can suppose in our present study that optimization of treatment was needed in severe refractory patients with no or insufficient response to ustekinumab. Thus, in these nonresponders, success was not achieved despite optimization.”
My take (partly borrowed from authors): “This large multicenter dedicated study adds
substantial evidence to the growing literature on ustekinumab effectiveness in refractory CD.” For pCD, optimization of ustekinumab has a low likelihood of improving response.
Related blog posts -De-escalation:
- Expert Guidance on Inflammatory Bowel Disease (Part 3) | gutsandgrowth
- High Risk of Relapse in Younger Patients after anti-TNF Therapy Withdrawal
- What happens when anti-TNF therapy is stopped
- What Happens After The First Anti-TNF Agent Doesn’t Work?
- Withdrawing Therapy Leads To Relapse, Even if in Deep …
- Stopping Infliximab -What Happens Next? | gutsandgrowth
Related blog posts -Ustekinumab/Crohn’s Disease:
- Dose Escalation of Ustekinumab & Support Tool -Should I Have Surgery?
- Landmark Publication for Ustekinumab (Stelara)
- Ustekinumab for Crohn’s Disease
- Ustekinumab in Pediatric Clinical Practice
- “Positioning Biologic Therapies in the Management of Pediatric Inflammatory Bowel Disease” & 14% of U.S. Infected with COVID-19
- Expert Guidance on Inflammatory Bowel Disease (Part 1) 2020
- Expert Guidance on Inflammatory Bowel Disease (Part 2)