Abstract
Background & Aims: It is not clear whether concomitant therapy with corticosteroids and anti-tumor necrosis factor (TNF) agents is more effective at inducing remission in patients with Crohn's disease (CD) than anti-TNF monotherapy. We aimed to determine whether patients with active CD receiving corticosteroids during induction therapy with anti-TNF agents had higher rates of clinical improvement than patients not receiving corticosteroids during induction therapy. Methods: We systematically searched the MEDLINE, Embase, and CENTRAL databases, through January 20, 2016, for randomized trials of anti-TNF agents approved for treatment of CD and identified 14 trials (5 of adalimumab, 5 of certolizumab, and 4 of infliximab). We conducted a pooled meta-analysis of individual patient and aggregated data from these trials. We compared data from participants who continued oral corticosteroids during induction with anti-TNF therapy to those treated with anti-TNF agents alone. The endpoints were clinical remission (CD activity index [CDAI] scores <150) and clinical response (a decrease in CDAI of 100 points) at the end of induction (weeks 4–14 of treatment). Results: We included 4354 patients who received induction therapy with anti-TNF agents, including 1653 [38.0%] who were receiving corticosteroids. The combination of corticosteroids and an anti-TNF agent induced clinical remission in 32.0% of patients, whereas anti-TNF monotherapy induced clinical remission in 35.5% of patients (odds ratio [OR], 0.93; 95% CI, 0.74–1.17). The combination of corticosteroids and an anti-TNF agent induced a clinical response in 42.7% of patients, whereas anti-TNF monotherapy induced a clinical response in 46.8% (OR 0.84; 95% CI, 0.73–0.96). These findings did not change with adjustment for baseline CDAI scores and concurrent use of immunomodulators. Conclusions: Based on a meta-analysis of data from randomized trials of anti-TNF therapies in patients with active CD, patients receiving corticosteroids during induction therapy with anti-TNF agents did not have higher rates of clinical improvement compared with patients not receiving corticosteroids during induction therapy. Given these findings and the risks of corticosteroid use, clinicians should consider early weaning of corticosteroids during induction therapy with anti-TNF agents for patients with corticosteroid-refractory CD.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 238-245.e4 |
| Journal | Clinical Gastroenterology and Hepatology |
| Volume | 19 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 2021 |
Bibliographical note
Funding Information:Conflicts of interest These authors disclose the following: Neeraj Narula has received honoraria for speakers bureau or advisory boards from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Jean-Frederic Colombel reports receiving research grants from AbbVie, Janssen Pharmaceuticals, and Takeda; receiving payment for lectures from AbbVie, Amgen, Allergan, Inc, Ferring Pharmaceuticals, Shire, and Takeda; receiving consulting fees from AbbVie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, Celgene Corporation, Celltrion, Eli Lilly, Enterome, Ferring Pharmaceuticals, Genentech, Janssen Pharmaceuticals, Landos, Ipsen, Medimmune, Merck, Novartis, Pfizer, Shire, Takeda, and Tigenix; and holding stock options in Intestinal Biotech Development and Genfit. The remaining authors disclose no conflicts.
Funding Information:
This study, carried out under YODA Project # 2016-0903, used data obtained from the Yale University Open Data Access Project, which has an agreement with Janssen Research & Development, LLC. The interpretation and reporting of research using this data are solely the responsibility of the authors and does not necessarily represent the official views of the Yale University Open Data Access Project or Janssen Research & Development, LLC. We thank AbbVie and UCB for generously giving us access to data from studies in which they acted as sponsor. David M. Faleck, MD (Conceptualization: Supporting; Data curation: Equal; Formal analysis: Supporting; Writing ? original draft: Lead), Eugenia Shmidt (Conceptualization: Lead; Data curation: Equal; Writing ? original draft: Equal), Ruiqi Huang (Formal analysis: Lead; Writing ? review & editing: Supporting), Leah G. Katta (Conceptualization: Supporting; Data curation: Supporting), Neeraj Narula (Conceptualization: Supporting; Writing ? review & editing: Supporting), Rachel Pinotti (Methodology: Equal), Mayte Suarez-Farinas (Formal analysis: Equal; Methodology: Equal; Writing ? review & editing: Supporting), Jean-Frederic Colombel (Conceptualization: Lead; Writing ? review & editing: Supporting)
Publisher Copyright:
© 2021 AGA Institute
Keywords
- Biologic
- IBD
- Inflammatory Bowel Diseases
- RCT
