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Multicenter Study
. 2022 Mar 7;28(9):961-972.
doi: 10.3748/wjg.v28.i9.961.

Relationship between clinical remission of perianal fistulas in Crohn's disease and serum adalimumab concentrations: A multi-center cross-sectional study

Laura Sirmai  1 , Anne-Laure Pelletier  1 , Nathalie Gault  2 , Camille Zallot  3 , Guillaume Bouguen  4 , Dominique Bouchard  5 , Pascale Roland Nicaise  6 , Marine Peyneau  6 , Sandrine Sironneau  7 , Marcelo De Carvalho Bittencourt  8 , Antoine Petitcollin  9 , Pedro Fernandez  10 , Xavier Roblin  11 , Laurent Siproudhis  4 , Laurent Abramowitz  12
Affiliations
Multicenter Study

Relationship between clinical remission of perianal fistulas in Crohn's disease and serum adalimumab concentrations: A multi-center cross-sectional study

Laura Sirmai et al. World J Gastroenterol. .

Abstract

Background: Crohn's disease (CD) is complicated by perianal fistulas in approximately 20% of patients. Achieving permanent fistula closure remains a challenge for physicians. An association between serum anti-tumor necrosis factor-α concentrations and clinical outcomes in patients with CD has been demonstrated; however, little information is available on serum adalimumab (ADA) concentrations and remission of perianal fistulas in such patients.

Aim: To study the relationship between serum ADA concentrations and clinical remission of CD-associated perianal fistulas.

Methods: This cross-sectional study of patients with CD-associated perianal fistulas treated with ADA was performed at four French hospitals between December 2013 and March 2018. At the time of each serum ADA concentration measurement, we collected information about the patients and their fistulas. The primary study endpoint was clinical remission of fistulas defined as the absence of drainage (in accordance with Present's criteria), with a PDAI ≤ 4, absence of a seton and assessment of the overall evaluation as favorable by the proctologist at the relevant center. We also assessed fistula healing [defined as being in clinical and radiological (magnetic resonance imaging, MRI) remission] and adverse events.

Results: The study cohort comprised 34 patients who underwent 56 evaluations (patients had between one and four evaluations). Fifteen patients had clinical remissions (44%), four of whom had healed fistulas on MRI. Serum ADA concentrations were significantly higher at evaluations in which clinical remission was identified than at evaluations in which it was not [14 (10-16) vs 10 (2-15) μg/mL, P = 0.01]. Serum ADA concentrations were comparable at the times of evaluation of patients with and without healed fistulas [11 (7-14) vs 10 (4-16) μg/mL, P = 0.69]. The adverse event rate did not differ between different serum ADA concentrations.

Conclusion: We found a significant association between high serum ADA concentrations and clinical remission of CD-associated perianal fistulas.

Keywords: Adalimumab; Clinical pharmacology; Crohn’s disease; Peri-anal disorders.

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Conflict of interest statement

Conflict-of-interest statement: Sirmai L reports having received grant support from Abbvie and congress invitations from Roche and Sandoz and having received conference or consultancy fees from Gilead, MSD, Abbvie, Mayoly Spindler, Takeda, Ipsen, Allergan France and Ferring; Pelletier AL reports having received grant support from Abbvie and financial support from Ferring; Zallot C reports having received financial support from Takeda, Abbvie, Ferring, Janssen and Pfizer; Bouguen G reports having received lecture fees from Abbvie, Ferring, MSD, Takeda and Pfizer and consultant fees from Takeda, Janssen, Mylan and Abbvie; Bouchard D reports having received speaking fees from Abbvie, MSD and Janssen, consultancy fees from Takeda, and congress invitations from Abbvie, Pfizer and Takeda; Gault N, Roland Nicaise P, Peyneau M, Sironneau S, Bittencourt M, Petitcollin A, Fernandez P all declare they have no conflicts of interest; Roblin X reports having received financial support from Abbvie, Amgen, Pfizer, Takeda, Janssen, MSD and Theradiag; Siproudhis L reports having received conference or consultancy fees from Gilead, MSD, Abbvie, Mayoly Spindler, Takeda, Ipsen, Allergan France and Ferring; Abramowitz L reports having received grant support from Abbvie and financial support from Takeda.

Figures

Figure 1
Figure 1
Serum adalimumab concentrations according to clinical remission status.
Figure 2
Figure 2
Clinical remission according to quartiles of serum adalimumab concentrations.
See this image and copyright information in PMC

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