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Multicenter Study
. 2025 May 8;19(5):jjaf056.
doi: 10.1093/ecco-jcc/jjaf056.

Fidaxomicin for Clostridioides difficile infection in patients with inflammatory bowel disease: a multicenter retrospective cohort study

Daniele Noviello  1 , María Chaparro  2 , Chiara Viganò  3   4 , Andreas Blesl  5 , Brigida Barberio  6 , Henit Yanai  7   8 , Ambrogio Orlando  9 , Rocío Ferreiro-Iglesias  10 , Cristina Bezzio  11   12 , Alessandra Zilli  13 , Tamás Molnár  14 , Cristian Gheorghe  15   16 , Francesco Conforti  17 , Tommaso Innocenti  18   19 , Simone Saibeni  20 , Peter Bossuyt  21 , Raquel Oliveira  22   23 , Anna Maria Carvalhas Gabrielli  24 , Alessandra Losco  25 , Sophie Vieujean  26 , Enrico Tettoni  27   28 , Lorena Pirola  3   4 , Silvia Calderone  9 , Maya Kornowski Cohen  7   8 , Gabriele Dragoni  18   19 , Timo Rath  29 , Manuel Barreiro-de Acosta  10 , Edoardo Vincenzo Savarino  6 , Javier Pérez Gisbert  2 , Maurizio Vecchi  1   17 , Raja Atreya  29 , Flavio Caprioli  1   17
Affiliations
Multicenter Study

Fidaxomicin for Clostridioides difficile infection in patients with inflammatory bowel disease: a multicenter retrospective cohort study

Daniele Noviello et al. J Crohns Colitis. .

Erratum in

Abstract

Background and aims: Inflammatory bowel disease (IBD) patients with Clostridioides difficile infection (CDI) are at increased risk of adverse outcomes. Data on fidaxomicin use in IBD remain scarce. We assessed the effectiveness and safety of fidaxomicin for CDI and its impact on IBD outcomes in a large international cohort.

Methods: Adult patients with ulcerative colitis (UC) or Crohn's disease (CD) treated with fidaxomicin for documented CDI were retrospectively included. The primary outcome was CDI recurrence rate within 8 weeks (C. difficile toxin detection and CDI-targeted therapy). Secondary outcomes included sustained response (no CDI-targeted therapy within 12 weeks), IBD therapy escalation, colectomy rate, and all-cause mortality within 30, 90, and 180 days.

Results: Ninety-six patients (57 UC and 39 CD) from 20 IBD centers were included. Most were on advanced IBD therapy. Half had a previous CDI episode, 15% a severe episode. CDI recurrence rate was 10% at week 8, and sustained response 82% at week 12. Compared with patients with previous CDI episode, patients at first episode tended to have a lower recurrence (4.3% vs 16%; P = .06) and higher sustained response (91% vs 75%; P = .04) rate. IBD therapy escalation was required in 48% with a numerically lower need for patients achieving vs not-achieving sustained response within 30 days (12% vs 20%; P = .42). Five UC patients underwent colectomy. One death unrelated to CDI or IBD occurred. One moderate and 5 mild adverse events were reported.

Conclusions: Fidaxomicin was effective and safe in IBD patients with CDI, with greater effectiveness in CDI-naïve patients, potentially influencing short-term IBD outcomes.

Keywords: Clostridioides difficile; CDI; fidaxomicin; inflammatory bowel disease.

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Conflict of interest statement

D.N. received unrestricted research grants from Pfizer, consulting fees from Dr. Falk and Abbvie, and lecturer fees from Ferring and Alfasigma.

M.C. has served as speaker, consultant, or research or education funding from MSD, Abbvie, Hospira, Pfizer, Takeda, Janssen, Ferring, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Biogen, Gilead, and Lilly.

C.V. received consultancy and lecture fees from: AbbVie, Galapagos, Janssen-Cilag, Johnson & Johnson, Pfizer, Takeda, Celltrion, Alfasigma, Eli Lilly, and research grant from Celltrion and Pfizer.

S.S. has received as lecture fees from and served on the advisory board and as a consultant for AbbVie, Arena, Ferring, Gilead, Janssen, MSD, and Takeda.

A.B. has served as speaker and consultant for Abbvie, Aengus, Boston Scientific, Bristol-Myers Squibb, Dr. Falk Pharma, Genericon, Gilead, Janssen, Lilly, MSD, Olympus, Pfizer, PSI, Sandoz, Takeda, and Vifor.

J.P.G. has served as speaker, consultant, and advisory member for or has received research funding from MSD, Abbvie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos, Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine, and Vifor Pharma.

B.B. has served as speaker for AbbVie, Agave, Alfasigma, AG Pharma, Janssen, MSD, Pfizer, Sofar, Takeda, and Unifarco and as a consultant for AbbVie and Janssen.

H.Y. Advisory Committee or Review Panels: Takeda, Abbvie, Pfizer, Janssen, BMS, and Eli Lilli; Grant/Research Support: Pfizer; Speaking and Teaching: Abbvie, Pfizer, Takeda, Novartis, and BMS.

R.F.I. has served as speaker, consultant, or research or education funding from MSD, Abbvie, Pfizer, Takeda, Janssen, Ferring, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Casen recordati, and Otsuka Pharmaceutical.

A.O. Consulting/advisory board fees from AbbVie, Alfa-Sigma, Biogen, Eli-Lilly, Ferring, Galapagos, Giuliani, Janssen, Johnson & Johnson, Lionhealth, MSD, Nestlé, Pfizer, Samsung Bioepis, Sandoz, and Takeda. Speaker’s fees from AbbVie, Alfa-Sigma, Biogen, Celltrion, Eli-Lilly, Ferring, Fresenius Kabi, Galapagos, Janssen, Lionealth, MSD, Pfizer, Samsung Bioepis, Sandoz, and Takeda. Research grants from Takeda and Pfizer.

C.B. served as a consultant or received lecture fees from AbbVie, Alfasigma, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Galapagos, Lionhealth, Johnson & Johnson, MSD, Pfizer, and Takeda.

A.Z. received lecture fees from AbbVie, Galapagos, Janssen, Tillots Pharma, and Takeda and served as a consultant for AbbVie and Galapagos.

M.a.V. has served as speaker for Abbvie, AGPharma, Alfasigma, Biogen, Celltrion, Galapagos, Johnson&Johnson, Eli Lilly, Ferring, Malesci, Pfizer, Sofar, Takeda; has served as consultant for Abbvie, Biogen, Bristol-Myers Squibb, Celltrion, Eli Lilly, Giuliani, Johnson&Johnson, Pfizer, Sofar, and Takeda; received research support from Giuliani, Pfizer, Sofar, and Takeda.

G.D. reports speaker fees from Alfasigma, Ferring, Johnson& Johnson, Novartis, Pfizer, and Takeda, and has served on the advisory board for AbbVie, Celltrion Healthcare, Eli Lilly, Johnson& Johnson, and Pfizer.

P.B. financial support for research: AbbVie, EG; lecture fees: AbbVie, AMC ICP, Amgen, Bristol Myers Squibb, Celltrion, Dr. Falk Benelux, EG, Galapagos, Globalport, Lilly, Medtalks, Materia Prima, Pentax, Springer Media; advisory board: AbbVie, Bristol Meyers Squibb, CIRC, Galapagos, Janssen, Lilly, Pentax, PSI-CRO, Roche, Takeda, and Tetrameros.

S.V. has received speaker’s fees from AbbVie, Alfasigma, Celltrion, Ferring, Janssen, Lilly, and Takeda.

M.B.A. has served as a speaker, consultant, and advisory member for or has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, Alphasigma, Pfizer, Sandoz, Biocon, BMS, Fresenius, Ferring, Tillots, Chiesi, Adacyte, and Oncostellae.

R.A. has served as a speaker, consultant, or received research grants from AbbVie, Abivax, AlfaSigma, AstraZeneca, Bristol-Myers Squibb, Celltrion Healthcare, Dr. Falk Pharma, Galapagos, Johnson & Johnson, Lilly, MSD, Pfizer, and Takeda Pharma.

T.I. received speaker’s fees from Ferring.

E.V.S. has served as speaker for Abbvie, Abivax, Agave, AGPharma, Alfasigma, Apoteca, Biosline, CaDiGroup, Celltrion, Dr. Falk, EG Stada Group, Fenix Pharma, Galapagos, Johnson&Johnson, JB Pharmaceuticals, Innovamedica/Adacyte, Eli Lilly, Malesci, Mayoly Biohealth, Montefarco, Novartis, Omega Pharma, Pfizer, Rafa, Reckitt Benckiser, Sandoz, Sanofi/Regeneron, SILA, Sofar, Takeda, Tillots, Unifarco; has served as consultant for Abbvie, Agave, Alfasigma, Biogen, Bristol-Myers Squibb, Celltrion, Dr. Falk, Eli Lilly, Fenix Pharma, Ferring, Giuliani, Grunenthal, Johnson&Johnson, JB Pharmaceuticals, Merck & Co, Nestlè, Pfizer, Reckitt Benckiser, Sanofi/Regeneron, SILA, Sofar, Takeda, Unifarco; received research support from Bonollo, Difass, Pfizer, Reckitt Benckiser, Sanofi/Regeneron, SILA, Sofar, Unifarco, and Zeta Farmaceutici.

F.C. served as consultant to Abbvie, MSD, Takeda, Janssen, Roche, Celgene, Bristol-Meyers Squibb, Galapagos, Gllead, Pfizer, Mundipharma, Galapagos, and Biogen, received lecture fees from Abbvie, Ferring, Takeda, Allergy Therapeutics, Janssen, Pfizer, and Biogen, and unrestricted research grants from Pfizer, Giuliani, Sofar, MSD, Takeda, and Abbvie.

Figures

Graphical Abstract
Graphical Abstract
Figure 1.
Figure 1.
CDI recurrence rate at week 8 and sustained response rate at week 12.
See this image and copyright information in PMC

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