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Peer-reviewedCC BY-NCTherapeutic Advances in Gastroenterology

Acceptability and tolerability of risankizumab maintenance therapy administered via on-body injector in patients with Crohn’s disease: Results of the ACCEPT-OBI study

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Abstract

Background: Risankizumab is administered via a new modality, so-called on-body injector (OBI). Objectives: To assess the acceptability and the tolerability of OBI-risankizumab therapy, and compare its acceptability with other available modalities in Crohn's disease (CD). Design: Longitudinal multicenter prospective study. Methods: All CD patients from an early access cohort treated with OBI-risankizumab were assessed from the first OBI use (week 0 = W0), W8, W16, and W24. The primary endpoint was acceptability (acceptability numerical scale = ANS). Patients were asked to grade the acceptability of OBI-risankizumab and other modalities of therapeutic maintenance regimen. Results: Among 58 CD patients (79.4% with at least four prior advanced therapies), OBI-risankizumab acceptability was 9.5±1.2 at W0 and remained stable until W24 (p=0.97). OBI-risankizumab acceptability showed a higher acceptability than intravenous infusions (p<0.0001), pen injectors (p<0.001), and syringes (p<0.001), and ranked as the preferred route in 64% of patients. OBI-risankizumab Q8 was the most accepted maintenance regimen (ANS = 9.2 ± 2.0), compared to long interval subcutaneous injections (Q12, Q8 or Q4), more frequent injections (weekly or eow), or intravenous infusions every 4-8 weeks (p < 0.05 for all comparisons). While 57.4% of patients did not experience any adverse event within 24 weeks, the two most frequent adverse events were mild application-site pain (19.0%) and localized erythema (20.7%) with no need for risankizumab discontinuation. Conclusion: OBI-risankizumab therapy is highly accepted and could be the most preferred maintenance regimen in patients with CD.

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BibTeX
@article{buisson2026acceptability,
  title = {{Acceptability and tolerability of risankizumab maintenance therapy administered via on-body injector in patients with Crohn’s disease: Results of the ACCEPT-OBI study}},
  author = {Anthony Buisson and Karim Gebara and Bénédicte Caron and Gilles Boschetti and Cyrielle Gilletta de Saint Joseph and Maria Nachury and Hedia Brixi and Pascal Juillerat and Mélanie Serrero and Lucine Vuitton and Xavier Hebuterne and Ludovic Caillo and Antoine Blain and David Laharie and Laurent Peyrin-Biroulet and Romain Altwegg and Guillaume Le Cosquer and Bruno Pereira and Mathurin Fumery},
  journal = {Therapeutic Advances in Gastroenterology},
  year = {2026},
  month = sep,
  doi = {10.1177/17562848261489118},
  url = {https://u-picardie.hal.science/hal-05749179v1},
  note = {CC BY-NC},
}
RIS
TY  - JOUR
TI  - Acceptability and tolerability of risankizumab maintenance therapy administered via on-body injector in patients with Crohn’s disease: Results of the ACCEPT-OBI study
AU  - Anthony Buisson
AU  - Karim Gebara
AU  - Bénédicte Caron
AU  - Gilles Boschetti
AU  - Cyrielle Gilletta de Saint Joseph
AU  - Maria Nachury
AU  - Hedia Brixi
AU  - Pascal Juillerat
AU  - Mélanie Serrero
AU  - Lucine Vuitton
AU  - Xavier Hebuterne
AU  - Ludovic Caillo
AU  - Antoine Blain
AU  - David Laharie
AU  - Laurent Peyrin-Biroulet
AU  - Romain Altwegg
AU  - Guillaume Le Cosquer
AU  - Bruno Pereira
AU  - Mathurin Fumery
PY  - 2026
DA  - 2026/09/10
JO  - Therapeutic Advances in Gastroenterology
DO  - 10.1177/17562848261489118
UR  - https://u-picardie.hal.science/hal-05749179v1
AB  - Background: Risankizumab is administered via a new modality, so-called on-body injector (OBI). Objectives: To assess the acceptability and the tolerability of OBI-risankizumab therapy, and compare its acceptability with other available modalities in Crohn's disease (CD). Design: Longitudinal multicenter prospective study. Methods: All CD patients from an early access cohort treated with OBI-risankizumab were assessed from the first OBI use (week 0 = W0), W8, W16, and W24. The primary endpoint was acceptability (acceptability numerical scale = ANS). Patients were asked to grade the acceptability of OBI-risankizumab and other modalities of therapeutic maintenance regimen. Results: Among 58 CD patients (79.4% with at least four prior advanced therapies), OBI-risankizumab acceptability was 9.5±1.2 at W0 and remained stable until W24 (p=0.97). OBI-risankizumab acceptability showed a higher acceptability than intravenous infusions (p<0.0001), pen injectors (p<0.001), and syringes (p<0.001), and ranked as the preferred route in 64% of patients. OBI-risankizumab Q8 was the most accepted maintenance regimen (ANS = 9.2 ± 2.0), compared to long interval subcutaneous injections (Q12, Q8 or Q4), more frequent injections (weekly or eow), or intravenous infusions every 4-8 weeks (p < 0.05 for all comparisons). While 57.4% of patients did not experience any adverse event within 24 weeks, the two most frequent adverse events were mild application-site pain (19.0%) and localized erythema (20.7%) with no need for risankizumab discontinuation. Conclusion: OBI-risankizumab therapy is highly accepted and could be the most preferred maintenance regimen in patients with CD.
SN  - 1756-283X
SN  - 1756-2848
ER  -