Efficacy, Safety, Patient Experience, and Tolerability of Risankizumab Administered by On-Body Injector for Moderate to Severe Crohn’s Disease

Edward V. Loftus, Jenny Griffith, Ezequiel Neimark, Alexandra Song, Kori Wallace, Sujani Nannapaneni, Ji Zhou, Rachel Byrne, Kristina Kligys, Yinuo Pang, Xiaomei Liao, Jasmina Kalabic, Marla Dubinsky

Research output: Contribution to journalArticlepeer-review


Introduction: In patients with moderate to severe Crohn’s disease (CD), intravenous induction and subcutaneous maintenance dosing with risankizumab was efficacious and well tolerated. Long-term management of CD via self-administration of risankizumab using an on-body injector (OBI) may improve treatment adherence through convenience and ease of use. Methods: Within the FORTIFY maintenance study, 46 patients from the United States (US) sites participated in an open-label extension Substudy and received 180 mg or 360 mg risankizumab delivered subcutaneously via OBI [360 mg (2.4 mL, 150 mg/mL) or 180 mg (1.2 mL, 150 mg/mL)]. At the Week 0 visit, patients were trained (pre-injection) by site staff, using Instructions for Use (IFU) and a training video, to self-administer risankizumab at Weeks 0 (on site), 8 (at home), and 16 (on site). Key objectives of the Substudy 4 were to assess OBI usability (observer rating of successful self-administration), hazard-free self-injection at Weeks 0 and 16, and patient rating of acceptability using the Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, and 16. Additionally, the proportion of patients in clinical remission (CD Activity Index < 150) was collected at Weeks 0 and 16. Results: All patients successfully self-administered risankizumab via OBI, including two patients who successfully self-administered with a second OBI (i.e., required two injection attempts). Acceptability of self-injection was high. Two patients (n = 2) experienced a use-related hazard. Stable clinical remission was observed with both risankizumab doses. Two patients experienced injection site reactions; neither was related to the OBI per investigator’s assessment. Two device-related adverse events related to topical adhesive reactions were reported, both mild and resolved. No new safety risks were observed. Conclusion: The efficacy and safety of maintenance risankizumab delivered via OBI and OBI usability support the use of this device in patients with moderate to severe CD. Trial Registration: ClinicalTrials.gov identifiers NCT03105102 (FORTIFY).

Original languageEnglish
Pages (from-to)2311-2325
Number of pages15
JournalAdvances in Therapy
Issue number5
StatePublished - May 2023


  • Crohn’s disease
  • Maintenance
  • On-body injector
  • Risankizumab


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