On-Body Injection of Risankizumab Tested

Intravenous induction and subcutaneous maintenance dosing with risankizumab have proved efficacious and well tolerated for patients with moderate to severe Crohn disease. However, traveling to receive infusions on a regular schedule can be a barrier to care due to inconvenience and cost, while negative experiences with self-injection can also diminish medication adherence.

Researchers sought to determine if patient adherence could be affected by self-administration of risankizumab via an on-body injector (OBI) that offers greater convenience and ease of use.

In the FORTIFY maintenance study, 46 patients from the US sites participated in an open-label extension substudy and received 180 mg or 360 mg risankizumab delivered subcutaneously via a single-dose pre-filled cartridge using a commercialized on-body injector (OBI), investigators reported in Advances in Therapy. “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).”

The primary objectives of the substudy were to assess the usability of OBI through observer rating of successful self-administration; to determine hazard-free self-injection at Weeks 0 and 16; and to rate the acceptability of OBI among patients using the Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, and 16. The proportion of patients in clinical remission as measured by the Crohn Disease Activity Index (< 150) was collected at Weeks 0 and 16.

“All patients successfully self-administered risankizumab via OBI, including 2 patients who successfully self-administered with a second OBI (i.e., required two injection attempts). Acceptability of self-injection was high,” the authors wrote. “Stable clinical remission was observed with both risankizumab doses.” Patients did not require additional training or intervention from the study site staff.

No new safety risks were observed. Two patients experienced a use-related hazard; 2 patients experienced injection site reactions; and 2 device-related adverse events related to topical adhesive reactions— both mild and resolved—were reported.

“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,” the investigators concluded.

Reference:

Loftus EV Griffith J, Neimark E, et al. Efficacy, safety, patient experience, and tolerability of risankizumab administered by on-body injector for moderate to severe Crohn’s disease. Adv Ther.  2023; 40(5): 2311–2325.