Maintenance Risankizumab Therapy Sustains Induction Response in Patients With Crohn's Disease
abstract
This abstract is available on the publisher's site.
Access this abstract nowBACKGROUND AND AIMS
Durable clinical remission, endoscopic healing, and biomarker normalization are key treatment goals for Crohn's disease. The selective anti-interleukin-23 p19 inhibitor risankizumab has demonstrated efficacy and safety in moderately to severely active Crohn's disease. This post-hoc analysis of data from the pivotal risankizumab maintenance study assessed whether risankizumab maintenance therapy sustained the clinical and endoscopic outcomes achieved with risankizumab induction therapy.
METHODS
We evaluated 462 patients who achieved a clinical response to risankizumab intravenous induction treatment and were re-randomized to receive subcutaneous risankizumab 360 mg, subcutaneous risankizumab 180 mg, or placebo [withdrawal] every 8 weeks for 52 weeks in the randomized, controlled FORTIFY maintenance study. Maintenance of clinical, endoscopic, and biomarker endpoints at week 52 among patients who achieved these endpoints after 12 weeks of induction treatment was evaluated.
RESULTS
A significantly higher proportion of patients receiving maintenance treatment with risankizumab 360 or 180 mg compared with placebo [withdrawal] maintained Crohn's Disease Activity Index remission [68.6%, 70.8%, vs 56.3%; p < 0.05], stool frequency/abdominal pain remission [69.2%, 64.1%, vs 50.5%; p < 0.01], endoscopic response [70.2%, 68.2%, vs 38.4%; p < 0.001], endoscopic remission [74.4%, 45.5%, vs 23.9%; p < 0.05], and Simple Endoscopic Score for Crohn's Disease of 0-2 [65.5%, 36.7%, vs 21.9%]. Most patients [56.8-83.3%] who achieved normalized faecal calprotectin or C-reactive protein during induction sustained them with maintenance risankizumab.
CONCLUSIONS
Subcutaneous risankizumab maintenance therapy results in durable improvement in clinical and endoscopic outcomes over 1 year in patients with moderately to severely active Crohn's disease.
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Additional Info
Disclosure statements are available on the authors' profiles:
Maintenance Risankizumab Sustains Induction Response in Patients with Crohn's Disease in a Randomized Phase 3 Trial
J Crohns Colitis 2024 Mar 01;18(3)416-423, M Ferrante, PM Irving, MT Abreu, J Axler, X Gao, Q Cao, T Fujii, A Rausch, J Torres, E Neimark, A Song, K Wallace, K Kligys, S Berg, X Liao, Q Zhou, J Kalabic, B Feagan, R PanaccioneFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Risankizumab is the first monoclonal antibody targeting the p19 subunit of interleukin-23 that is approved for the treatment of moderate-to-severe Crohn’s disease. Phase III clinical trials have demonstrated that induction and maintenance risankizumab is superior to placebo for symptom relief and improvement in endoscopic inflammation in Crohn’s disease. However, the durability of maintaining clinical and endoscopic response has not been previously described. In this post hoc analysis, Ferrante et al assessed 462 patients with clinical response to risankizumab intravenous induction for the durability of clinical and endoscopic endpoints through week 52. They found that when compared with placebo (ie, the risankizumab withdrawal group), subcutaneous risankizumab maintained clinical and endoscopic response and remission through week 52. They also observed that 360-mg dosing of risankizumab maintained a higher proportion of patients in endoscopic response and remission compared with 180-mg dosing.
This work highlights the efficacy and durability of risankizumab to maintain remission of Crohn’s disease compared with placebo, which underscores the importance of continuing risankizumab therapy in this population. The study results also suggest that 360-mg risankizumab dosing may be superior to 180-mg dosing in maintaining endoscopic remission. As secondary loss of response is a concern for many patients with moderate-to-severe Crohn’s disease, providers may be encouraged by these data to maintain their patients on 360-mg maintenance dosing. Importantly, no new safety signals for risankizumab were identified during the maintenance period. Additional research is needed to compare the long-term durability of risankizumab with that of other advanced therapies for Crohn’s disease beyond 52 weeks, which will further guide treatment selection.