Patients ‘continue to respond’ to subcutaneous Skyrizi despite failed IV induction in UC
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Key takeaways:
- Maintenance subcutaneous risankizumab may induce remission in patients with ulcerative colitis who failed IV induction.
- Patients achieved greater clinical response and remission with subcutaneous vs. IV doses.
WASHINGTON — A maintenance dose of subcutaneous Skyrizi may still induce clinical response in patients with ulcerative colitis who failed to achieve response after 12 weeks of IV induction, noted a presenter at Digestive Disease Week.
Skyrizi (risankizumab, AbbVie) has previously demonstrated efficacy in achieving clinical remission after 12 weeks in patients with moderately to severely active ulcerative colitis, according to results of the phase 3 INSPIRE and COMMAND studies. However, questions linger for patients who did not exhibit an initial response: What treatment comes next?
“[We] aimed to address whether patients who were not in clinical response at the end of the 12-week induction period had benefit from continuing on the drug at one of three different doses,” Gil Y. Melmed, MD, MS, director of clinical trials at the Inflammatory Bowel Disease Center at Cedars-Sinai in Los Angeles, told Healio. “This is an important question because, when we start a new drug, if at 12 weeks the patient hasn’t achieved the type of response that we think is appropriate, do we continue the drug or stop the drug? Do we switch them to a new drug?”
To determine the efficacy of extended risankizumab treatment for an additional 12 weeks in patients with UC who lacked an initial clinical response, Melmed and colleagues conducted an analysis of the INSPIRE and COMMAND studies.
Patients who failed to achieve clinical response by 12 weeks in the INSPIRE study (n = 209) were subsequently randomized to extended treatment with subcutaneous risankizumab 180 mg or 360 mg at 12 and 20 weeks or IV risankizumab 1,200 mg at 12, 16 and 20 weeks. In the COMMAND study, patients who demonstrated clinical response with subcutaneous risankizumab at 24 weeks maintained this dose every 8 weeks for 52 weeks.
The researchers assessed clinical response, clinical remission and safety, as well as endoscopic improvement, endoscopic remission and histologic-endoscopic mucosal improvement, following extended induction at week 24 and maintenance week 52.
According to study results, 57.1% of patients achieved clinical response, with 15.7% attaining clinical remission, on subcutaneous risankizumab 360 mg at week 24 compared with subcutaneous risankizumab 180 mg (response: 56.3%; remission: 12.7%) and IV risankizumab 1,200 mg (response: 50%; remission: 8.8%). Rates of endoscopic improvement, endoscopic remission and histologic-endoscopic mucosal improvement were comparable across all groups.
“There were benefits to continuing on with the drug at any dose, and those effects were similar across the three doses,” Melmed told Healio. “This teaches us that for a patient who is starting on this medication, at 12 weeks, if they haven’t achieved the outcomes that we think would be indicative of a response, that doesn’t mean to stop the drug. You can still transition them onto the maintenance dose and expect that a good proportion of those patients are still going to achieve an adequate response.”
Additionally, researchers found that for patients who had achieved clinical response at week 24 and continued on subcutaneous risankizumab doses in the COMMAND study, 17.9% achieved clinical remission on 180 mg vs. 22.8% on 360 mg at maintenance week 52.
“We normally think of an IV dose as more powerful than a subcutaneous dose, so it was interesting to see that you are still going to pick up a good proportion of additional responders, even with a subcutaneous dose without any additional advantage of an IV dose,” Melmed said. “Practically, this makes a world of difference because getting another IV dose is not so easy, so being able to just continue them on the standard way you would normally do is a huge advantage.”
The researchers found no additional benefit for supplementary IV risankizumab vs. starting subcutaneous therapy after week 24, suggesting that the duration of risankizumab exposure — not the dose — could be a key factor in inducing remission in patients with refractory UC.
“Transitioning all patients onto their subcutaneous dosing after the induction period should be standard, even in patients who may not have necessarily achieved the types of responses at 12 weeks,” Melmed said. “Continuing with additional dosing is entirely appropriate and patients will continue to respond even beyond that point.”
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Panaccione R, et al. Additional risankizumab therapy is effective in patients with moderately to severely active ulcerative colitis who did not achieve clinical response to initial 12-week induction therapy: An analysis of phase 3 INSPIRE and COMMAND studies. Presented at: Digestive Disease Week; May 18-21, 2024; Washington (hybrid).
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