FDA approved an at-home induction option for risankizumab-rzaa in adults with moderate-to-severe Crohn's disease, based on the phase 3 AFFIRM trial.
The FDA today approved a subcutaneous induction regimen for AbbVie's Skyrizi (risankizumab-rzaa) in adults with moderately to severely active Crohn's disease.1 The decision lets patients start treatment at home with an on-body injector (OBI) induction pack instead of an intravenous infusion, and continue with the same device during maintenance.1
AbbVie filed for the new regimen April 27 and had said it anticipated approval later in 2026.2 The decision changes how therapy begins, not who is eligible, because intravenous induction remains an option.1
"People living with Crohn's disease need treatments that can deliver meaningful disease control from the start," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "With the approval of subcutaneous induction, we are building on the strong efficacy of Skyrizi while giving patients and physicians greater flexibility in how treatment is initiated. This is one more example of how AbbVie continues to advance treatment to better meet the needs of people living with Crohn's disease."
The subcutaneous regimen is 720 mg delivered by the OBI induction pack at weeks 0, 2, 4 and 8.1 Patients can still begin intravenously with 600 mg at weeks 0, 4 and 8. Either way, maintenance dosing starts at week 12 and is given by OBI every eight weeks.1
The device was first introduced in 2022 for Crohn's disease maintenance.1
Lead investigator Millie D. Long, M.D., of the University of North Carolina at Chapel Hill, said: "When patients and I discuss treatment, they want to know two things: will it work? And how will it fit into their lives? AFFIRM answered the first question, with superior rates of clinical remission and endoscopic response versus placebo during induction with subcutaneous Skyrizi, particularly in patients new to advanced therapy. This approval answers the second. As a physician who has used the Skyrizi OBI, I've seen firsthand the convenience it can offer patients. Now with this approval, patients can start treatment at home and continue the same way through maintenance."
AFFIRM randomly assigned 274 adults 2:1 to subcutaneous risankizumab or placebo, and 65% had previously failed advanced therapy.1 The co-primary endpoints at week 12 were clinical remission, defined as a Crohn's disease activity index score below 150, and endoscopic response.1
In the total population, 56% of treated patients reached clinical remission versus 30% with placebo, and 43% had an endoscopic response versus 15% (both p<0.001).1 Endoscopic remission, a secondary endpoint, occurred in 26% versus 11%.1
Results were stronger in patients without prior advanced therapy failure: 74% versus 27% for clinical remission and 60% versus 15% for endoscopic response. In patients who had failed advanced therapy, the rates were 45% versus 31% and 33% versus 15%.1 AbbVie reported no new safety risks.1
Skyrizi is an interleukin-23 inhibitor that binds the p19 subunit and is also approved for ulcerative colitis, plaque psoriasis and psoriatic arthritis.1 In Crohn's disease, the earlier phase 3 ADVANCE and MOTIVATE trials tested intravenous induction.
Clinical remission at week 12 occurred in 45% of patients receiving 600 mg versus 25% with placebo in ADVANCE, and 42% versus 20% in MOTIVATE.3 The trials enrolled different populations, so those figures cannot be compared directly with AFFIRM.
Crohn's disease is a chronic, progressive condition that most often affects the area between the small intestine and colon, causing persistent diarrhea and abdominal pain, and it can lead to complications or surgery.1 In AFFIRM, advanced therapy referred to biologics or Janus kinase inhibitors, and the 65% prior-failure rate reflects how many participants had already tried earlier treatment without adequate results.1
The advanced therapy-naive subgroup was small, with 65 treated and 33 placebo patients, and the p-values AbbVie reported apply to the total population rather than subgroups.1 The company's description of the results as market-leading is a comparative claim, and the release includes no head-to-head data to support it.
Results from AFFIRM's extension periods were not reported in the announcement, and the safety conclusion rests on the sponsor's summary.1
FDA also approved revised prescribing information across all indications, advising clinicians to consider tuberculosis evaluation based on clinical judgment; no test is mandatory before treatment.1 Liver monitoring guidance for Crohn's disease remains in the label.1
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