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SKYRIZI® (risankizumab) Achieved Superiority Versus Apremilast for Co-Primary Endpoints Among Adult Patients with Moderate Plaque Psoriasis in Phase 4 Head-to-Head Study

Published: 2023-07-26 12:05:00 ET
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  • An open-label, efficacy assessor-blinded study comparing SKYRIZI® (risankizumab) to Otezla® (apremilast) for the treatment of adult patients with moderate plaque psoriasis who were candidates for systemic therapy was published in the British Journal of Dermatology1
  • Significantly more patients in the study achieved co-primary endpoints of PASI 90 and sPGA 0/1 at Week 16 with risankizumab versus apremilast1
  • In apremilast patients not achieving PASI 75 at Week 16, significantly more achieved the primary endpoint of PASI 90 at Week 52 who were re-randomized to risankizumab versus continued with apremilast1
  • Based on TSQM-9, higher treatment satisfaction domain scores were reported at Week 16 for patients taking risankizumab (nominal p-values versus apremilast)1
  • Risankizumab was well-tolerated with no new safety signals identified1

NORTH CHICAGO, Ill., July 26, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the British Journal of Dermatologypublished results from the head-to-head Phase 4 IMMpulse study that evaluated the efficacy and safety of SKYRIZI® (risankizumab) compared to Otezla® (apremilast) among adult patients with moderate plaque psoriasis eligible for systemic therapy.1 This study achieved all primary and ranked secondary endpoints with no new safety signals identified.1

"This study highlights the efficacy of SKYRIZI compared to Otezla in helping systemic-eligible patients achieve high levels of skin clearance and reinforces the safety profile observed in previous studies," said Mudra Kapoor, M.D., vice president, global medical affairs, immunology, AbbVie. "These head-to-head data are crucial to help patients and their doctors make informed treatment decisions for uncontrolled disease and add to the body of evidence supporting SKYRIZI as a treatment option for adults living with moderate psoriasis."

Highlights from this open-label, efficacy assessor-blinded study include:

  • At Week 16, a significantly higher proportion of patients who received risankizumab achieved the Period A co-primary endpoints of Psoriasis Area and Severity Index (PASI) 90 and Static Physician's Global Assessment (sPGA) 0/1 [55.9% (66/118) of patients achieved PASI 90 and 75.4% (89/118) achieved sPGA 0/1 with risankizumab versus 5.1% (12/234) and 18.4% (43/234) with apremilast; both with P