Results from the PHASE3 study (NCT03671148) investigating Risankizumab (Skyrizi) in participants with Psoriatic Arthritis (PsA) were posted on 2020-06-22. The trial demonstrated that Risankizumab achieved a 51.3% American College of Rheumatology 20% (ACR20) response at Week 24, compared to 26.5% for placebo, with a statistically significant difference of 24.5% (p-value 0.001).

Background

Risankizumab (Skyrizi) was investigated for the treatment of moderately to severely active Psoriatic Arthritis (PsA). The study aimed to evaluate its safety and efficacy in this adult patient population, including those with a history of inadequate response or intolerance to biologic therapies.

Trial design

The PHASE3 study, identified as NCT03671148, enrolled 444 participants with moderately to severely active Psoriatic Arthritis (PsA). The study compared Risankizumab to placebo in participants, including those who had a history of inadequate response or intolerance to biologic therapies. The primary efficacy endpoint was the percentage of participants achieving an American College of Rheumatology 20% (ACR20) response at Week 24.

Key results

The trial demonstrated significant improvements across key endpoints for Risankizumab compared to placebo:

  • At Week 24, 51.3% of Risankizumab participants achieved an American College of Rheumatology 20% (ACR20) response compared to 26.5% for placebo. The response rate difference was 24.5% (95% Confidence Interval 15.9, 33.0), with a p-value of 0.001.
  • The change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 was -0.22 for Risankizumab versus -0.05 for placebo. The least squares mean difference was -0.16 (95% Confidence Interval -0.26, -0.07), with a p-value of 0.001.
  • At Week 24, 55.0% of Risankizumab participants achieved a Psoriasis Area Severity Index (PASI) 90 response compared to 10.2% for placebo. The response rate difference was 44.3% (95% Confidence Interval 33.9, 54.6), with a p-value of 0.001.

What this means

The results from this PHASE3 study indicate that Risankizumab provides significant clinical benefits for adults with moderately to severely active Psoriatic Arthritis (PsA). The observed improvements in ACR20 response, physical function (HAQ-DI), and skin manifestations (PASI 90) demonstrate its efficacy across multiple domains relevant to PsA patients. These findings support the potential of Risankizumab as an effective treatment option for this patient population.

Source

This information was sourced from ClinicalTrials.gov, documenting the results of trial NCT03671148, which were posted on 2020-06-22. The study details are available on clinicaltrials.gov.