Late-Breaking Results from Phase 3 Trials of Risankizumab Advances

New, long-term data analyses of the KEEPsAKE 1 and 2 trials evaluating risankizumab 150 mg in adult patients with active psoriatic arthritis showed that at week 100, more than half of patients achieved a 90% reduction in the Psoriasis Area and Severity Index (PASI 90) and an American College of Rheumatology 20 (ACR20) response.

These results were featured during the "Late Breaking News" session at the 31st European Academy of Dermatology and Venereology (EADV) Hybrid Congress onsite in Milan and online.

Risankizumab is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.^9,10 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic, immune-mediated diseases, including psoriasis and psoriatic arthritis.⁹

The new data from the open-label extension period showed that at 100 weeks, 64% and 57% of patients initially treated with risankizumab achieved ACR20 response in KEEPsAKE 1 and 2, respectively.¹ Among patients initially treated with risankizumab and who had a body surface area involvement greater than or equal to 3% at baseline, 71% from KEEPsAKE 1 and 67% of those from KEEPsAKE 2 achieved PASI 90.¹

In addition, pooled results from KEEPsAKE 1 and 2 at week 100 of patients initially treated with risankizumab showed that 76% and 57%, respectively, achieved resolution of dactylitis and enthesitis.¹ For patients in KEEPsAKE 1 initially treated with risankizumab who had nail psoriasis at baseline, mean scores for Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and modified Nail Psoriasis Severity Index (mNAPSI) were maintained at week 100 compared with week 52.¹

Risankizumab was generally well-tolerated, according to the data. No new safety signals were noted in both KEEPsAKE 1 and 2 at 100 weeks of treatment.^1-4 The most frequently reported adverse reactions were upper respiratory infections. Commonly (≥ 1/100 to < 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue, and injection site reactions.

KEEPsAKE 1 and 2 are both Phase 3, multicenter, randomized, double-blind, and placebo-controlled studies designed to evaluate the safety and efficacy of  risankizumab in adult patients with active psoriatic arthritis. KEEPsAKE 1 included patients with an inadequate response or intolerance to one or more conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR), while KEEPsAKE 2 included patients with an inadequate response to csDMARD-IR and/or with an inadequate response or intolerance to one or two biologic therapies. In the first phase of the studies (Period 1), patients were randomized to risankizumab or placebo through week 24. At week 24, the open-label extension (Period 2) began, and all patients were treated with risankizumab.

The two KEEPsAKE studies are ongoing to evaluate the long-term safety, tolerability, and efficacy of risankizumab in patients with psoriatic arthritis. Risankizumab is approved in the U.S. to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, as well as to treat active psoriatic arthritis in adults.⁵

Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.⁵  

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.⁵

Prior to initiating therapy with risankizumab, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.⁵

References:

1. Kristensen, L.E., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Trials. 2022 European Academy of Dermatology and Venereology (EADV) Hybrid Congress.
2. Kristensen, L.E., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 52-Week Results From the KEEPsAKE 1 and KEEPsAKE 2 Trials. 2021 European Academy of Dermatology and Venereology Virtual Congress.
3. Kristensen, L.E., et al. Efficacy and Safety of Risankizumab in Patients With Active Psoriatic Arthritis After Inadequate Response or Intolerance to DMARDs: 24-Week Results From the Phase 3, Randomized, Double-Blind KEEPsAKE 1 Trial. 2021 World Psoriatic and Arthritis Conference.
4. Östör, A., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis, Including Patients With Inadequate Response or Intolerance to Biologic Therapies: 24-Week Results From the Phase 3, Randomized, Double-blind, KEEPsAKE 2 Trial.
5. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.; 2022.