FDA Approves Skyrizi for Active Psoriatic Arthritis Save

On Friday, the U.S. Food and Drug Administration (FDA) approved risankizumab-rzaa (Skyrizi) for the treatment of adults with active psoriatic arthritis (PsA), with similar dosing in plaque psoriasis - a single 150mg subcutaneous injection four times a year after two starter doses (at weeks 0 and 4) and can be used with or without background disease-modifying antirheumatic drugs (DMARDs).

The FDA approval is based on data from two pivotal studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated the efficacy and safety of risankizumab (RIZ) in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic DMARDs. In both Phase 3 studies, the primary endpoint of ACR20 response at week 24 was superior to placebo (57.3% vs 33.5% and 51.3% vs 26.5%) and also showed significant benefits to other secondary outcomes (functional measures, MDA,ACR50 and ACR70, dactylitis and enthesitis) as well as showing significant improvements in the Psoriasis Area Severity Index (PASI 90) at week 24.

The overall safety profile observed in patients with psoriatic arthritis treated with SKYRIZI is generally consistent with the safety profile in patients with plaque psoriasis.

RIZ is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.8 IL-23. The drug is already approved for use in moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.  Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.

The new product label for RIZ includes:

Indications: moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and active psoriatic arthritis in adults

Warnings: Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur

• Infections: SKYRIZI may increase the risk of infection.... do not administer SKYRIZI until the infection resolves.
• Tuberculosis (TB): Evaluate for TB prior to initiating treatment
• Administration of Vaccines: Avoid use of live vaccine

Common Adverse Events: Most common adverse reactions (≥ 1%) are upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

Dosing: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. In patients with psoriatic arthritis SKYRIZI can be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs).