Psoriatic arthritis is a chronic inflammatory disease that affects both the skin and the joints, often leading to significant burden for patients. Despite advancements in treatment, many individuals struggle to find adequate relief from the signs and symptoms of this condition. AbbVie's SKYRIZI® (risankizumab-rzaa) has emerged as a significant treatment option for adults with active psoriatic arthritis, offering a targeted approach to managing this complex disease.
Understanding SKYRIZI® (risankizumab-rzaa)
SKYRIZI® is a prescription medication designed to treat moderate to severe plaque psoriasis and active psoriatic arthritis in adults. It functions as an interleukin-23 (IL-23) inhibitor, selectively blocking IL-23 by binding to its p19 subunit. This mechanism of action targets a key cytokine involved in inflammatory diseases.
Mechanism of Action
SKYRIZI selectively targets and inhibits interleukin-23 (IL-23), a cytokine that plays a crucial role in the inflammatory processes associated with psoriatic arthritis. By binding to the p19 subunit of IL-23, risankizumab-rzaa effectively disrupts the signaling pathway that contributes to the disease's manifestations.
Approved Indications and Administration
SKYRIZI has received approval from regulatory bodies for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Additionally, it is approved for the treatment of active psoriatic arthritis in adults. The approved dosage for SKYRIZI is 150 mg, administered via subcutaneous injection. The treatment regimen involves initial doses at week 0 and week 4, followed by maintenance doses every 12 weeks thereafter. This dosing schedule allows for administration with a single injection four times a year after the initial starter doses.
Clinical Efficacy in Psoriatic Arthritis
The efficacy and safety of SKYRIZI in treating active psoriatic arthritis have been evaluated in pivotal clinical studies, notably the KEEPsAKE-1 and KEEPsAKE-2 trials. These multicenter, randomized, double-blind, placebo-controlled studies were designed to assess SKYRIZI's effectiveness in adult patients with active psoriatic arthritis.
KEEPsAKE-1 and KEEPsAKE-2 Trials
KEEPsAKE-1 focused on patients who had an inadequate response or intolerance to at least one disease-modifying antirheumatic drug (DMARD). KEEPsAKE-2 included patients with an inadequate response or intolerance to biologic therapy and/or DMARDs. In these studies, patients were randomized to receive either SKYRIZI 150 mg or a placebo. The primary endpoint for both studies was the achievement of ACR20 response at week 24, which indicates at least a 20 percent improvement in tender and swollen joints, along with other key outcome measures.
Key Efficacy Endpoints
- ACR20 Response: In KEEPsAKE-1, 57.3% of patients receiving SKYRIZI achieved ACR20 response at week 24, compared to 33.5% on placebo. In KEEPsAKE-2, 51.3% of patients on SKYRIZI achieved ACR20 response, versus 26.5% on placebo.
- Improvement in Joint Symptoms: SKYRIZI demonstrated significant improvement in joint symptoms, including swollen, tender, and painful joints, compared to placebo.
- Dactylitis and Enthesitis: The studies also showed improvement in dactylitis (inflammation of fingers and toes) and enthesitis (inflammation where tendons or ligaments attach to bone).
- Minimal Disease Activity (MDA): Ranked secondary endpoints included the achievement of minimal disease activity (MDA), defined by specific criteria related to joint counts, skin involvement, pain, global disease activity, functional disability, and enthesitis.
- Psoriasis Area and Severity Index (PASI 90): Skin symptoms were measured by a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90).
Safety and Risk Information
As with any medication, it is important to be aware of the potential side effects and contraindications associated with SKYRIZI. Patients should discuss these with their healthcare provider before starting treatment.
Contraindications and Warnings
- Hypersensitivity Reactions: SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of its excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported.
- Risk of Infection: SKYRIZI may increase the risk of infections. Patients with a chronic infection or a history of recurrent infection should be carefully evaluated. Healthcare providers must check for infections and tuberculosis (TB) before initiating treatment. Treatment for latent or active TB may be necessary for some patients. Patients should seek medical advice if signs or symptoms of a clinically important infection occur.
- Live Vaccines: Live vaccines should be avoided in patients treated with SKYRIZI, as medications that interact with the immune system may increase the risk of infection following their administration.
Potential Side Effects
- Liver Problems: Drug-induced liver injury has been reported in patients treated with SKYRIZI. Liver enzymes and bilirubin should be evaluated at baseline and during induction dosing (up to 12 weeks), with continued monitoring thereafter. Alternate treatment should be considered for patients with evidence of liver cirrhosis. Treatment should be interrupted if drug-induced liver injury is suspected until it is excluded.
- Lipid Elevations: Increases in lipids from baseline were observed in patients treated with SKYRIZI in Crohn's disease studies.
Pregnancy and Breastfeeding
Patients who are pregnant or plan to become pregnant should discuss the use of SKYRIZI with their healthcare provider. Women who become pregnant while taking SKYRIZI are encouraged to enroll in the Pregnancy Registry to collect information about the health of the mother and baby.
Patient Support and Access
AbbVie is committed to helping patients access SKYRIZI. The company offers a patient support program and co-pay card that can reduce out-of-pocket costs for eligible, commercially-insured patients. For individuals with limited or no health insurance, the myAbbVie Assist program provides SKYRIZI at no charge to those who qualify.
AbbVie's Commitment to Health
AbbVie's mission is to discover and deliver innovative medicines that address serious health issues and medical challenges. The company focuses on key therapeutic areas including immunology, oncology, neuroscience, eye care, virology, and women's health, in addition to its Allergan Aesthetics portfolio. For more information about AbbVie, please visit www.abbvie.com.
Creating Medicines for the Future
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