AbbVie Expands Immunology Portfolio in Canada as Health Canada approves SKYRIZI® (risankizumab) for the Treatment of Adults with Active Psoriatic Arthritis
- Approval supported by data from two Phase 3 studies evaluating SKYRIZI in psoriatic arthritis patients, KEEPsAKE-1 and KEEPsAKE-21,2
- Psoriatic arthritis is a systemic inflammatory disease that impacts the skin and joints, affecting approximately 30 percent of patients with psoriasis3,4,5
MONTREAL, March 17, 2022 /CNW/ – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced Health Canada has approved SKYRIZI® (risankizumab), for the treatment of adult patients with active psoriatic arthritis. In PsA, SKYRIZI can be used alone or in combination with a conventional non-biologic disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).
“SKYRIZI receiving Notice of Compliance for the treatment of active psoriatic arthritis gives additional hope to patients. Results from the Phase 3 clinical trial program indicate improvement in the signs and symptoms associated with this disease,” said Dr. Kim Alexander Papp, MD, PhD, FRCPC, FAAD, Probity Medical Research.
“At AbbVie, we strive to transform the standard of care for immunocompromised people, and we are excited with Health Canada’s approval of SKYRIZI for the treatment of adults with active psoriatic arthritis,” said Tracey Ramsay, Vice President and General Manager, AbbVie Canada.
This is the second indication for SKYRIZI in Canada. In April 2019, Health Canada approved SKYRIZI for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.6
About Psoriatic Arthritis
Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin. In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and the presence of psoriatic lesions.4,5
About KEEPsAKE-1 and KEEPsAKE-21,2
KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of SKYRIZI in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated SKYRIZI in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated SKYRIZI in patients who had an inadequate response or intolerance to biologic therapy and/or DMARD.
About SKYRIZI® (risankizumab)6
Risankizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds with high affinity to the p19 subunit of human interleukin 23 (IL-23) cytokine and inhibits IL-23, a cytokine involved in inflammatory and immune responses.
For important safety information, please consult the SKYRIZI Product Monograph at www.abbvie.ca.
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie Canada on Twitter, on Instagram or find us on LinkedIn.
|1 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.|
|2. 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.|
|3. Psoriatic Arthritis. 2019. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076. Accessed on October 25, 2021.|
|4. Duarte G.V., et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003|
|5. Diseases & Conditions: Psoriatic Arthritis. 2019. American College of Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed on October 25, 2021|
|6. AbbVie Product Monograph. March 2022. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/SKYRIZI_PM_EN.pdf|
SOURCE AbbVie Canada