AbbVie Expands Immunology Portfolio in the European Union with the European Commission Approval of SKYRIZI? (risankizumab) for the Treatment of Adults with Active Psoriatic Arthritis
AbbVie?(NYSE: ABBV) today announced that the European Commission (EC) has approved SKYRIZI??(risankizumab, 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate (MTX), for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Marking the second indication for SKYRIZI, the Marketing Authorization will be valid in all member states of the European Union, as well as?Iceland,?Liechtenstein,?Norway?and?Northern Ireland.
Global Media Jenina Nu? ez +1 (708) 603-5755 jenina.nunez@abbvie.com U.S. Media: Brittany Seagraves +1 (224) 229-2144 brittany.seagraves@abbvie.com Investors Liz Shea +1 (847) 935-2211
liz.shea@abbvie.com
"People living with psoriatic arthritis struggle with psoriatic lesions and joint inflammation that causes swelling and pain. Reducing these symptoms may give people the ability to resume their daily activities and improve their quality of life," said?Michael Severino, M.D., vice chairman and president, AbbVie. "We are excited by the EC approval of SKYRIZI for the treatment of adults with active psoriatic arthritis."
SKYRIZI received EC approval based on data from two Phase 3 clinical studies, KEEPsAKE-1 and KEEPsAKE-2.1-3,6?In these studies, SKYRIZI met the primary endpoint of ACR20 response at week 24 versus placebo, and ranked secondary endpoints including, but not limited to, improvements in several clinical manifestations of psoriatic arthritis such as physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) at week 24.1-3,6
Highlights from the pivotal Phase 3 program1-3,6
- In KEEPsAKE-1 and KEEPsAKE-2, 57.3 and 51.3 percent of patients receiving SKYRIZI achieved the primary endpoint of ACR20 response at week 24, respectively, versus 33.5 and 26.5 percent receiving placebo (p<0.001).
- SKYRIZI-treated patients showed significantly greater improvement from baseline in physical function as measured by HAQ-DI -0.31 and -0.22, compared to placebo -0.11 and -0.05 at week 24 (p<0.001) in KEEPSAKE-1 and KEEPSAKE-2, respectively.
- At week 24, 25.0 percent and 25.6 percent of SKYRIZI-treated patients achieved MDA, in KEEPSAKE-1 and KEEPSAKE-2 respectively, compared to 10.2 percent and 11.4 percent of those on placebo (p<0.001).
- 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 EADV Virtual Congress. D1T01.4A.
- 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.
- ?st?r, 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.
- Clinicaltrials.gov.?A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1). clinicaltrials.gov; 2021.?October 25, 2021.?https://clinicaltrials.gov/ct2/show/NCT03675308.
- Clinicaltrials.gov.?A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2). clinicaltrials.gov; 2021. Accessed?October 25, 2021.?https://clinicaltrials.gov/ct2/show/NCT03671148.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf. Accessed on?October 25, 2021.
- Psoriatic Arthritis. 2019. Mayo Clinic. Available at:?https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076. Accessed on?October 25, 2021.
- Galezowski, A., et al. Rhumatisme psoriasique en?France, du nourrisson ? la personne ?g?e: donn?es de deux ?tudes transversales multicentriques [Psoriatic arthritis in?France, from infants to the elderly: Findings from two cross-sectional, multicenter studies]. Ann Dermatol Venereol. 2018;145(1):13-20. doi:10.1016/j.annder.2017.10.008.
- 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.
- 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.
- Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11.
- A Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease. ClinicalTrials.gov. 2021. Available at:?https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed?October 25, 2021.
- A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants with Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2021. Available at:?https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed on?October 25, 2021.
- Pipeline ? Our Science | AbbVie. AbbVie. 2021. Available at:?https://www.abbvie.com/our-science/pipeline.html. Accessed on?October 25, 2021.
Contact(s)
Global Media Jenina Nu? ez +1 (708) 603-5755 jenina.nunez@abbvie.com U.S. Media: Brittany Seagraves +1 (224) 229-2144 brittany.seagraves@abbvie.com Investors Liz Shea +1 (847) 935-2211
liz.shea@abbvie.com