– Approval based on results from clinical studies showing high rates of skin clearance at 16 weeks; this clearance was durable at one year with every 12-week dosing[1-4]
– SKYRIZI™ (risankizumab), a humanized immunoglobulin G1 (IgG1) monoclonal antibody designed to selectively inhibit IL-23 by binding to its p19 subunit, offers moderate to severe psoriasis patients a new therapeutic option[5]
– Psoriasis is a chronic condition affecting 125 million people worldwide and many patients still do not reach treatment goals or lose treatment response over time[6-8]
NORTH CHICAGO, IL, USA I April 30, 2019 I AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Commission (EC) has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. SKYRIZI (150 mg) is approved to be administered by two subcutaneous injections every 12 weeks following two initiation doses at week 0 and week 4. In clinical studies, SKYRIZI demonstrated high rates of skin clearance at 16 weeks and this clearance was durable at one year (52 weeks).1-4 This approval allows for the marketing of SKYRIZI in all member states of the European Union, as well as Iceland, Liechtenstein and Norway.
“This approval is an important step forward in providing people living with moderate to severe psoriasis with a new treatment option,” said Michael Severino, M.D., vice chairman and president, AbbVie. “The results seen in our clinical studies, including high levels of complete skin clearance with 12-week dosing and a favorable safety profile, suggest SKYRIZI has the potential to provide long-term relief from the signs and symptoms of psoriasis. We are proud to expand our portfolio of treatment options for people living with this condition in Europe.”
“In clinical studies, patients saw significantly higher rates of skin clearance with SKYRIZI compared to current standards of care,” said Hervé Bachelez, professor at the University Paris Diderot and the Department of Dermatology of the Saint-Louis Hospital-Assistance Publique Hôpitaux de Paris, France and a principal investigator of the ultIMMa-2 study. “As many as 80 percent of patients who achieved clear skin at 16 weeks maintained completely clear skin through one year. We look forward to seeing more of the two-year data from the IMMhance study at the World Congress of Dermatology in June.”
SKYRIZI received EC approval based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.1-4 Across all four studies, the co-primary endpoints were at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) at week 16.1-4 SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
Highlights from the pivotal Phase 3 program
- In the ultIMMa-1 and ultIMMa-2 studies, SKYRIZI met the co-primary endpoints of sPGA 0/1 and PASI 90 at week 16 (p<0.001).1,4 After 16 weeks of treatment, 88 percent (ultIMMa-1) and 84 percent (ultIMMa-2) of SKYRIZI patients achieved sPGA 0/1 and 75 percent of patients receiving SKYRIZI in both studies achieved PASI 90.1,4
- An integrated analysis of patients who received SKYRIZI in the ultIMMa-1 and ultIMMa-2 studies showed that, of patients who achieved PASI 90 with SKYRIZI at week 16, 88 percent of these patients maintained PASI 90 with SKYRIZI at one year (52 weeks). Of patients who achieved PASI 100 with SKYRIZI at week 16, 80 percent maintained PASI 100 with SKYRIZI at one year (52 weeks).4
- SKYRIZI demonstrated superiority versus adalimumab in the IMMvent study, with 72 percent of patients achieving PASI 90 compared to 47 percent of patients treated with adalimumab at week 16 (p<0.001).2,4 Following re-randomization at week 16, 66 percent of patients who started on adalimumab and switched to SKYRIZI achieved PASI 90, compared to 21 percent who continued on adalimumab at week 44 (p<0.001).2,4 The co-primary endpoints of sPGA 0/1 and PASI 90 at week 16 were met (p<0.001).2,4
- Results from IMMhance showed that, among people receiving SKYRIZI who achieved clear or almost clear skin (sPGA 0/1) response at week 28 and were re-randomized to continue SKYRIZI (n=111), 87 percent maintained this response at week 52 compared to 61 percent re-randomized to withdraw (n=225).9 The co-primary endpoints of sPGA 0/1 at week 16 and week 52 were met (p<0.001).3,4
- SKYRIZI was also reported to improve health-related quality of life in Phase 3 studies. In ultIMMa-1 and ultIMMa-2, significantly more patients treated with SKYRIZI self-reported a Dermatology Life Quality Index (DLQI) score of 0 or 1 (75 percent in ultIMMa-1 and 71 percent in ultIMMa-2) compared with ustekinumab (47 percent in ultIMMa-1 and 44 percent in ultIMMa-2) at one year (p<0.001).1,4 DLQI is a measure of a patient’s health-related quality of life, ranging from 0 to 30, with lower scores indicating the disease has less impact on life quality.10
More information about this program can be found on www.clinicaltrials.gov (NCT02672852, NCT02694523, NCT02684370, NCT02684357).
The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients.4 Common adverse reactions (frequency defined as greater than or equal to 1/100 events to less than 1/10) included tinea infections, headache, pruritus, fatigue and injection site reactions.4
AbbVie received approval of SKYRIZI from the Japanese Ministry of Health, Labour and Welfare for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in March 2019, as well as approval for the treatment of adults with moderate to severe plaque psoriasis from Health Canada and the U.S. Food and Drug Administration in April 2019.
About SKYRIZI (risankizumab) in the European Union
SKYRIZI (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
About AbbVie
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
References:
- Gordon K, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet. 2018 Aug 25;392(10148):650-661.
- Reich, K., et al. Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate-to-Severe Plaque Psoriasis: Results from the Phase 3 IMMvent Trial. ePoster #P1813. European Academy of Dermatology and Venereology Congress. 2018.
- Blauvelt, A. et al. Risankizumab Efficacy/Safety in Moderate-to-Severe Plaque Psoriasis: 16-Week Results From IMMhance [abstract P066]. Acta Derm Venereol. 2018; 98(suppl 219): 30.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu.
- Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.
- International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/wp-content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf. Accessed March 22, 2019.
- Mroweitz, U., et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan; 303(1): 1–10.
- Levin, et al. Biologic fatigue in psoriasis. J Dermatolog Treat. 2014 Feb;25(1):78-82. doi: 10.3109/09546634.2013.826341.
- Langley, et al. Efficacy and Safety of Continuous Q12W Risankizumab versus Treatment Withdrawal: Results from the Phase 3 IMMhance Trial. Poster #10093. 2019 American Academy of Dermatology Annual Meeting. 2019.
- Hongbo Y, et al. Translating the science of quality of life into practice: What do dermatology life quality index scores mean? J Invest Dermatol. 2005 Oct;125(4):659-64.
- HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Last updated October 5, 2017. Accessed March 22, 2019.
SOURCE: AbbVie
Post Views: 27
– Approval based on results from clinical studies showing high rates of skin clearance at 16 weeks; this clearance was durable at one year with every 12-week dosing[1-4]
– SKYRIZI™ (risankizumab), a humanized immunoglobulin G1 (IgG1) monoclonal antibody designed to selectively inhibit IL-23 by binding to its p19 subunit, offers moderate to severe psoriasis patients a new therapeutic option[5]
– Psoriasis is a chronic condition affecting 125 million people worldwide and many patients still do not reach treatment goals or lose treatment response over time[6-8]
NORTH CHICAGO, IL, USA I April 30, 2019 I AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Commission (EC) has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. SKYRIZI (150 mg) is approved to be administered by two subcutaneous injections every 12 weeks following two initiation doses at week 0 and week 4. In clinical studies, SKYRIZI demonstrated high rates of skin clearance at 16 weeks and this clearance was durable at one year (52 weeks).1-4 This approval allows for the marketing of SKYRIZI in all member states of the European Union, as well as Iceland, Liechtenstein and Norway.
“This approval is an important step forward in providing people living with moderate to severe psoriasis with a new treatment option,” said Michael Severino, M.D., vice chairman and president, AbbVie. “The results seen in our clinical studies, including high levels of complete skin clearance with 12-week dosing and a favorable safety profile, suggest SKYRIZI has the potential to provide long-term relief from the signs and symptoms of psoriasis. We are proud to expand our portfolio of treatment options for people living with this condition in Europe.”
“In clinical studies, patients saw significantly higher rates of skin clearance with SKYRIZI compared to current standards of care,” said Hervé Bachelez, professor at the University Paris Diderot and the Department of Dermatology of the Saint-Louis Hospital-Assistance Publique Hôpitaux de Paris, France and a principal investigator of the ultIMMa-2 study. “As many as 80 percent of patients who achieved clear skin at 16 weeks maintained completely clear skin through one year. We look forward to seeing more of the two-year data from the IMMhance study at the World Congress of Dermatology in June.”
SKYRIZI received EC approval based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.1-4 Across all four studies, the co-primary endpoints were at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) at week 16.1-4 SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
Highlights from the pivotal Phase 3 program
- In the ultIMMa-1 and ultIMMa-2 studies, SKYRIZI met the co-primary endpoints of sPGA 0/1 and PASI 90 at week 16 (p<0.001).1,4 After 16 weeks of treatment, 88 percent (ultIMMa-1) and 84 percent (ultIMMa-2) of SKYRIZI patients achieved sPGA 0/1 and 75 percent of patients receiving SKYRIZI in both studies achieved PASI 90.1,4
- An integrated analysis of patients who received SKYRIZI in the ultIMMa-1 and ultIMMa-2 studies showed that, of patients who achieved PASI 90 with SKYRIZI at week 16, 88 percent of these patients maintained PASI 90 with SKYRIZI at one year (52 weeks). Of patients who achieved PASI 100 with SKYRIZI at week 16, 80 percent maintained PASI 100 with SKYRIZI at one year (52 weeks).4
- SKYRIZI demonstrated superiority versus adalimumab in the IMMvent study, with 72 percent of patients achieving PASI 90 compared to 47 percent of patients treated with adalimumab at week 16 (p<0.001).2,4 Following re-randomization at week 16, 66 percent of patients who started on adalimumab and switched to SKYRIZI achieved PASI 90, compared to 21 percent who continued on adalimumab at week 44 (p<0.001).2,4 The co-primary endpoints of sPGA 0/1 and PASI 90 at week 16 were met (p<0.001).2,4
- Results from IMMhance showed that, among people receiving SKYRIZI who achieved clear or almost clear skin (sPGA 0/1) response at week 28 and were re-randomized to continue SKYRIZI (n=111), 87 percent maintained this response at week 52 compared to 61 percent re-randomized to withdraw (n=225).9 The co-primary endpoints of sPGA 0/1 at week 16 and week 52 were met (p<0.001).3,4
- SKYRIZI was also reported to improve health-related quality of life in Phase 3 studies. In ultIMMa-1 and ultIMMa-2, significantly more patients treated with SKYRIZI self-reported a Dermatology Life Quality Index (DLQI) score of 0 or 1 (75 percent in ultIMMa-1 and 71 percent in ultIMMa-2) compared with ustekinumab (47 percent in ultIMMa-1 and 44 percent in ultIMMa-2) at one year (p<0.001).1,4 DLQI is a measure of a patient’s health-related quality of life, ranging from 0 to 30, with lower scores indicating the disease has less impact on life quality.10
More information about this program can be found on www.clinicaltrials.gov (NCT02672852, NCT02694523, NCT02684370, NCT02684357).
The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients.4 Common adverse reactions (frequency defined as greater than or equal to 1/100 events to less than 1/10) included tinea infections, headache, pruritus, fatigue and injection site reactions.4
AbbVie received approval of SKYRIZI from the Japanese Ministry of Health, Labour and Welfare for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in March 2019, as well as approval for the treatment of adults with moderate to severe plaque psoriasis from Health Canada and the U.S. Food and Drug Administration in April 2019.
About SKYRIZI (risankizumab) in the European Union
SKYRIZI (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
About AbbVie
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
References:
- Gordon K, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet. 2018 Aug 25;392(10148):650-661.
- Reich, K., et al. Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate-to-Severe Plaque Psoriasis: Results from the Phase 3 IMMvent Trial. ePoster #P1813. European Academy of Dermatology and Venereology Congress. 2018.
- Blauvelt, A. et al. Risankizumab Efficacy/Safety in Moderate-to-Severe Plaque Psoriasis: 16-Week Results From IMMhance [abstract P066]. Acta Derm Venereol. 2018; 98(suppl 219): 30.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu.
- Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.
- International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/wp-content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf. Accessed March 22, 2019.
- Mroweitz, U., et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan; 303(1): 1–10.
- Levin, et al. Biologic fatigue in psoriasis. J Dermatolog Treat. 2014 Feb;25(1):78-82. doi: 10.3109/09546634.2013.826341.
- Langley, et al. Efficacy and Safety of Continuous Q12W Risankizumab versus Treatment Withdrawal: Results from the Phase 3 IMMhance Trial. Poster #10093. 2019 American Academy of Dermatology Annual Meeting. 2019.
- Hongbo Y, et al. Translating the science of quality of life into practice: What do dermatology life quality index scores mean? J Invest Dermatol. 2005 Oct;125(4):659-64.
- HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Last updated October 5, 2017. Accessed March 22, 2019.
SOURCE: AbbVie
Post Views: 27
