New Data Show SKYRIZI (risankizumab) Maintains Completely Clear Skin for Over Three Years in Nearly Two-Thirds of Patients with Moderate to Severe Plaque Psoriasis
Press Release
By:
Ref: Cision
Published: 10/29/2020
- Long-term data highlight that continuous treatment with SKYRIZI can provide significant rates of sustained skin clearance and a sustained improvement in health-related quality of life for adult patients living with moderate to severe plaque psoriasis1,2
- In two separate analyses, no new safety findings were observed up to 5.5 years1,3
- Results presented at the 29th European Academy of Dermatology and Venerology (EADV) Virtual Congress
MAIDENHEAD, UK, OCTOBER 29, 2020 – AbbVie (NYSE: ABBV) today announced that nearly two-thirds (63 percent) of patients with moderate to severe plaque psoriasis treated with SKYRIZI®▼ achieved completely clear skin for over 3 years (172 weeks), as measured by 100 percent improvement from baseline in the Psoriasis Area and Severity Index (PASI 100).1 Additionally, after more than 3 years of treatment with risankizumab, 88 percent of patients achieved clear or almost clear skin, as measured by a static Physician’s Global Assessment of clear or almost clear (sPGA 0/1) or a 90 percent improvement from baseline in the Psoriasis Area and Severity Index (PASI 90).1 No new safety signals were noted through more than 3 years of continuous treatment.1 New results from the Phase 3 open-label extension (OLE) study, LIMMitless, were presented at the 29th European Academy of Dermatology and Venereology (EADV) Virtual Congress, October 29-31.
A separate analysis of Dermatology Life Quality Index (DLQI) scores from the LIMMitless study showed that risankizumab had a substantially positive impact on health-related quality of life.2 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.4 After continuous treatment with risankizumab for more than 3 years, the majority of patients (85 percent) achieved a DLQI score of 0 or 1, indicating a significant improvement in quality of life.2 Additionally, after more than 3 years (172 weeks), approximately 91 percent of patients achieved a clinically meaningful reduction in DLQI scores (at least a 4 point reduction from baseline).2 The proportion of patients achieving this reduction remained consistent from one year (week 52; n=873) to over 3 years (week 172; n=505).2
Integrated safety results across psoriasis studies also being presented show that risankizumab’s safety profile remained consistent over the long-term, with no new safety signals identified up to 5.5 years with continuous treatment with SKYRIZI.3 The latest data was from a separate study that evaluated the short-term (16 weeks) and long-term (up to 5.5 years) safety of risankizumab in data pooled from 17 Phase 1-3 studies.3 This analysis was the largest reporting of safety data for risankizumab to date, including more than 3,000 patients with over 7,900 patient years (PY) of exposure from the psoriasis clinical trial programme.3
“Long-term, complete skin clearance is now a realistic treatment goal, and the data being presented at EADV reinforce that,” said Belinda Byrne, AbbVie UK Medical Director. “It is encouraging to see that patients who were continuously treated with risankizumab were able to improve their quality of life over the long-term.”
“People with moderate to severe plaque psoriasis want treatment options that help them achieve and maintain clear skin so they can return to a better quality of life,” said Kim Papp, M.D., Ph.D., founder and president, Probity Medical Research, Waterloo, Ontario. “Alleviating the burden of living with psoriasis is a critical focus for the scientific community. It is wonderful and exciting to see new research showing how risankizumab has helped make this happen.”
Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.
About the LIMMitless Phase 3 OLE Study1,2
LIMMitless is an ongoing Phase 3, multicentre, international open-label extension study designed to evaluate the long-term safety and efficacy of risankizumab (150 mg) in adults with moderate to severe plaque psoriasis receiving continuous risankizumab with a loading dose. Patients enrolled in LIMMitless receive risankizumab 150 mg every 12 weeks. The analysis includes integrated data from five Phase 2 and 3 studies (ultIMMa-1, ultIMMa-2, SustaIMM, IMMvent and NCT03255382) and the LIMMitless study.
More information on this trial can be found at www.clinicaltrials.gov (NCT03047395).
About risankizumab in the European Union5
Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Important EU Safety Information5
Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.
The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.
▼Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com. With biological medicines, healthcare professionals should report adverse reactions by brand name and batch number.
This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc . Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie in Dermatology
For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases, including psoriasis, psoriatic arthritis, hidradenitis suppurativa and atopic dermatitis. With a broad clinical trial programme, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease.
About AbbVie
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.co.uk. Follow @abbvieuk on Twitter.
###
|
Media: AbbVie UK External Affairs +44 (0)7818 428111 |
Investors: Liz Shea +1 (847) 935-2211 |
References:
-
Papp, K. et al., Long-term Efficacy and Safety of Continuous Risankizumab Every 12 Weeks: An Interim Analysis from the Open-Label Extension Trial, LIMMitless. 2020 EADV Meeting (Virtual). European Academy of Dermatology and Venerology Annual Meeting 2020.
- Papp, K. et al., Long-term durable improvements in health-related quality of life among psoriasis patients treated with Risankizumab for more than 3 years: Analysis of using Dermatology Life Quality Index (DLQI) scores. 2020 EADV Meeting (Virtual). European Academy of Dermatology and Venerology Annual Meeting 2020.
- Papp, K. et al., Long-Term Safety of Risankizumab in Patients With Moderate-to-Severe Plaque Psoriasis: Results From Pooled Clinical Studies. 2020 EADV Meeting (Virtual). European Academy of Dermatology and Venerology Annual Meeting 2020.
- Dermatology Life Quality Index. Cardiff University School of Medicine. Available at: https://www.cardiff.ac.uk/medicine/resources/quality-of-life-questionnaires/dermatology-life-quality-index.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu.