New Two-Year Data at the 24th World Congress of Dermatology Shows SKYRIZI™ (risankizumab) Maintains Complete Skin Clearance

NORTH CHICAGO, Ill., June 11, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new results showing a significant number of patients treated with SKYRIZI™ (risankizumab) experienced complete skin clearance at week 94.¹ In the study, at week 28 patients who achieved a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) were re-randomized to continue treatment with SKYRIZI or withdrawal.¹ After 94 weeks of continuous treatment with SKYRIZI, 73 percent and 72 percent of these patients achieved a sPGA score of clear (sPGA 0) and a 100 percent improvement in the Psoriasis Area and Severity Index (PASI 100), respectively, compared to 2 percent of patients re-randomized to withdrawal (p<0.001).¹ These two-year results (up to 104 weeks) from the Phase 3 IMMhance study, evaluating the efficacy and safety of SKYRIZI in adult patients with moderate to severe psoriasis, will be presented today at the 24th World Congress of Dermatology (WCD) in Milan.

"Results show that SKYRIZI has the potential to provide long-term relief from the signs and symptoms of psoriasis," said Marek Honczarenko, M.D., Ph. D., vice president, immunology development, AbbVie. "Our studies demonstrated that SKYRIZI can not only offer complete skin clearance at two years of treatment for the majority of patients, but re-treatment with SKYRIZI following a relapse can help patients regain skin clearance in just 16 weeks. We are pleased to add positive long-term data to the growing body of evidence supporting the efficacy and safety profile of SKYRIZI for adult patients with moderate to severe psoriasis."

SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

There were two phases in the IMMhance study.¹ Results from the first phase were previously reported and showed that after 16 weeks of treatment, SKYRIZI (n=407) met the co-primary endpoints of PASI 90 and sPGA 0/1 versus placebo (n=100) (p<0.001).¹ The second phase (week 28 through week 104) evaluated the efficacy and safety of continuous therapy with SKYRIZI versus randomized withdrawal, as well as re-treatment.¹ Patients who achieved sPGA 0/1 at week 28 with SKYRIZI were re-randomized to continue SKYRIZI (n=111) every 12 weeks or to withdrawal (n=225).¹ The primary endpoint from the second phase of the study, sPGA 0/1, was also met at one year (52 weeks) (p<0.001).¹

For those re-randomized to continue SKYRIZI, the last dose was given at week 88.¹ Between one year (week 52) and week 94, the proportion of these patients who achieved complete skin clearance continued to increase.¹ sPGA 0 and PASI 100 responses increased from 65 percent and 64 percent at week 52 to 73 percent and 72 percent at week 94, respectively (p<0.001).¹ At two years, 81 percent and 78 percent of patients treated with continuous SKYRIZI maintained clear or almost clear skin (sPGA 0/1 or PASI 90) compared to 7 percent and 4 percent re-randomized to withdrawal, respectively (p<0.001).¹

Among patients re-randomized to withdrawal who experienced a loss of response (defined as a sPGA score of moderate to severe [≥3]) on or after week 32 (n=153), 84 percent regained clear or almost clear skin (sPGA 0/1) after 16 weeks of re-treatment with SKYRIZI.¹

"In the IMMhance study, SKYRIZI provided an increasing number of patients with complete skin clearance up to 94 weeks," said Melinda Gooderham, M.D., dermatologist and medical director at the SKiN Centre for Dermatology in Peterborough, Ontario and a study investigator. "SKYRIZI not only offers relief from the signs and symptoms of psoriasis following a withdrawal from medication, but the study further demonstrates the significant rates of complete skin clearance that can be achieved with continuous treatment at the recommended dose. These data underscore the lasting impact this new treatment option could provide for people living with psoriasis."

No new safety findings were observed in patients who continued with SKYRIZI for two years compared with those who withdrew to placebo at week 28.¹ Rates of treatment-emergent adverse events were similar to placebo at week 16 and remained stable over time in patients treated with SKYRIZI.¹

About the Phase 3 IMMhance Study¹

The IMMhance study is an ongoing Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of SKYRIZI compared to placebo in adult patients with moderate to severe plaque psoriasis. In the first phase, patients were randomized 4:1 to SKYRIZI (n=407)(150 mg), given as a subcutaneous injection at baseline, 4 weeks later and every 12 weeks thereafter, or placebo (n=100). In the second phase of this study (week 28 through week 104), patients originally randomized to SKYRIZI who achieved sPGA 0/1 at week 28 were re-randomized to SKYRIZI (maintenance, n=111) or placebo (withdrawal, n=225). Safety was assessed in all patients. Patients received their last dose of SKYRIZI at week 88 and follow up was conducted until week 104.

This Phase 3 study was conducted in cooperation between AbbVie and Boehringer Ingelheim. More information on this trial can be found at www.clinicaltrials.gov (NCT02672852).

About SKYRIZI (risankizumab) in the European Union³

SKYRIZI (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information³

SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI 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 SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI 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 SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization 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 SKYRIZI. Patients treated with SKYRIZI 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.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

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.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2018 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

1. Blauvelt, A., et al. Efficacy and Safety of Continuous Q12W Risankizumab Versus Treatment Withdrawal: 2-Year Double-Blinded Results from the Phase 3 IMMhance Trial. 24th World Congress of Dermatology. 2019.
2. Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.
3. SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu. 

SOURCE AbbVie

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