AbbVie Presents New Late-Breaking Data Showing SKYRIZI® (risankizumab-rzaa) Achieves Superior Rates of Complete Skin Clearance Versus COSENTYX® (secukinumab) at 52 Weeks

- New head-to-head data from the IMMerge Phase 3b open-label study show SKYRIZI demonstrated superiority to COSENTYX at week 52, with 66 percent of SKYRIZI patients achieving completely clear skin (PASI 100) versus 40 percent of COSENTYX patients[1]

- No new safety signals were observed for SKYRIZI through 52 weeks[1]

- Results presented at the American Academy of Dermatology virtual annual meeting

News provided by

AbbVie

Jun 12, 2020, 15:02 ET

NORTH CHICAGO, Ill., June 12, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new late-breaking Phase 3b head-to-head data showing superior rates of skin clearance for SKYRIZI^® (risankizumab-rzaa) to COSENTYX^® (secukinumab) at week 52.¹ Particularly, 66 percent of psoriasis patients receiving SKYRIZI achieved completely clear skin—100 percent clearance in the Psoriasis Area and Severity Index (PASI 100)—versus 40 percent of patients receiving COSENTYX at week 52 (p<0.001).¹

These new head-to-head results from the IMMerge Phase 3b open-label study were shared today during an online late-breaking presentation by the American Academy of Dermatology (AAD). AbbVie previously announced top-line results from this study in January.

"I've seen first-hand how achieving and maintaining completely clear skin can have an incredibly positive impact on the lives of my psoriasis patients," said chief investigator Richard B. Warren, M.D., Ph.D., professor and honorary consultant dermatologist at the Dermatology Centre Salford Royal NHS Foundation Trust, University of Manchester. "These new data are critical as they underscore that complete skin clearance is a realistic treatment goal for people living with psoriasis."

SKYRIZI met both PASI 90 primary endpoints of non-inferiority to COSENTYX at week 16 and superiority to COSENTYX at week 52.¹ At week 16, 74 percent of SKYRIZI-treated patients achieved PASI 90 compared to 66 percent of COSENTYX-treated patients.¹ Of patients treated with SKYRIZI, 87 percent achieved PASI 90 at week 52 compared to 57 percent of patients treated with COSENTYX (p<0.001).¹

Additional results demonstrated a significantly higher proportion of patients treated with SKYRIZI achieved a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) compared to those treated with COSENTYX at week 52 (88 percent versus 58 percent, respectively, p<0.001).¹

Current safety data available demonstrated that the safety profile of SKYRIZI was consistent with that seen in previously reported studies, with no new safety signals observed through week 52.^1-4 The rates of adverse events (AEs) were comparable between SKYRIZI and COSENTYX.¹ The most common AEs were nasopharyngitis, upper respiratory tract infection, headache, arthralgia and diarrhea.¹ The rates of serious AEs were 5.5 percent in the SKYRIZI group and 3.7 percent in the COSENTYX group.¹ Adverse events leading to discontinuation of the study drug were 1.2 percent in the SKYRIZI group and 4.9 percent in the COSENTYX group.¹ There were no deaths in either treatment group.¹

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

About the IMMerge Phase 3b Study^1,5

IMMerge is a Phase 3b, multicenter, randomized, open-label (both arms), efficacy assessor-blinded, active-comparator study designed to evaluate the safety and efficacy of SKYRIZI compared to COSENTYX in adult patients with moderate to severe plaque psoriasis. Patients were randomized 1:1 to SKYRIZI (n=164) (150 mg), given as two 75 mg subcutaneous injections at baseline, four weeks later and every 12 weeks thereafter, or to COSENTYX (n=163) (300 mg), given as two 150 mg subcutaneous injections at baseline, weeks 1, 2, 3 and 4, and then every four weeks thereafter. The study has two primary endpoints (non-inferiority at week 16 as well as superiority at week 52, both at PASI 90) and three ranked secondary endpoints (PASI 100 at week 52, sPGA 0/1 at week 52 and PASI 75 at week 52). Safety was assessed in all patients.

More information on this trial can be found at www.clinicaltrials.gov (NCT03478787).

About SKYRIZI (risankizumab-rzaa) in the United States⁶

SKYRIZI is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Important Safety Information

Infection

SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis (TB)

Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.

Immunizations

Prior to initiating SKYRIZI, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with SKYRIZI.

Adverse Reactions

Most common (≥1%) adverse reactions associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

This is not a complete summary of all safety information. See SKYRIZI.com for full prescribing information. 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 program, 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. For more information on AbbVie in dermatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/dermatology.html.

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.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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 2019 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:

Warren, R.B., et al. Risankizumab Versus Secukinumab in Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 3 Trial. 2020 AAD Meeting (Virtual). American Academy of Dermatology Annual Meeting. 2020.
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. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019 Aug 17;394(10198):576-586. doi: 10.1016/S0140-6736(19)30952-3.
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. Poster #478. 24th World Congress of Dermatology. 2019.
Risankizumab Versus Secukinumab for Subjects With Moderate to Severe Plaque Psoriasis. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03478787.
SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

COSENTYX^® is a registered trademark of Novartis AG

SOURCE AbbVie