AbbVie Presents New Late-Breaking Data Showing SKYRIZI▼® (risankizumab) 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 66percent of SKYRIZI patients achieving completely clear skin (PASI100) versus 40 percent of COSENTYX patients1

-No new safety signals were observed for SKYRIZI through 52 weeks1

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

MAIDENHEAD, UK, June 12, 2020– 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)to COSENTYX® (secukinumab) at week 52. Particularly, 66 percent of psoriasis patients receiving risankizumab achieved completely clear skin (PASI100 in the Psoriasis Area and Severity Index) versus 40 percent of patients receiving secukinumab 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).

"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 and professor 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.”

Risankizumab met both PASI90 primary endpoints of non-inferiority to secukinumab at week 16 and superiority to secukinumab at week 52.1 At week 16, 74 percent of risankizumab-treated patients achieved PASI90 compared to 66 percent of secukinumab-treated patients.1 Of patients treated with risankizumab, 87 percent achieved PASI90 at week 52 compared to 57 percent of patients treated with secukinumab (p<0.001).1

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

Current safety data available demonstrated that the safety profile of risankizumab 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 risankizumab and secukinumab.1 The most common AEs were nasopharyngitis, upper respiratory tract infection, headache, arthralgia and diarrhoea.1 The rates of serious AEs were 5.5 percent in the risankizumab group and 3.7 percent in the secukinumab group.1 Adverse events leading to discontinuation of the study drug were 1.2 percent in the risankizumab group and 4.9 percent in the secukinumab group.1 There were no deaths in either treatment group.1

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

About the IMMerge Phase 3b Study1,5

IMMerge is a Phase 3b, multicentre, randomised, open-label (both arms), efficacy assessor-blinded, active-comparator study designed to evaluate the safety and efficacy of risankizumab compared to secukinumab in adult patients with moderate to severe plaque psoriasis. Patients were randomised 1:1 to risankizumab (n=164) (150 mg), given as two 75 mg subcutaneous injections at baseline, four weeks later and every 12 weeks thereafter, or to secukinumab (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 to secukinumab at week 52, both at PASI90) and three ranked secondary endpoints (PASI100 at week 52, sPGA 0/1 at week 52 and PASI75 at week 52). Safety was assessed in all patients.

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

About risankizumab in the European Union6

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information6

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 21 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.

###

UK Media: Sarah Beck

+44 (0)7818 428111

Sarah.beck@abbvie.com

References:

1.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.

2.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.

3.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.

4.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.

5.Risankizumab Versus Secukinumab for Subjects With Moderate to Severe Plaque Psoriasis. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03478787.

6.SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu

COSENTYX is a registered trademark of Novartis AG

About Us

We're a company that takes on the toughest health challenges.AbbVie is a global, research-driven 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.co.uk. Follow us on twitter: @abbvieuk.

Subscribe