New Head-to-Head Phase 3 Data Show SKYRIZI▼™ (risankizumab) Superior to Cosentyx® (secukinumab) Across Primary and All Ranked Secondary Endpoints in Adults with Moderate to Severe Plaque Psoriasis at 52 Weeks

-Risankizumab met both primary and all secondary endpoints in a head-to-head, open-label study versus secukinumab¹

-Of patients treated with risankizumab, 87 percent achieved PASI 90 compared to 57 percent of secukinumab-treated patients at 52 weeks (p<0.001)¹

-No new safety signals were observed¹

MAIDENHEAD, January 14, 2020– AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that SKYRIZI▼(risankizumab) met both primary and all ranked secondary endpoints, including superiority at week 52, versus Cosentyx (secukinumab) in a head-to-head Phase 3 study.¹ Risankizumab showed significantly higher rates of skin clearance compared to secukinumab, meeting the primary endpoint of superiority with at least a 90 percent improvement from baseline in the Psoriasis Area and Severity Index (PASI 90) at week 52.¹ Of patients treated with risankizumab, 87 percent achieved PASI 90 compared to 57 percent of risankizumab -treated patients at 52 weeks (p<0.001).¹ At week 16, risankizumab also met the other primary endpoint of non-inferiority to secukinumab with 74 percent of risankizumab patients achieving PASI 90 compared to 66 percent of secukinumab patients.¹

"In this study, risankizumab showed superior efficacy compared to secukinumab in helping patients achieve and maintain high levels of skin clearance at week 52,” said Michael Severino, M.D., vice chairman and president, AbbVie. “Head-to-head data like these are crucial to help patients and their doctors make informed treatment decisions. We are pleased to add these results to the growing body of evidence supporting risankizumab as a differentiated treatment option for adults living with psoriasis.”

Risankizumab also showed superiority compared to secukinumab for all ranked secondary endpoints, including PASI 100, and PASI 75, as well as a static Physician Global Assessment score of clear or almost clear (sPGA 0/1) at week 52 (p<0.001).¹

Current safety data available demonstrated that the safety profile of risankizumab was consistent with that observed 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 rate 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 Head-to-Head Phase 3 Study^1,5

This Phase 3, multicentre, randomised, open-label, efficacy assessor-blinded, active-comparator study was 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 I (n=164) (150 mg), given as two 75 mg subcutaneous injections at baseline, 4 weeks later and every 12 weeks thereafter, or secukinumab (n=163) (300 mg) given as two 150 mg subcutaneous injections, at baseline, weeks 1, 2, 3 and 4, and then every 4 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 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 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.

References:

• 1.AbbVie. Data on File. ABVRRTI69849.
• 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