SKYRIZI® (risankizumab) Achieved Superiority Versus Apremilast for Co-Primary Endpoints Among Adult Patients with Moderate Plaque Psoriasis in Phase 4 Head-to-Head Study

• An open-label, efficacy assessor-blinded study comparing SKYRIZI^® (risankizumab) to Otezla^® (apremilast) for the treatment of adult patients with moderate plaque psoriasis who were candidates for systemic therapy was published in the British Journal of Dermatology¹
• Significantly more patients in the study achieved co-primary endpoints of PASI 90 and sPGA 0/1 at Week 16 with risankizumab versus apremilast¹
• In apremilast patients not achieving PASI 75 at Week 16, significantly more achieved the primary endpoint of PASI 90 at Week 52 who were re-randomized to risankizumab versus continued with apremilast¹
• Based on TSQM-9, higher treatment satisfaction domain scores were reported at Week 16 for patients taking risankizumab (nominal p-values versus apremilast)¹
• Risankizumab was well-tolerated with no new safety signals identified¹

NORTH CHICAGO, Ill., July 26, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the British Journal of Dermatology published results from the head-to-head Phase 4 IMMpulse study that evaluated the efficacy and safety of SKYRIZI^® (risankizumab) compared to Otezla^® (apremilast) among adult patients with moderate plaque psoriasis eligible for systemic therapy.¹ This study achieved all primary and ranked secondary endpoints with no new safety signals identified.¹

"This study highlights the efficacy of SKYRIZI compared to Otezla in helping systemic-eligible patients achieve high levels of skin clearance and reinforces the safety profile observed in previous studies," said Mudra Kapoor, M.D., vice president, global medical affairs, immunology, AbbVie. "These head-to-head data are crucial to help patients and their doctors make informed treatment decisions for uncontrolled disease and add to the body of evidence supporting SKYRIZI as a treatment option for adults living with moderate psoriasis."

Highlights from this open-label, efficacy assessor-blinded study include:

• At Week 16, a significantly higher proportion of patients who received risankizumab achieved the Period A co-primary endpoints of Psoriasis Area and Severity Index (PASI) 90 and Static Physician's Global Assessment (sPGA) 0/1 [55.9% (66/118) of patients achieved PASI 90 and 75.4% (89/118) achieved sPGA 0/1 with risankizumab versus 5.1% (12/234) and 18.4% (43/234) with apremilast; both with P<0.001].¹
• The proportion of patients achieving the ranked secondary endpoint of PASI 75 at Week 16 was also significantly higher in risankizumab- versus apremilast-treated patients [84.7% (100/118) versus 18.8% (44/234) respectively; P<0.001].¹
• At Week 52, among patients who failed to achieve PASI 75 after 16 weeks of treatment with apremilast, a significantly higher proportion of patients re-randomized to treatment with risankizumab achieved the Period B primary endpoint of PASI 90 as compared to those re-assigned to continue treatment with apremilast [72.3% (60/83) versus 2.6% (2/78); P<0.001].¹
• After 52 weeks of continuous treatment, 73.7% of risankizumab patients achieved the pre-specified endpoints of PASI 90 and 63.6% PASI 100, with 4.5% and 2.7% of apremilast patients achieving PASI 90 and PASI 100 at Week 52, respectively (nominal p-value <0.001 for both comparisons).

The safety profile for risankizumab in this study was consistent with previously reported studies; it was well-tolerated with no new safety signals identified.¹ The most frequent adverse events (reported in ≥5%) in risankizumab-treated patients were COVID-19, nasopharyngitis and upper respiratory tract infection.¹ Diarrhea, nausea and headache were most frequent among apremilast-treated patients.¹ Serious adverse events were reported in 0.8% and 2.9% of risankizumab-treated patients and 1.7% and 2.1% of apremilast-treated patients in Periods A and B, respectively.¹ During Period A and Period B among the re-randomization arms, 6.8% and 5.2% of apremilast-treated patients discontinued treatment due to an adverse event, respectively, while no patient discontinued on risankizumab; on the continuous risankizumab arm, one patient discontinued due to an adverse event.¹

"As a physician, it's crucial to validate different options that can achieve high treatment targets, and this study provides practice-relevant data," said lead study investigator, Linda Stein Gold, M.D., director of clinical research, department of dermatology, Henry Ford Health System. "These data reinforce the efficacy of SKYRIZI for use in systemic-eligible moderate psoriasis patients with an observed safety profile similar to prior studies."

Based on analyses of the Treatment Satisfaction Questionnaire for Medication version 9 (TSQM-9), which were pre-specified unranked endpoints, risankizumab-treated patients reported greater treatment satisfaction at Week 16, with higher scores (out of 100) in all three domains of satisfaction with effectiveness (80.6), satisfaction with convenience (84.9) and global satisfaction (86.2) compared to apremilast-treated patients (46.9, 69.0 and 47.7, respectively; nominal p-value <0.001 for all comparisons).¹

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

About Psoriasis
Psoriasis is a chronic, immune-mediated, inflammatory skin condition that produces thickened, scaling skin due to rapid growth of skin cells.² It affects around 2-3% of people worldwide.³ People with psoriasis also experience a significant emotional, psychological and social burden that can negatively impact their quality of life.⁴

About IMMpulse Study^1,5
IMMpulse is a Phase 4, global, multicenter, randomized, open-label, efficacy assessor-blinded, active comparator study examining the effect of risankizumab (150 mg X 1 s.c at wk0, wk4, wk16, wk28, wk40) compared to apremilast (30 mg BID oral following titration) in adults with moderate plaque psoriasis who are candidates for systemic therapy. Patients must have stable moderate psoriasis at both screening and baseline, defined as: 1) BSA ≥10% and ≤15%; 2) PASI ≥12; 3) sPGA =3 (moderate) to enter the study. The study design comprised a screening period of up to 35 days, a 52-week treatment period and a follow-up phone call for safety. The 52-week treatment duration included two periods: Period A from Weeks 0 to 16, which evaluated the superiority of risankizumab over apremilast, and Period B from Weeks 16 to 52, which evaluated the outcomes following re-randomization to risankizumab versus continuing apremilast in patients who were PASI 75 non-responders with apremilast at Week 16.

About SKYRIZI^® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.⁶ IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.⁶

EU Indications and Important Safety Information about SKYRIZI^® (risankizumab)⁷

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

Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

Skyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Important Safety Information
Risankizumab is contraindicated in patients hypersensitive to the active substance or to any of the excipients, and in patients with clinically important active infections (e.g. active tuberculosis). 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.

Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and risankizumab should not be administered until the infection resolves.

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.

If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated.

The most frequently reported adverse reactions were upper respiratory infections (from 13% in psoriasis to 15.6% in Crohn's disease). Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, rash, fatigue and injection site reactions.

This is not a complete summary of all safety information.

Please see the SmPC for complete prescribing information.
Globally, prescribing information varies; refer to the individual country product label for complete information.

About the British Journal of Dermatology (BJD)
The British Journal of Dermatology (BJD) is a top-ranked international dermatology journal, publishing the highest-quality research to advance the understanding and management of skin disease to improve patient outcomes. The BJD is one of the journals of the British Association of Dermatologists, the professional membership body for dermatologists in the UK.

Oxford University Press (OUP) is BAD's publishing partner. OUP publishes over 500 academic and research journals covering a broad range of subject areas, two-thirds of which are published in collaboration with learned societies and other international organizations. OUP has been publishing journals for more than a century and, as the world's largest university press, has more than 500 years of publishing expertise. For more information, visit academic.oup.com.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

AbbVie 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, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. 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 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. 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.

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