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

2023-07-27

临床结果临床3期

NORTH CHICAGO, IL, USA I July 26, 2023 I 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:

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 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 Study1,5

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 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.

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SOURCE: AbbVie