Risankizumab (SKYRIZI®) Phase 3 Results Demonstrate Improvements in Disease Activity Across Joint and Skin Symptoms Among Psoriatic Arthritis Patients

- In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved the primary endpoint of ACR20 response at week 24, respectively, versus 34 and 27 percent receiving placebo (p<0.001)[1]

- KEEPsAKE-1 and KEEPsAKE-2 evaluated risankizumab in adult patients with active psoriatic arthritis, and included patients who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs)[1]

- The safety results in these studies to-date were generally consistent with the known profile of risankizumab in psoriasis patients[1-4]

- Risankizumab (SKYRIZI), an interleukin-23 (IL-23) inhibitor, is being evaluated as a treatment for adults with active psoriatic arthritis and several other immune-mediated diseases[1,5-7]

NORTH CHICAGO, IL, USA I January 05, 2021 I AbbVie (NYSE: ABBV) today announced positive top-line results from two Phase 3 studies in adults with active psoriatic arthritis, KEEPsAKE-1 and KEEPsAKE-2, showing that significantly more patients treated with risankizumab (150 mg) achieved the primary endpoint of ACR20 response at week 24 versus placebo.1 In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved ACR20 response at week 24, respectively, versus 34 and 27 percent receiving placebo (p<0.001).1

Results of ranked secondary endpoints showed significant improvements in skin clearance (as measured by at least a 90 percent improvement in Psoriasis Area Severity Index [PASI 90]), physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) at week 24.1 These two Phase 3 studies evaluated risankizumab in adult patients with active psoriatic arthritis, and included patients who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).1

"We are encouraged by these positive results showing the potential of risankizumab in psoriatic arthritis," said Michael Severino, M.D., vice chairman and president, AbbVie. "These results underscore our commitment to research that can provide health care practitioners with important treatment options for patients with psoriatic disease."

KEEPsAKE-1 and KEEPsAKE-2 Results at Week 24*,1
  KEEPsAKE-1 KEEPsAKE-2
  Risankizumab
150 mg
(n=483)
Placebo
(n=481)
Risankizumab
150 mg
(n=224)
Placebo
(n=219)
ACR20a 57% 34% 51% 27%
ACR50a,f 33% 11% 26% 9%
ACR70a,f 15% 5% 12% 6%
PASI 90b 52% 10% 55% 10%
HAQ-DIc -0.31 -0.11 -0.22 -0.05
MDAd 25% 10% 26% 11%
PsA-mTSSe,† 0.23 0.32 N/A N/A
 
* In both studies, ACR20 at week 24 was the primary endpoint, and PASI 90, HAQ-DI and MDA at week 24 were ranked secondary endpoints. ACR20, PASI 90, HAQ-DI and MDA achieved p-values of <0.001. Not all ranked secondary endpoints are shown.
a ACR20/50/70 is defined as at least a 20 percent/50 percent/70 percent reduction from baseline in the number of both tender and swollen joint counts and equivalent improvement in three or more of the five American College of Rheumatology core set measures: patient assessments of pain, patient global assessment of disease activity, physical function, physician global assessment of disease activity and acute phase reactant.
b PASI 90 is defined as achievement of at least a 90 percent reduction in Psoriasis Area Severity Index. It was assessed in patients with a body surface area (BSA) ≥3 percent at baseline.
c HAQ-DI is defined as change in baseline in the Health Assessment Questionnaire Disability Index, which is a patient-reported questionnaire including categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. It asks patients about the amount of difficulty they experience in these activities as well as the use of aids and/or devices.
d MDA is defined as the fulfillment of 5 of 7 outcome measures: TJC ≤1; SJC ≤1; PASI ≤1 or BSA-Ps ≤3 percent; Patient's Assessment of Pain Numerical Rating Scale (NRS) ≤1.5; PtGA-Disease Activity NRS ≤2.0; HAQ-DI score ≤0.5; and LEI (Leeds Enthesitis Index) ≤1.
e PsA-mTSS is defined as a change in modified total Sharp score (mTSS) from baseline.
f ACR50 and ACR70 at week 24 were secondary endpoints and achieved nominal p-values of <0.05. These endpoints were not controlled for multiplicity.
 PsA-mTSS at week 24 was a ranked secondary endpoint that did not reach statistical significance (p=0.496). It was not evaluated in KEEPsAKE-2.

In KEEPsAKE-1, the ranked secondary endpoint of PsA Sharp/van der Heijde Score (PsA-mTSS) was 0.23 and 0.32 at week 24 in the risankizumab and placebo groups, respectively (p=0.496 [note: a lower score denotes lower radiographic progression]).1

In these studies, the safety profile of risankizumab through week 24 was generally consistent with safety findings in previous studies in psoriasis.1-4 Serious adverse events occurred in 2.5 percent and 4.0 percent of patients treated with risankizumab in KEEPsAKE-1 and KEEPsAKE-2, respectively, compared with 3.7 percent and 5.5 percent on placebo.1 Rates of serious infections were similar between treatment groups (1.0 and 0.9 percent in risankizumab-treated patients in KEEPsAKE-1 and KEEPsAKE-2, respectively, and 1.2 and 2.3 percent in patients who received placebo).1 The rates of adverse events leading to discontinuation of the study drug were 0.8 percent and 0.9 percent of patients treated with risankizumab in KEEPsAKE-1 and KEEPsAKE-2, respectively, compared with 0.8 percent and 2.3 percent on placebo.1 In KEEPsAKE-1, there was one death in the risankizumab group not related to the study drug per investigator.1 There were no deaths reported in KEEPsAKE-2.1

Full results from the KEEPsAKE studies will be presented at upcoming medical conferences and published in a peer-reviewed medical journal. Use of risankizumab in psoriatic arthritis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

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

About Psoriatic Arthritis

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin.8,9 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and cause a red, scaly rash.8,9

About KEEPsAKE-1 and KEEPsAKE-21,10,11

KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of risankizumab in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated risankizumab in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated risankizumab in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomized to risankizumab 150 mg or placebo followed by risankizumab 150 mg at week 24.

The primary endpoint for both studies was the achievement of ACR20 response at week 24 from the treatment with the study medication. Ranked secondary endpoints included change from baseline in HAQ-DI, as well as the achievement of PASI 90 and MDA at week 24. Other secondary endpoints included ACR50 and ACR70 (not controlled for multiplicity) at week 24. The studies are ongoing, and the long-term extension remains blinded to evaluate the long-term safety, tolerability and efficacy of risankizumab in patients who have completed the placebo-controlled period.

More information on these trials can be found at www.clinicaltrials.gov (KEEPsAKE-1: NCT03675308; KEEPsAKE-2: NCT03671148).

About risankizumab (SKYRIZI®)

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.12,13 In April 2019, SKYRIZI received U.S. Food and Drug Administration approval for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The approved dose for SKYRIZI is 150 mg (two 75 mg injections), administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter. SKYRIZI was also approved by the European Commission in April 2019. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease and psoriatic arthritis are ongoing.5-7,10,11 Use of SKYRIZI in psoriatic arthritis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About SKYRIZI (risankizumab-rzaa) in the United States13

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

Please click here for Full Prescribing Information and Medication Guide for SKYRIZI.

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

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 TwitterFacebook, Instagram, YouTube and LinkedIn.

References:

  1. AbbVie. Data on File: ABVRRTI71470.
  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. A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03047395. Accessed on December 3, 2020.
  6. A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed on December 3, 2020.
  7. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03398148. Accessed on December 3, 2020.
  8. Duarte G.V., et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003.
  9. Diseases & Conditions: Psoriatic Arthritis. 2019. American College of Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed on December 3, 2020.
  10. A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03675308. Accessed on December 3, 2020.
  11. A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(ies) (KEEPsAKE2). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on December 3, 2020.
  12. Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
  13. SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

SOURCE: AbbVie

La Merie Biologics

FREE Weekly News Bulletin

Sign Up

2019 Sales ofAntibodies & Proteins

New Product Alert

For La Merie Publishing

Sign Up

Top