– Analyses included 100-week efficacy plus safety data from the four-year, open-label extension period of KEEPsAKE 1 and 2 evaluating SKYRIZI in patients with active psoriatic arthritis 1
– Ongoing treatment with SKYRIZI demonstrated consistent long-term efficacy in psoriatic arthritis along with similar rates of improvement in skin (PASI 90) and joint (ACR, enthesitis, dactylitis) symptoms at week 100 as those reported at 7 days 52 one
— No new safety signals were observed through one hundred weeks 1-4
NORTH CHICAGO, Ill. , Sept. 10, 2022 /PRNewswire/ — AbbVie ( NYSE: ABBV ) announced new, long-term data analyses of Momento 1 plus 2, Phase 3 trials evaluating SKYRIZI ® (risankizumab, 150 mg) within adult patients with active psoriatic joint disease. Results showed that in week a hundred of the open-label extension period, patients receiving SKYRIZI documented improvement in skin and joint signs and symptoms, with more than half of individuals in Souvenir 1 plus 2 achieving a 90 percent reduction in the Psoriasis Area and Severity Index (PASI 90) and an American College associated with Rheumatology 20 (ACR20) response. Additionally, the data demonstrated no new noticed safety signals through hundred weeks. 1-4 These results were featured during the “Late Breaking News” session at the 31 st European Academy of Dermatology plus Venereology (EADV) Hybrid Congress onsite in Milan and online.
“We’re pleased to share these new, nearly two-year analyses, which demonstrated SKYRIZI maintained improvements across joint plus skin measures of psoriatic arthritis over time, ” said Doina Cosma-Roman , M. D., vice president and global head, Clinical Development, Immunology, AbbVie. “It is critically important for physicians in order to have treatment options that demonstrate lasting effectiveness, as we know people living with psoriatic arthritis discontinue therapies due to loss of efficiency or tolerability. ”
The new data from your open-label expansion period showed that from 100 several weeks, 64 and 57 percent of sufferers initially treated with SKYRIZI achieved ACR20 reaction in Memento 1 plus 2, respectively. 1 Additionally, with week 100, 71 and 67 % of patients from KEEPsAKE 1 plus 2, correspondingly, initially given SKYRIZI and who had a body surface area involvement greater than or equal to ≥3 percent at baseline, achieved PASI 90. 1
Furthermore, at week 100, pooled results from KEEPsAKE one and 2 showed that 76 plus 57 % of individuals, respectively, initially treated with SKYRIZI achieved resolution of dactylitis and enthesitis. 1 For sufferers in Momento 1 along with nail psoriasis at primary and who were at first treated with SKYRIZI, mean scores with regard to Physician’s Global Assessment associated with Fingernail Psoriasis (PGA-F) and modified Nail Psoriasis Severity Index (mNAPSI) were managed at 7 days 100 compared with week 52. 1
“Psoriatic joint disease often presents with musculoskeletal symptoms, including pain plus swelling in the knees, wrists, ankles and fingers, as well as pain within the hips plus heels, which can significantly reduce a person’s quality of life, inch said Lars Erik Kristensen , M. D., Ph. D., consultant and head of science in the Parker Institute inside Copenhagen, Denmark and associate professor, SUS University Hospital in Lund, Sweden . “These results highlight SKYRIZI’s potential to relieve symptoms in both biologic-naïve and -experienced patients with active psoriatic arthritis in the extensive. ”
SKYRIZI was generally well-tolerated, plus no brand new safety indicators were noted in each KEEPsAKE one and two at one hundred weeks of treatment. 1-4 Serious treatment-emergent adverse events (TEAEs) occurred on 7. 6 events/100 patient-years (E/100PY) and 9. 9 E/100PY within KEEPsAKE 1 and 2, respectively. 1 Rates of serious infections in KEEPsAKE one and 2 were two. 3 plus 1 . six E/100PY, respectively. 1 Major undesirable cardiac events (MACE) occurred at 0. 1 E/100PY in Souvenir 1 and 0. 5 E/100PY within KEEPsAKE 2. one The prices of TEAEs leading to discontinuation from the study drug in KEEPsAKE 1 was two. 1 E/100PY and 1. 2 E/100PY in Memento 2 . 1 There were six deaths inside KEEPsAKE one, which had been not related to the study drug, per investigator. 1* In KEEPsAKE 2, there was one death not associated to the research drug, for each investigator. 1
SKYRIZI is part associated with a collaboration between Boehringer Ingelheim plus AbbVie, along with AbbVie leading development and commercialization globally.
About Psoriatic Arthritis
Psoriatic arthritis will be a heterogeneous, systemic plus inflammatory disease with hallmark manifestations throughout multiple domains including joints and pores and skin. five, 6 In psoriatic joint disease, the immune system creates inflammation that can lead in order to pain, fatigue, stiffness in the important joints and cause a red, scaly rash. 5, 6
About KEEPsAKE 1 and 2 1-4, 7, 8
Momento 1 plus 2 are both Phase 3, multicenter, randomized, double-blind and placebo-controlled studies designed to evaluate the safety and efficacy of SKYRIZI in adult patients with active psoriatic arthritis. Souvenir 1 included patients along with an inadequate response or intolerance to one or more conventional synthetic disease modifying antirheumatic drugs (csDMARD-IR), while KEEPsAKE two included individuals with an inadequate response to csDMARD-IR and/or with an insufficient response or even intolerance to 1 or two biologic treatments. In the first phase of the research (Period 1), patients were randomized in order to SKYRIZI or placebo through week 24. At 7 days 24, the particular open-label extension (Period 2) began, plus all patients were given SKYRIZI.
The two studies are ongoing to evaluate the long lasting safety, tolerability and effectiveness of SKYRIZI in sufferers with psoriatic arthritis.
More information on these types of trials can be found at www.clinicaltrials.gov (KEEPsAKE 1: NCT03675308; KEEPsAKE 2: NCT03671148).
About SKYRIZI ® (risankizumab)
SKYRIZI is usually an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. nine, 10 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic, immune-mediated diseases, which includes psoriasis. 9 SKYRIZI is approved within the U. S. to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or even phototherapy, as well while to treat active psoriatic arthritis in adults. 11 In the EU, SKYRIZI is indicated for the therapy of reasonable to serious plaque psoriasis in grown ups that are applicants for systemic therapy; SKYRIZI, alone or in combination with methotrexate (MTX), is definitely indicated regarding the treatment of active psoriatic arthritis in grown-ups who have had an inadequate response or even who have been intolerant to one or more disease-modifying antirheumatic medicines (DMARDs). 10 The approved dose for SKYRIZI is a hundred and fifty mg (one 150 mg pre-filled pen or pre-filled syringe) administered by subcutaneous injections at week 0 and 4 and every 12 days thereafter. 10 Stage 3 tests of SKYRIZI in psoriatic arthritis, psoriasis, Crohn’s illness and ulcerative colitis are usually ongoing. 12-14
EU Indications and Important Safety Information about SKYRIZI ® (risankizumab) 10
Skyrizi (risankizumab) can be indicated intended for the remedying of moderate in order to severe plaque psoriasis in adults who are candidates to get systemic therapy.
Skyrizi, alone or within combination along with methotrexate (MTX), is pointed out for that treatment of energetic psoriatic arthritis in adults who have had an inadequate response or even who possess been intolerant to one or more disease-modifying antirheumatic medications (DMARDs).
Important Safety Information
Risankizumab is certainly contraindicated inside patients with hypersensitivity to the active substance or to any associated with the excipients. Risankizumab may increase the particular risk of infection. Inside patients along with a chronic infection, a history of recurrent infection, or known risk factors pertaining to infection, risankizumab should be used with caution. Treatment with risankizumab should not end up being initiated in patients along with any clinically important energetic infection until the infection resolves or is adequately treated.
Prior in order to initiating therapy with risankizumab, patients ought to be evaluated for tuberculosis (TB) contamination. Patients getting risankizumab should be monitored meant for signs plus symptoms associated with active TB. Anti-TB treatment should become considered prior to initiating risankizumab in patients with a history of latent or even 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 the patient has received live vaccination (viral or bacterial), it is recommended in order to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines throughout treatment and for a minimum of 21 several weeks after therapy.
The most frequently reported adverse reactions were upper respiratory infections. Commonly (≥ 1/100 to < 1/10) documented adverse reactions included tinea infections, headache, pruritus, fatigue and injection site responses.
This is not really a complete summary of all security information.
See SKYRIZI full overview of product characteristics (SmPC) at www.ema.europa.eu .
Globally, prescribing info varies; refer to the individual country item label designed for complete details.
Regarding AbbVie within Dermatology
For a lot more than a decade, AbbVie offers worked to uncover new solutions and improve care just for people with severe skin diseases, including psoriasis, psoriatic joint disease, hidradenitis suppurativa and atopic dermatitis. With a broad clinical trial program, all of us continue in order to actively research and adapt to the evolving needs of the particular dermatology community and advance our pipeline to help individuals achieve their treatment goals and reside beyond their own skin disease. For more information on AbbVie in dermatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/dermatology.html .
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today plus 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 throughout its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us in www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Some statements in this news release are usually, or may be considered, forward-looking statements for the purpose of purposes of the Private Securities Litigation Reform Act of 1995. The words “believe, ” “expect, ” “anticipate, ” “project” and similar expressions, among others, usually identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks plus 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 in order to, failure to realize the particular expected benefits from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and effectively integrate Allergan’s businesses, competition from other products, difficulties to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes in order to laws plus regulations applicable to our industry and the effect of public health outbreaks, epidemics or even pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that could affect AbbVie’s operations is set forth in Item 1A, “Risk Factors, inches of AbbVie’s 2021 Annual Report upon Form 10-K, which has been filed with the Securities and Exchange Commission, because updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes zero obligation to release publicly any revisions to forward-looking statements as a result of subsequent occasions or developments, except like required by law.
- Kristensen, L. E., et al. Efficacy plus Safety associated with Risankizumab for Active Psoriatic Arthritis: 100-Week Results through the Memento 1 and KEEPsAKE two Trials. 2022 European Academy of Dermatology and Venereology (EADV) Hybrid Congress.
- Kristensen, L. Electronic., et ing. Efficacy plus Safety of Risankizumab with regard to Active Psoriatic Arthritis: 52-Week Results From the particular KEEPsAKE one and KEEPsAKE 2 Trials. 2021 Western Academy associated with Dermatology and Venereology Virtual Congress.
- Kristensen, L. E., et ‘s. Efficacy plus Safety of Risankizumab within Patients Along with Active Psoriatic Arthritis After Inadequate Response or Intolerance to DMARDs: 24-Week Results From the Phase a few, Randomized, Double-Blind KEEPsAKE 1 Trial. 2021 World Psoriatic and Joint disease Conference.
- Östör, A., et al. Efficacy and Security of Risankizumab for Active Psoriatic Arthritis, Including Individuals With Inadequate Response or Intolerance in order to Biologic Therapies: 24-Week Comes from the Phase 3, Randomized, Double-blind, Momento 2 Trial.
- Duarte G. V., ainsi que al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb; 26(1): 147-56. doi: ten. 1016/j. berh. 2012. 01. 003.
- Diseases & Conditions: Psoriatic Joint disease. 2019. American College associated with Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis . Accessed August 17, 2022 .
- A Phase a few, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Reaction to or even Intolerance in order to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1). clinicaltrials. gov. 2021. Available from: https://clinicaltrials.gov/ct2/show/NCT03675308 . Accessed August 17, 2022 .
- The Phase three or more, Randomized, Double-Blind Study Evaluating Risankizumab to Placebo within Subjects Along with Active Psoriatic Arthritis Including Those Who Have the History associated with Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2). clinicaltrials. gov. 2021. Available with: https://clinicaltrials.gov/ct2/show/NCT03671148 . Accessed Aug 17, 2022 .
- Duvallet E., Sererano L., Assier E., ou al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7): 503-11.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https:// www.ema.europa.eu/en/documents/product- information/skyrizi-epar-product-information_en. pdf. Accessed September 17, 2022 .
- SKYRIZI [package insert]. North Chicago, IL : AbbVie Inc.; 2022.
- A Study of the particular Efficacy and Safety of Risankizumab in Participants with Crohn’s Illness. clinicaltrials. gov. 2021. Obtainable at: https://clinicaltrials. gov/ct2/show/NCT03105102 . Accessed Ones 17, 2022 .
- A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Effectiveness and Protection of Risankizumab in Participants with Moderately to Severely Active Ulcerative Colitis. clinicaltrials. gov. 2021. Available on: https://clinicaltrials. gov/ct2/show/record/NCT03398148 . Accessed August 17, 2022 .
- Pipeline – Our Science | AbbVie. AbbVie. 2021. Offered at: https:// www.abbvie.com/our-science/pipeline. html . Utilized August seventeen, 2022 .
* Within KEEPsAKE one, there were 6 subjects along with fatal activities, but seven different events were reported.