NORTH CHICAGO, Ill., Sept. 30, 2021/ PRNewswire/– AbbVie(NYSE: ABBV)today provided arise from brand-new Phase 3 data analyses of KEEPsAKE-1 and KEEPsAKE-2, assessing risankizumab(SKYRIZI ®, 150 mg )in grownups with active psoriatic arthritis for one year( 52 weeks ).1 These outcomes were featured during the” Late Breaking News, Reviews and Updates “session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.
KEEPsAKE-1 included adult patients with active psoriatic arthritis who responded inadequately to non-biologic disease-modifying anti-rheumatic drugs (DMARDs). KEEPsAKE-2 included adult patients with active psoriatic arthritis who had responded improperly or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).2 -5 In the very first phase of the studies (Duration 1), clients were randomized to risankizumab or placebo until week 24.1 At week 24, the open label extension (Duration 2) began, and all clients were treated with risankizumab.1,4,5
The new long-term information from the open-label extension duration revealed that 70 and 58 percent of patients initially treated with risankizumab achieved American College of Rheumatology 20 (ACR20) action in KEEPsAKE-1 and KEEPsAKE-2 respectively at one year, where clients with missing information were classified as non-responders.1 Among clients initially treated with risankizumab, 43 percent in KEEPsAKE-1 and 32 percent in KEEPsAKE-2 accomplished ACR50 reaction, and 26 percent in KEEPsAKE-1 and 17 percent in KEEPsAKE-2 achieved ACR70 action at one year.1
Additionally, at one year, 68 and 64 percent of patients at first treated with risankizumab and with a body area ≥ 3 percent at standard accomplished a 90 percent decrease in the Psoriasis Area and Severity Index (PASI 90) in KEEPsAKE-1 and KEEPsAKE-2, respectively.1
“Countless individuals still suffer everyday with signs of psoriatic arthritis, driving us to advance treatment choices for these clients,” said Thomas Hudson, senior vice president of research and development, chief scientific officer, AbbVie. “These new analyses at one year support the capacity of risankizumab to preserve improvements across multiple symptoms of psoriatic arthritis.”
In terms of improvement in physical function (as determined by the Health Evaluation Questionnaire Disability Index [HAQ-DI], clients at first randomized to risankizumab reported mean decrease (i.e., improvement) of 0.41 and 0.26 from baseline in HAQ-DI rating for KEEPsAKE-1 and KEEPsAKE-2, respectively, at week 52.1
In addition, pooled results from KEEPsAKE-1 and KEEPsAKE-2 showed that 76 and 55 percent of patients attained the resolution of dactylitis and resolution of enthesitis, respectively, at week 52.1
“Dactylitis is a typical sign in psoriatic arthritis that can cause extreme swelling in the fingers and toes that result in everyday tasks becoming difficult,” said Lars Erik Kristensen, M.D., Ph.D., expert and head of science at the Parker Institute Copenhagen Denmark, associate professor, Lund Sweden, SUS University Hospital. “These results provide crucial insights on how both biologic-naïve and experienced clients might benefit from treatment with risankizumab.”
Both KEEPsAKE-1 and KEEPsAKE-2 showed constant long-term security profiles with those shared at week 24, without any brand-new safety findings observed from week 24 through week 52.1 Major treatment-emergent adverse occasions (TEAE) occurred at 7.4 events/100 patient-years (E/100 PYs) and 9.4 E/100 PYs in KEEPsAKE-1 and KEEPsAKE-2, respectively.1 Rates of major infections in KEEPsAKE-1 and KEEPsAKE-2 were 2.8 and 2.0 E/100 PYs, respectively.1 The rates of TEAEs leading to discontinuation of the study drug in KEEPsAKE-1 was 2.3 E/100 PYs and 1.6 E/100 PYs in KEEPsAKE-2.1 In KEEPsAKE-1, there were two deaths and both were not associated with the research study drug per investigator.1 There were no deaths reported in KEEPsAKE-2.1 In KEEPsAKE-2, 3 significant unfavorable heart occasions (MACE) were reported, which were not related to the research study drug per the private investigator.1 No MACE were reported in KEEPsAKE-1.1
In January 2021, AbbVie announced favorable top-line results from the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 research studies, showing that risankizumab (150 mg) accomplished the main endpoint of ACR20 reaction versus placebo during the 24-week double-blinded, placebo-controlled, parallel-group duration (period 1).2,3
Risankizumab (SKYRIZI) belongs to a collaboration in between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.Use of risankizumab in psoriatic arthritis is not authorized and its safety and efficacy have actually not been evaluated by regulative authorities.About Psoriatic Arthritis Psoriatic arthritis is a heterogeneous
, systemic inflammatory illness with trademark manifestations throughout several domains consisting of joints and skin.6,7 In psoriatic arthritis, the body immune system develops inflammation that can result in discomfort, fatigue, stiffness in the joints and trigger a red, flaky rash.6,7 About KEEPsAKE-1 and KEEPsAKE-22-5 KEEPsAKE-1 and KEEPsAKE-2 are both Stage 3, multicenter, randomized, double-blind, placebo-controlled research studies created to assess the safety and effectiveness of risankizumab in adult patients with active psoriatic arthritis. KEEPsAKE-1 examined risankizumab in clients who had an insufficient response or intolerance to a minimum of one DMARD. KEEPsAKE-2 assessed risankizumab in clients who had an insufficient 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 research studies was the accomplishment of ACR20 action at week 24 from the treatment with the research study medication. Ranked secondary endpoints consisted of modification from baseline in HAQ-DI, along with the accomplishment of PASI 90 and MDA at week 24. Other secondary endpoints included ACR50 and ACR70 (not controlled for multiplicity)at week 24. The research studies are ongoing, and the long-term extension stays blinded to examine the long-term security, tolerability and effectiveness of risankizumab in clients who have finished the placebo-controlled duration. 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 obstructs IL-23 by binding to its p19 subunit.8,9 IL-23, a cytokine associated with inflammatory processes, is thought to
be linked to a variety of persistent immune-mediated diseases, consisting of psoriasis.8 In April 2019 SKYRIZI was approved by the European Commission for the treatment of moderate to severe plaque psoriasis in adults who are prospects for systemic therapy. The authorized dosage for SKYRIZI is 150 mg, administered by subcutaneous injection prefilled pen or prefilled syringe at week 0 and 4, and every 12 weeks afterwards. Stage 3 trials of SKYRIZI in psoriasis, Crohn’s disease, ulcerative colitis and psoriatic arthritis are ongoing.10-12 Important EU Safety Information about SKYRIZI ®(risankizumab )9 SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. SKYRIZI might increase the risk of infection. In clients with a chronic infection, a history of persistent infection, or known danger aspects for infection, SKYRIZI ought to be used with caution. Treatment with SKYRIZI must not be initiated in clients with any scientifically essential active infection up until the infection deals with or is properly treated.Prior to starting treatment with SKYRIZI, clients ought to be examined for tuberculosis(TB )infection. Clients receiving SKYRIZI must be monitored for signs and symptoms of active TB. Anti-TB therapy must be considered prior to starting SKYRIZI in clients with a past history of hidden or active TB in whom a sufficient course of treatment can not be confirmed.Prior to initiating treatment with SKYRIZI, conclusion of all proper immunizations must be thought about according to current immunization guidelines. If a patient has received live vaccination(viral or bacterial ), it is suggested to wait a minimum of 4 weeks prior to beginning treatment with SKYRIZI. Clients treated with SKYRIZI need to not receive live vaccines during treatment and for a minimum of 21 weeks after treatment.The most frequently reported unfavorable responses were upper breathing infections, which occurred in 13 percent of patients. Frequently(higher than or equivalent to 1/100 to less than 1/10) reported negative reactions included tinea infections, headache, pruritus, tiredness and injection site reactions.This is not a complete summary of all security info. See SKYRIZI complete summary of product qualities(SmPC )at www.ema.europa.eu. Internationally, prescribing info varies; refer to the specific country product label for total details. About AbbVie AbbVie’s mission is to discover and deliver ingenious medicines that fix serious health concerns today and deal with the medical difficulties of tomorrow. We make every effort to have a remarkable impact on people’s lives throughout several key therapeutic locations: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to product or services throughout its AllerganLooks portfolio. To learn more about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram
, YouTube and LinkedIn.Forward-Looking Statements Some declarations in this news release are, or might be thought about, positive statements for purposes of the Private Securities Litigation Reform Act of 1995. The words” believe, “”anticipate,” “prepare for,””job”and similar expressions, among others, typically recognize forward-looking declarations. AbbVie cautions that these positive statements undergo threats and uncertainties that might trigger actual outcomes to vary materially from those shown in the forward-looking statements. Such risks and uncertainties include, but are not restricted to, failure to recognize the anticipatedgain from AbbVie’s acquisition of Allergan plc (“Allergan “), failure to quickly and efficiently integrate Allergan’s businesses, competition from other items, obstacles to intellectual property, difficulties inherent in the research and development process, negative lawsuits or federal government action, changes to laws and regulations relevant to our industry and the impact of public health break outs, epidemics or pandemics, such as COVID-19. Extra information about the financial, competitive, governmental, technological and other aspects that might affect AbbVie’s operations is set forth in Item 1A,” Threat Aspects, “of AbbVie’s 2020 Yearly Report on Form 10-K, which has been submitted with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Type 10-Q. AbbVie undertakes no responsibility to launch publicly any revisions to forward-looking declarations as a result of subsequent occasions or advancements, except as required by law. ### Recommendations: Kristensen, L.E., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 52-Week Results From the KEEPsAKE 1 and Memento 2 Trials. 2021 EADV Virtual Congress. D1T01.4 A. Kristensen, L.E., et al. Effectiveness and Security of Risankizumab in Patients With Active Psoriatic Arthritis After Inadequate Reaction or Intolerance to DMARDs: 24-Week Results From the Stage 3, Randomized, Double-Blind Memento 1 Trial. Östör, A., et al. Effectiveness and Safety of Risankizumab for Active Psoriatic Arthritis, Consisting Of Patients With Inadequate Action or Intolerance to Biologic Treatments: 24-Week Arise From the Stage 3, Randomized, Double-blind, MEMENTO 2 Trial. Clinicaltrials.gov. A Stage 3, Randomized, Double-Blind, Research Study Comparing Risankizumab
to Placebo in
- Subjects With Active Psoriatic Arthritis( PsA)Who Have a History of Inadequate Action to or Intolerance to a minimum of One Illness Modifying Anti-Rheumatic Drug (DMARD)Therapy (KEEPsAKE 1). clinicaltrials.gov; 2021. Accessed July 7, 2021. https://clinicaltrials.gov/ct2/show/NCT03675308. Clinicaltrials.gov. A Phase 3, Randomized, Double-Blind Research Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have
- a History of Inadequate Reaction or Intolerance to Biologic Therapy (Ies)( MEMENTO 2 ). clinicaltrials.gov; 2021. Accessed July 7, 2021. https://clinicaltrials.gov/ct2/show/NCT03671148. 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. Diseases & Issues: Psoriatic Arthritis. 2019. American College of Rheumatology. Offered at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed on December 3, 2020. Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011.
- Nov 43(7):503 -11. SKYRIZI [Summary of Item Characteristics] AbbVie Ltd. Available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf. Accessed on June 21, 2021. A Studyof the Efficacy and Safety of Risankizumab in Individuals with Crohn’s Illness. ClinicalTrials.gov.
- 2021. Offered at: https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed June 21, 2021. A Multicenter, Randomized,
- Double-Blind, Placebo Controlled Induction Research Study to Evaluate the Efficacy and Safety of Risankizumab in Participants with Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2021. Offered at: https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed on June 21, 2021. Pipeline– Our Science|AbbVie. AbbVie. 2021. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on July 27, 2021. SOURCE AbbVie< img alt="" src ="https://rt.prnewswire.com/rt.gif?NewsItemId=CG24258&Transmission_Id=202109300945PR_NEWS_USPR_____CG24258&DateId=20210930 "/ >
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