AB0905 Routine Assessment of Patient Index Data 3 (RAPID3) in Patients With Active Psoriatic Arthritis (PsA) After Inadequate Response or Intolerance to DMARDs: Pooled Results From the Phase 3, Randomized, Double-Blind KEEPsAKE 1 and 2 Trials

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AB0905 Routine Assessment of Patient Index Data 3 (RAPID3) in Patients With Active Psoriatic Arthritis (PsA) After Inadequate Response or Intolerance to DMARDs: Pooled Results From the Phase 3, Randomized, Double-Blind KEEPsAKE 1 and 2 Trials
Autor: Ogdie, A. ; Coates, L. ; Acayaba DE Toledo, R. ; Biljan, A. ; Jones, H. ; Tacelosky, K. ; Yue, C. ; Padilla, B. ; Bergman, M.
É parte de: Annals of the rheumatic diseases, 2022-06, Vol.81 (Suppl 1), p.1582-1582
Descrição: Background PsA is a chronic, systemic inflammatory disease with diverse clinical manifestations that can impact a patients’ quality of life. Risankizumab (RZB), a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit, is approved for the treatment of active PsA in adults. In the phase 3 KEEPsAKE 1 and 2 studies, RZB treatment resulted in significantly greater improvements in signs and symptoms of active PsA compared with placebo (PBO). 1,2 RAPID3 is frequently used in clinical practice to evaluate PsA disease activity and consists of 3 key patient-reported measures (physical function, pain, and patient’s global assessment of disease activity [PtGA]). 3 Objectives To evaluate short- (24 week) and long-term (52 week) improvements in RAPID3 scores and achievement of RAPID3 minimal clinically important difference (MCID) across the RZB KEEPsAKE 1 and 2 clinical program. Methods In KEEPsAKE 1 ( NCT03675308 ) and KEEPsAKE 2 ( NCT03671148 ), patients with active PsA who experienced inadequate response or intolerance to ≥ 1 csDMARD (KEEPsAKE 1) and/or ≤ 2 biological therapies (KEEPsAKE 2) were randomized to PBO or RZB 150 mg from baseline to week (W) 24; from W28–W52, all patients received open-label RZB 150 mg. At W16, nonresponders could add or modify rescue therapy. This post hoc analysis assessed the mean change from baseline to W24 and W52 in RAPID3 scores and the proportion of patients who achieved a RAPID3 MCID (defined as a decrease of ≥3.8 points 4 ). Modified RAPID3 scores (range: 0–30) were calculated using pain scores, PtGA, and HAQ-DI, each rescaled to 0–10 and summed together. 3 Results A total of 961 and 443 patients were included from KEEPsAKE 1 and 2, respectively. At baseline, mean RAPID3 scores were 15.3 in both treatment arms of KEEPsAKE 1 (PBO n = 479, RZB n = 482) and 15.1 (PBO n = 219) and 14.8 (RZB n = 224) in KEEPsAKE 2. From W4 to W24, RAPID3 scores were significantly reduced with RZB treatment compared with PBO in both KEEPsAKE 1 (mean change from baseline at W24 of −5.3 vs −2.4, respectively, P <.001) and KEEPsAKE 2 (−3.8 vs −1.6, P <.001; Figure 1 A, B ), and a significantly greater proportion of patients achieved MCID at W24 with RZB than with PBO in KEEPsAKE 1 (57.0% vs 36.4%, P <.001) and KEEPsAKE 2 (48.8% vs 32.8%, P <.001; Table 1). At W52 among patients who received RZB from W0–W52, mean change from baseline was −7.0 (KEEPsAKE 1) and −5.2 (KEEPsAKE 2; Figure 1 C, D ), and MCID was achieved by 67.5% (KEEPsAKE 1) and 56.5% (KEEPsAKE 2) of patients. Patients who switched from PBO to RZB at W24 experienced similar and substantial improvements in RAPID3 scores by W52. Table 1. Proportion of Patients Achieving a Minimal Clinically Important Difference From Baseline in RAPID3 (AO). Patients, % (n/N) [95% CI] KEEPsAKE 1 KEEPsAKE 2 PBO RZB 150 mg PBO RZB 150 mg W24 36.4 (166/456) [32.0, 40.8] 57.0 (262/460) [52.4, 61.5]*** 32.8 (64/195) [26.2, 39.4] 48.8 (104/213) [42.1, 55.5]*** PBO to RZB 150 mg a RZB 150 mg PBO to RZB 150 mg a RZB 150 mg W52 59.8 (260/435) [55.2, 64.4] 67.5 (297/440) [63.1, 71.9] 57.4 (105/183) [50.2, 64.5] 56.5 (109/193) [49.5, 63.5] a Patients randomized to PBO at W0 switched to open-label RZB 150 mg at W24. ***, P < .001 vs PBO. AO, as observed; PBO, placebo; RAPID3, Routine Assessment of Patient Index Data 3; RZB, risankizumab; W, week. Figure 1. Mean Change From Baseline in RAPID3 Scores During KEEPsAKE 1 and 2. **, P < .01; ***, P < .001 vs PBO. AO, as observed; LS, least squares; MMRM, mixed-effect model repeated measurement; PBO, placebo; RAPID3, Routine Assessment of Patient Index Data 3; RZB, risankizumab. Conclusion RZB 150 mg was associated with improvement in RAPID3 total scores over 24–52 weeks of treatment in patients with active PsA in KEEPsAKE 1 and 2. References [1]Kristensen LE, et al. Ann Rheum Dis . 2022;81:225–231. [2]Östör A, et al. Ann Rheum Dis . 2021;annrheumdis-2021-221048. [3]Coates LC, et al. Arthritis Care Res (Hoboken ). 2018;70:1198–1205. [4]Ward MM, et al. J Rheumatol . 2019;46:27–30. Acknowledgements AbbVie Inc. participated in the study design; study research; collection, analysis, and interpretation of data; and writing, reviewing, and approving of this abstract for submission. All authors had access to the data; participated in the development, review, and approval of and in the decision to submit this abstract to EULAR 2022 for consideration as a poster or oral presentation. No honoraria or payments were made for authorship. AbbVie and the authors thank all study investigators for their contributions and the patients who participated in this study. AbbVie funded the research for this study and provided writing support for this abstract. Medical writing assistance, funded by AbbVie, was provided by Callie A. S. Corsa, PhD, of JB Ashtin. Disclosure of Interests Alexis Ogdie Consultant of: AO has received consulting fees and/or honoraria from AbbVie, Amgen, Bristol Myers Squibb, Celgene, CorEvitas, Gilead, Janssen, Eli Lilly, Novartis, Pfizer, and UCB, Grant/research support from: AO has received grants from AbbVie, Novartis, and Pfizer to the trustees of University of Pennsylvania, and from Amgen to Forward., Laura Coates Speakers bureau: LCC has been paid as a speaker for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer and UCB., Consultant of: LCC has worked as a paid consultant for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer and UCB, Grant/research support from: LCC has received grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB, RICARDO ACAYABA DE TOLEDO Speakers bureau: RAT has received honoraria as a speaker/consultant for Abbvie, Celltrion, Janssen, Novartis, Pfizer, and UCB, Consultant of: RAT has received honoraria as a speaker/consultant for Abbvie, Celltrion, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: RAT has received grants as an investigator from Abbvie, GSK, Novartis, and Pfizer., Ana Biljan Shareholder of: AB may hold AbbVie stock or stock options., Employee of: AB is a full-time employee of AbbVie., Heather Jones Shareholder of: HJ may hold AbbVie stock or stock options., Employee of: HJ is a full-time employee of AbbVie., Kristin Tacelosky Shareholder of: KT may hold AbbVie stock or stock options., Employee of: KT is a full-time employee of AbbVie., Cuiyong Yue Shareholder of: CY may hold AbbVie stock or stock options., Employee of: CY is a full-time employee of AbbVie., Byron Padilla Shareholder of: BP may hold AbbVie stock or stock options., Employee of: BP is a full-time employee of AbbVie., Martin Bergman Shareholder of: MB is a stock holder of Johnson & Johnson and Merck., Speakers bureau: MB has received honoraria as a speaker/consultant for Abbvie, Amgen, GSK, Janssen, Novartis, Pfizer, Sanofi, and Scipher, Consultant of: MB has received honoraria as a speaker/consultant for Abbvie, Amgen, GSK, Janssen, Novartis, Pfizer, Sanofi, and Scipher
Idioma: Inglês

AB0905 Routine Assessment of Patient Index Data 3 (RAPID3) in Patients With Active Psoriatic Arthritis (PsA) After Inadequate Response or Intolerance to DMARDs: Pooled Results From the Phase 3, Randomized, Double-Blind KEEPsAKE 1 and 2 Trials

Ogdie, A. ; Coates, L. ; Acayaba DE Toledo, R. ; Biljan, A. ; Jones, H. ; Tacelosky, K. ; Yue, C. ; Padilla, B. ; Bergman, M.

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