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Efficacy and safety of risankizumab for active psoriatic arthritis : 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial

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Abstract
Objectives Risankizumab is an interleukin-23 inhibitor under study for the treatment of patients with psoriatic arthritis (PsA). The phase 3 KEEPsAKE 2 trial investigated the efficacy and safety of risankizumab versus placebo in patients with active PsA who had previous inadequate response or intolerance to <= 2 biological therapies (Bio-IR) and/or >= 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR). Results through week 24 are reported here. Methods Adults with PsA who were Bio-IR and/or csDMARD-IR were randomised to receive subcutaneously administered risankizumab 150 mg or placebo at weeks 0, 4 and 16 during a 24-week, double-blind treatment period. The primary endpoint was the proportion of patients who achieved >= 20% improvement in American College of Rheumatology score (ACR20) at week 24. Secondary endpoints assessed key domains of PsA and patient-reported outcomes. Results A total of 444 patients (median age 53 years, range 23-84 years) were randomised to risankizumab (n=224) or placebo (n=220); 206 patients (46.5%) were Bio-IR. At week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (51.3% vs 26.5%, p<0.001) and all secondary endpoints (p<0.05) compared with placebo. Serious adverse events were reported for 4.0% and 5.5% of risankizumab-treated and placebo-treated patients, respectively; serious infections were reported for 0.9% and 2.3%, respectively. Conclusion Treatment with risankizumab resulted in significant improvements versus placebo in key disease outcomes and was well tolerated in patients with PsA who were Bio-IR and/or csDMARD-IR.arthritis; arthritis; psoriatic; biological therapy
Keywords
arthritis, arthritis, psoriatic, biological therapy, THERAPIES, RISK

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MLA
Ostor, Andrew, et al. “Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis : 24-Week Results from the Randomised, Double-Blind, Phase 3 KEEPsAKE 2 Trial.” ANNALS OF THE RHEUMATIC DISEASES, vol. 81, no. 3, 2022, pp. 351–58, doi:10.1136/annrheumdis-2021-221048.
APA
Ostor, A., Van den Bosch, F., Papp, K., Asnal, C., Blanco, R., Aelion, J., … Kivitz, A. (2022). Efficacy and safety of risankizumab for active psoriatic arthritis : 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. ANNALS OF THE RHEUMATIC DISEASES, 81(3), 351–358. https://doi.org/10.1136/annrheumdis-2021-221048
Chicago author-date
Ostor, Andrew, Filip Van den Bosch, Kim Papp, Cecilia Asnal, Ricardo Blanco, Jacob Aelion, Gabriela Alperovich, et al. 2022. “Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis : 24-Week Results from the Randomised, Double-Blind, Phase 3 KEEPsAKE 2 Trial.” ANNALS OF THE RHEUMATIC DISEASES 81 (3): 351–58. https://doi.org/10.1136/annrheumdis-2021-221048.
Chicago author-date (all authors)
Ostor, Andrew, Filip Van den Bosch, Kim Papp, Cecilia Asnal, Ricardo Blanco, Jacob Aelion, Gabriela Alperovich, Wenjing Lu, Zailong Wang, Ahmed M. Soliman, Ann Eldred, Lisa Barcomb, and Alan Kivitz. 2022. “Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis : 24-Week Results from the Randomised, Double-Blind, Phase 3 KEEPsAKE 2 Trial.” ANNALS OF THE RHEUMATIC DISEASES 81 (3): 351–358. doi:10.1136/annrheumdis-2021-221048.
Vancouver
1.
Ostor A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, et al. Efficacy and safety of risankizumab for active psoriatic arthritis : 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. ANNALS OF THE RHEUMATIC DISEASES. 2022;81(3):351–8.
IEEE
[1]
A. Ostor et al., “Efficacy and safety of risankizumab for active psoriatic arthritis : 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial,” ANNALS OF THE RHEUMATIC DISEASES, vol. 81, no. 3, pp. 351–358, 2022.
@article{8731700,
  abstract     = {{Objectives Risankizumab is an interleukin-23 inhibitor under study for the treatment of patients with psoriatic arthritis (PsA). The phase 3 KEEPsAKE 2 trial investigated the efficacy and safety of risankizumab versus placebo in patients with active PsA who had previous inadequate response or intolerance to <= 2 biological therapies (Bio-IR) and/or >= 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR). Results through week 24 are reported here. 

Methods Adults with PsA who were Bio-IR and/or csDMARD-IR were randomised to receive subcutaneously administered risankizumab 150 mg or placebo at weeks 0, 4 and 16 during a 24-week, double-blind treatment period. The primary endpoint was the proportion of patients who achieved >= 20% improvement in American College of Rheumatology score (ACR20) at week 24. Secondary endpoints assessed key domains of PsA and patient-reported outcomes. 

Results A total of 444 patients (median age 53 years, range 23-84 years) were randomised to risankizumab (n=224) or placebo (n=220); 206 patients (46.5%) were Bio-IR. At week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (51.3% vs 26.5%, p<0.001) and all secondary endpoints (p<0.05) compared with placebo. Serious adverse events were reported for 4.0% and 5.5% of risankizumab-treated and placebo-treated patients, respectively; serious infections were reported for 0.9% and 2.3%, respectively. 

Conclusion Treatment with risankizumab resulted in significant improvements versus placebo in key disease outcomes and was well tolerated in patients with PsA who were Bio-IR and/or csDMARD-IR.arthritis; arthritis; psoriatic; biological therapy}},
  author       = {{Ostor, Andrew and Van den Bosch, Filip and Papp, Kim and Asnal, Cecilia and Blanco, Ricardo and Aelion, Jacob and Alperovich, Gabriela and Lu, Wenjing and Wang, Zailong and Soliman, Ahmed M. and Eldred, Ann and Barcomb, Lisa and Kivitz, Alan}},
  issn         = {{0003-4967}},
  journal      = {{ANNALS OF THE RHEUMATIC DISEASES}},
  keywords     = {{arthritis,arthritis,psoriatic,biological therapy,THERAPIES,RISK}},
  language     = {{eng}},
  number       = {{3}},
  pages        = {{351--358}},
  title        = {{Efficacy and safety of risankizumab for active psoriatic arthritis : 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial}},
  url          = {{http://doi.org/10.1136/annrheumdis-2021-221048}},
  volume       = {{81}},
  year         = {{2022}},
}

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