PMID- 35920763
OWN - NLM
STAT- MEDLINE
DCOM- 20221014
LR  - 20230117
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Print)
IS  - 0926-9959 (Linking)
VI  - 36
IP  - 11
DP  - 2022 Nov
TI  - The effect of risankizumab on achieving minimal clinically important differences 
      in patient-reported outcomes in patients with psoriatic arthritis: results from 
      KEEPsAKE 1 and 2.
PG  - 2120-2129
LID - 10.1111/jdv.18475 [doi]
AB  - BACKGROUND: Psoriatic arthritis (PsA) is a chronic inflammatory disease that 
      reduces the quality of life. This study assessed the effects of risankizumab 
      (RZB) on the achievement of minimal clinically important differences (MCID) in 
      patient-reported outcomes (PROs). METHODS: KEEPsAKE-1 and -2 are randomized, 
      placebo-controlled Phase 3 clinical studies assessing RZB (150 mg) vs. placebo 
      (PBO) in adult patients with PsA with inadequate response or intolerance to 
      disease-modifying antirheumatic drugs and/or biologics. Patients were randomized 
      1:1 to receive RZB or PBO for 24 weeks; starting at Week 24, all patients 
      received RZB 150 mg through Week 52. PROs assessed were Patient's Global 
      Assessment of Disease Activity (PtGA), Patient's Assessment of Pain, Health 
      Assessment Questionnaire-Disability Index (HAQ-DI), Short-Form 36 Physical and 
      Mental Component Summary scores (PCS and MCS, respectively), 5-Level EQ-5D 
      (EQ-5D-5L), Functional Assessment of Chronic Illness Therapy-Fatigue 
      (FACIT-Fatigue), and Work Productivity and Activity Impairment (WPAI). The 
      proportion of patients achieving MCID at Weeks 24 and 52 are reported. Odds 
      ratios of achieving MCID with RZB treatment at Week 24, relative to PBO, were 
      estimated by logistic regression controlling for baseline and stratification 
      factors. RESULTS: In KEEPsAKE-1, RZB- vs. PBO-treated patients were more likely 
      to report MCID in all PROs at Week 24; similar results were obtained in 
      KEEPsAKE-2, except for SF-36 MCS and WPAI presenteeism domain. In KEEPsAKE-1 and 
      KEEPsAKE-2, 65% and 62% of RZB-treated patients, respectively, reported MCID in 
      PtGA at Week 24, which increased to 74% and 68%, respectively, at Week 52. 
      Approximately 48% of all PBO-treated patients reported MCID in PtGA at Week 24 
      and, after initiating RZB, >65% reported MCID at Week 52. Results were similar in 
      the remaining PROs. CONCLUSIONS: These data demonstrate that patients with PsA 
      receiving RZB treatment are more likely to report clinically important 
      improvements in PROs compared with patients receiving PBO.
CI  - (c) 2022 AbbVie Inc and The Authors. Journal of the European Academy of Dermatology 
      and Venereology published by John Wiley & Sons Ltd on behalf of European Academy 
      of Dermatology and Venereology.
FAU - Kristensen, L E
AU  - Kristensen LE
AD  - The Parker Institute, Copenhagen University Hospital, Bispebjerg and 
      Frederiksberg, Copenhagen, Denmark.
FAU - Soliman, A M
AU  - Soliman AM
AD  - AbbVie, Inc., North Chicago, IL, USA.
FAU - Papp, K
AU  - Papp K
AUID- ORCID: 0000-0001-9557-3642
AD  - Probity Medical Research and K Papp Clinical Research, Waterloo, ON, Canada.
FAU - Barcomb, L
AU  - Barcomb L
AD  - AbbVie, Inc., North Chicago, IL, USA.
FAU - Eldred, A
AU  - Eldred A
AD  - AbbVie, Inc., North Chicago, IL, USA.
FAU - Ostor, A
AU  - Ostor A
AD  - Cabrini Hospital, Monash University & Emeritus Research, Melbourne, VIC., 
      Australia.
LA  - eng
GR  - AbbVie/
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biological Products)
RN  - 90ZX3Q3FR7 (risankizumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal
MH  - *Antirheumatic Agents/therapeutic use
MH  - *Arthritis, Psoriatic/drug therapy
MH  - *Biological Products/therapeutic use
MH  - Double-Blind Method
MH  - Fatigue
MH  - Humans
MH  - Minimal Clinically Important Difference
MH  - Patient Reported Outcome Measures
MH  - Quality of Life
MH  - Treatment Outcome
PMC - PMC9828059
EDAT- 2022/08/04 06:00
MHDA- 2022/10/15 06:00
PMCR- 2023/01/09
CRDT- 2022/08/03 10:33
PHST- 2021/12/22 00:00 [received]
PHST- 2022/07/11 00:00 [accepted]
PHST- 2022/08/04 06:00 [pubmed]
PHST- 2022/10/15 06:00 [medline]
PHST- 2022/08/03 10:33 [entrez]
PHST- 2023/01/09 00:00 [pmc-release]
AID - JDV18475 [pii]
AID - 10.1111/jdv.18475 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2022 Nov;36(11):2120-2129. doi: 10.1111/jdv.18475.