PMID- 31421033
OWN - NLM
STAT- MEDLINE
DCOM- 20201209
LR  - 20201215
IS  - 2151-4658 (Electronic)
IS  - 2151-464X (Print)
IS  - 2151-464X (Linking)
VI  - 72
IP  - 11
DP  - 2020 Nov
TI  - Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative 
      Instrument Performance Based on the Efficacy of Guselkumab in an Interventional 
      Phase II Trial.
PG  - 1579-1588
LID - 10.1002/acr.24046 [doi]
AB  - OBJECTIVE: To assess performance of psoriatic arthritis (PsA) composite indices 
      and evaluate guselkumab's effect on achieving low disease activity or remission. 
      METHODS: In this phase II trial, patients with active PsA (>/=3 tender and >/=3 
      swollen joints, C-reactive protein level >/=0.3 mg/dl, >/=3% body surface-area with 
      psoriasis involvement) were randomized 2:1 to subcutaneous guselkumab 100 mg (n = 
      100) or placebo (n = 49) at week 0, week 4, and every 8 weeks through week 44. At 
      week 16, patients with <5% improvement in swollen and tender joints could early 
      escape to open-label ustekinumab. Patients continuing placebo crossed over to 
      receive guselkumab 100 mg at weeks 24, 28, 36, and 44 (placebo to guselkumab). 
      PsA composite indices (Psoriatic Arthritis Disease Activity Score [PASDAS], Group 
      for Research and Assessment of Psoriasis and Psoriatic Arthritis composite score 
      [GRACE], modified Composite Psoriatic Disease Activity Index [mCPDAI], and 
      Disease Activity in Psoriatic Arthritis [DAPSA]) were analyzed as secondary 
      outcomes (last observation carried forward for missing/post-early escape data 
      through week 24; observed data post-week 24). Instrument performance was 
      assessed. RESULTS: Baseline PASDAS, GRACE, mCPDAI, and DAPSA scores indicated 
      moderate-to-high disease activity. At week 24, mean changes in each of these 
      composite indices showed significant improvement with guselkumab (-2.50, -2.73, 
      -3.8, and -23.08, respectively) versus placebo (-0.49, 0.35, -0.8, and -4.98, 
      respectively; P < 0.001 for all). Significantly more guselkumab-treated patients 
      achieved low/very low/remitted disease activity states according to PASDAS (very 
      low + low 35% versus 4%; P < 0.001), GRACE (30% versus 2%; P < 0.001), mCPDAI 
      (46% versus 10%; P < 0.001), and DAPSA (remission + low 40% versus 12%; P < 
      0.001). A total of 12% of guselkumab-treated versus no placebo-treated patients 
      achieved DAPSA remission (P < 0.01). The PASDAS and GRACE instruments were more 
      sensitive than the mCPDAI and DAPSA tools in detecting treatment effect. Residual 
      skin disease and enthesitis were marginally more prominent in patients achieving 
      DAPSA low disease activity versus other indices. CONCLUSION: Guselkumab 
      demonstrated efficacy in achieving low disease activity/remission based on all 
      PsA composite indices assessed. Composite index use in PsA trials and the clinic 
      requires careful consideration to optimize feasibility and instrument 
      performance.
CI  - (c) 2019, The Authors. Arthritis Care & Research published by Wiley Periodicals, 
      Inc. on behalf of American College of Rheumatology.
FAU - Helliwell, Philip S
AU  - Helliwell PS
AUID- ORCID: 0000-0002-4155-9105
AD  - University of Leeds, Leeds, UK.
FAU - Deodhar, Atul
AU  - Deodhar A
AD  - Oregon Health and Science University, Portland.
FAU - Gottlieb, Alice B
AU  - Gottlieb AB
AD  - Icahn School of Medicine at Mount Sinai, New York, New York.
FAU - Boehncke, Wolf-Henning
AU  - Boehncke WH
AD  - Geneva University Hospitals and University of Geneva, Geneva, Switzerland.
FAU - Xu, Xie L
AU  - Xu XL
AD  - Janssen Research & Development, LLC, San Diego, California.
FAU - Xu, Stephen
AU  - Xu S
AD  - Janssen Research & Development, LLC, Spring House, Pennsylvania.
FAU - Wang, Yuhua
AU  - Wang Y
AD  - Janssen Research & Development, LLC, Spring House, Pennsylvania.
FAU - Hsia, Elizabeth C
AU  - Hsia EC
AD  - Janssen Research & Development, LLC, Spring House, and University of Pennsylvania 
      Medical Center, Philadelphia, Pennsylvania.
FAU - Gladman, Dafna D
AU  - Gladman DD
AD  - University of Toronto, Krembil Research Institute, and Toronto Western Hospital, 
      Toronto, Ontario, Canada.
FAU - Ritchlin, Christopher T
AU  - Ritchlin CT
AD  - University of Rochester Medical Center, Rochester, New York.
LA  - eng
SI  - ClinicalTrials.gov/NCT02319759
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arthritis Care Res (Hoboken)
JT  - Arthritis care & research
JID - 101518086
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 089658A12D (guselkumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage
MH  - Arthritis, Psoriatic/*drug therapy
MH  - Disability Evaluation
MH  - Female
MH  - Humans
MH  - Induction Chemotherapy/*methods
MH  - Male
MH  - Middle Aged
MH  - *Patient Reported Outcome Measures
MH  - *Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC7702129
EDAT- 2019/08/20 06:00
MHDA- 2020/12/15 06:00
PMCR- 2020/11/30
CRDT- 2019/08/18 06:00
PHST- 2019/02/20 00:00 [received]
PHST- 2019/08/13 00:00 [accepted]
PHST- 2019/08/20 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PHST- 2019/08/18 06:00 [entrez]
PHST- 2020/11/30 00:00 [pmc-release]
AID - ACR24046 [pii]
AID - 10.1002/acr.24046 [doi]
PST - ppublish
SO  - Arthritis Care Res (Hoboken). 2020 Nov;72(11):1579-1588. doi: 10.1002/acr.24046.