PMID- 35766811
OWN - NLM
STAT- MEDLINE
DCOM- 20230203
LR  - 20230314
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Print)
IS  - 1462-0324 (Linking)
VI  - 62
IP  - 2
DP  - 2023 Feb 1
TI  - Guselkumab provides sustained domain-specific and comprehensive efficacy using 
      composite indices in patients with active psoriatic arthritis.
PG  - 606-616
LID - 10.1093/rheumatology/keac375 [doi]
AB  - OBJECTIVES: To evaluate the efficacy of guselkumab for the treatment of active 
      PsA utilizing composite indices. METHODS: Data were pooled from the phase 3 
      DISCOVER-1 (n = 381) and DISCOVER-2 (n = 739) studies. In both studies, patients 
      were randomized 1:1:1 to subcutaneous guselkumab 100 mg every 4 weeks (Q4W); 
      guselkumab 100 mg at week 0, week 4, then Q8W; or placebo Q4W with crossover to 
      guselkumab 100 mg Q4W at week 24. Composite indices used to assess efficacy 
      through week 52 included Disease Activity Index for Psoriatic Arthritis (DAPSA), 
      Psoriatic Arthritis Disease Activity Score (PASDAS), minimal disease activity 
      (MDA), and very low disease activity (VLDA). Through week 24, treatment failure 
      rules were applied. Through week 52, non-responder imputation was used for 
      missing data. RESULTS: Greater proportions of guselkumab- than placebo-treated 
      patients achieved DAPSA low disease activity (LDA) and remission, PASDAS LDA and 
      VLDA, MDA, and VLDA at week 24 vs placebo (all unadjusted P < 0.05). At week 52, 
      in the guselkumab Q4W and Q8W groups, respectively, response rates were as 
      follows: DAPSA LDA, 54.2% and 52.5%; DAPSA remission, 18.2% and 17.6%; PASDAS 
      LDA, 45.3% and 41.9%; PASDAS VLDA, 16.9% and 19.5%; MDA, 35.9% and 30.7%; and 
      VLDA, 13.1% and 14.4%. In the placebo-crossover-to-guselkumab group, response 
      rates for all composite indices increased after patients switched to guselkumab, 
      from week 24 through week 52. CONCLUSION: Treatment with guselkumab provided 
      robust and sustained benefits across multiple PsA domains through 1 year, 
      indicating that guselkumab is an effective therapy for the diverse manifestations 
      of PsA. TRIAL REGISTRATION: NCT03162796; NCT03158285.
CI  - (c) The Author(s) 2022. Published by Oxford University Press on behalf of the 
      British Society for Rheumatology.
FAU - Coates, Laura C
AU  - Coates LC
AUID- ORCID: 0000-0002-4756-663X
AD  - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, 
      University of Oxford, Oxford, UK.
FAU - Ritchlin, Christopher T
AU  - Ritchlin CT
AD  - Department of Medicine, Allergy/Immunology and Rheumatology, University of 
      Rochester Medical Center, Rochester, NY, USA.
FAU - Gossec, Laure
AU  - Gossec L
AD  - Department of Rheumatology, Institut Pierre Louis d'Epidemiologie et de Sante 
      Publique, INSERM, Sorbonne Universite, Paris.
AD  - Rheumatology Department, Pitie-Salpetriere Hospital, AP-HP, Paris, France.
FAU - Helliwell, Philip S
AU  - Helliwell PS
AD  - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 
      Leeds, UK.
FAU - Rahman, Proton
AU  - Rahman P
AD  - Discipline of Medicine, Division of Rheumatology, Craig L Dobbin Genetics 
      Research Centre, Memorial University of Newfoundland, St Johns, NL, Canada.
FAU - Kollmeier, Alexa P
AU  - Kollmeier AP
AD  - Department of Immunology, Janssen Research & Development, LLC, San Diego, CA.
FAU - Xu, Xie L
AU  - Xu XL
AD  - Department of Immunology, Janssen Research & Development, LLC, San Diego, CA.
FAU - Shawi, May
AU  - Shawi M
AD  - Immunology, Rheumatology Global Medical Affairs, Janssen Pharmaceutical Companies 
      of Johnson & Johnson, Horsham.
FAU - Karyekar, Chetan S
AU  - Karyekar CS
AD  - Department of Immunology, Janssen Research & Development, LLC, Spring House, PA, 
      USA.
FAU - Contre, Christine
AU  - Contre C
AD  - Janssen Cilag, Issy-les-Moulineaux, Ile-de-France, France.
FAU - Noel, Wim
AU  - Noel W
AD  - Department of Immunology, Janssen Scientific Affairs, LLC, Brussels, Belgium.
FAU - Sheng, Shihong
AU  - Sheng S
AD  - Department of Statistics and Decision Sciences, Immunology, Janssen Research & 
      Development, LLC, Spring House, PA.
FAU - Wang, Yanli
AU  - Wang Y
AD  - Department of Statistics and Decision Sciences, Immunology, Janssen Research & 
      Development, LLC, Spring House, PA.
FAU - Xu, Stephen
AU  - Xu S
AD  - Department of Statistics and Decision Sciences, Immunology, Janssen Research & 
      Development, LLC, Spring House, PA.
FAU - Mease, Philip J
AU  - Mease PJ
AUID- ORCID: 0000-0002-6620-0457
AD  - Department of Rheumatology Research, Swedish Medical Center/Providence St. Joseph 
      Health.
AD  - University of Washington, Rheumatology Research, Seattle, WA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03162796
SI  - ClinicalTrials.gov/NCT03158285
GR  - DH_/Department of Health/United Kingdom
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
RN  - 089658A12D (guselkumab)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - Humans
MH  - *Arthritis, Psoriatic/drug therapy
MH  - *Antirheumatic Agents/therapeutic use
MH  - Treatment Outcome
MH  - Antibodies, Monoclonal, Humanized/therapeutic use
MH  - Severity of Illness Index
PMC - PMC9891416
OTO - NOTNLM
OT  - PsA
OT  - composite indices
OT  - guselkumab
OT  - joint disease
OT  - remission
OT  - skin clearance
EDAT- 2022/06/30 06:00
MHDA- 2023/02/04 06:00
PMCR- 2022/06/29
CRDT- 2022/06/29 09:43
PHST- 2022/03/04 00:00 [received]
PHST- 2022/06/18 00:00 [accepted]
PHST- 2022/06/30 06:00 [pubmed]
PHST- 2023/02/04 06:00 [medline]
PHST- 2022/06/29 09:43 [entrez]
PHST- 2022/06/29 00:00 [pmc-release]
AID - 6619576 [pii]
AID - keac375 [pii]
AID - 10.1093/rheumatology/keac375 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2023 Feb 1;62(2):606-616. doi: 
      10.1093/rheumatology/keac375.