PMID- 36762512
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230315
IS  - 2578-5745 (Electronic)
IS  - 2578-5745 (Linking)
VI  - 5
IP  - 3
DP  - 2023 Mar
TI  - Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients With 
      Active Psoriatic Arthritis With and Without Prior Tumor Necrosis Factor Inhibitor 
      Experience: Analysis of the Phase 3, Randomized, Placebo-Controlled DISCOVER-1 
      Study.
PG  - 149-164
LID - 10.1002/acr2.11523 [doi]
AB  - OBJECTIVE: To evaluate efficacy and safety of the interleukin-23p19-subunit 
      inhibitor, guselkumab, in DISCOVER-1 patients with active psoriatic arthritis 
      (PsA) by prior use of tumor necrosis factor inhibitor (TNFi). METHODS: The phase 
      3, randomized, placebo-controlled DISCOVER-1 study enrolled patients with active 
      PsA (swollen joint count >/=3, tender joint count >/=3, and C-reactive protein 
      level >/= 0.3 mg/dl) despite standard therapies; approximately one-third could have 
      received two or fewer prior TNFi. Patients were randomized to 100 mg of 
      guselkumab every 4 weeks (Q4W); 100 mg of guselkumab at week 0, at week 4, and 
      every 8 weeks (Q8W); or placebo with crossover to guselkumab Q4W at week 24. 
      Efficacy end points of >/=20% and >/=50% improvement in individual American College 
      of Rheumatology (ACR) criteria and achieving the minimal disease activity (MDA) 
      components were summarized by prior TNFi status. RESULTS: In DISCOVER-1, 118 
      (31%) patients previously received one or two TNFi. As previously reported, rates 
      for acheiving >/=20% improvement in the composite ACR response at week 24 and week 
      52 were similar in TNFi-naive and TNFi-experienced patients randomized to 
      guselkumab Q4W (76% and 68%, respectively) and Q8W (61% and 58%, respectively). 
      Similar trends were observed for response rates of >/=20% and >/=50% improvement in 
      individual ACR criteria and for achieving individual MDA components at week 24; 
      TNFi-naive patients were more likely to achieve end points related to physical 
      function and pain than TNFi-experienced patients. Overall, response rates were 
      maintained or increased through week 52 regardless of prior TNFi use. Through 
      week 60 in guselkumab-treated TNFi-naive and TNFi-experienced patients, 62% and 
      64%, respectively, reported one or more adverse events (AEs); 4% and 6% had 
      serious AEs, respectively. CONCLUSION: Through 1 year, 100 mg of guselkumab Q4W 
      and Q8W provided sustained improvements across multiple domains in both 
      TNFi-naive and TNFi-experienced patients with active PsA.
CI  - (c) 2023 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on 
      behalf of American College of Rheumatology.
FAU - Ritchlin, Christopher T
AU  - Ritchlin CT
AUID- ORCID: 0000-0002-2602-1219
AD  - University of Rochester Medical Center, Rochester, New York, USA.
FAU - Deodhar, Atul
AU  - Deodhar A
AUID- ORCID: 0000-0002-2130-1246
AD  - Oregon Health & Science University, Portland, USA.
FAU - Boehncke, Wolf-Henning
AU  - Boehncke WH
AD  - Geneva University Hospitals, Geneva, Switzerland.
FAU - Soriano, Enrique R
AU  - Soriano ER
AUID- ORCID: 0000-0003-3143-1084
AD  - Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
FAU - Kollmeier, Alexa P
AU  - Kollmeier AP
AD  - Janssen Research & Development, LLC, San Diego, California, USA.
FAU - Xu, Xie L
AU  - Xu XL
AD  - Janssen Research & Development, LLC, San Diego, California, USA.
FAU - Zazzetti, Federico
AU  - Zazzetti F
AD  - Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, 
      USA.
FAU - Shawi, May
AU  - Shawi M
AD  - Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, 
      USA.
FAU - Jiang, Yusang
AU  - Jiang Y
AD  - Cytel Inc on behalf of Janssen Research & Development, LLC, Spring House, 
      Pennsylvania, USA.
FAU - Sheng, Shihong
AU  - Sheng S
AD  - Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
FAU - Helliwell, Philip S
AU  - Helliwell PS
AUID- ORCID: 0000-0002-4155-9105
AD  - University of Leeds, Leeds, UK.
LA  - eng
GR  - Janssen Research & Development, LLC/
PT  - Journal Article
DEP - 20230210
PL  - United States
TA  - ACR Open Rheumatol
JT  - ACR open rheumatology
JID - 101740025
PMC - PMC10010489
EDAT- 2023/02/11 06:00
MHDA- 2023/02/11 06:01
PMCR- 2023/02/10
CRDT- 2023/02/10 04:32
PHST- 2022/11/29 00:00 [revised]
PHST- 2022/07/26 00:00 [received]
PHST- 2022/12/01 00:00 [accepted]
PHST- 2023/02/11 06:00 [pubmed]
PHST- 2023/02/11 06:01 [medline]
PHST- 2023/02/10 04:32 [entrez]
PHST- 2023/02/10 00:00 [pmc-release]
AID - ACR211523 [pii]
AID - 10.1002/acr2.11523 [doi]
PST - ppublish
SO  - ACR Open Rheumatol. 2023 Mar;5(3):149-164. doi: 10.1002/acr2.11523. Epub 2023 Feb 
      10.