PMID- 33934076
OWN - NLM
STAT- MEDLINE
DCOM- 20220131
LR  - 20220131
IS  - 1499-2752 (Electronic)
IS  - 0315-162X (Linking)
VI  - 48
IP  - 12
DP  - 2021 Dec
TI  - Pooled Safety Results Through 1 Year of 2 Phase III Trials of Guselkumab in 
      Patients With Psoriatic Arthritis.
PG  - 1815-1823
LID - 10.3899/jrheum.201532 [doi]
AB  - OBJECTIVE: Evaluate the safety of guselkumab (monoclonal antibody targeting 
      interleukin [IL]-23p19) in patients with psoriatic arthritis (PsA) through 1 year 
      (1Y) of the phase III DISCOVER-1 and DISCOVER-2 trials. METHODS: Patients with 
      active PsA (n = 1120; biologic-naive except 118 patients treated with tumor 
      necrosis factor inhibitors in DISCOVER-1) were randomized to subcutaneous 
      guselkumab 100 mg every 4 weeks (Q4W) or at Week 0, Week 4, then every 8 weeks 
      (Q8W); or placebo. At Week 24, patients in the placebo group switched to 
      guselkumab 100 mg Q4W. Treatment continued through 1Y and 2 years for DISCOVER-1 
      and DISCOVER-2, respectively. In this pooled analysis, patients with >/= 1 adverse 
      event (AE) through 1Y were standardized for 100 patient-years [100 PYs] of 
      follow-up. RESULTS: Through Week 24, adverse events (AEs) were consistent between 
      patients treated with placebo and guselkumab (Q4W + Q8W). AEs were 142.8/100 PYs 
      and 150.6/100 PYs, serious AEs were 7.1/100 PYs and 4.4/100 PYs, and AEs leading 
      to study agent discontinuation were 4.1/100 PYs and 3.8/100 PYs, respectively. 
      Through 1Y in patients treated with guselkumab, no uveitis, active tuberculosis, 
      opportunistic infections, or inflammatory bowel disease were observed, and low 
      rates of malignancy and major adverse cardiovascular (CV) events were observed. 
      Injection-site reactions occurred in 1.7%, and antibodies to guselkumab in 4.5% 
      of patients treated with guselkumab through 1Y; the vast majority of antibodies 
      to guselkumab were nonneutralizing. Serum hepatic transaminase elevations (more 
      common with Q4W than Q8W dosing) and decreased neutrophil counts were generally 
      mild, transient, and did not require treatment discontinuation, with minimal 
      change from Week 24 to 1Y. CONCLUSION: Guselkumab 100 mg Q4W and Q8W were well 
      tolerated in patients with PsA, with no new safety concerns through 1Y of the 
      phase III DISCOVER trials. Guselkumab safety through 1Y in patients with PsA is 
      consistent with that established in patients with psoriasis who were treated with 
      guselkumab. [ClinicalTrials.gov: NCT03162796 and NCT03158285].
CI  - Copyright (c) 2021 by the Journal of Rheumatology.
FAU - Rahman, Proton
AU  - Rahman P
AD  - P. Rahman, MD, Memorial University of Newfoundland, St. John's, Newfoundland, 
      Canada; prahman@mun.ca.
FAU - Ritchlin, Christopher T
AU  - Ritchlin CT
AD  - C.T. Ritchlin, MD, MPH, University of Rochester, Rochester, New York, USA.
FAU - Helliwell, Philip S
AU  - Helliwell PS
AUID- ORCID: 0000-0002-4155-9105
AD  - P.S. Helliwell, PhD, University of Leeds, Leeds, UK.
FAU - Boehncke, Wolf-Henning
AU  - Boehncke WH
AD  - W.H. Boehncke, MD, Geneva University Hospitals, Geneva, Switzerland.
FAU - Mease, Philip J
AU  - Mease PJ
AUID- ORCID: 0000-0002-6620-0457
AD  - P.J. Mease, MD, Swedish Medical Center/Providence St Joseph Health and University 
      of Washington School of Medicine, Seattle, Washington, USA.
FAU - Gottlieb, Alice B
AU  - Gottlieb AB
AUID- ORCID: 0000-0002-2927-8618
AD  - A.B. Gottlieb, MD, PhD, Icahn Medical School at Mount Sinai, New York, New York, 
      USA.
FAU - Kafka, Shelly
AU  - Kafka S
AD  - S. Kafka, MD, Janssen Scientific Affairs, Horsham, Pennsylvania, USA.
FAU - Kollmeier, Alexa P
AU  - Kollmeier AP
AD  - A.P. Kollmeier, MD, X.L. Xu, PhD, Janssen Research & Development, San Diego, 
      California, USA.
FAU - Hsia, Elizabeth C
AU  - Hsia EC
AD  - E.C. Hsia, MD, Janssen Research & Development, Spring House, Pennsylvania, USA, 
      and University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, 
      USA.
FAU - Xu, Xie L
AU  - Xu XL
AD  - A.P. Kollmeier, MD, X.L. Xu, PhD, Janssen Research & Development, San Diego, 
      California, USA.
FAU - Shawi, May
AU  - Shawi M
AD  - M. Shawi, PhD, Immunology Global Medical Affairs, Janssen Pharmaceutical 
      Companies of Johnson & Johnson, Horsham, Pennsylvania, USA.
FAU - Sheng, Shihong
AU  - Sheng S
AD  - S. Sheng, PhD, P. Agarwal, PhD, B. Zhou, PhD, P. Ramachandran, MD, MPH, Y. 
      Zhuang, PhD, Janssen Research & Development, Spring House, Pennsylvania, USA.
FAU - Agarwal, Prasheen
AU  - Agarwal P
AD  - S. Sheng, PhD, P. Agarwal, PhD, B. Zhou, PhD, P. Ramachandran, MD, MPH, Y. 
      Zhuang, PhD, Janssen Research & Development, Spring House, Pennsylvania, USA.
FAU - Zhou, Bei
AU  - Zhou B
AD  - S. Sheng, PhD, P. Agarwal, PhD, B. Zhou, PhD, P. Ramachandran, MD, MPH, Y. 
      Zhuang, PhD, Janssen Research & Development, Spring House, Pennsylvania, USA.
FAU - Ramachandran, Paraneedharan
AU  - Ramachandran P
AD  - S. Sheng, PhD, P. Agarwal, PhD, B. Zhou, PhD, P. Ramachandran, MD, MPH, Y. 
      Zhuang, PhD, Janssen Research & Development, Spring House, Pennsylvania, USA.
FAU - Zhuang, Yanli
AU  - Zhuang Y
AD  - S. Sheng, PhD, P. Agarwal, PhD, B. Zhou, PhD, P. Ramachandran, MD, MPH, Y. 
      Zhuang, PhD, Janssen Research & Development, Spring House, Pennsylvania, USA.
FAU - McInnes, Iain B
AU  - McInnes IB
AUID- ORCID: 0000-0003-4449-8501
AD  - I.B. McInnes, MD, PhD, University of Glasgow, Glasgow, UK.
LA  - eng
SI  - ClinicalTrials.gov/NCT03162796
SI  - ClinicalTrials.gov/NCT03158285
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210501
PL  - Canada
TA  - J Rheumatol
JT  - The Journal of rheumatology
JID - 7501984
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 089658A12D (guselkumab)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized
MH  - *Arthritis, Psoriatic/drug therapy
MH  - Double-Blind Method
MH  - Humans
MH  - *Psoriasis
MH  - Severity of Illness Index
MH  - Treatment Outcome
OTO - NOTNLM
OT  - adverse effects
OT  - biologics
OT  - psoriatic arthritis
OT  - safety
OT  - tolerability
EDAT- 2021/05/03 06:00
MHDA- 2022/02/01 06:00
CRDT- 2021/05/02 21:02
PHST- 2021/04/20 00:00 [accepted]
PHST- 2021/05/03 06:00 [pubmed]
PHST- 2022/02/01 06:00 [medline]
PHST- 2021/05/02 21:02 [entrez]
AID - jrheum.201532 [pii]
AID - 10.3899/jrheum.201532 [doi]
PST - ppublish
SO  - J Rheumatol. 2021 Dec;48(12):1815-1823. doi: 10.3899/jrheum.201532. Epub 2021 May 
      1.