PMID- 30485400
OWN - NLM
STAT- MEDLINE
DCOM- 20200703
LR  - 20200703
IS  - 1365-2133 (Electronic)
IS  - 0007-0963 (Linking)
VI  - 180
IP  - 5
DP  - 2019 May
TI  - Safety of guselkumab in patients with moderate-to-severe psoriasis treated 
      through 100 weeks: a pooled analysis from the randomized VOYAGE 1 and VOYAGE 2 
      studies.
PG  - 1039-1049
LID - 10.1111/bjd.17454 [doi]
AB  - BACKGROUND: Long-term evaluation is required to confirm the safety profile of 
      newer biologic agents. OBJECTIVES: To report on pooled safety data from the 
      ongoing VOYAGE 1 (NCT02207231) and VOYAGE 2 (NCT02207244) trials through 100 
      weeks of follow-up. METHODS: Patients were randomized to either guselkumab 100 mg 
      at weeks 0 and 4 and every 8 weeks thereafter; placebo at weeks 0, 4, 12 followed 
      by guselkumab 100 mg at weeks 16 and 20 and every 8 weeks thereafter; or 
      adalimumab 80 mg at week 0, 40 mg at week 1, and 40 mg every 2 weeks thereafter. 
      Patients who received adalimumab crossed over to guselkumab at week 52 (VOYAGE 1) 
      and at/after week 28 based on clinical response (VOYAGE 2). Open-label 
      extensions, in which all patients received guselkumab, started at week 52 (VOYAGE 
      1) and week 76 (VOYAGE 2). Rates of adverse events (AEs) per 100 patient-years 
      (PYs) are presented through 100 weeks of follow-up. RESULTS: Through week 52, 
      observed rates for guselkumab- and adalimumab-treated patients, respectively, 
      were 262.45 per 100 PYs and 328.28 per 100 PYs for AEs, 6.20 per 100 PYs and 7.77 
      per 100 PYs for serious AEs (SAEs), 1.22 per 100 PYs and 1.79 per 100 PYs for 
      serious infections (SIs), 0.28 per 100 PYs and 0.40 per 100 PYs for malignancies 
      other than nonmelanoma skin cancers (NMSCs), 0.56 per 100 PYs and 0.40 per 100 
      PYs for NMSCs, and 0.47 per 100 PYs and 0.40 per 100 PYs for major adverse 
      cardiovascular events (MACEs). Rates among patients treated with guselkumab 
      through week 52 and week 100, respectively, were 262.45 per 100 PYs and 210.41 
      per 100 PYs for AEs, 6.20 and 6.29 per 100 PYs, for SAEs, 1.22 per 100 PYs and 
      1.06 per 100 PYs for SIs, 0.28 per 100 PYs and 0.38 per 100 PYs for malignancies, 
      0.56 per 100 PYs and 0.39 per 100 PYs for NMSCs, and 0.47 per 100 PYs and 0.38 
      per 100 PYs for MACEs. Among patients treated with adalimumab, rates of AEs, 
      SAEs, SIs, malignancies, NMSCs, and MACEs showed some variability before and 
      after crossover to guselkumab, although no new safety signals were noted after 
      crossover. CONCLUSIONS: The safety profile for guselkumab remains favourable 
      through 100 weeks of treatment in patients with moderate-to-severe psoriasis.
CI  - (c) 2018 British Association of Dermatologists.
FAU - Reich, K
AU  - Reich K
AUID- ORCID: 0000-0001-5248-4332
AD  - Dermatologikum Berlin and SCIderm Research Institute, Hamburg, Germany.
FAU - Papp, K A
AU  - Papp KA
AUID- ORCID: 0000-0001-9557-3642
AD  - K Papp Clinical Research and Probity Research, Inc., Waterloo, Canada.
FAU - Armstrong, A W
AU  - Armstrong AW
AUID- ORCID: 0000-0002-6892-6286
AD  - University of Southern California, Los Angeles, CA, U.S.A.
FAU - Wasfi, Y
AU  - Wasfi Y
AD  - Janssen Research & Development, LLC, Spring House, PA, U.S.A.
FAU - Li, S
AU  - Li S
AD  - Janssen Research & Development, LLC, Spring House, PA, U.S.A.
FAU - Shen, Y K
AU  - Shen YK
AD  - Janssen Research & Development, LLC, Spring House, PA, U.S.A.
FAU - Randazzo, B
AU  - Randazzo B
AD  - Janssen Research & Development, LLC, Spring House, PA, U.S.A.
FAU - Song, M
AU  - Song M
AD  - Janssen Research & Development, LLC, Spring House, PA, U.S.A.
FAU - Kimball, A B
AU  - Kimball AB
AUID- ORCID: 0000-0001-9405-0479
AD  - Harvard Medical School and Beth Israel Deaconess Medical Center, Inc., Boston, 
      MA, U.S.A.
LA  - eng
SI  - ClinicalTrials.gov/NCT02207244
PT  - Clinical Trial, Phase III
PT  - Equivalence Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - England
TA  - Br J Dermatol
JT  - The British journal of dermatology
JID - 0004041
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (IL23A protein, human)
RN  - 0 (Interleukin-23 Subunit p19)
RN  - 089658A12D (guselkumab)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
CIN - Br J Dermatol. 2019 May;180(5):977-978. PMID: 31025743
MH  - Adalimumab/*adverse effects
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*adverse effects
MH  - Cardiovascular Diseases/chemically induced/*epidemiology
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Interleukin-23 Subunit p19/antagonists & inhibitors/immunology
MH  - Male
MH  - Middle Aged
MH  - Psoriasis/diagnosis/*drug therapy/immunology
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2018/11/30 06:00
MHDA- 2020/07/04 06:00
CRDT- 2018/11/29 06:00
PHST- 2018/11/23 00:00 [accepted]
PHST- 2018/11/30 06:00 [pubmed]
PHST- 2020/07/04 06:00 [medline]
PHST- 2018/11/29 06:00 [entrez]
AID - 10.1111/bjd.17454 [doi]
PST - ppublish
SO  - Br J Dermatol. 2019 May;180(5):1039-1049. doi: 10.1111/bjd.17454.