PMID- 32289190
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210514
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Linking)
VI  - 34
IP  - 8
DP  - 2020 Aug
TI  - Safety in moderate-to-severe plaque psoriasis patients with latent tuberculosis 
      treated with guselkumab and anti-tuberculosis treatments concomitantly: results 
      from pooled phase 3 VOYAGE 1 & VOYAGE 2 trials.
PG  - 1744-1749
LID - 10.1111/jdv.16460 [doi]
AB  - BACKGROUND: Patients treated with tumour necrosis factor (TNF) inhibitors are at 
      risk of new-onset tuberculosis (TB) or reactivation of latent tuberculosis 
      infection (LTBI). Association between TB/LTBI and interleukin (IL)-23 inhibitors 
      for psoriasis is unclear. Patients with LTBI typically initiate LTBI therapy 
      before receiving biologics. OBJECTIVES: Safety in moderate-to-severe psoriasis 
      patients with LTBI treated with guselkumab (IL-23 inhibitor) and LTBI treatment 
      was evaluated. METHODS: In the VOYAGE 1 & VOYAGE 2 studies, patients screened for 
      LTBI were randomized to guselkumab, placebo, or adalimumab (TNF inhibitor) at 
      baseline. Placebo --> guselkumab crossover occurred at week 16 and 
      adalimumab --> guselkumab at week 52 (VOYAGE 1), or at week 28 or later (VOYAGE 2). 
      Incidence of active TB, adverse events (AEs), serious AEs (SAEs), and markedly 
      abnormal liver function tests [alanine aminotransferase test (ALT); aspartate 
      aminotransferase test (AST)] were evaluated using pooled data through week 100 in 
      guselkumab-treated patients receiving and not receiving LTBI treatment. RESULTS: 
      At baseline, 130 randomized patients (guselkumab: n = 69; adalimumab: n = 36; 
      placebo: n = 25) tested positive for LTBI and received concomitant LTBI 
      treatments (LTBI+). No active TB was reported among guselkumab-treated patients 
      without LTBI (LTBI-) through week 100. Two cases of active TB occurred in LTBI- 
      patients treated with adalimumab. Through week 16, across all treatment groups, 
      greater proportions of LTBI+ patients reported ALT and AST elevations compared 
      with LTBI- patients. Through week 100, proportions of patients experiencing AEs 
      and SAEs were comparable between LTBI+ and LTBI- patients. CONCLUSIONS: No cases 
      of active TB, including reactivation of LTBI, were reported in patients with or 
      without LTBI treated with guselkumab through up to 2 years. LTBI treatment was 
      effective across all treatment groups in preventing reactivation of LTBI. 
      Long-term treatment with guselkumab was generally well-tolerated through up to 
      2 years in patients receiving LTBI medications.
CI  - (c) 2020 European Academy of Dermatology and Venereology.
FAU - Puig, L
AU  - Puig L
AUID- ORCID: 0000-0001-6083-0952
AD  - Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
FAU - Tsai, T-F
AU  - Tsai TF
AD  - National Taiwan University Hospital, Taipei, Taiwan.
FAU - Bhutani, T
AU  - Bhutani T
AD  - University of California San Francisco Medical Center, San Francisco, CA, USA.
FAU - Uy, J
AU  - Uy J
AD  - Janssen Scientific Affairs, LLC, Horsham, PA, USA.
FAU - Ramachandran, P
AU  - Ramachandran P
AD  - Janssen Research & Development, LLC, Spring House, PA, USA.
FAU - Song, M
AU  - Song M
AD  - Janssen Research & Development, LLC, Spring House, PA, USA.
FAU - You, Y
AU  - You Y
AD  - Janssen Research & Development, LLC, Spring House, PA, USA.
FAU - Gooderham, M
AU  - Gooderham M
AD  - SKiN Centre for Dermatology, Peterborough, ON, Canada.
FAU - Lebwohl, M
AU  - Lebwohl M
AD  - Icahn School of Medicine at Mount Sinai, New York, NY, USA.
LA  - eng
GR  - Janssen Research and Development/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200515
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antitubercular Agents)
RN  - 089658A12D (guselkumab)
SB  - IM
MH  - Antibodies, Monoclonal/adverse effects
MH  - Antibodies, Monoclonal, Humanized
MH  - Antitubercular Agents/adverse effects
MH  - Double-Blind Method
MH  - Humans
MH  - *Latent Tuberculosis/drug therapy
MH  - *Psoriasis/drug therapy
MH  - Severity of Illness Index
EDAT- 2020/04/15 06:00
MHDA- 2021/05/15 06:00
CRDT- 2020/04/15 06:00
PHST- 2019/12/18 00:00 [received]
PHST- 2020/03/27 00:00 [accepted]
PHST- 2020/04/15 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2020/04/15 06:00 [entrez]
AID - 10.1111/jdv.16460 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2020 Aug;34(8):1744-1749. doi: 10.1111/jdv.16460. 
      Epub 2020 May 15.