PMID- 22803615
OWN - NLM
STAT- MEDLINE
DCOM- 20130411
LR  - 20220311
IS  - 1365-2133 (Electronic)
IS  - 0007-0963 (Linking)
VI  - 167
IP  - 5
DP  - 2012 Nov
TI  - The safety of ustekinumab treatment in patients with moderate-to-severe psoriasis 
      and latent tuberculosis infection.
PG  - 1145-52
LID - 10.1111/j.1365-2133.2012.11142.x [doi]
AB  - BACKGROUND: Ustekinumab is a monoclonal antibody that targets interleukin 
      (IL)-12/23 p40 to treat psoriasis. The IL-12 pathway is also important in 
      regulating immunity to Mycobacterium tuberculosis. OBJECTIVES: To evaluate the 
      safety of isoniazid (INH) prophylaxis for newly identified latent tuberculosis 
      infection (LTBI) in ustekinumab-treated patients with psoriasis. METHODS: Safety 
      data from 3177 psoriasis patients evaluated across five phase III trials of 
      ustekinumab (45 or 90 mg) conducted in North America, Europe and Asia were 
      analysed. LTBI was diagnosed based on positive tuberculin skin test or 
      QuantiFERON((R)) -TB test (Cellestis, Carnegie, Vic., Australia) without evidence 
      of active tuberculosis. RESULTS: At baseline, 101/2898 (3.5%) non-Asian and 
      66/279 (23.7%) Asian patients were newly identified with LTBI, and all were 
      treated with INH. Through week 12, among patients who received INH, rates of 
      adverse events (AEs) representative of INH toxicity were generally comparable 
      between control and ustekinumab-treated patients, as well as between ustekinumab 
      dose groups. Markedly abnormal alanine transaminase values occurred with 
      comparable incidences between control and ustekinumab-treated patients. The rate 
      of study agent discontinuation due to INH toxicity was low (5/167, 3.0%) and 
      comparable between control and ustekinumab groups through week 12. The rate of 
      INH-related AEs did not increase disproportionately through week 28. No cases of 
      active tuberculosis were reported in patients who received concomitant INH 
      starting at baseline. CONCLUSIONS: Across five trials of ustekinumab-treated 
      patients with psoriasis, no cases of LTBI reactivation were observed in patients 
      receiving concomitant INH prophylaxis for LTBI. INH prophylaxis was generally 
      well tolerated by these patients with psoriasis.
CI  - (c) 2012 The Authors. BJD (c) 2012 British Association of Dermatologists.
FAU - Tsai, T-F
AU  - Tsai TF
AD  - Department of Dermatology, National Taiwan University Hospital, 7 Chung-Shan S. 
      Road, Taipei, Taiwan. tftsai@yahoo.com
FAU - Ho, V
AU  - Ho V
FAU - Song, M
AU  - Song M
FAU - Szapary, P
AU  - Szapary P
FAU - Kato, T
AU  - Kato T
FAU - Wasfi, Y
AU  - Wasfi Y
FAU - Li, S
AU  - Li S
FAU - Shen, Y K
AU  - Shen YK
FAU - Leonardi, C
AU  - Leonardi C
CN  - PHOENIX 1, PHOENIX 2, ACCEPT, PEARL and Japanese Ustekinumab Study Groups
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Br J Dermatol
JT  - The British journal of dermatology
JID - 0004041
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antitubercular Agents)
RN  - 0 (Interleukin-23)
RN  - 187348-17-0 (Interleukin-12)
RN  - FU77B4U5Z0 (Ustekinumab)
RN  - V83O1VOZ8L (Isoniazid)
SB  - IM
CIN - Br J Dermatol. 2012 Nov;167(5):968-9. PMID: 23106352
MH  - Adult
MH  - Antibodies, Monoclonal/adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antitubercular Agents/*therapeutic use
MH  - Case-Control Studies
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Interleukin-12/immunology
MH  - Interleukin-23/immunology
MH  - Isoniazid/*therapeutic use
MH  - Latent Tuberculosis/*prevention & control
MH  - Male
MH  - Middle Aged
MH  - Psoriasis/complications/*drug therapy/immunology
MH  - Randomized Controlled Trials as Topic
MH  - Severity of Illness Index
MH  - Tuberculin Test
MH  - Ustekinumab
EDAT- 2012/07/19 06:00
MHDA- 2013/04/12 06:00
CRDT- 2012/07/19 06:00
PHST- 2012/07/19 06:00 [entrez]
PHST- 2012/07/19 06:00 [pubmed]
PHST- 2013/04/12 06:00 [medline]
AID - 10.1111/j.1365-2133.2012.11142.x [doi]
PST - ppublish
SO  - Br J Dermatol. 2012 Nov;167(5):1145-52. doi: 10.1111/j.1365-2133.2012.11142.x.