PMID- 23301632
OWN - NLM
STAT- MEDLINE
DCOM- 20130919
LR  - 20220310
IS  - 1365-2133 (Electronic)
IS  - 0007-0963 (Linking)
VI  - 168
IP  - 4
DP  - 2013 Apr
TI  - Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: 
      final results from 5 years of follow-up.
PG  - 844-54
LID - 10.1111/bjd.12214 [doi]
AB  - BACKGROUND: Long-term safety evaluations of biologics are needed to inform 
      patient management decisions. OBJECTIVES: To evaluate the safety of ustekinumab 
      in patients with moderate-to-severe psoriasis treated for up to 5 years. METHODS: 
      Safety data were pooled from four studies of ustekinumab for psoriasis. Rates of 
      adverse events (AEs), serious AEs (SAEs) and AEs of interest [infections, 
      nonmelanoma skin cancers (NMSCs), other malignancies and major adverse 
      cardiovascular events (MACE)] per 100 patient-years (PY) of follow-up were 
      analysed by ustekinumab dose (45 or 90 mg) and by year of follow-up (years 1-5) 
      to evaluate the dose response and impact of cumulative exposure. Observed rates 
      of overall mortality and other malignancies were compared with those expected in 
      the general U.S. population. RESULTS: Analyses included 3117 patients (8998 PY) 
      who received one or more doses of ustekinumab, with 1482 patients treated for >/=4 
      years (including 838 patients >/=5 years). At year 5, event rates (45 mg, 90 mg, 
      respectively) for overall AEs (242.6, 225.3), SAEs (7.0, 7.2), serious infections 
      (0.98, 1.19), NMSCs (0.64, 0.44), other malignancies (0.59, 0.61) and MACE (0.56, 
      0.36) were comparable between dose groups. Year-to-year variability was observed, 
      but no increasing trend was evident. Rates of overall mortality and other 
      malignancies were comparable with those expected in the general U.S. population. 
      CONCLUSIONS: No dose-related or cumulative toxicity was observed with increasing 
      duration of ustekinumab exposure for up to 5 years. Rates of AEs reported in 
      ustekinumab psoriasis trials are generally comparable with those reported for 
      other biologics approved for the treatment of moderate-to-severe psoriasis.
CI  - (c) 2013 The Authors. BJD (c) 2013 British Association of Dermatologists.
FAU - Papp, K A
AU  - Papp KA
AD  - Probity Medical Research, 135 Union Street East, Waterloo, ON N2J1C4, Canada. 
      kapapp@probitymedical.com
FAU - Griffiths, C E M
AU  - Griffiths CE
FAU - Gordon, K
AU  - Gordon K
FAU - Lebwohl, M
AU  - Lebwohl M
FAU - Szapary, P O
AU  - Szapary PO
FAU - Wasfi, Y
AU  - Wasfi Y
FAU - Chan, D
AU  - Chan D
FAU - Hsu, M-C
AU  - Hsu MC
FAU - Ho, V
AU  - Ho V
FAU - Ghislain, P D
AU  - Ghislain PD
FAU - Strober, B
AU  - Strober B
FAU - Reich, K
AU  - Reich K
CN  - PHOENIX 1 Investigators
CN  - PHOENIX 2 Investigators
CN  - ACCEPT Investigators
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
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, Humanized)
RN  - 0 (Dermatologic Agents)
RN  - FU77B4U5Z0 (Ustekinumab)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/*adverse effects
MH  - Cardiovascular Diseases/chemically induced
MH  - Clinical Trials, Phase II as Topic
MH  - Clinical Trials, Phase III as Topic
MH  - Dermatologic Agents/administration & dosage/*adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Infections/chemically induced
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/chemically induced
MH  - Psoriasis/*drug therapy
MH  - Randomized Controlled Trials as Topic
MH  - Ustekinumab
EDAT- 2013/01/11 06:00
MHDA- 2013/09/21 06:00
CRDT- 2013/01/11 06:00
PHST- 2013/01/11 06:00 [entrez]
PHST- 2013/01/11 06:00 [pubmed]
PHST- 2013/09/21 06:00 [medline]
AID - 10.1111/bjd.12214 [doi]
PST - ppublish
SO  - Br J Dermatol. 2013 Apr;168(4):844-54. doi: 10.1111/bjd.12214.