PMID- 22395580
OWN - NLM
STAT- MEDLINE
DCOM- 20120628
LR  - 20220311
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 11
IP  - 3
DP  - 2012 Mar
TI  - An update on the long-term safety experience of ustekinumab: results from the 
      psoriasis clinical development program with up to four years of follow-up.
PG  - 300-12
AB  - BACKGROUND: The efficacy and safety profile of ustekinumab with up to three years 
      of exposure suggested a favorable benefit-risk profile in patients with moderate 
      to severe psoriasis. OBJECTIVE: To evaluate the safety of ustekinumab in patients 
      with moderate to severe psoriasis treated for up to four years. METHODS: Safety 
      data were pooled across four Phase II/III randomized controlled trials. Rates 
      over time and cumulative rates of adverse events (AEs), AEs leading to treatment 
      discontinuation, serious adverse events (SAEs), serious infections, malignancies, 
      and major adverse cardiovascular events (MACE) (i.e., cardiovascular death, 
      myocardial infarction [MI], or stroke as adjudicated by an independent panel of 
      academic cardiologists) were evaluated. Observed rates of AEs of interest were 
      compared with those expected in the general (malignancies, MI, and stroke) and 
      psoriasis (serious infections, MI, and stroke) populations. RESULTS: Overall, 
      3,117 patients were followed for up to four years (6,791 patient-years). Rates of 
      AEs, AEs leading to treatment discontinuation, and SAEs remained stable over 
      time, whereas cumulative rates were generally comparable between patients who 
      received 45 mg and 90 mg of ustekinumab. The rates of AEs of interest also 
      remained stable over time, and cumulative rates per 100 patient-years were 0.80 
      and 1.32 (serious infections), 0.70 and 0.53 (nonmelanoma skin cancer), 0.63 and 
      0.61 (other malignancies), and 0.56 and 0.46 (MACE) in patients treated with 45 
      mg and 90 mg, respectively. Rates of AEs of interest were consistent with those 
      in the general and psoriasis populations. CONCLUSION: The safety profile of 
      long-term ustekinumab treatment with up to four years of continuous use remains 
      consistent with previous reports, with no evidence of cumulative toxicity.
FAU - Reich, Kristian
AU  - Reich K
AD  - Dermatologikum Hamburg, Germany. reich@dermatologikum.de
FAU - Papp, Kim A
AU  - Papp KA
FAU - Griffiths, Christopher E M
AU  - Griffiths CE
FAU - Szapary, Philippe O
AU  - Szapary PO
FAU - Yeilding, Newman
AU  - Yeilding N
FAU - Wasfi, Yasmine
AU  - Wasfi Y
FAU - Ott, Elyssa
AU  - Ott E
FAU - Hsu, Ming-Chun
AU  - Hsu MC
FAU - Lebwohl, Mark
AU  - Lebwohl M
FAU - Gordon, Kenneth B
AU  - Gordon KB
CN  - PHOENIX 1, PHOENIX 2, and ACCEPT investigators
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Dermatologic Agents)
RN  - FU77B4U5Z0 (Ustekinumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal/administration & dosage/*adverse effects/therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Cross-Over Studies
MH  - Dermatologic Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Psoriasis/*drug therapy/pathology
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Ustekinumab
EDAT- 2012/03/08 06:00
MHDA- 2012/06/29 06:00
CRDT- 2012/03/08 06:00
PHST- 2012/03/08 06:00 [entrez]
PHST- 2012/03/08 06:00 [pubmed]
PHST- 2012/06/29 06:00 [medline]
PST - ppublish
SO  - J Drugs Dermatol. 2012 Mar;11(3):300-12.