TY - JOUR
T1 - Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part I of II)
T2 - Results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials
AU - Lebwohl, Mark
AU - Leonardi, Craig
AU - Griffiths, Christopher E.M.
AU - Prinz, Jörg C.
AU - Szapary, Philippe O.
AU - Yeilding, Newman
AU - Guzzo, Cynthia
AU - Li, Shu
AU - Hsu, Ming Chun
AU - Strober, Bruce
N1 - Funding Information:
Disclosure: M. Lebwohl has served as a consultant and received honoraria from Abbott, Allos, Amgen/Pfizer, Astellas, Celgene, Centocor/Janssen/Johnson & Johnson, DermaGenoma, Dermipsor, Galderma, GlaxoSmithKline-Stiefel, Leo Pharma, and Novartis; he has served as a lecturer and received honoraria for Ranbaxy. C. Leonardi has served as a consultant for Abbott, Amgen, Centocor, Eli Lilly, and Pfizer; as an investigator for Abbott, Amgen, Celgene, Centocor, Eli Lilly, Galderman, Genentech, Genzyme, GlaxoSmithKline, Incyte, Novartis, Novo Nordisk, Pfizer, Schering-Plough, Sirtris, Stiefel, Vascular Biogenics, and Wyeth and as a speaker for Abbott and Amgen; C. E. M. Griffiths is partially supported by the National Institute for Health Research Manchester Biomedical Research Centre and has served as an advisor and investigator for Abbott, Centocor, Janssen, Pfizer, and Procter & Gamble, as a consultant and advisor for Leo, Merck, and Novartis, and as an advisor for Incyte, a consultant for Stiefel, and an investigator for Celgene; J. Prinz has served as an advisor, speaker, and investigator for Abbott, Essex Pharma, Janssen, and Wyeth, and as an advisor and speaker for Pfizer; P. Szapary, N. Yeilding, C. Guzzo, S. Li are employees of Centocor and own stock in Johnson & Johnson, of which Centocor is a wholly owned subsidiary; M.-C. Hsu is an employee of Centocor; B. Strober has served as an advisor, consultant, investigator, and speaker for Abbott, Amgen, and Centocor, and as an advisor, consultant, and investigator for Celgene and Pfizer.
PY - 2012/5
Y1 - 2012/5
N2 - Background: Ustekinumab targets interleukin (IL)-12 and IL-23 in the treatment of moderate-to-severe psoriasis. Objective: To evaluate overall pooled study data to assess the safety profile of ustekinumab through 3 years of treatment. Methods: Cumulative safety data were pooled from studies in 3117 ustekinumab-treated patients. Results: During the placebo-controlled periods (Phase 2, PHOENIX 1, PHOENIX 2), rates of adverse events (AEs) were comparable among patients treated with placebo (50.4%), with ustekinumab 45 mg (57.6%), or with ustekinumab 90 mg (51.6%); similar findings were observed during the controlled period of the ACCEPT trial (etanercept: 70.0%; ustekinumab 45 mg: 66.0%; and ustekinumab 90 mg: 69.2%). Rates of serious AEs (SAEs) through the controlled periods were low and comparable among all groups (1.2% to 1.9%). Through 3 years, rates of AEs per 100 patient-years of follow-up (/100 patient-yrs) (45 mg: 305.2/100 patient-yrs; 90 mg: 305.9/100 patient-yrs) and SAEs (45 mg: 6.8/100 patient-yrs; 90 mg: 8.2/100 patient-yrs) were comparable between ustekinumab doses. No cases of demyelination or tuberculosis were reported in these trials. No dose response in rates of AEs, overall infections, or SAEs was apparent through 3 years. Rates of AEs, infections, SAEs, and AEs leading to study agent discontinuation remained generally stable or decreased over time. Limitations: Controlled periods did not extend beyond 12 to 20 weeks. Only 1247 of the 3117 ustekinumab-treated patients were treated for 2 or more years. Conclusions: The safety profile of continued ustekinumab exposure through up to 3 years is favorable and consistent with previous short-term reports.
AB - Background: Ustekinumab targets interleukin (IL)-12 and IL-23 in the treatment of moderate-to-severe psoriasis. Objective: To evaluate overall pooled study data to assess the safety profile of ustekinumab through 3 years of treatment. Methods: Cumulative safety data were pooled from studies in 3117 ustekinumab-treated patients. Results: During the placebo-controlled periods (Phase 2, PHOENIX 1, PHOENIX 2), rates of adverse events (AEs) were comparable among patients treated with placebo (50.4%), with ustekinumab 45 mg (57.6%), or with ustekinumab 90 mg (51.6%); similar findings were observed during the controlled period of the ACCEPT trial (etanercept: 70.0%; ustekinumab 45 mg: 66.0%; and ustekinumab 90 mg: 69.2%). Rates of serious AEs (SAEs) through the controlled periods were low and comparable among all groups (1.2% to 1.9%). Through 3 years, rates of AEs per 100 patient-years of follow-up (/100 patient-yrs) (45 mg: 305.2/100 patient-yrs; 90 mg: 305.9/100 patient-yrs) and SAEs (45 mg: 6.8/100 patient-yrs; 90 mg: 8.2/100 patient-yrs) were comparable between ustekinumab doses. No cases of demyelination or tuberculosis were reported in these trials. No dose response in rates of AEs, overall infections, or SAEs was apparent through 3 years. Rates of AEs, infections, SAEs, and AEs leading to study agent discontinuation remained generally stable or decreased over time. Limitations: Controlled periods did not extend beyond 12 to 20 weeks. Only 1247 of the 3117 ustekinumab-treated patients were treated for 2 or more years. Conclusions: The safety profile of continued ustekinumab exposure through up to 3 years is favorable and consistent with previous short-term reports.
KW - adverse events
KW - long-term safety
KW - moderate-to-severe psoriasis
KW - serious adverse events
KW - ustekinumab
UR - https://www.scopus.com/pages/publications/84859826969
U2 - 10.1016/j.jaad.2011.06.011
DO - 10.1016/j.jaad.2011.06.011
M3 - Article
C2 - 21930328
AN - SCOPUS:84859826969
SN - 0190-9622
VL - 66
SP - 731
EP - 741
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
IS - 5
ER -