Long-term safety experience of ustekinumab in patients with moderate to severe psoriasis (Part II of II): Results from analyses of infections and malignancy from pooled phase II and III clinical trials - 16/04/12
, Kim A. Papp, MD b, Richard G. Langley, MD c, Vincent Ho, MD d, Alexa B. Kimball, MD e, Cynthia Guzzo, MD f, Newman Yeilding, MD f, Philippe O. Szapary, MD, MSCE f, Steven Fakharzadeh, MD, PhD f, Shu Li, MS f, Ming-Chun Hsu, PhD f, Kristian Reich, MD g
Reprint requests: Kenneth B. Gordon, MD, Department of Dermatology, Northwestern University, Feinberg School of Medicine, 676 N St. Clair St, Chicago, IL 60611.Abstract |
Background |
Ustekinumab targets interleukin (IL)-12 and IL-23 in the treatment of moderate to severe psoriasis.
Objective |
We sought to evaluate the impact of ustekinumab on infections and malignancies, both theoretical risks of blocking IL-12 and IL-23, in patients exposed up to 3 years.
Methods |
Rates of infections and malignancies were evaluated in cumulative safety data from 3117 ustekinumab-treated patients across 4 studies.
Results |
During the placebo-controlled periods, rates of overall infections per 100 patient-years were similar among placebo (121.0), ustekinumab 45-mg (145.7), and ustekinumab 90-mg (132.2) groups, with overlapping confidence intervals, and remained stable through 3 years in ustekinumab groups. Rates of serious infections during the placebo-controlled periods were similar between placebo (1.70) and 90-mg (1.97) groups, yet lower in the 45-mg group (0.49). Rates remained stable (90 mg) or decreased (45 mg) over time, and were comparable with those for the US psoriasis population based on a managed care database. Rates of malignancies during the placebo-controlled periods were comparable among groups (placebo: 1.70; 45 mg: 0.99; 90 mg: 0.98) and remained stable over time in ustekinumab groups. Rates of malignancies, excluding nonmelanoma skin cancer, were comparable with rates expected in the general US population based on the Surveillance, Epidemiology, and End Results database.
Limitations |
Controlled periods do not extend beyond 12 to 20 weeks. Only 1247 patients were treated for at least 2 years, to date. Comparator database populations may not fully represent the clinical trial population.
Conclusions |
The emerging safety profile of ustekinumab remains favorable and does not suggest increased rates of infection or malignancy through 3 years.
Le texte complet de cet article est disponible en PDF.Key words : malignancy, nonmelanoma skin cancer, psoriasis, safety, serious infection, ustekinumab
Abbreviations used : CI, IL, IQR, NCI, NMSC, PUVA, SEER, TB, UV
Plan
| Supported by Centocor Research & Development Inc. |
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| Disclosure: Dr Gordon has served as a consultant and investigator for Abbott, Amgen, Centocor, and Merck and as a consultant for Eli Lily and Pfizer. Dr Papp has served as an advisor, consultant, investigator, and speaker for Abbott, Amgen, Wyeth, and Pfizer and as an advisor, consultant, and investigator for Centocor. Dr Langley has served as an advisor, investigator, and speaker for Abbott, Amgen, Biogen, Celgene, Merck, and Pfizer. Dr Ho has served as an advisor, investigator, and speaker for Abbott, Amgen, Janssen, Merck, and Pfizer; an advisor for Astellas; and an investigator for Novartis. Dr Kimball has served as a consultant and investigator for Abbott, Amgen, and Centocor. Drs Guzzo, Yeilding, Szapary, Fakharzadeh, and Hsu, and Ms Li are employees of Centocor. Drs Guzzo, Yeilding, Szapary, Fakharzadeh, and Ms Li own stock in Johnson & Johnson, of which Centocor is a wholly owned subsidiary. Dr Reich has served as an advisor and/or consultant, and/or speaker, and/or participated in clinical trials sponsored by Abbott, Basilea, Biogen-Idec, Celgene, Centocor, Essex Pharma, Forward Pharm, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, Schering-Plough, UCB, and Wyeth. |
Vol 66 - N° 5
P. 742-751 - mai 2012 Retour au numéro
Article précédent
- Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part I of II): Results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials
- Mark Lebwohl, Craig Leonardi, Christopher E.M. Griffiths, Jörg C. Prinz, Philippe O. Szapary, Newman Yeilding, Cynthia Guzzo, Shu Li, Ming-Chun Hsu, Bruce Strober
- High-dose curcuminoids are efficacious in the reduction in symptoms and signs of oral lichen planus
- Nita Chainani-Wu, Erin Madden, Francina Lozada-Nur, Sol Silverman
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