Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population - 14/01/12
, Yves Poulin, MD b, Robert Bissonnette, MD c, Marc Bourcier, MD d, Darryl Toth, MD e, Leslie Rosoph, MD f, Melanie Poulin-Costello, BMath, MSc, Pstat g, Mike Setterfield, MSc g, Jerry Syrotuik, MA g
Reprint requests: Kim A. Papp, MD, PhD, Probity Medical Research, 135 Union St E, Waterloo, Ontario, Canada N2J 1C4.Abstract |
Background |
Etanercept is well tolerated and effective in moderate to severe plaque psoriasis. However, effectiveness and safety data beyond 2.5 years have not been reported.
Objective |
We sought to assess the effectiveness and safety profile of up to 4 years of etanercept therapy in psoriasis.
Methods |
We analyzed prospective data from previous trials and open-label extensions, including 506 patients who initiated etanercept therapy in either of two phase III trials. Patients received etanercept, 25 mg twice weekly, 50 mg weekly, or 50 mg twice weekly, depending on which trial therapy was started. Dosage adjustments were allowed in open-label extensions, but no patients exceeded 50 mg twice weekly. Outcomes included change from baseline for the static Physician Global Assessment and Dermatology Life Quality Index scores. Exposure-adjusted adverse event (AE) rates were calculated.
Results |
In all, 75.9% (95% confidence interval 67.9-84.0) and 27.8% (95% confidence interval 19.3-36.2) maintained Dermatology Life Quality Index response (≥5-point improvement from baseline) and static Physician Global Assessment response (clear or almost clear) at 48 months, respectively. AE and serious AE rates were 243.5 and 7.8 events per 100 patient-years, respectively. No serious AE rates exceeded 1.0 event per 100 patient-years. Overall infection and serious infection rates were 96.9 and 0.9 events per 100 patient-years, respectively. No cases of tuberculosis or lymphoma were reported.
Limitations |
Effectiveness data were limited to static Physician Global Assessment and Dermatology Life Quality Index scores. Analysis of AE rates was limited to available comparator databases.
Conclusion |
Etanercept demonstrated sustained effectiveness and a favorable safety profile with no cumulative toxicity for up to 4 years, representing, to our knowledge, the longest published study on etanercept use in psoriasis to date.
Le texte complet de cet article est disponible en PDF.Key words : biological therapy, etanercept, psoriasis, safety, tumor necrosis factor
Abbreviations used : AE, BCC, BIW, CI, DLQI, NMSC, PASI, PGA, PY, QW, SCC, SIR, TNF, UV
Plan
| Supported in part by Amgen Canada Inc and Pfizer Canada. Amgen Canada Inc oversaw the design, conduct, and collection of data in the study and assisted in the analysis and interpretation of data. Medical writing assistance was funded by Amgen Canada Inc. |
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| Disclosure: Dr Papp has received consultancies and/or honoraria, is a member of a speaker’s bureau, or has received research grants from Abbott, Amgen, Centocor, Johnson & Johnson, MedImmune, Schering-Plough, and Wyeth, a Pfizer company. Dr Poulin has received consultancies and/or honoraria, is a member of a speaker’s bureau, or has received research grants from Abbott, Amgen, Astellas, Celgene, Centocor, EMD Serono, Galderma, Janssen-Ortho, Johnson & Johnson, Merck, Novartis, Pfizer, Schering-Plough, Stiefel, and Wyeth, a Pfizer company. Dr Bissonnette has received consultancies and/or honoraria from Amgen; Wyeth, a Pfizer company; MedImmune; Janssen Ortho; Abbott; Astellas; and Schering Plough/Merck, and research grants from Amgen; Wyeth, a Pfizer company; Centocor; Janssen Ortho; Abbott; Astellas; Novartis; and Schering/Merck. Dr Bourcier has received financial funding, grants, and/or honoraria from Abbott, Amgen, Astellas, Celgene, EMD Serono, Galderma, Graceway Pharmaceuticals, Janssen-Ortho, Janssen-Cilag, Johnson & Johnson, Merck Frosst, Novartis, Ortho-Biotech, Pfizer, Schering-Plough, and Wyeth, a Pfizer company, and grants and/or honoraria from GlaxoSmithKline, Roche-Posay, and Stiefel. Dr Toth is a member of a speaker’s bureau for Amgen, Abbott, Genentech, and Johnson & Johnson. Dr Rosoph has been a paid investigator for conducting clinical trials from Amgen, Genentech, Abbott, Centocor, Basilea, Leo, Isotechnika, Stiefel, GSK, Galderma, 3-M, Serono, Novartis, and Pfizer. Ms Poulin-Costello, Mr Syrotuik, and Mr Setterfield are employees of, and have stock options in Amgen Canada Inc. |
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| Trial Registration: clinicaltrials.gov Identifier NCT00121615. |
Vol 66 - N° 2
P. e33-e45 - février 2012 Retour au numéro
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