A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis - 12/08/11
, Steven R. Feldman, MD, PhD b, Gerald D. Weinstein, MD c, Kim Papp, MD, PhD d, Robert Evans, PharmD e, Cynthia Guzzo, MD f, Shu Li, MS f, Lisa T. Dooley, DrPH f, Cynthia Arnold, BS f, Alice B. Gottlieb, MD, PhD g
Reprint requests: Alan Menter, MD, Division of Dermatology, Baylor University Medical Center, UT Southwestern Medical School, 5310 Harvest Hill Rd, Ste 260, Dallas, TX 75230.Dallas, Texas; Winston-Salem, North Carolina; Irvine and Fremont, California; Waterloo, Ontario, Canada; Malvern, Pennsylvania; and Boston, Massachusetts
Abstract |
Background |
Previous studies of infliximab in psoriasis have demonstrated rapid improvement with induction therapy and sustained response with regularly administered maintenance therapy.
Objective |
The efficacy and safety of continuous (every–8-week) and intermittent (as-needed) maintenance regimens were compared.
Methods |
Patients with moderate-to-severe psoriasis (n = 835) were randomized to induction therapy (weeks 0, 2, and 6) with infliximab 3 mg/kg or 5 mg/kg or placebo. Infliximab-treated patients were randomized again at week 14 to continuous or intermittent maintenance regimens at their induction dose.
Results |
At week 10, 75.5% and 70.3% of patients in the infliximab 5 mg/kg and 3 mg/kg groups, respectively, achieved PASI 75; 45.2% and 37.1% achieved PASI 90 (vs 1.9% [PASI 75] and 0.5% [PASI 90] for placebo; P < .001). Through week 50, PASI responses were better maintained with continuous compared with intermittent therapy within each dose, and with 5 mg/kg compared with 3 mg/kg continuous therapy.
Limitations |
Longer term (>1 year) maintenance therapy and further study of infliximab serum concentrations over this period, in both PASI 75 responders and non-responders, would be preferable.
Conclusions |
Through week 50, response was best maintained with continuous infliximab therapy. Infliximab was generally well-tolerated in most patients.
Il testo completo di questo articolo è disponibile in PDF.Abbreviations used : ALT, AST, ANOVA, BSA, DLQI, EXPRESS, EXPRESS II, PASI, PASI 75, PASI 90, PGA, PPD, QOL, TB, TNF⍺, ULN
Mappa
| Supported by Centocor, Inc, Malvern, Penn, and Schering-Plough, Kenilworth, NJ. Conflicts of interest can be found in the appendix. Please visit www.eblue.org for a listing of EXPRESS II study investigators. Presented at the 64th Annual Meeting of the American Academy of Dermatology, San Francisco, Calif, March 3-7, 2006. |
Vol 56 - N° 1
P. 31.e1-31.e15 - gennaio 2007 Ritorno al numero
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