A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis.
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.


CONCLUSIONS
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.
Menter
Alan
A
Division of Dermatology, Baylor University Medical Center, UT Southwestern Medical School, 5310 Harvest Hill Rd, Ste 260, Dallas, TX 75230, USA. amderm@gmail.com
Feldman
Steven R
SR
Weinstein
Gerald D
GD
Papp
Kim
K
Evans
Robert
R
Guzzo
Cynthia
C
Li
Shu
S
Dooley
Lisa T
LT
Arnold
Cynthia
C
Gottlieb
Alice B
AB
D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology / Q000493:pharmacokinetics / Q000627:therapeutic use; D015535:Arthritis, Psoriatic / Q000188:drug therapy; D002170:Canada; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology / Q000493:pharmacokinetics / Q000627:therapeutic use; D000069285:Infliximab; D007262:Infusions, Intravenous; D008180:Lupus Erythematosus, Systemic / Q000139:chemically induced / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology / Q000209:etiology; D010361:Patients / Q000523:psychology; D011565:Psoriasis / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014376:Tuberculosis / Q000453:epidemiology / Q000209:etiology; D014481:United States
D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D000069285:Infliximab