Abstract | BACKGROUND: OBJECTIVE: This phase II randomized, double-blind, placebo-controlled multicenter study evaluated the efficacy and safety of efalizumab for the treatment of PsA. METHODS: Patients were required to be on at least one of the following concomitant systemic therapies for PsA: nonsteroidal anti-inflammatory drugs, corticosteroids, and/or sulfasalazine or methotrexate. One hundred fifteen patients with active PsA were enrolled and randomized in the study. Of these, 107 were treated weekly with efalizumab 1 mg/kg or placebo for 12 weeks, followed by 12 additional weeks of open-label efalizumab. RESULTS: At week 12, 28% of efalizumab-treated patients achieved ACR-20 response (a 20% reduction from the baseline in the American College of Rheumatology response criteria), the primary end point, compared with 19% of placebo patients (p = .27). The safety profile was comparable between efalizumab- and placebo-treated patient groups, regardless of methotrexate background therapy, and no worsening of joint disease occurred with efalizumab therapy. CONCLUSIONS:
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Authors | Kim A Papp, Ivor Caro, Hoi M Leung, Marvin Garovoy, Philip J Mease |
Journal | Journal of cutaneous medicine and surgery
(J Cutan Med Surg)
2007 Mar-Apr
Vol. 11
Issue 2
Pg. 57-66
ISSN: 1203-4754 [Print] United States |
PMID | 17374316
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- CD11 Antigens
- Immunosuppressive Agents
- efalizumab
- Methotrexate
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Topics |
- Adult
- Aged
- Antibodies, Monoclonal
(therapeutic use)
- Antibodies, Monoclonal, Humanized
- Arthritis, Psoriatic
(drug therapy)
- CD11 Antigens
(drug effects)
- Cell Migration Inhibition
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Humans
- Immunosuppressive Agents
(therapeutic use)
- Male
- Methotrexate
(therapeutic use)
- Middle Aged
- Treatment Outcome
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