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Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: results of a randomized, double-blind, placebo-controlled study

All Rights Reserved. Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: results of a randomized, double-blind, placebo-controlled study. Mease, Philip J.; Gladman, Dafna D.; Keystone, Edward C. (The Alefacept in Psoriatic Arthritis Study Group; Swedish Medical Center, Seattle, WA, USA). Arthritis & Rheumatism, 54(5), 1638-1645 (English) 2006 John Wiley & Sons, Inc. CODEN: ARHEAW. ISSN: 0004-3591. DOCUMENT TYPE: Journal CA Section: 1 (Pharmacology) Section cross-reference(s): 15 Objective: To evaluate the efficacy and safety of alefacept in combination with methotrexate (MTX) for the treatment of psoriatic arthritis (PsA). Methods: Patients were eligible for this randomized, double-blind, placebo-controlled trial if they were ages 18-70 years and had active PsA (33 swollen joints and 33 tender joints) despite treatment with MTX for 33 mo (a stable dosage for 34 wk prior to enrollment). Patients were stratified according to psoriasis body surface area (BSA) involvement (33% or <3%). Alefacept (15 mg) or placebo was administered i.m. once weekly for 12 wk in combination with MTX, followed by 12 wk of observation during which only MTX treatment was continued. The primary efficacy end point was the proportion of patients achieving a 20% improvement in disease activity according to the American College of Rheumatol. 59-05-2 and 222535-22-0 which are cas registry numbers are also used here. criteria (an ACR20 response) at week 24. Results: One hundred eighty-five patients were randomly assigned to receive alefacept plus MTX (n = 123) or placebo plus MTX (n = 62). At week 24, 54% of patients in the alefacept plus MTX group achieved an ACR20 response, compared with 23% of patients in the placebo plus MTX group (P < 0.001). Mean redns. in tender and swollen joint counts in patients receiving alefacept plus MTX were -8.0 and -6.3, resp. In patients with psoriasis involving 33% BSA (n = 87), a 50% redn. from the baseline Psoriasis Area Severity Index at week 14 was achieved by 53% of patients receiving alefacept plus MTX compared with 17% of those receiving placebo plus MTX (P < 0.001). Most adverse events were mild to moderate in severity. In the alefacept plus MTX group, the incidence of serious adverse events was low (1.6%), and no opportunistic infections or malignancies were reported. Conclusion: Alefacept in combination with MTX may be an effective and safe treatment for PsA. .

An overview of infliximab, etanercept, efalizumab, and alefacept as biologic therapy for psoriasis

An overview of infliximab, etanercept, efalizumab, and alefacept as biologic therapy for psoriasis. Weinberg, Jeffrey M. (Department of Dermatology, Beth Israel Medical Center, St. Lukes-Roosevelt Hospital Center, New York, NY, USA). Clinical Therapeutics, 25(10), 2487-2505 (English) 2003 Excerpta Medica, Inc. CODEN: CLTHDG. ISSN: 0149-2918. DOCUMENT TYPE: Journal; General Review CA Section: 15 (Immunochemistry) Section cross-reference(s): 1 A review. Background: Psoriasis is a chronic skin disorder that affects ~2% of the US and European populations. One of the major focuses in psoriasis research has been the development of biol. therapies that provide selective, immunol. directed intervention with fewer adverse effects than traditional therapies. Objective: The aim of this review was to summarize the progress of 4 biol. agents available or under investigation for clin. use: infliximab, etanercept, efalizumab, and alefacept. Methods: Relevant information was identified through a MEDLINE search of the literature (1966 to May 2003) using the terms biol. therapy, psoriasis, infliximab, etanercept, efalizumab, and alefacept. In addn., meeting posters from the American Academy of Dermatol. (2003) and international Investigative Dermatol. (2003) were reviewed and included if perceived to be reliable and relevant. Results: In a Phase II trial of infliximab, the percentages of patients reaching 375% improvement from baseline in the psoriasis area and severity index (PASI 75) at week 10 were as follows: 6% with placebo (3/51), 72% with infliximab 3 mg/kg (71/98), and 88% with infliximab 5 mg/kg (87/99). In a Phase III study, 34% of patients receiving etanercept 25 mg SC twice weekly (55/162) achieved PASI 75 at 12 wk and 44% (71/162) at 24 wk. Also, 49% of those receiving etanercept 50 mg (81/164) achieved PASI 75 at 12 wk, and 59% (97/164) at 24 wk. In 2 Phase III trials with SC efalizumab 1. 185243-69-0 and 222535-22-0 are also in the experiment.0 mg/kg or 2.0 mg/kg or placebo, 30% in the 1.0-mg/kg per wk group (117/394) achieved PASI 75; in the 2.0-mg/kg per wk group, 28% (113/409) did. In the placebo group, 3.4% (10/292) achieved PASI 75. In a Phase III trial of IM alefacept 15 mg once weekly for 12 wk, IM alefacept 10 mg once weekly for 12 wk, or placebo, 21% of the 15-mg dose group (35/166) achieved PASI 75 at 2 wk after the last dose, compared with 5% of the placebo group (8/168). In a Phase III study of the efficacy and tolerability of once-weekly alefacept 7.5 mg via IV bolus, 14% (53/367) and 4% (7/186) of patients receiving alefacept and placebo achieved PASI 75 at week 14, resp. Among those who received 2 courses of alefacept, 40% (73/183) and 71% (130/183) achieved PASI 75 and 350% improvement in PASI, resp. All 4 drugs have been generally well tolerated. Conclusions: In the patients treated to date, infliximab, etanercept, efalizumab, and alefacept have achieved successful therapy of psoriasis without the organ toxicity seen with traditional systemic therapies. Potential limitations in the use of these agents include the expected high costs of treatment, lack of long-term follow-up, and the selective nature of the patient populations treated thus far. .