Ongoing Developments in Biologic Therapy




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Meetings/Links : Meeting Reports : American Academy of Dermatology Meeting
American Academy of Dermatology
February 6-11, 2004
Washington, DC

The 62nd Annual Meeting of the American Academy of Dermatology was held recently (February 6-11, 2004) in Washington, DC. New data surrounding the use of biologic agents for the treatment of moderate to severe plaque psoriasis were presented and are summarized below.

Alefacept
Alefacept is a T-cell therapy approved for the treatment of moderate to severe plaque psoriasis. The newly presented data related primarily to the use of alefacept with other therapies and for other indications, as well as the impact of multiple courses of therapy. Alefacept added to other psoriasis treatment regimens (ie, topical therapies, phototherapies, systemic therapies) was safe and associated with improved outcomes. Preliminary data also showed that the use of alefacept therapy allowed for tapering of cyclosporine and methotrexate safely and with continued efficacy. In terms of new indications, data showed response to alefacept therapy in nail psoriasis, and pilot data showed response in rheumatoid arthritis (RA) when used in combination with methotrexate. Data associated with multiple courses of therapy showed continued response in the majority of patients who responded initially and no increase in adverse events with up to 4 courses of alefacept therapy. Data analyzing less frequent (biweekly) monitoring of CD4+ cells did not show any impairment of patient safety. And finally, data from a pilot study suggested that treatment with 16 weeks of therapy was associated with an improved response rate and duration of response with safety (including CD4+ counts) comparable to that seen with 12 weeks of therapy.

Efalizumab
New data exploring the use of efalizumab, a T-cell modulating agent also recently approved for the treatment of moderate to severe plaque psoriasis, focused on an interim analysis of 24 months of continuous therapy. These data showed that efficacy was maintained with 2 years of continuous treatment with efalizumab, with no increase in adverse events. Pooled results from phase III clinical trials were also presented, showing that efalizumab therapy is efficacious, with a demonstrated safety profile, and has a significant positive impact on patient-reported outcomes.

Etanercept
Etanercept, a cytokine inhibitor approved for the treatment of RA, psoriatic arthritis, and juvenile inflammatory arthritis, is currently under FDA review for the treatment of moderate to severe plaque psoriasis. New etanercept data related to relapse, rebound, and retreatment were presented. Mean time to relapse following cessation of therapy was 85 days (91 days with higher dosing); only 1 patient in the 25 mg/wk group experienced rebound per the National Psoriasis Foundation definition; and response to retreatment was comparable to response seen with initial courses of therapy. Data relating to switching between available dosing regimens were also presented, with 77% of patients initiating therapy at 50 mg twice weekly for three months and then transferred to 25 mg twice weekly maintaining their response at this lower dose.

Infliximab
Infliximab is another cytokine inhibitor, and it is approved for the treatment of Crohn's disease and RA and is currently in phase III clinical trials for the treatment of psoriatic arthritis and plaque psoriasis. Approval for psoriatic arthritis is expected in 2005, with approval for plaque psoriasis following. New quality-of-life data showed a very high quality-of-life response associated with infliximab therapy, with clinical response greatly enhancing life quality as measured by the Dermatology Life Quality Index (DLQI). In addition, improvement of plaque psoriasis and safety in patients with psoriatic arthritis receiving infliximab was equivalent to that shown previously in patients with plaque psoriasis.

Adalimumab
Phase II data for the biologic agent adalimumab, a cytokine inhibitor currently approved for the treatment of RA, were also presented. With subcutaneous administration for 12 weeks at two dosing schedules (N=148), 53% to 80% of patients achieved a PASI 75 response at week 12. Response was seen as early as 1 week, and adverse events in this small phase II trial were equivalent to placebo.

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