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Each month, subscribers to The Formulary Monograph Service receive five to six well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing inservices. A comprehensive target drug utilization evaluation (DUE) is also provided each month. With a subscription, the monographs are sent in print and are also available online. Monographs can be customized to meet the needs of a facility. Subscribers to The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.LX.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service or The F.LX., call The Formulary at 800-322-4349. The April 2010 monograph topics are on liraglutide, dalfampridine, collagenase clostridium histolyticum for injection, roflumilast, and belimulnab. The DUE is on liraglutide. [ABSTRACT FROM AUTHOR]

Patients with psoriasis may experience impaired psychosocial mental status regardless of their objectively defined disease severity. The objective clinical measures of disease that are commonly used to evaluate a patient's psoriasis fail to take into account the effect of psoriasis on patients' quality of life (QOL). As a result, a significant number of patients are dissatisfied with conventional treatments and are searching for new options. A high unmet need for effective and safe long-term therapies that can also improve patients' QOF exists in psoriasis. Alefacept, a selective biologic agent specifically designed for the treatment of psoriasis, provides improvement in both the physical (as measured by the Psoriasis Area and Severity Index) and mental (as measured by the Dermatology Life Quality index) aspects of the disease. Additionally, alefacept is extremely well tolerated, with no negative effect on QOL, and the improvement in QOL is maintained off-treatment, which is consistent with its remittive effects on the disease. Alefacept helps fulfill the needs of psoriasis patients by providing efficacy, safety, oil-treatment remissions, and improvement in QOL. [ABSTRACT FROM AUTHOR]

Traditional systemic treatments for moderate to severe chronic plaque psoriasis are often poorly tolerated and are associated with safety concerns that restrict their long- term use. Alefacept is a hilly human fusion protein that selectively targets memory T cells, and it is expected to provide enhanced safety over traditional nonselective agents. The safety and tolerability profile of alefacept is reviewed using data from the clinical development program. The most common adverse events were similar among alefacept and placebo groups. As expected from its mechanism of action, alefacept reduced the number of CD4+ and CD8+ T cells, with selectivity for the memory subsets. This reduction was not associated with an increase in the incidence of infections. Alefacept was not immunogenic. Patients have received up to six courses of alefacept therapy and the safety and tolerability profile over multiple courses is similar to that of a single course. Alefacept offers hope for a safer means to provide long-term management of psoriasis. [ABSTRACT FROM AUTHOR]

The duration of response to treatment with alefacept has been assessed in patients with moderate to severe chronic plaque psoriasis who responded to alefacept therapy in phase 2 and phase 3 clinical studies. In a phase 2 trial, duration of response was based on time to retreatment with alefacept. In two phase 3 studies, the more objective measure of maintenance of a ≥50% reduction from baseline Psoriasis Area and Severity Index (PASI 50) was used. Two patient subsets were analyzed: (1) those who achieved a PASI 75 at any time during the trials and (2) those who achieved a Physician Global Assessment of "clear" or "almost clear" at any time during the trials. Regardless of the criterion used or the route of alefacept administration (intravenous or intramuscular), the median duration of response to alefacept therapy ranged from 7 to 1 0 months across the three studies. Alefacept is a remittive therapy for psoriasis. [ABSTRACT FROM AUTHOR]

With the completion of several phase 2 and phase 3 clinical studies, the efficacy and tolerabIity of alefacept in patients with chronic plaque psoriasis is now well studied. The majority of patients treated with a single course of intravenous or intramuscular alefacept experienced a clinically meaningful response. The efficacy of alefacept correlated with its ability to selectively target and reduce the number of pathogenic memory T cells. A second course of alefacept resulted in further clinical improvement, with increasing response rates and prolonged response dun don following treatment cessation. Subpopulation analyses demonstrated that alefacept is effective in a broad spectrum of patients with psoriasis, regardless of disease severity, history of and response to prior antipsoriatic treatment, or whether patients are refractory to or have contra indications to other systemic psoriasis therapies or phototherapy. [ABSTRACT FROM AUTHOR]