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PubMed2003

Remittive effects of intramuscular alefacept in psoriasis.

Alefacept is the first biologic agent approved for the treatment of chronic plaque psoriasis in the United States. Alefacept, administered intravenously (i.v.) or intramuscularly (i.m.), was found to be well tolerated, safe, and efficacious in two pivotal phase 3 studies in patients with moderate to severe psoriasis. Treatment with i.v. alefacept was associated with a median duration of off-treatment response of 216 days (approximately 7 months). In a follow-up extension study to the phase 3 i.m. study, duration of therapeutic response was also examined. Patients who achieved a > or = 75% reduction in baseline Psoriasis Area and Severity Index (PASI 75) with the first course of alefacept 15 mg i.m. in the phase 3 study maintained a PASI 50 for a median duration of 209 days. In addition, the extension study demonstrated that a second course of i.m. alefacept is safe and well tolerated in patients with psoriasis.

Adult↗
PubMed2003

Intramuscular alefacept improves health-related quality of life in patients with chronic plaque psoriasis.

BACKGROUND: Psoriasis profoundly affects patient quality of life (QOL). Amevive (alefacept), a novel and selective biologic agent, was clinically effective and significantly improved QOL in a phase 2 study. METHODS: The present placebo-controlled, randomized phase 3 study examined the effects of a 12-week course of intramuscular alefacept on QOL in 507 patients with chronic plaque psoriasis using both dermatology-specific questionnaires [Dermatology Life Quality Index (DLQI); Dermatology Quality of Life Scales (DQOLS)] and the Short Form-36 Health Survey (SF-36), a generic, general health questionnaire. RESULTS: All 3 QOL measures (DLQI, DQOLS, SF-36) demonstrated that alefacept 15 mg was significantly more effective than placebo in improving QOL in patients with chronic plaque psoriasis. In addition, the improvements in QOL for patients in the alefacept 15 mg group were of similar magnitude for all 3 QOL measures. CONCLUSION: The findings of this study are an important addition to the QOL literature for psoriasis treatments.

Alefacept↗
PubMedDate not supplied

Alefacept-induced decreases in circulating blood lymphocyte counts correlate with clinical response in patients with chronic plaque psoriasis.

This international, double-blind study examined the effects of alefacept on circulating lymphocytes in 507 patients with chronic plaque psoriasis, and determined whether these effects were related to clinical improvement. Patients were randomized to intramuscular placebo, alefacept 10 mg, or alefacept 15 mg once weekly for 12 weeks followed by 12 weeks of observation. Alefacept dose-dependently reduced CD4+ and CD8+ memory T cells, while sparing the na ve population. The greatest reductions in disease activity occurred in patients with the largest decreases in memory T cells. For example, a 50 % reduction from baseline Psoriasis Area Severity Index at any time during treatment or follow-up was observed in 66 % of patients who had the greatest reductions in CD4+ memory T cells versus in 40 % of patients who had the smallest reductions in this T-cell subset. These results provide further support for the deleterious roles of CD4+ and CD8+ memory T-cell subpopulations in psoriasis pathogenesis.

Alefacept↗
PubMed2002

Alefacept treatment in psoriatic arthritis: reduction of the effector T cell population in peripheral blood and synovial tissue is associated with improvement of clinical signs of arthritis.

OBJECTIVE: To investigate whether alefacept (a fully human lymphocyte function-associated antigen 3 [LFA-3]/IgG1 fusion protein that blocks the LFA-3/CD2 interaction) is able to reduce the signs and symptoms of joint inflammation in patients with active psoriatic arthritis (PsA). METHODS: Eleven patients with active PsA were treated with alefacept for 12 weeks in an open-label and explorative study. Clinical joint assessment and laboratory assessments were performed at baseline and after 4, 9, 12, and 16 weeks of treatment. Serial synovial tissue (ST) biopsy specimens from an inflamed index joint (knee, ankle, wrist, or metacarpophalangeal joint) were obtained by arthroscopy at baseline and after 4 and 12 weeks of treatment. RESULTS: At the completion of treatment, 6 of 11 patients (55%) fulfilled the Disease Activity Score (DAS) response criteria. Nine patients (82%) fulfilled the DAS response criteria at any point during the study. There was a statistically significant reduction in CD4+ lymphocytes (P < 0.05), CD8+ lymphocytes (P = 0.05), and CD68+ macrophages (P < 0.02) in the ST after 12 weeks of treatment compared with baseline. The ST and peripheral blood of those patients fulfilling the DAS response criteria contained more CD45RO+ cells at baseline and displayed a significant reduction in these cells compared with nonresponding patients. CONCLUSION: The changes in ST, together with the improvement in clinical joint scores, after treatment with alefacept support the hypothesis that T cell activation plays an important role in this chronic inflammatory disease. Furthermore, since alefacept, a T cell-specific agent, led to decreased macrophage infiltration, the data indicate that T cells are highly involved in synovial inflammation in PsA.

Adult↗
PubMed2005

Treatment of psoriasis with alefacept in patients with hepatitis C infection: a report of two cases.

Alefacept is a fully human fusion protein for use in adult patients with moderate to severe chronic plaque psoriasis. Its dual mechanism of action involves inhibition of T-cell activation and selective reduction of memory T cells. We report the clinical course of two patients with hepatitis C virus (HCV) infection who have received alefacept for psoriasis. Consistent with its mechanism of action, administration of alefacept led to transient decreases in CD4+ and CD8+ T-cell counts. However, these reductions were not associated with an increase in HCV viral load or exacerbation of infection. Liver enzymes remained stable throughout the treatment and follow-up periods. Alefacept has a selective mechanism of action that specifically targets memory T cells and this selectivity may account for its safety and tolerability in patients with hepatitis.

Adult↗
PubMed2006

Therapeutic effects of a 12-week course of alefacept on nail psoriasis.

BACKGROUND AND OBJECTIVES: Nail psoriasis is a common finding in psoriatic patients and it affects the quality of life in a great proportion of patients. Topical or systemic treatments have limited effectiveness or have a serious toxicity potential. Biologicals such as alefacept are the most recent treatment modalities for psoriasis. In the present study we evaluated changes in nail pathology in patients with plaque psoriasis and nail involvement during treatment with alefacept. PATIENTS AND METHODS: Digital photographs from eight patients were produced, which were analysed using the nail psoriasis severity index (NAPSI). A minimal NAPSI of 15 was chosen to divide patients into a moderate to very severe nail psoriasis group and a group with no or mild nail psoriasis. A decrease in NAPSI of at least 25% was considered a significant response to therapy. RESULTS: In the group with at least moderate nail psoriasis, two patients improved, in two patients the nail changes remained unchanged and in one patient the nail pathology was aggravated. The group with no or mild nail psoriasis showed variable results. CONCLUSIONS: Although alefacept showed some results in treating nail pathology in psoriasis, a more extensive study is required, covering both more patients and a more extensive time period. Furthermore, it would also be clinically relevant to compare the effects of alefacept on nail psoriasis with other biologicals.

Adult↗
PubMed2003

Effects of alefacept on health-related quality of life in patients with psoriasis: results from a randomized, placebo-controlled phase II trial.

INTRODUCTION: Chronic plaque psoriasis has a profound impact on patient quality of life (QOL), including adverse psychosocial effects, impaired daily activities, anxiety, and depression. OBJECTIVE: To assess health-related QOL in a randomized phase II trial of alefacept (human LFA-3/IgG(1) fusion protein), a selective immunomodulator for psoriasis. STUDY DESIGN: Multicenter, randomized, placebo-controlled, double-blind trial. METHODS: 229 patients with moderate to severe psoriasis were randomized to alefacept (0.025, 0.075, or 0.150 mg/kg) or placebo by 30-second intravenous bolus once weekly for 12 weeks and followed for 12 additional weeks. Patients completed a general (SF-36) Health Survey) and dermatology-specific (Dermatology Life Quality Index [DLQI] and Dermatology Quality Of Life Scales [DQOLS]) QOL surveys at each study visit. RESULTS: Patients treated with alefacept had significantly greater improvements on dermatology-specific QOL scales compared with patients receiving placebo (p < 0.05). Patients who achieved a >or=50% or a >or=75% reduction in Psoriasis Area and Severity Index (PASI) reported similar improvement in QOL, which was significantly greater than that of other patients. CONCLUSIONS: The clinical effect of alefacept on psoriasis is associated with an improvement in patients' QOL. Among patients with moderate to severe psoriasis, an improvement in PASI of 50% or more is associated with better QOL scores.

Adult↗
PubMed2003

The use of alefacept in the treatment of psoriasis.

Alefacept (AMEVIVE or LFA#TIP, Biogen) is the newest effective systemic therapy for chronic plaque psoriasis and was approved by the US FDA in January 2003. Clinical studies have shown that alefacept, given via weekly IM or IV injections for 12 weeks, was well tolerated, with no reported serious adverse events. Most significantly, it was found that alefacept provides a long-lasting remittive effect. These findings support the use of alefacept as a viable treatment of psoriasis, without the toxicities associated with some of the current systemic treatments available.

Adjuvants, Immunologic↗
PubMedDate not supplied

Safety and efficacy of alefacept in elderly patients and other special populations.

BACKGROUND: The safety of biologic agents for psoriasis treatment is of particular importance in patient groups at higher risk for adverse events. We assessed the safety and efficacy of alefacept in elderly, obese, and diabetic patients with moderate to severe chronic plaque psoriasis by integrating data from phase 2 and 3 clinical studies and their extensions. OBSERVATIONS: Ninety-nine elderly, 652 obese, and 122 diabetic patients received at least 1 course of alefacept. In each cohort, accidental injury, headache, and pharyngitis were among the most common adverse events; infections were primarily common colds; and malignancies were mostly skin carcinomas. No opportunistic infections were reported. Safety was maintained over repeated courses. The safety profile of alefacept in each cohort was consistent with that of the overall population; however, additional data are needed to confirm our findings in the elderly and diabetic subgroups in the later courses due to the limited sample sizes. In course 1, 24% to 33% of patients achieved 75% or greater improvement in Psoriasis Area and Severity Index (PASI) at any time, with further enhancement of benefit with subsequent courses (eg, course 3, 41% to 58%). CONCLUSIONS: Alefacept was well-tolerated and effective in elderly, obese, and diabetic patients with psoriasis.

Age Factors↗
PubMed2003

Alefacept: potential new therapy for patients with moderate-to-severe psoriasis.

Alefacept is a new biotechnology product designed for the treatment of patients with chronic plaque-type psoriasis who have disease severe enough to make them eligible for phototherapy or systemic therapy. In two randomized controlled phase III trials of patients with moderate-to-severe disease, alefacept showed a modest but statistically significant increase in the number of responders compared to placebo. Alefacept's dose-dependent CD4+ T lymphocyte-depleting effect requires monitoring; however, no association has been found between this adverse effect and serious adverse events, particularly infection. Due to lack of direct comparative data, it is difficult to predict exactly how alefacept will fit into the current rotational psoriasis therapy paradigm.

Canada↗
PubMed2005

[Alefacept. Successful long-term therapy of a severe psoriasis].

Alefacept, a recombinant protein produced by fusion of human LFA(3 )and IgG(1), was the first biologic specially designed and approved for the treatment of psoriasis. Results of clinical trials reveal both an efficacy comparable to established systemic therapies and a high drug safety. A 62-year old male patient with psoriasis and incomplete response to several standard therapies was treated with alefacept (baseline PASI 23.1). After three courses of 15 mg alefacept i.m. weekly for 12 weeks, each followed by a 12 week post-dosing observation period, the PASI regressed to 2.0. Adverse drug reactions were not observed.

Alefacept↗
PubMed2004

Alefacept therapy reduces the effector T-cell population in lesional psoriatic epidermis.

Alefacept, a LFA-3/IgG1 fusion protein, interferes with the activation and proliferation of T cells by binding to the CD2 receptor on their surfaces. The clinical efficacy of this drug has been demonstrated in chronic plaque psoriasis. We performed a single-center, open-label study to investigate the immunohistochemical effects in psoriatic lesional skin. A group of 11 patients with plaque psoriasis all received 12 weekly doses of 7.5 mg alefacept intravenously. Skin biopsies were obtained at baseline and on days 8, 43 and 92, and were evaluated by digital image analysis after immunohistochemical staining. After completion of treatment, 8 out of the 11 patients experienced a reduction in PASI of 50% or more compared to baseline. Immunohistochemical analysis displayed a gradual decrease in the number of cutaneous T cells during therapy, with a significant reduction in epidermal CD8+ cells and dermal CD4+ cells on day 92. Patients with a reduction in PASI of 50% or more after therapy had a clearance of effector/memory T cells from the epidermis, in contrast to patients with a reduction in PASI of less than 50%. These findings support the hypothesis that effector/memory T cells play a prominent role in the pathogenesis of psoriasis, and that alefacept is capable of reducing these cells in lesional psoriatic skin.

Adult↗
PubMed2004

The effect of psoriasis on patients' quality of life and improvements associated with alefacept therapy.

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' QOL 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 are 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, off-treatment remissions, and improvement in QOL.

Alefacept↗
PubMed2004

Alefacept: a review of the literature and practical guidelines for management.

Alefacept is the first biologic agent approved for the treatment of chronic, moderate to severe plaque-type psoriasis. It is a fully human fusion toxin, which binds to CD2, blocks costimulatory signaling, and selectively induces apoptosis of activated memory T cells involved in the pathogenesis of psoriasis. Alefacept has a slow onset of action, peaking approximately 18 weeks after the first injection of a 12-week course. However, it has several important advantages over the existing conventional immunosuppressive therapies for psoriasis: it is associated with long remissions without the need for maintenance therapy; its efficacy improves with subsequent courses; and it has a high safety profile. This review summarizes the mechanism of action of alefacept and the results of the clinical trials, with special emphasis on efficacy, pharmacodynamic effects on circulating lymphocytes, and safety and tolerability. Current guidelines based on the best available data to date are also presented.

Alefacept↗
PubMed2003

Alefacept for chronic plaque psoriasis: a selective therapy with long-lasting disease remissions and an encouraging safety profile.

Alefacept (Amevive) is a recombinant, fully human fusion protein that selectively targets memory T cells that have been implicated in the pathogenesis of psoriasis. Alefacept is approved in the United States as a treatment for chronic plaque psoriasis. Alefacept is unique among treatments for moderate to severe psoriasis because of its selective therapeutic action, favorable safety profile, and ability to induce lengthy disease remissions.

Alefacept↗
PubMedDate not supplied

Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis.

Psoriasis is a chronic immune-mediated disease affecting the skin and sometimes the joints. Approximately 14 million people in Europe have psoriasis and the disease has a profound effect on the quality of life of patients worldwide. Currently available therapies for psoriasis have several shortcomings, including organ-based toxicity, generalized immunosuppression, short duration of response, and inconvenient regimens. Alefacept is a recombinant, fully human fusion protein that selectively targets the memory T cell population implicated in psoriasis pathogenesis. Alefacept is unique among psoriasis treatments because of its selective therapeutic action, ability to induce lengthy disease remissions even in the absence of continued therapy, positive effect on quality of life, and favorable safety profile. Two courses of alefacept confer greater efficacy and duration of clinical improvement versus that observed with a single course. This novel biologic agent is currently approved in the United States and under regulatory review in Europe for moderate to severe chronic plaque psoriasis.

Adult↗
PubMedDate not supplied

Alefacept in combination with ultraviolet B phototherapy for the treatment of chronic plaque psoriasis: results from an open-label, multicenter study.

Combination therapy for moderate to severe psoriasis is often used to enhance efficacy and minimize treatment-related side effects; however, data are limited on combination therapy with the newer biologic agents. The current study examined patients who received alefacept in combination with ultraviolet B phototherapy as part of an international, open-label study evaluating up to 3 courses of alefacept in combination with other psoriasis therapies. Physician Global Assessment [corrected] scores improved by [greater than or equal to] 1 category in 88% [corrected] of patients and by [greater than or equal to] 2 categories in 76% [corrected] of patients in course A; [corrected] corresponding response rates were 100% and 55% in Course [corrected] B, and 85% and 77% in Course [corrected] C. At week 14, a PGA of "almost clear" or "clear" was achieved by 13%, 14%, and 8% of patients in courses A, B, and C, respectively. There was no evidence of a cumulative effect on T cells after multiple courses of therapy. The combination of alefacept and ultraviolet B was well tolerated and provided improvement in psoriasis.

Adolescent↗
PubMed2006

Alefacept in the treatment of recalcitrant palmoplantar and erythrodermic psoriasis.

Alefacept is the first biologic agent approved by the US Food and Drug Administration for moderate to severe chronic plaque psoriasis. Prior clinical studies excluded patients with palmoplantar psoriasis or erythroderma. We report 2 patients with recalcitrant psoriasis who responded completely to a full course of alefacept. One patient presented with severe palmoplantar psoriasis recalcitrant to acitretin and methotrexate; another patient presented with erythroderma and was transitioned successfully from cyclosporine A. Alefacept provides another treatment option for palmoplantar and erythrodermic psoriasis and should be considered in the management of patients with these conditions.

Adult↗