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Biomedical subjects

M Alan Menter

Publications and source records attributed to M Alan Menter.

14 recordsLinked to original sources
PubMed2006

Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: double-blind, randomized controlled trial and open-label extension study.

BACKGROUND: Tumor necrosis factor is pivotal in the pathogenesis of psoriasis. Adalimumab is a fully human monoclonal immunoglobulin G1 antibody that neutralizes tumor necrosis factor. OBJECTIVES: We sought to assess the efficacy and safety of adalimumab in patients with moderate to severe plaque psoriasis. METHODS: In this multicenter, randomized, double-blind, placebo-controlled study, 147 patients received adalimumab (40 mg every other week or 40 mg/wk) or placebo. After 12 weeks of blinded therapy, patients taking adalimumab could continue their assigned dosages in a 48-week extension trial; patients taking placebo were switched to adalimumab (40 mg every other week). RESULTS: At week 12, 53% of patients taking adalimumab every other week, 80% of patients taking adalimumab weekly, and 4% of patients taking placebo achieved 75% improvement in Psoriasis Area and Severity Index score (P < .001). Responses were sustained for 60 weeks. No new safety signals were noted compared with the existing adalimumab clinical safety database. LIMITATIONS: The study was insufficiently powered to detect rare adverse events associated with adalimumab. CONCLUSIONS: Adalimumab significantly improved psoriasis and was well tolerated for 60 weeks.

Adalimumab↗
PubMed2006

Quality-of-life issues in psoriasis and psoriatic arthritis: outcome measures and therapies from a dermatological perspective.

Psoriasis and psoriatic arthritis are inflammatory immune-mediated skin and joint conditions with major impacts on patients' health-related quality of life (HRQOL). Physical manifestations include unsightly, scaly, pruritic plaques and inflamed joints for patients with psoriatic arthritis. These symptoms can severely impair physical functioning and occupational capability and negatively affect psychosocial domains. Consequently, patients often experience feelings of embarrassment, helplessness, and depression. Recent therapies, including the biologics, have been shown to improve not only the physical signs and symptoms of these conditions, but also patients' HRQOL. To accurately assess these improvements, standardized and validated instruments are needed. However, there are currently a limited number of feasible and validated tools available in dermatology for measuring HRQOL and function. Valuable insights can be acquired from the rheumatology field, and refinement of existing outcome measures through a cooperative and consensus building process between dermatologists and rheumatologists will lead to standardization of assessment tools in the years ahead.

Activities of Daily Living↗
PubMed2003

Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines.

The objective of this study was to evaluate the efficacy and safety of botulinum toxin type A for the treatment of glabellar lines. Patients with moderate or severe glabellar lines at maximal frown received intramuscular injections of placebo or 20 U of botulinum toxin type A (Botox; Allergan, Inc., Irvine, Calif.) distributed among five injection sites (one in the procerus muscle and two in each corrugator supercilii). Follow-up assessments were performed at 7, 30, 60, 90, and 120 days after injections. Efficacy measures were the physician's rating of glabellar line severity at maximal frown and at rest (none, mild, moderate, or severe) and the patient's global assessment of changes in glabellar lines, from +4 (100 percent better) to -4 (100 percent worse). A total of 273 patients were enrolled (botulinum toxin, 202 patients; placebo, 71 patients). All except five patients (botulinum toxin, two patients; placebo, three patients) completed the study. For the physician's rating at maximal frown, the responder rate (percentage of patients with severity ratings of none or mild in follow-up evaluations) for the botulinum toxin group peaked at 77 percent at day 30 and was significantly greater than that for the placebo group at every follow-up visit (p < 0.001). For the patient's assessment, the responder rate (percentage of patients with scores of +2 or more) for the botulinum toxin group peaked at 89 percent at day 30 and was significantly greater than that for the placebo group at every follow-up visit (p < 0.001). Rates of adverse events were similar for the two groups. The only adverse event with an incidence of >/=5 percent was headache (botulinum toxin, 11 percent; placebo, 20 percent). The incidence of blepharoptosis was 1 percent for the botulinum toxin group. Botulinum toxin type A was remarkably safe and effective in reducing glabellar lines.

Botulinum Toxins, Type A↗
PubMed2003

Tazarotene cream in the treatment of psoriasis: Two multicenter, double-blind, randomized, vehicle-controlled studies of the safety and efficacy of tazarotene creams 0.05% and 0.1% applied once daily for 12 weeks.

BACKGROUND: Tazarotene in a gel formulation is widely used in the treatment of psoriasis. OBJECTIVE: To determine the efficacy and safety of tazarotene 0.1% and 0.05% creams in the treatment of psoriasis. METHODS: A total of 1303 patients participated in 2 clinical trials. Patients applied tazarotene creams 0.1% and 0.05% or vehicle once daily to all psoriatic lesions for 12 weeks followed by a 12-week posttreatment period. RESULTS: Both creams were significantly more effective than vehicle on the basis of an overall assessment of psoriasis, a global response to treatment, and reduction in plaque elevation and scaling. Therapeutic effect was maintained during the posttreatment period. Common adverse events included signs and symptoms of skin irritation. CONCLUSION: Tazarotene creams were associated with significant reductions in the severity of the clinical signs of psoriasis and were found to be safe with acceptable tolerability. Tazarotene cream 0.1% was generally more effective, although slightly less well tolerated, than the 0.05% cream.

Administration, Topical↗
PubMed2002

A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines.

BACKGROUND: Botulinum toxin type A (BTX-A) is widely used for facial esthetics but is incompletely studied. OBJECTIVE: This study was conducted to evaluate the efficacy and safety of BTX-A treatment of glabellar lines. METHODS: Patients with moderate to severe glabellar lines at maximum frown received intramuscular injections of 20 U BTX-A (BOTOX, Allergan, Inc, Irvine, Calif) or placebo into 5 glabellar sites. Patients were followed up for 120 days after injection. Outcome measures were physician rating of glabellar line severity at maximum frown and rest, patient assessment of improvement, and vital sign and adverse event monitoring. RESULTS: Two hundred sixty-four patients were enrolled (BTX-A: 203, placebo: 61). There was a significantly greater reduction in glabellar line severity with BTX-A than with placebo (all measures, every follow-up visit; P <.022). The effect was maintained for many patients through day 120. There was a low occurrence (5.4%) of mostly mild blepharoptosis in the BTX-A group. CONCLUSION: BTX-A injections are safe and effective in reducing the severity of glabellar lines.

Adolescent↗