Open label trial of alefacept in palmoplantar pustular psoriasis

P2775

P2777

Open label trial of alefacept in palmoplantar pustular psoriasis Mandeep Kaur, MD, Wake Forest University Health Sciences, Winston-Salem, NC, United States; Alan Fleischer, MD, Wake Forest University Health Sciences, Winston-Salem, NC, United States; Steven Feldman, MD, PhD, Wake Forest University Health Sciences, Winston-Salem, NC, United States

Efficacy and safety of adalimumab in a 120-week open-label extension study in patients with moderate to severe chronic plaque psoriasis Kim Papp, MD, Probity Medical Research, Waterloo, ON, Canada; Craig Leonardi, MD, Central Dermatology Inc., St. Louis, MO, United States; Kenneth Gordon, MD, Dermatology, Evanston Northwestern Healthcare, Evanston, IL, United States; Lisa Frevert, MD, MPH, Abbott Laboratories, Parsippany, NJ, United States Objective: To determine the long-term (120 weeks) efficacy and safety of adalimumab in patients with moderate to severe plaque psoriasis.

Background: Palmoplantar pustular psoriasis (PPP) is a form of psoriasis associated with considerable morbidity that is difficult to treat. This Phase IV trial was designed to obtain pilot data on the efficacy and safety of alefacept in the treatment of palmoplantar pustular psoriasis. Purpose: To assess the effectiveness of alefacept in PPP and the safety of a 30 mg/week dose in those that poorly respond to 15 mg/week after 8 weeks of treatment. Methods: Fifteen subjects with PPP were given 15 mg/week intramuscular (IM) alefacept for 16 weeks. The dose was increased to 30 mg/week IM at week 9 if there was no clinical response. Outcomes included efficacy, safety, and CD41 T-lymphocyte counts. Clinical response was observed for 12 weeks after the last injection for a total study time of 28 weeks. Results: The severity of PPP improved as measured with both the PPP severity instrument (PSI) and the physician’s global assessment (PGA) (p \ 0.0001 and p = 0.0009 respectively). Much of the improvement occurred after 10 weeks of therapy. Nail severity scores significantly decreased (p = .0001). CD41 counts decreased, but all remained [250 cells/mm3. There were no severe adverse effects. Limitations: Besides the open-label study design, the use of concomitant therapy complicates interpretation of the results. Other limitations of the study include the lack of a comparator, the small sample size, and limited duration of follow-up. This study was supported by a grant from Astellas.

Methods: M03-658 is a Phase III open-label extension (OLE) study of adalimumab in patients with moderate to severe chronic plaque psoriasis (PASI $ 12, PGA of at least moderate, BSA $ 10%) who completed 60-week, lead-in Phase II adalimumab clinical trials (M02-528 and M02-529). This report summarizes results in patients treated with adalimumab for 120 weeks (60 weeks in the preceding Phase II studies and for 60 weeks in the Phase III extension trial [M03-658]). Patients who had completed the lead-in studies could enroll in the OLE trial, during which they received adalimumab 40 mg every other week (eow). After 24 weeks of OLE therapy, patients with an inadequate response (PASI \ 50 relative to baseline of M02-528) could increase to adalimumab 40 mg weekly. PASI responses and PGA scores were analyzed as observed. Patients whose dosages increased were counted as nonresponders from the time of dosage escalation. Adverse events were collected throughout the 120-week period. Results: Of the 106 patients who completed M02-529, 101 continued into the OLE study. Baseline data of M02-528 were consistent with moderate to severe psoriasis; mean age was 44 years, mean duration of psoriasis was 19.34 years, mean baseline PASI score was 15.55 (range 2-42.4), and mean % BSA involvement was 27% (range, 5.1-82.5). 100% supported by Abbott.

P2776 Ointment for psoriasis: What were we thinking? Steven Feldman, MD, PhD, Wake Forest University Health Sciences, WinstonSalem, NC, United States Background: Topical corticosteroids are the most common treatment used for psoriasis in the U.S. Conventional dermatologic wisdom is that ointment preparations provide the highest potency (due to their occlusive nature and moisturizing ability) and are best suited for psoriasis. Purpose: To describe evidence challenging the conventional wisdom that ointment vehicles are best for psoriasis patients. Methods: We compiled evidence from clinical trials and clinical practice addressing a variety of issues relevant to topical treatment of psoriasis. Results: Systematic review of the efficacy of clinical trials of potent topical corticosteroids do not support greater efficacy or even greater delivery of potent topical corticosteroids with ointment vehicles compared to other topical preparations. Moreover, preference studies demonstrate that psoriasis patients often find application of ointment to be messy, raising concerns about both short-term and long-term adherence to treatment. Recent compliance studies demonstrate that poor compliance to topical treatment is ubiquitous among psoriasis patients and contributes to poor psoriasis treatment outcomes. Finally, anecdotal reports from the 1990s clearly demonstrated that non-messy, easy to use clobetasol is far more potent (in actual practice) then traditional ointment vehicles. Conclusions: Much of the poor outcomes in psoriasis, even tachyphylaxis, probably relates less to actual medication failure and more to failure to apply the medication. Patients have been crying out that they find ointments messy and difficult to use. Topical psoriasis treatment is likely to be more successful when physicians and patients discuss what type of vehicle the patient will use and to plan treatment accordingly. The Center for Dermatology Research is funded by an educational grant from Galderma Laboratories, L.P. Dr. Feldman has received research funding and other support from Galderma Laboratories, L.P. and from Connetics Corporation.

FEBRUARY 2007

P2778 Efficacy and safety of narrow band UVB home phototherapy Christopher Yelverton, MD, MBA, Wake Forest University Health Sciences, Winston-Salem, NC, United States; Steven Feldman, MD, PhD, Wake Forest University Health Sciences, Winston-Salem, NC, United States Background: Phototherapy is an effective and relatively inexpensive therapy for psoriasis. Very little data regarding the efficacy of home-administered phototherapy are available. Objective: To assess the efficacy and safety of home phototherapy with NarrowBand Ultraviolet-B (NBUVB) light in the treatment of psoriasis. Methods: An open-label clinical trial of self-administered home NBUVB phototherapy for the treatment of moderate-to-severe psoriasis was conducted. Efficacy and safety of the treatment were assessed. Results: In the first phase of the project, a clearance phase involving combination use with acitretin, home UV was well tolerated and effective with no major adverse events. The open-label home UV monotherapy phase continues. Conclusions: Home phototherapy is a convenient and less costly option for many people with psoriasis. This study was supported by a grant from National Biological Corporation.

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