Psoriasis: Bagel J

Pariser DM, Bagel J, Gelfand JM, Korman NJ, Ritchlin CT, Strober BE, Van Voorhees AS, Young M, Rittenberg S, Lebwohl MG, Horn EJ, Anonymous00184. · Department of Dermatology, Eastern Virginia Medical School, Norfolk, VA, USA. · Arch Dermatol. · Pubmed #17310004 links to  free full text

Abstract: OBJECTIVES: A task force of the National Psoriasis Foundation Medical Board was convened to evaluate the current severity criteria of mild, moderate, and severe psoriasis and to make recommendations concerning a 2-tiered categorization of severity based on current clinical practice and related to intent to treat. PARTICIPANTS: This volunteer task force, led by David M. Pariser, MD, included Jerry Bagel, MD, Joel M. Gelfand, MD, MSCE, Neil J. Korman, MD, PhD, Christopher T. Ritchlin, MD, Bruce E. Strober, MD, PhD, Abby S. Van Voorhees, MD, and Melodie Young, MSN, RN, ANP. Meetings were held by teleconference and were coordinated and funded by the National Psoriasis Foundation. EVIDENCE: This task force reviewed psoriasis severity criteria and other published psoriasis consensus statements. Current standards of care and expert opinion were used to inform the process. CONSENSUS PROCESS: Based on meetings of the task force and under the guidance of David M. Pariser, MD, a statement was drafted by Elizabeth J. Horn, PhD, presented to the task force, and reviewed and approved by the task force. This statement was then reviewed and approved by Robert E. Kalb, MD, Gerald G. Krueger, MD, and Alan Menter, MD. The National Psoriasis Foundation Medical Board reviewed and endorsed this statement by a majority vote on March 2, 2006, at the medical board meeting. CONCLUSIONS: This clinical consensus statement proposes a 2-tiered system for plaque psoriasis therapy that reflects more accurately than the current system how patients are treated in clinical practice. This statement, focused on plaque psoriasis, is intended to assist medical professionals and insurance payers in understanding these 2 categories of patients with psoriasis and choosing appropriate therapies for these patients.

Feldman SR, Koo JY, Menter A, Bagel J. · Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157-1071, USA. · J Am Acad Dermatol. · Pubmed #15965429 No free full text.

Abstract: Psoriasis has a tremendous effect on health-related quality of life. Phototherapy and systemic treatments are used for patients with more debilitating (physically and emotionally) forms of the disease. These treatments can be extremely effective but can also have potentially significant adverse effects. The decision to undertake systemic treatment of psoriasis is a complex one that requires both experience and judgment. With the recent advent of new biologic systemic drugs for moderate to severe psoriasis, the need to clarify patient candidates for systemic therapy has become very important. Here, we present a diagnostic algorithm and a formal measure, the Koo-Menter Psoriasis Instrument (KMPI), to aid in identifying patients that would benefit from systemic therapy. In addition, the KMPI can be used to document and justify treatment decisions for health care payers. While the decision to undertake systemic treatment and the choice of specific treatment plan must ultimately be made mutually by the patient and physician, these tools are designed to provide information that will be valuable in these determinations.

Bagel J. · Psoriasis Center of Central New Jersey, New Brunswick, USA. · Dermatol Clin. · Pubmed #10791162 No free full text.

Abstract: Running an effective psoriasis treatment center requires 1) capable phototherapists who have received the appropriate education and training; 2) a full range of equipment, including light boxes, hand-foot units, scalp débridement machines, and a whirlpool bath; 3) adequate space; 4) economic considerations, including reimbursements so patients can receive treatment and the center can be paid; and 5) the medical expertise necessary to care for the most severe psoriatic patients. These and other issues are discussed in this article.

Kircik L, Bagel J, Korman N, Menter A, Elmets CA, Koo J, Yang YC, Chiou CF, Dann F, Stevens SR, Anonymous00125. · Department of Dermatology, Indiana University School of Medicine, Indianapolis, IN, USA. · J Drugs Dermatol. · Pubmed #18380206 No free full text.

Abstract: BACKGROUND: Moderate to severe psoriasis is a significant inflammatory disease that frequently requires systemic therapies to effectively treat the underlying disorder. Etanercept and narrow-band ultraviolet light B (NB-UVB) are widely used to treat this disease. OBJECTIVE: To evaluate the effectiveness, tolerability, and patient-reported outcomes of combination etanercept plus NB-UVB phototherapy in moderate to severe plaque psoriasis. METHODS: This 12-week, single-arm, open-label study evaluated the combination of etanercept 50 mg twice weekly and NB-UVB thrice weekly in 86 patients. The primary outcome measure was > or =75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75). Other measures included PASI 90, PASI 100, and the Dermatology Life Quality Index (DLQI). RESULTS: At week 12, 26.0% achieved PASI 100, 58.1% achieved PASI 90, and 84.9% of patients achieved PASI 75. Mean improvement from baseline in DLQI was 84.4%. No unexpected, untoward adverse events were noted. CONCLUSIONS: A 12-week course of etanercept plus NB-UVB phototherapy was well tolerated and produced clinically meaningful improvements in signs and symptoms of moderate to severe plaque psoriasis and in patient-reported outcomes. Further investigation of the safety and efficacy of the use of such combination for this indication in controlled clinical trials would be of interest.

Lowe NJ, Gonzalez J, Bagel J, Caro I, Ellis CN, Menter A. · Clinical Research Specialists, Santa Monica, California, USA. · Int J Dermatol. · Pubmed #12653922 No free full text.

Abstract: BACKGROUND: Psoriasis is a chronic, relapsing skin disease that may require multiple treatment courses. Alefacept targets the memory T cells implicated in psoriasis pathogenesis. This open-label study evaluated the safety and tolerability, efficacy, and pharmacodynamics of repeat courses of alefacept in men and women with chronic plaque psoriasis. This article reports the interim results of this ongoing study. METHODS: Patients (n = 174) who participated in previous phase II studies of alefacept were included in this retreatment study. Intravenous alefacept (7.5 mg) was administered once weekly for 12 weeks followed by 12 weeks of observation. Initial and subsequent retreatment courses were only given when, in the opinion of the investigators, disease had returned and necessitated treatment; CD4+ T-cell counts had to be at or above the lower limit of normal. RESULTS: Adverse events were similar regardless of the retreatment course. No opportunistic infections, rebound of disease, or flares were reported. Low titers of anti-alefacept antibodies occurred in a few patients without related safety issues. Sixty-six per cent of patients achieved a >/= 50% reduction in the Psoriasis Area and Severity Index (PASI) at any time after the first dose of retreatment course 1. Patients who received two retreatment courses (n = 50) had consistent or improved responses after the second course; 64% and 68% of these patients achieved a >/= 50% PASI improvement at any time after the first dose of retreatment courses 1 and 2, respectively. Alefacept selectively reduced memory T cells without cumulative effects. CONCLUSIONS: Repeat courses of alefacept were well tolerated, and subsequent retreatment courses were at least as effective as the initial course of therapy.

Martin A, Gutierrez E, Muglia J, McDonald CJ, Guzzo C, Gottlieb A, Pappert A, Garland WT, Bagel J, Bacha P. · Department of Dermatology, Washington University School of Medicine, St Louis, Missouri 63110, USA. · J Am Acad Dermatol. · Pubmed #11712032 No free full text.

Abstract: BACKGROUND: Denileukin diftitox, a fusion protein targeting both malignant and normal activated lymphocytes, has been shown previously to have antipsoriatic activity. However, the ideal dosing regimen for treating psoriasis was not established. OBJECTIVE: We examined the safety and efficacy of denileukin diftitox in patients with severe plaque-type psoriasis. METHODS: This was a cohort dose-escalation trial. Patients were administered denileukin diftitox on 3 consecutive days every other week. Patients were evaluated for toxicity, improvement in psoriasis, immunogenicity, and serum levels. RESULTS: Thirty-five patients were treated at 3 dose levels. Eight patients had a 50% decrease or more in Psoriasis Area and Severity Index score from baseline (0/10 at 0.5 microg/kg per day, 1/10 at 1.5 microg/kg per day, and 7/15 at 5 microg/kg per day). Adverse events primarily consisted of constitutional events and skin reactions. CONCLUSIONS: The potential antipsoriatic activity of denileukin diftitox demonstrated in this study was comparable to that observed in other psoriasis studies with this agent. However, this dosing regimen was better tolerated than the dosing regimen used in the last study with denileukin diftitox in psoriasis patients.

Bagel J. · Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ 08520, USA. · J Drugs Dermatol. · Pubmed #19363853 No free full text.

Abstract: BACKGROUND: Use of coal tar with narrowband (NB) ultraviolet B (UVB) light (the Goeckerman regimen) is an effective treatment for plaque psoriasis that has become impractical in outpatient care mainly due to the inconvenience and aesthetic concerns of coal tar. OBJECTIVE: This study evaluated the safety, efficacy, and convenience of adding a novel LCD (coal tar) solution to standard NB-UVB phototherapy in adults with chronic plaque psoriasis. METHODS: Patients applied LCD solution to half-body twice daily at home and received outpatient full-body NB-UVB light therapy 3 times a week for up to 12 weeks. A blinded investigator graded psoriasis severity of body halves and bilateral target lesions and monitored adverse reactions. Patients rated their psoriasis symptoms and LCD solution aesthetics. RESULTS: NB-UVB + LCD therapy reduced the median time to clearance or minimal disease in at least 50% of the population by 3 weeks (4 weeks with NB-UVB + LCD versus 7 weeks with NB-UVB alone). A statistically superior clinical response was observed by the end of week 4 with NB-UVB + LCD versus NB-UVB alone (P < 0.05) for: PGA, target lesions, ESI scores, and patient-reported symptoms. CONCLUSION: Incorporating an at-home regimen with a novel LCD solution into outpatient NB-UVB light therapy is safe, convenient, effective, and can improve psoriasis more quickly than NB-UVB light therapy alone.

Kalb RE, Bagel J, Korman NJ, Lebwohl MG, Young M, Horn EJ, Van Voorhees AS, Anonymous00091. · Department of Dermatology, State University of New York School of Medicine and Biomedical Sciences, Buffalo, New York, USA. · J Am Acad Dermatol. · Pubmed #19103363 No free full text.

Abstract: BACKGROUND: Involvement of areas of the skin fold is common in patients with psoriasis although the exact incidence is unknown. This report summarizes studies regarding the therapy of intertriginous psoriasis. OBJECTIVE: A task force of the National Psoriasis Foundation Medical Board was convened to evaluate treatment options. Our aim was to arrive at a consensus on therapy for intertriginous or inverse psoriasis. METHODS: Reports in the literature were reviewed regarding psoriasis affecting the skin-fold areas and its therapy. LIMITATIONS: There are few evidence-based studies on the treatment of intertriginous psoriasis. RESULTS: The recommended short-term (2-4 weeks) therapy for inverse psoriasis is low- to mid-potency topical steroids. For long-term therapy, topical calcipotriene (calcipotriol) or one of the immunomodulating agents, pimecrolimus or tacrolimus, is favored. CONCLUSIONS: Low- to mid-potency topical steroids are recommended as first-line, short-term treatment. It is recommended that their use should either be of limited duration (less than 2-4 weeks) or that the lowest effective strength be used intermittently for long-term care to minimize the potential for risks. Calcipotriene (calcipotriol), pimecrolimus, and tacrolimus, while not as highly efficacious as topical steroids, are associated with fewer long-term risks and are therefore recommended for long-term therapy when feasible.

Lebwohl M, Bagel J, Gelfand JM, Gladman D, Gordon KB, Hsu S, Kalb RE, Kimball AB, Korman NJ, Krueger GG, Mease P, Morison WL, Paller A, Pariser DM, Ritchlin C, Strober B, Van Voorhees A, Weinstein GD, Young M, Horn L. · Department of Dermatology, Mount Sinai School of Medicine, New York, New York, USA. · J Am Acad Dermatol. · Pubmed #17980456 No free full text.

Abstract: BACKGROUND: Biologics are widely used in the treatment of psoriasis and psoriatic arthritis. OBJECTIVE: Our aim was to arrive at a consensus on the kind of monitoring and the vaccinations that should be performed before and during biologic therapy. METHODS: Medical literature and data presented at meetings were reviewed and a consensus conference was held by members of the Medical Board of the National Psoriasis Foundation. RESULTS: Consensus was established on monitoring and vaccination practices that included discussion and recognition of variations in those practices. History, physical examination, chemistry screen with liver function tests, complete blood cell count, and platelet count and tuberculosis testing are widely obtained at baseline and with variable frequencies thereafter. Patients treated with efalizumab have platelet counts checked more often; liver function tests are repeated more frequently in patients treated with infliximab; patients taking tumor necrosis factor blockers undergo tuberculosis testing more often; and patients treated with alefacept have CD4 counts checked approximately every 2 weeks. Avoidance of live vaccines during biologic therapy and administration of essential vaccines before biologic therapy were discussed, although vaccination is performed only to a variable degree. There was no consistency in the measurement of antinuclear antibodies among the experts. LIMITATIONS: There are few evidence-based studies on monitoring practices for patients with psoriasis taking biologic therapies. CONCLUSIONS: In patients taking biologic therapies for psoriasis, monitoring of blood chemistries, blood counts, CD4 counts, antinuclear antibodies, tuberculin skin tests, history, and physical examination may be warranted depending on the particular therapy and the particular patient. Vaccination practices are also addressed.

Koo JY, Bagel J, Sweetser MT, Ticho BS. · Psoriasis and Skin Treatment Center, University of California, San Francisco, CA, USA. · J Drugs Dermatol. · Pubmed #16865867 No free full text.

Abstract: 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.