Psoriasis: Pariser DM

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.

Pariser DM, Gordon KB, Papp KA, Leonardi CL, Kwon P, Compton PG, Rundle AC, Walicke PA, Lebwohl M. · Department of Dermatology, Eastern Virginia Medical School, Norfolk, VA, USA. · J Cutan Med Surg. · Pubmed #16699904 No free full text.

Abstract: BACKGROUND: Effective psoriasis therapies are needed for long-term symptom control. OBJECTIVE: Assess efalizumab (Raptiva) efficacy in a large cohort of psoriasis patients. METHODS: Data from three Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter studies were pooled. Patients (n = 1,651) with moderate to severe plaque psoriasis received 12 weeks of subcutaneous efalizumab 1 or 2 mg/kg/wk or placebo. RESULTS: All efficacy measures reached statistical significance within each of the individual studies (p < 0.001) and overall. More efalizumab-treated patients achieved > or = 75% and > or = 50% Psoriasis Area and Severity Index (PASI) improvement at week 12 than did placebo-treated patients (27.8% vs 3.8% [p < 0.001] and 56.1% vs 14.6% [p < 0.001], respectively). Significant PASI improvements occurred as early as week 2 (12.5% vs 7.9%, p =0.0001). Adverse events were generally mild to moderate. CONCLUSION: Efalizumab resulted in early and significant improvement for all efficacy endpoints and was well tolerated in patients with moderate to severe chronic plaque psoriasis.

Pariser DM. · Department of Dermatology, Eastern Virginia Medical School, 601 Medical Tower, Norfolk, VA 23507, USA. · Manag Care. · Pubmed #14723104 No free full text.

This publication has no abstract.

Callen JP, Krueger GG, Lebwohl M, McBurney EI, Mease P, Menter A, Paller AS, Pariser DM, Weinblatt M, Zimmerman G, Anonymous00189. · No affiliation provided · J Am Acad Dermatol. · Pubmed #14576671 No free full text.

This publication has no abstract.

Pariser DM. · No affiliation provided · Manag Care. · Pubmed #12747028 No free full text.

This publication has no abstract.

Menter A, Hamilton TK, Toth DP, Leung HM, Wetherill G, Hennessey B, Garovoy M, Kwon P, Pariser DM, Anonymous00434. · Baylor University Medical Center, Dallas, Texas, USA. · Int J Dermatol. · Pubmed #17550570 No free full text.

Abstract: BACKGROUND: Rebound in psoriasis is, by definition, a rapid worsening of disease following the discontinuation of therapy for psoriasis; it occurs following the abrupt discontinuation of many therapies. To prevent rebound on discontinuation of efalizumab, this study evaluated the effectiveness of transitioning patients to an alternative psoriasis therapy. METHODS: Patients (n = 130) received subcutaneous efalizumab 1 mg/kg/week for 12 weeks. Efalizumab was discontinued at 12 weeks; patients were evaluated for improvement from baseline in the Psoriasis Area and Severity Index (PASI) and a 12-week transition period was begun. Patients who achieved PASI improvement of 75% or more (PASI-75) at week 12 of efalizumab treatment were observed during the transition period and treated only if psoriasis recurred. Patients who did not attain PASI-75 at week 12 of efalizumab treatment were immediately transitioned to an alternative psoriasis therapy at the physician's discretion. All patients were evaluated for signs of rebound following efalizumab discontinuation. RESULTS: Rebound was not observed in any PASI-75 responder (n = 46). Rebound was observed in two of 32 patients who achieved between PASI-50 and PASI-75, and was more common in nonresponders (14/49). Rebound was observed in none of the eight patients treated with cyclosporine and in two of the 12 patients treated with methotrexate during the transition period. CONCLUSIONS: These results suggest that efalizumab-responsive patients are less likely to experience rebound than nonresponders and may not require treatment until disease recurrence following efalizumab discontinuation. Efalizumab nonresponders are at higher risk of developing rebound and thus should be considered for transition to an appropriate psoriasis therapy immediately following efalizumab discontinuation.

Guenther LC, Poulin YP, Pariser DM. · Private practice and University of Western Ontario, London, Canada. · Clin Ther. · Pubmed #11110233 No free full text.

Abstract: BACKGROUND: Both tazarotene (a retinoid prodrug) and calcipotriene (a synthetic analog of vitamin D3) are effective in the treatment of plaque psoriasis, but no reports in the literature directly compare the efficacy and tolerability of these 2 drugs. Tazarotene is commonly used in conjunction with a topical corticosteroid. In this study, tazarotene was used with mometasone furoate (a synthetic corticosteroid), and the 2-drug regimen was compared with calcipotriene monotherapy. OBJECTIVE: This study was conducted to compare the efficacy and tolerability of tazarotene 0.1% gel once daily plus mometasone furoate 0.1% cream once daily with those of calcipotriene 0.005% ointment twice daily in the treatment of plaque psoriasis. METHODS: In this multicenter, investigator-blinded, parallel-group study, adult patients with chronic, stable plaque psoriasis affecting 5% to 20% of their body surface area were randomly allocated to receive up to 8 weeks of treatment with either tazarotene 0.1% gel once daily (in the evening) plus mometasone furoate 0.1% cream once daily (in the morning) or calcipotriene 0.005% ointment twice daily. Patients were assessed at baseline and at weeks 2, 4, and 8 of treatment. Patients who demonstrated complete clearance of plaque psoriasis after 2 or 4 weeks of treatment and those whose psoriasis had improved > or = 50% after 8 weeks of treatment entered a 12-week posttreatment follow-up phase during which they applied only moisturizer. Patients were reassessed after 4, 8, and 12 weeks of posttreatment follow-up. Physician-rated measures of efficacy included global improvement, plaque elevation, scaling, erythema, and percentage of body surface area involvement. Patient-rated assessments included efficacy of study treatment compared with previous therapies, comfort of treated skin, outlook for long-term control of psoriasis, and overall impression of treatment. RESULTS: Of 120 patients with moderate to severe psoriasis enrolled from 3 centers, 106 (88%) completed the study. No significant differences in baseline clinical variables were observed between the 2 groups. Twenty-seven patients (45%) in the tazarotene plus cortico-steroid group achieved marked improvement (> or = 75% global improvement) after 2 weeks of treatment compared with 15 patients (26%) in the calcipotriene group (P < or = 0.05). Between-group comparisons of the percentage of patients achieving complete or almost complete clearance (> or = 90% global improvement) did not reach statistical significance at any time point. When compared with the calcipotriene regimen, the tazarotene plus corticosteroid regimen resulted in significantly greater efficacy on trunk lesions in reducing plaque elevation (at the end of treatment and at week 4 of the posttreatment phase, P < or = 0.05), scaling (week 4 of treatment and week 4 of the posttreatment phase, P < or = 0.05), erythema (week 4 of treatment and at the end of treatment, P < or = 0.05), and percentage of body surface area involvement (weeks 2 and 4 of treatment, P < or = 0.01). In addition, the tazarotene plus corticosteroid regimen was significantly more effective in reducing the percentage of body surface area involvement in upper limb lesions (weeks 2 [P < or = 0.05] and 4 [P < or = 0.01] of treatment). Forty-two of 55 patients (76%) in the tazarotene plus corticosteroid group rated their medication as more or much more effective than previous therapies compared with 30 of 52 patients (58%) in the calcipotriene group (P < or = 0.05). Although adverse events (burning, pruritus, irritation, and erythema) occurred in a significantly greater proportion of patients who received tazarotene plus corticosteroid than in those who received calcipotriene (P < or = 0.05), 47 of 55 patients (85%) in both groups rated the comfort of their treated skin as "somewhat comfortable" or better and both groups had similar discontinuation rates due to treatment-related adverse events (3% and 5%, respectively). CONCL

Pariser DM. · Department of Dermatology, Eastern Virginia Medical School, Norfolk, VA, USA. · Manag Care. · Pubmed #18567144 No free full text.

Abstract: David M. Pariser, MD, presented an outline of the proposed American Academy of Dermatology consensus statement (since approved by the AAD Board of Directors), which he summarizes in this article. Pariser then moderated a roundtable discussion, in which participants discussed recent developments in the treatment of psoriasis that led to the new consensus statement. The panelists also addressed how to apply the statement to clinical practice, the effects its changes will have on physicians and patients, how managed care organizations might respond to new therapies, and how physicians can work with MCOs to ensure a smooth transition when integrating these therapies into their practices.

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.

Lebwohl M, Menter A, Weiss J, Clark SD, Flores J, Powers J, Balin AK, Kempers S, Glinert RJ, Fleming T, Liu Y, Graeber M, Pariser DM. · Department of Dermatology, Mount Sinai School of Medicine, New York, NY 10029-6574, USA. · J Drugs Dermatol. · Pubmed #17668541 No free full text.

Abstract: BACKGROUND: Psoriasis is a chronic skin disorder affecting approximately 2% of the US population. Psoriasis may occur anywhere on the body with initial presentation usually seen between 15 and 30 years of age. Calcitriol 3 microg/g ointment has demonstrated good clinical efficacy as well as topical and systemic safety when used to treat psoriasis. OBJECTIVES: To confirm the efficacy and safety of calcitriol 3 microg/g ointment versus its vehicle in the treatment of subjects with mild to moderate chronic plaque psoriasis. METHODS: Suitable subjects were randomized to receive either calcitriol 3 microg/g ointment or its vehicle twice daily for up to 8 weeks in 2 multicenter, randomized, vehicle-controlled, double-blind parallel group studies. Efficacy was evaluated through a Global Severity Score dichotomized in success (clear and minimal) or failure. Erythema, plaque elevation, scaling and dermatologic sum score (sum of the scores for erythema, plaque elevation, and scaling), pruritus, and global improvement were also assessed. Routine safety and clinical laboratory parameters, including calcium homeostasis, were evaluated throughout the study. RESULTS: In total, 839 subjects were included in the 2 studies: 419 patients received calcitriol 3 microg/g ointment and 420 received the vehicle. In both studies, calcitriol 3 microg/g ointment was shown to be significantly more effective than its vehicle, with onset of therapeutic effect seen as early as week 2 and sustained at all subsequent visits. Calcitriol 3 microg/g ointment demonstrated good systemic and local safety profile comparable to its vehicle with no effect on calcium homeostasis. CONCLUSION: Calcitriol 3 microg/g ointment applied for 8 weeks is effective and safe in the treatment of mild to moderate psoriasis.

Koo JY, Fleischer AB, Abramovits W, Pariser DM, McCall CO, Horn TD, Gottlieb AB, Jaracz E, Rico MJ. · University of California-San Francisco Psoriasis and Skin Treatment Center, San Francisco, California, USA. · J Am Acad Dermatol. · Pubmed #16021175 No free full text.

Abstract: OBJECTIVE: We sought to evaluate the safety and efficacy of tacrolimus ointment in a large cohort of adult and pediatric patients with atopic dermatitis (AD). METHODS: A cohort of 3964 adult and 3959 pediatric patients with AD were enrolled in this open-label noncomparative study. Patients applied tacrolimus 0.03% or 0.1% ointment twice daily to the affected areas. Efficacy and safety assessments included percentage of body surface area affected and incidence of adverse events, respectively. RESULTS: A total of 7923 patients were evaluated; 95.5% had severe or moderate AD at baseline. There was a 52% decrease from baseline in the mean percentage of body surface area affected at month 1 and a 91% decrease at month 18. Two of the most common adverse events, skin burning and pruritus, were generally mild, transient in nature, and decreased in prevalence as AD improved. Severity and frequency of other common adverse events were consistent with expected rates in the general population. CONCLUSION: Tacrolimus ointment monotherapy in almost 8000 pediatric and adult patients led to continuous improvement in AD and revealed no change in the safety profile reported in previous clinical trials.

Pariser DM. · Department of Dermatology, Eastern Virginia Medical School, Norfolk, VA, USA. · Manag Care. · Pubmed #18564552 No free full text.

This publication has no abstract.