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`March 22, 2005
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`HEALTIl SCIENCES
`LIBRARIES
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`MYLAN PHARMS. INC. EXHIBIT 1116 PAGE 1
`
`

`

`SUPPLEMENT TO
`JOURNAL OF THE AMERICAN ACADEMY OF
`
`DERMATOLOGY
`
`VOLUME 52
`
`MARCH 2005
`
`NUMBER 3
`
`Poster Abstracts
`
`American Academy of Dermatology
`63rd Annual Meeting
`February 18-22,2005
`New Orleans, LA
`
`Production and publication
`of this supplement made possible
`by a grant from
`Abbott Immunology
`
`MYLAN PHARMS. INC. EXHIBIT 1116 PAGE 2
`
`

`

`SUPPLEMENT TO
`JOURNAL OF THE AMERICAN ACADEMY OF
`
`DERMATOLOGY
`
`VOLUME 52
`Copyright Ó 2005 by the American Academy of Dermatology, Inc.
`
`NUMBER 3
`
`P1
`
`P3
`
`P4
`
`P6
`
`P8
`
`P10
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`P26
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`P33
`
`P36
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`P41
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`P65
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`P66
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`P75
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`P80
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`P83
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`P97
`
`Continued on page 8A
`
`Statements and opinions expressed in the articles and communications herein are those of the author(s)
`and not necessarily those of the Editor(s), publisher, or Academy, and the Editor(s), publisher, and Acad-
`emy disclaim any responsibility or liability for such material. Neither the Editor(s), publisher, nor the Acad-
`emy guarantees, warrants, or endorses any product or service advertised in this publication, nor do they
`guarantee any claim made by the manufacturer of such product or service.
`
`7A
`
`POSTER DISCUSSION SESSIONS
`
`Production and publication of this supplement made possible by
`a grant from Abbott Immunology
`
`PDS 491—Psoriasis
`
`PDS 492—Lasers in Dermatology
`
`PDS 493—Acne
`
`PDS 494—Infections and Anti-ineffectives
`
`PDS 495—Pediatrics
`
`Acne
`
`Aging/Geriatrics
`
`Art, History, and Humanities of Dermatology
`
`Basic Science
`
`Clinical Dermatology and Other Cutaneous Disorders
`
`Connective Tissue Diseases
`
`Dermatitis (Atopic)
`
`Dermatitis (Contact and Allergic Irritant)
`
`Ginat W. Mirowski, DMD, MD
`Indianapolis, Indiana
`
`Dermatopathology
`
`Dermatopharmacology/Cosmeceuticals
`
`Digital/Electronic Technology
`
`March 2005
`
`Editor
`Jeffrey D. Bernhard, MD
`
`Deputy Editors
`Thomas G. Cropley, MD
`Karen Wiss, MD
`
`Editorial Office
`University of Massachusetts
`Medical School
`55 Lake Avenue
`North Worcester, MA 01655
`508-856-2583
`E-mail: melissa.derby@
`umassmed.edu
`
`Associate Editors
`Andrew Blauvelt, MD
`Portland, Oregon
`
`Ponciano D. Cruz, Jr, MD
`Dallas, Texas
`
`Jane M. Grant-Kels, MD
`Farmington, Connecticut
`
`Alexandra Boer-Kimball, MD
`Stanford, California
`
`Stuart J. Salasche, MD
`Tucson, Arizona
`
`Martin A. Weinstock, MD
`Providence, Rhode Island
`
`Assistant Editors
`Michael E. Bigby, MD
`Boston, Massachusetts
`
`Jean L. Bologonia, MD
`New Haven, Connecticut
`
`Mark Lebwohl, MD
`New York, New York
`
`Donald J. Miech, MD
`Marshfield, Wisconsin
`
`Scott A. Norton, MD
`Bethesda, Maryland
`
`Elise Olsen, MD
`Durham, North Carolina
`
`Founding Editor
`J. Graham Smith, Jr, MD
`Mobile, Alabama
`
`Editor Emeritus
`Richard L. Dobson, MD
`Charleston, South Carolina
`
`MYLAN PHARMS. INC. EXHIBIT 1116 PAGE 3
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`

`

`Contents
`
`continued
`
`Education and Teaching in Dermatology
`
`Epidemiology and Health Services Administration
`
`Genodermatoses
`
`Hair and Nail Disorders
`
`Immunodermatology and Blistering Disorders
`
`Infection (Bacterial)
`
`Infection (Fungal)
`
`Infection (Viral, including AIDS)
`
`Internal Medicine Dermatology
`
`Lymphoma, Cutaneous/Mycosis Fungoides
`
`Melanoma and Pigmented Lesions
`
`Nonmelanoma Skin Cancer
`
`Pediatric Dermatology
`
`Photobiology, Phototherapy, and Photosensitivity Diseases
`
`Pigmentary Disorders and Vitiligo
`
`Psoriasis and Other Papulosquamous Disorders
`
`Skin Anatomy, Embryology, and Physiology
`
`Surgery (Cosmetic)
`
`Surgery (Dermatologic)
`
`Surgery (Laser)
`
`Wound Healing and Ulcers
`
`Author Index
`
`Subject Index
`
`P99
`
`P102
`
`P109
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`P111
`
`P115
`
`P117
`
`P121
`
`P131
`
`P134
`
`P137
`
`P143
`
`P147
`
`P151
`
`P157
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`P167
`
`P171
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`P205
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`P205
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`P206
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`P208
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`P210
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`214
`
`223
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`8A MARCH 2005
`
`J AM ACAD DERMATOL
`
`MYLAN PHARMS. INC. EXHIBIT 1116 PAGE 4
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`

`

`P2784
`REBOUND IN PATIENTS ABRUPTLY DISCONTINUED FROM ETANERCEPT
`Craig Leonardi, MD, Saint Louis University School of Medicine, St. Louis, MO,
`United States
`
`Psoriasis is a chronic disease that gradually returns after discontinuation of therapy.
`In some cases, disease can return to a greater extent than when treatment was
`initiated. Psoriasis relapse and rebound have been documented in multiple case
`reports of patients withdrawn from psoriasis treatment.1-6 To provide a clear
`definition for relapse and rebound, the Medical Advisory Board of the National
`Psoriasis Foundation defined rebound as ‘‘PASI of 125% or greater from baseline or
`new generalized pustular, erythrodermic or more inflammatory psoriasis occurring
`within 3 months of stopping therapy.’’7 Etanercept, an antietumor necrosis factor
`(TNF)-a targeted fusion protein, was recently approved for the treatment of
`moderate to severe chronic plaque psoriasis. During the clinical trials, rebound
`occurred in 1 of 409 patients (0.2%) during the 12-week observation period after
`etanercept treatment. Patients in clinical practice often present a variety of unique
`challenges that may differ markedly from the experience gathered during clinical
`trials. Four patients who developed conversion of morphology or significant
`worsening of psoriasis during commercial treatment with etanercept will be
`discussed. Three of these patients were successfully controlled with etanercept
`but experienced significant disease worsening on discontinuation of treatment. The
`fourth patient experienced a dramatic flare while receiving etanercept therapy. The
`management of these 4 patients will be described. These case reports highlight the
`importance of close clinical follow-up with patients whenever systemic psoriasis
`therapies are used.
`
`References
`1. Boyd, Menter. J Am Acad Dermatol 1989;21:985.
`2. Cacoub et al. Lancet 1988;2:219.
`3. Heidenheim et al. Br J Dermatol 1990;122:719.
`4. Mahendran, Grech. Br J Dermatol 1998;139:934.
`5. Georgala et al. Br J Dermatol 2000;142:1057.
`6. Kamarashev et al. Dermatology 2002;205:213.
`7. Gordon et al. Psoriasis Forum 2002;8:1.
`
`Dr. Leonardi is on the Advisory Boards of Amgen, Genentech, Centocor, and Serono;
`has received grant support from Amgen and Genentech; and is a member of the
`speakers’ bureau for Amgen, Genentech, and Serono.
`
`P2786
`REPEATED COURSES OF ALEFACEPT ARE COST-EFFECTIVE FOR THE LONG-
`TERM MANAGEMENT OF PSORIASIS
`Steven Feldman, MD, Wake Forest University School of Medicine, Winston-Salem,
`NC, United States; Alan Menter, MD, Texas Dermatology Associates, Dallas, TX,
`United States
`
`Physicians attempting to obtain a second course of alefacept therapy are often
`confronted with payers questioning the cost-effectiveness of continued treatment.
`Alefacept is a safe remittive agent, with a proportion of patients maintaining
`response after completion of treatment. The purpose of this study was to assess the
`cost-effectiveness of alefacept in patients for whom the decision has been made to
`continue therapy. Cost-efficacy per day is calculated for each of the 3 biologic agents
`approved for psoriasis: alefacept 15 mg intramuscularly weekly; efalizumab 1 mg/kg
`subcutaneously (SC) weekly; and etanercept 50 mg SC twice weekly for 3 months,
`followed by 25 mg SC twice weekly. The analysis examines total direct costs
`(including drug costs, office visit fees, injection fees) and costs for laboratory
`monitoring during treatment as per product labeling. These direct utilization-related
`costs are divided by the efficacy as determined by PASI 75 response rates from large-
`scale clinical trials. The cost-efficacy is then divided by the number of days for 18-
`and 24-month periods to provide cost-efficacy per day. For PASI 75 responders to
`alefacept, median remission periods of 7 months for the first course and 12 months
`for the second course were assumed based on clinical trials.1,2 At 18 months, cost-
`efficacy per day was $122 for alefacept (2 courses of the drug), $203 for efalizumab,
`and $123 for etanercept. At 24 months, cost-efficacy per day was $91 for alefacept,
`$203 for efalizumab, and $119 for etanercept. Advantages of alefacept are due in part
`to the long treatment-free remission periods and its safety profile. Repeated courses
`of alefacept are cost-effective for the long-term management of patients with
`psoriasis.
`
`References
`1. J Am Acad Dermatol 2002;47:821.
`2. J Drugs Dermatol 2003;2:624.
`
`Dr. Feldman is a consultant for Biogen Idec, Inc.
`
`Supported by Biogen Idec, Inc.
`
`P2785
`REFRACTORY ERYTHRODERMA: CASE REPORT (JUST PSORIASIS OR
`PSYCHIATRIC DISORDER?)
`Carolina Gouveia, MD, Carlos Garcia, MD, Miguel-Duarte Reis, MD, Joa˜o Pedro
`Freitas, MD, University Clinic of Dermatology, Hospital de Santa Maria, Lisbon,
`Lisbon, Portugal
`
`A 51-year-old male history teacher was admitted to our clinic in April 2003 with
`erythroderma of 2 months’ duration. He had suffered from bipolar disorder since the
`age of 26; he had re-started lithium carbonate therapy a few days before the
`appearance of the dermatosis, after a 10-year interval. His father and grandfather had
`had psoriasis.
`
`During hospitalization, biopsies were performed, which disclosed ‘‘drug eruption.’’
`Lithium carbonate therapy was discontinued, and he started prednisolone therapy
`(30 mg daily), with rapid improvement; he was discharged with steroid and
`carbamazepine therapy (psychiatrist’s prescription). Two weeks later there was
`a new flare of generalized erythema, chills, and fever, which led to the suspension of
`carbamazepine thereapy and readmission to the hospital after 20 days.
`
`We started prednisolone and increased the dosage to 70 mg/d. New biopsies
`showed ‘‘eczema.’’ After 2 weeks of high-dose steroid therapy without improvement,
`it was gradually tapered and 4 new biopsies revealed ‘‘psoriasis.’’ Five weeks after
`admission, acitretin was started. Meanwhile, because the patient was not medicated
`with any mood stabilizer, he had been allowed to spend his weekends at home; we
`observed a slight worsening every Monday/Tuesday. We started measuring lithium
`blood levels and noticed a repetitive pattern: positive values (although subthera-
`peutic) at the beginning and no measurable values at the end of the week.
`Confronted with this fact, both the patient and close family members strongly
`denied ingestion of the drug.
`
`Nine weeks after admission we started intramuscularly administered methotrexate
`(25 mg weekly), discontinued acitretin, and suspended the ‘‘weekend break,’’ with
`gradual clinical improvement and normalization of lithium blood levels. He was
`dismissed at the third month, with moderate clinical improvement, and was closely
`monitored in our outpatient clinic; blood lithium levels were again positive, and
`there was worsening of his clinical condition.
`
`After being submitted to a medical committee in order to retire earlier from his job
`because of
`the skin disease, he showed a gradual clinical
`improvement.
`Methotrexate was tapered and he attended our clinic irregularly for some months.
`In a later outpatient visit, we observed a complete remission. The patient told us he
`was already retired.
`
`Nothing to disclose.
`
`MARCH 2005
`
`P2787
`RESULTS OF A PHASE 2 DOSE-RANGING AND SAFETY EXTENSION STUDY
`OF A NOVEL ORAL FUMARATE, BG-12,
`IN PATIENTS WITH SEVERE
`PSORIASIS
`A. Langner, MD, Medical University of Warsaw, Warsaw, Poland; M. C. Spellman,
`MD, Biogen Idec, Inc., San Diego, CA, United States
`
`Fumaric acid esters have been used to treat patients with psoriasis for more than 10
`years in Germany, but their use is limited by gastrointestinal adverse events, which
`frequently lead to discontinuation. A novel oral
`fumarate, BG-12, has been
`developed to improve the efficacy and tolerability of fumaric acid esters in patients
`with psoriasis. A phase II multicenter, double-blind, placebo-controlled, dose-
`ranging trial was conducted in Poland to evaluate the efficacy, safety, and tolerability
`of BG-12. The trial also included a 24-week, open-label, safety extension phase.
`Patients with chronic plaque, exanthematic guttate, erythrodermic, palmoplantar,
`or pustular psoriasis for 1 year or longer and a baseline PASI score of 16 to 24 were
`eligible. Therapies for psoriasis were discontinued before study enrollment, except
`for topical salicylic acid and emollients. In the double-blind phase, patients
`(N = 144) were equally randomized to 1 of 4 treatment groups: placebo or BG-12
`120 mg (1 capsule), 360 mg (3 capsules), or 720 mg (6 capsules) daily (study drug
`dosed 3 times per day) for 12 weeks. Patients who completed the double-blind phase
`or who withdrew after 8 weeks because of lack of efficacy were eligible to enroll in
`the open-label phase. Assessments included PASI, Physician’s Clinical Global
`Impression, patient’s global assessment, quality of life, and reported adverse events.
`Improvement in psoriasis was observed as early as 2 weeks and was dose-related.
`BG-12 was well tolerated, with infrequent gastrointestinal complaints. The open-
`label extension phase enrolled 108 patients (28 from each of the placebo and 120-
`mg BG-12 groups and 26 each from the 360-mg and 720-mg BG-12 groups). The
`results of this phase II study are promising, with substantial efficacy and good
`tolerability for this novel oral fumarate.
`
`Supported by Biogen Idec, Inc.
`
`J AM ACAD DERMATOL
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`P193
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`MYLAN PHARMS. INC. EXHIBIT 1116 PAGE 5
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