P8388Higher health care costs and dose escalation rates in psoriasis patientstreated with ustekinumab compared to adalimumab

Annie Gu�erin, Analysis Group, Inc, Boston, MA, United States; Ke Wang, AbbVieInc, North Chicago, IL, United States; Murali Sundaram, AbbVie Inc, NorthChicago, IL, United States

Objective: To compare health care costs and dose escalation rates of psoriasis (Ps)patients previously treated with biologics and initiated on UST or ADA, usingretrospective claims data.

Methods: Adult patients with ¼ 2 Ps diagnoses (ICD-9 code 696.1x) who initiatedUST or ADA on/after 09/25/2009 were identified from the Truven Health AnalyticsMarketScan database (Q1 2000eQ4 2011). The first prescription fill for ADA or USTwas defined as the index date. Patients were required to be previously treated withanother biologic during the 6-month period prior to the index date and becontinuously enrolled in a health care plan ¼ 6 months before and ¼ 12 monthsafter the index date. Pharmacy costs and medical service costs from a payerperspective (USD $ 2012) were measured over the 12-month period after the indexdate. Dose escalation was defined as an increase of ¼ 45 mg for UST or ¼ 40 mg forADA, or a decrease in the number of days between injections, and the observationperiod spanned index date until the first dose escalation, ADA/UST discontinuation,or the end of the 12-month study period, whichever occurred first. Cost differenceswere estimated using a generalized linear regression model with log link and gammadistribution and 2-part models. Dose escalation was compared using Cox propor-tional hazards regression models.

Results: Overall, 473 UST and 431 ADA users met the sample selection criteria. Themajority of patients weremiddle-aged (48-50 years old) males (55%). The unadjustedaverage total annual cost was $43,506 for UST users and $30,126 for ADA users(difference ¼ $13,379). After multivariate adjustment for potential confoundingfactors, UST users had a greater total annual cost by $11,872, P\.0001 and greatertotal pharmacy costs by $14,990, P\ .0001. UST users were more than twice aslikely as ADA users to have a dose escalation compared to ADA (unadjusted: 19.2%vs. 11.2%; adjusted hazard ratio ¼ 2.2; P\.0001).

Conclusions: Over a 12-month period, patients initiated on UST compared to ADAincurred higher costs, where the cost difference was mainly driven by higherpharmacy costs. Patients initiated on UST compared to ADA also had higher rates ofdose escalation.

MAY 201

tudy conduct, and financial support for the study were provbbVie participated in the interpretation of data, review, and app

Design, s ided byAbbVie; A roval ofthe abstract; all authors contributed to the development of the publication andmaintained control over the final content.

P7858How do patients with chronic plaque psoriasis describe the color of theirskin lesions across Fitzpatrick skin types?

Mona Martin, RN, MPA, Health Research Associates, Mountlake Terrace, WA,United States; Carla Ascoytia, Health Research Associates, Mountlake Terrace,WA, United States; Dina Chau, PharmD, Amgen Inc, Thousand Oaks, CA, UnitedStates; Hema N. Viswanathan, PhD, Amgen Inc, Thousand Oaks, CA, UnitedStates; Kelly McCarrier, MPH, PhD, Health Research Associates, MountlakeTerrace, WA, United States

Objectives: Patients with psoriasis experience varying degrees of skin discolorationbecause of plaque lesions. Patient input supported the inclusion of a question on theredness of skin lesions during development of the Psoriasis Symptom Inventory(PSI), an 8-item patient-reported outcome measure. While the term ‘‘redness’’ is alsoincluded in clinical assessments, there is a lack of qualitative data on the descriptionof lesion color among personswith darker skin tones. This qualitative study aimed toidentify patient language for describing discoloration of skin lesions among thosewith different skin tones including Fitzpatrick skin types IV to VI (Mediterranean,dark brown, and black) and to further evaluate the content validity of the PSI.

Methods: A qualitative study was conducted in adult patients with moderate tosevere plaque psoriasis (Body Surface Area ¼ 10, PASI ¼ 12, Physician GlobalAssessment ¼ 3) across all Fitzpatrick skin types. Subjects were recruited from 4different US sites. Concept elicitation (N ¼ 20) and cognitive interviews (N ¼ 10)were conducted using semistructured guides. Concept interviewswere coded usingAtlas.ti software and patient language was grouped by similar content.

Results: The 30 subjects interviewed had a mean age of 51.9 years (range, 27-75),were 57% (N¼ 17) white or fair skinned, and 43% (N¼ 13) Fitzpatrick skin types IV,V, and VI. A total of 119 color-related expressions were coded from the conceptinterviews. 60% of these expressions (N ¼ 72) cited red or reddish lesion color.Another 12% (N ¼ 14) cited shades of pink to red tones, and another 8% (N ¼ 10)described purplish red and dark red tones. Those with scores of IV, V, or VI describedtheir lesions as red, bright red, flashy red, reddish brown, deep red, and dark red.New lesions were described by subjects with lighter skin tones as pink and peach orlight orange, while those with darker skin tones reported only pink tones. Allparticipants described fading lesions using red to reddish brown moving to tan andbrown skin tones. For all participants, lesion color at its worst for fully developedlesions was described as dark red, deep red, really red, blotchy red, and fire enginered.

Conclusions: The term ‘‘redness’’ was found to be the most common and bestunderstood descriptor of discoloration by psoriasis patients including those withdarker skin tones. Findings lend further support to the content validity of the PSI.

y was funded by Amgen Inc.

This stud

4

P8254Hydrocortisone cream once daily plus emollient, keratolytic, kerato-plastic, and antinflammatory cream in comparison with hydrocortisonetwice daily for mild to moderate plaque psoriasis: An intrapatient,randomized, assessor-blinded, ultrasound evaluation

Francesco Lacarrubba, MD, Dermatology Clinic, University of Catania, Catania,Italy; Giuseppe Micali, MD, Dermatology Clinic, University of Catania, Catania,Italy; Maria Letizia Musumeci, MD, PhD, Dermatology Clinic, University ofCatania, Catania, Italy; Massimo Milani, ISDIN Medical Department, Milano, Italy

Background: Concomitant use of emollients with topical corticosteroids has beendemonstrated to be efficacious in plaque psoriasis, improving clinical response witha steroid-sparing effect. However, so far, no trials with objective measurementevaluations are available. The aim of this pilot intrapatient (left site vs. right site)randomized, assessor-blinded, 4-week study was to evaluate, through ultrasoundimaging, the efficacy and tolerability of the combination of hydrocortisone valerate0.1% cream (HVC) once daily with an emollient, keratolytic, keratoplastic, andantinflammatory cream (EKC) containing urea 20%, salycilic acid 2% and niacin-amide once daily vs. HVC alone applied twice daily for the treatment of plaquepsoriasis.

Methods: Fifteen patients (12 M, 3 F, age range: 30-76 years) with mild to moderateplaque psoriasis were enrolled. For each patient, 2 symmetrical, target lesions wereselected and randomized to receive either HVC and EKC, both applied once daily, orHVC twice daily for 4 weeks. The primary efficacy parameter was the reduction ofskin thickness by ultrasound evaluation, which was performed in an operator-blinded fashion using a 20-MHz B-mode high-resolution system (EasyScan Echo). Asecondary endpoint was the evaluation of a Target Lesion Score (TLS) includingdegree of erythema, scaling, infiltration and pruritus with a 5-point scale (0¼ none,1 ¼ mild, 2 ¼ moderate, 3 ¼ severe, and 4 ¼ very severe).

Results: Combination therapy with HVC and EKC was as effective as corticosteroidtwice daily treatment with a similar reduction of psoriatic skin thickness at week 4 incomparison with baseline (combination therapy group: from 2.59 mm 6 0.4 atbaseline to 2.19 mm 6 0.4 at week 4, P ¼.005; monotherapy group: from 2.56 mm6 0.4 to 2.14 mm6 0.37, P ¼.005). The efficacy results were paralleled by the TLSat the end of the study (from 8.8 6 2.1 to 5.4 6 2.3 in the combination therapygroup and from 8.8 6 2.1 to 5.5 6 2.2 in the monotherapy group).

Conclusions: Our results suggest that the addition of EKC to once-daily HVC offers aclinical response, objectively evaluated, that is equal to corticosteroid monotherapyapplied twice daily, improving the risk/benefit ratio.

d 25% by ISDIN Medical Department.

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P8118Impact of baseline characteristics on the efficacy of ixekizumab inpatients with moderate to severe psoriasis in a phase 2 study

Kim Papp, MD, Probity Medical Research, Waterloo, Canada; Baojin Zhu, PhD, EliLilly and Company, Indianapolis, IN, United States; Craig Leonardi, MD, St. LouisSchool of Medicine, St. Louis, MO, United States; Gregory Cameron, PhD, Eli Lillyand Company, Indianapolis, IN, United States; Janelle Erickson, PhD, Eli Lilly andCompany, Indianapolis, IN, United States; Michael Heffernan, MD, Eli Lilly andCompany, Indianapolis, IN, United States; Subhashis Banerjee, MD, Eli Lilly andCompany, Indianapolis, IN, United States

Background: This analysis evaluated the impact of baseline variables that may impactthe effectiveness of biologics (body weight, previous biologic use, duration ofdisease, and sex) on the clinical response of patients treated with ixekizumab.

Methods: A total of 142 patients were randomized to receive subcutaneousinjections of 10, 25, 75, or 150 mg of ixekizumab or placebo at weeks 0, 2, 4, 8,12, and 16. Randomization was stratified according to body weight (\100 kg or ¼100 kg) and by previous biologic use. Subgroup analyses were conducted todetermine the effect of previous biologic use, bodyweight, sex, and disease durationon PASI 75 response rates at week 12 for the combined low dose (10 mg and 25 mg,n ¼ 58) and high dose (75 mg and 150 mg, n ¼ 57) groups. Disease duration wasdivided into three equal sample size groups (\10.5 years, 10.5 to 20.5 years,[20.5years). Missing values were imputed based on the last observation carried forwardmethod and statistical comparisons between groups were made using the Fisherexact test.

Results: Among patients na€ıve to biologic therapy and patients with previousbiologic use, PASI 75 response rates were 82% and 83% (P ¼ 1.0) at week 12 in thehigh dose group, respectively, while in the low dose group, the PASI 75 responserateswere 70% and 32%, respectively (P¼.008). For disease durations of\10.5, 10.5to 20.5,[20.5 years, 78%, 86% and 85% of patients in the high dose group (P¼.904)achieved a PASI 75 response, respectively, and 80%, 47% and 42% in the low dosegroup (P ¼ .052) achieved a PASI 75 response, respectively. For patients weighing\100 kg and ¼ 100 kg PASI 75 response rates were 86% and 75% in the high dosegroup (P ¼ .298), respectively, and 61% and 41% in the low dose group (P ¼ .178),respectively. Gender showed no significant impact on the efficacy of ixekizumabregardless of dose with 83% and 82% of patients in the high dose group (P ¼ 1.00)and 58% and 50% in the low dose group (P¼.599) achieving a PASI 75 at week 12 forfemale and male patients, respectively.

Conclusions: Body weight, previous biologic use, and duration of disease did notappear to have a major impact on the efficacy of ixekizumab in patients receivinghigher doses (75 mg and 150 mg) while they may impact efficacy at lower doses (10and 25mg). Because of the low numbers of patients in the subgroups in this analysis,larger trials are needed to fully understand the impact of these factors.

d 100% by Eli Lilly and Company.

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J AM ACAD DERMATOL AB171