adalimumab for the treatment of psoriasis: a retrospective study of 51 patients

P6174Acitretin for the treatment of psoriasis: An assessment of national trends

Brad A. Yentzer, MD, Wake Forest School of Medicine, Winston Salem, NC,United States; Pedram Ghasri, Wake Forest School of Medicine, Winston Salem,NC, United States; Samantha Smith, MD, Wake Forest School of Medicine,Winston Salem, NC, United States; Sarah D. Fenerty, Wake Forest School ofMedicine, Winston Salem, NC, United States; Scott A. Davis, Wake Forest Schoolof Medicine, Winston Salem, NC, United States; Steve R. Feldman, MD, PhD,Wake Forest School of Medicine, Winston Salem, NC, United States; Tushar S.Dabade, MD, Wake Forest School of Medicine, Winston Salem, NC, United States

Background: Acitretin is an effective oral retinoid for psoriasis that seems to find itsgreatest value when complemented by other topical and systemic treatments. It isalso a potent teratogen whose use should be avoided if possible in women of childbearing potential.

Objective: The primary aims of this study are to assess the use of acitretin incombination with other treatments for psoriasis, and to determine the demograph-ics of its use to see whether it is being used in women of child bearing potential.

Methods: We assessed the use of acitretin for the treatment of psoriasis usingnationally representative survey data from the National Ambulatory Medical CareSurvey (NAMCS). Demographics of acitretin patients, as well as other medicationscoprescribed with acitretin, were analyzed.

Results: Among visits where acitretin was listed in the NAMCS, other psoriasismedications were coprescribed at 62% of visits. The coprescribed medicationsincluded topical corticosteroids (51%), calcipotriene (31%), biologics (6%), cyclo-sporine (5%), methotrexate (5%), and tazarotene (2%). There was just 1 record of afemale patient under the age of 50 being prescribed acitretin from the years 1996 to2007, which corresponded to 2% of all acitretin users.

Conclusion: Acitretin is infrequently being prescribed to women of child bearingpotential, presumably because of its long-lasting teratogenic effects. The use ofacitretin in combination with other psoriasis treatments, including biologics, topicalcorticosteroids, and calcipotriene, is a common practice. The immune-sparingmethod of action of acitretin makes combination treatment with the systemic agentsan attractive treatment option, especially in patients where further immunosup-pression is unwarranted.

AB192

d by a grant from Stiefel.

P6695Adalimumab for the treatment of psoriasis: A retrospective study of51 patients

Ana Maria Mota-Burgos, Universitary Clinic Hospital, Malaga, Spain; BlancaMoyano-Almagro, Universitary Clinic Hospital, Malaga, Spain; Enrique Herrera-Acosta, Universitary Clinic Hospital, Malaga, Spain; Enrique Herrera-Ceballos,Universitary Clinic Hospital, Malaga, Spain; Maria Victoria Mendiola-Fern�andez,Universitary Clinic Hospital, Malaga, Spain

Background: Adalimumab is a fully humanized antibody, which specifically binds totumor necrosis factor (TNF-alfa) and blocks its activity. Based on previous evidencethat TNF-alfa has been involved in the pathogenesis of psoriasis, multiple controlledtrials have shown that adalimumab has provided a high degree of clinical benefit inthe treatment of psoriasis and psoriatic arthritis.

Objectives: To evaluate the efficacy and safety of adalimumab in a series of patientswith moderate to severe psoriasis treated in Universitary Clinic Hospital in Malaga(Spain).

Methods: We reviewed the clinical records of 51 patients with severe psoriasis whostarted adalimumab therapy between 2007 and 2011. All patients were evaluated atweeks 0 and 4 and every 8 weeks thereafter. Data on demographics (age, gender),medical history, previous systemic therapy, previous biologic therapies, PsoriasisArea and Severity Index (PASI), Dermatology Life Quality Index (DLQI), psoriaticarthritis and toxicity of treatment were collected from the medical records. Otherinformation included start date and dose. All patients had previously received, atleast, one systemic treatment.

Results: We treated 51 patients (18 men and 16 women; age 45.26 13.2 years) witha mean baseline PASI of 16.1. All patients had previously received, at least, onesystemic treatment. Psoriatic arthritis was present in 8 patients (24%). The averageduration of treatment was 66.7 weeks. Overall 72% and 95%, patients achievedPASI75 response rates at weeks 12 and 24, respectively. Furthermore, this responsewas maintained long-term (overall 95% patients achieved PASI 75 response at week50). Treatment was discontinued in 16 patients; because of nonrecoverable loss ofefficacy (8 patient lost efficacy at week 32), no improvement in PASI baseline at4 months of treatment (4 cases), and patients lost to follow-up (2 cases). There wereno adverse effects.

Conclusion: Based on our clinical practice, adalimumab demonstrates sustainedeffectiveness and a favorable safety profile with no cumulative toxicity.

cial support: None identified.

J AM ACAD DERMATOL

P6332An approach to patient-centered care for patients with psoriatic arthritis

Chureen Carter, PharmD, MS, Janssen Scientific Affairs, LLC, Horsham, PA,United States; Brad Schenkel, MS, Janssen Scientific Affairs, LLC, Horsham, PA,United States; Deborah Freedman, PhD, Kantar Health, New York, NY, UnitedStates; Kathy Annunziata, PhD, Kantar Health, New York, NY, United States

Background: One tenet of patient-centered care is incorporating the patient’sperspective in care plans.

Objective: To assess differences in patient-reported beliefs about physician (MD)relationship concepts and medication compliance between patients with andwithout psoriatic arthritis (PsA).

Methods: Data were generated from the National Health and Wellness Surveyelectronically administered to U.S. adults January-September 2011. Study partici-pants were self-identified as having MD-diagnosed PsA (PsA) or not experiencingarthritis (non-PsA). MD relationship concepts included patient perspectives on MDattentiveness and frequency of MD contact. Medication compliance beliefs includedfrequency of taking medication, patient decision-making for stopping medication,medication side effects, and desirable attributes of medication regimens.

Results: Data from 59, 568 (185 PsA; 59, 383 non-PsA) respondents were assessed. Asignificantly higher percentage of PsA patients, compared with non-PsA (all P\.05),believed they should consult a medical professional when feeling ill (42% vs 27%),MD was attentive to needs/concerns (76% vs 56%), and regular MD contact was thebest way to avoid illness (58% vs 42%). A significantly higher percentage of the PsAgroup, compared with non-PsA (all P \ .05), believed it is best to continuemedications unless there is good reason to stop (85% vs 59%), it is more difficult totake medication if required to be taken with food (42% vs 31%), all prescriptionmedications have side effects (69% vs 54%), and medication regimens should havefewer pills (52% vs 37%). More PsA patients attempt to take medication daily at thesame time (84% vs 63% for non-PsA; P\.05) and expressed willingness to take dailyprescription medication for the rest of their lives to prevent a disease for which theyare at risk (59% vs 43% for non-PsA; P\.05).

Conclusion: PsA patients appear to view MD relationships in a positive manner, asindicated by the majority reporting their MD was attentive and regular MD contactbeing a driver of illness avoidance. In addition, the majority of PsA patients reportedawareness of prescription medication side effects, a desire to continue medicationunless there is cause for stopping, and preference for simplistic medicationregimens. An understanding of PsA patient beliefs about the patient-MD relationshipand medication compliance may aid dermatologists in adopting patient-centeredcare strategies for PsA.

cientific Affairs, LLC.

P6389An evaluation of the effect of topical tofacitinib (CP-690, 550) on pruritusand patient satisfaction with study medication in a phase IIA trial forplaque psoriasis

Carla Mamolo, Pfizer Inc, Groton, CT, United States; Robert Bissonnette,Innovaderm Research, Montreal, Canada; Shahbaz Khan, PharmaNet/i3,Princeton, NJ, United States; Shuping Lan, Pfizer Inc, Groton, CT, UnitedStates; William Ports, Pfizer Inc, Groton, CT, United States; Yves Poulin, Centerde Recherche Dermatologique du Quebec Metropolitain, Quebec, Canada

Aims: To evaluate the effect on pruritus and patient satisfaction with topicaltofacitinib (CP-690, 550) in subjects with mild-to-moderate plaque psoriasis.

Methods: In this double-blind, vehicle-controlled, phase IIA trial (NCT01246583),2 ointment formulations of 2% tofacitinib were evaluated in adults (N ¼ 71) withmild to moderate psoriasis. Subjects were randomized 2:1:2:1 to ointment1 (Oint1; n ¼ 23), vehicle 1 (Veh1; n ¼ 13), ointment 2 (Oint2; n ¼ 25), or vehicle2 (Veh2; n¼ 10). Study drugwas applied twice daily for 4 weeks to a single fixed 300cm2 target treatment area on the trunk or limbs, which included at least onepsoriasis plaque and normal skin. Pruritus of the target plaque was assessed usingthe Itch Severity Item (ISI), a 0 (‘‘no itching’’) to 10 (‘‘worst possible itching’’) scaleadministered weekly. Overall satisfaction was assessed at Week 4 with the PatientSatisfaction with Study Medication item (PSSM), a 7-category scale with responsesranging from ‘‘very dissatisfied’’ to ‘‘very satisfied.’’ The comparisons of interest werethe differences between the treatment and corresponding vehicle (ie, Oint1 vsVeh1; Oint2 vs Veh2).

Results: At baseline, mean (SD) ISI scores were 4.09 (2.52), 5.54 (3.10), 4.36 (2.53),and 6.20 (2.62) for Oint1, Veh1, Oint2, and Veh2, respectively, indicating amoderatelevel of pruritus. At week 4, least square mean change from baseline was -2.64(1.97), -2.15 (2.85), -2.13 (2.65), and -1.78 (3.87) for Oint1, Veh1, Oint2, and Veh2,respectively. At weeks 1 and 4, 90% upper confidence limits (CLs) for the changefrom baseline for Oint1 vs Veh1 were\0, whereas for Oint2 vs Veh2 CLs were[0 atall 4 weeks. Oint1 thus demonstrated significant efficacy compared with Veh1 atweeks 1 and 4, whereas Oint2 did not differentiate from Veh2. At week 4, 50.0% ofsubjects who received Oint1 had PSSM responses of ‘‘very satisfied’’ compared with23.1%, 32.0%, and 0.0% of subjects who received Veh1, Oint2, and Veh2, respec-tively. In an ANOVA on PSSM scored as a continuous variable, the 90% upper CL forOint1 vs Veh1 was[0, whereas for Oint2 vs Veh2 it was\0, indicating that Oint1only was preferred to its vehicle.

Conclusion: Tofacitinib ointment 1 reduced pruritus of a target treatment area inmild to moderate psoriasis subjects, with many reporting satisfaction with the studymedication compared to vehicle 1. Additional investigation of tofacitinib Ointment1 for the treatment of plaque psoriasis is warranted.

d by 100% Pfizer Inc.

APRIL 2013