Adherence to topical hydrocortisone 17-butyrate 0.1% in different vehicles in adults with atopic...

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The efficacy of MTX is mainly related to its effect on epidermal cell proliferation. However, in vitro studies demonstrate that MTX has a more signifi- cant effect on lymphoid cells. 2 Nylander Lundqvist et al 3 treated four patients with erosive LP with MTX (10-15 mg/wk) in combination of topical corticosteroids for 17 months and concluded that MTX was a well tolerated and effective treatment for severe erosive LP. To our knowledge, no clinical trials for MTX in generalized LP have been reported previously. The results of this small retrospective case series suggest that use of weekly oral MTX can be a highly effective and tolerable treatment alternative to systemic corticosteroids. Larger pro- spective controlled trials are needed to establish the optimal dosage and duration of MTX therapy for generalized LP. Hakan Turan, MD, Emel Bulbul Baskan, MD, Sukran Tunali, MD, Serkan Yazici, MD, and Hayriye Saricaoglu, MD Department of Dermatology, Uludag University Medical Faculty, Bursa, Turkey Funding sources: None. Conflicts of interest: None declared. Correspondence to: Hakan Turan, MD, Depart- ment of Dermatology, Uludag University Medical Faculty, Gorukle 16059, Bursa, Turkey E-mail: [email protected] REFERENCES 1. Gallant C, Kenny P. Oral glucocorticoids and their complica- tions. A review. J Am Acad Dermatol 1986;14(2 pt 1):161-77. 2. Jeffes EW 3rd, McCullough JL, Pittelkow MR, McCormick A, Almanzor J, Liu G, et al. Methotrexate therapy of psoriasis: differential sensitivity of proliferating lymphoid and epithelial cells to cytotoxic and growth inhibitory effects of methotrexate. J Invest Dermatol 1995;104:183-8. 3. Nylander Lundqvist E, Wahlin YB, Hofer PA. Methotrexate supplemented with steroid ointments for the treatment of severe erosive lichen ruber. Acta Derm Venereol 2002;82: 63-64. doi:10.1016/j.jaad.2008.09.054 Adherence to topical hydrocortisone 17-butyrate 0.1% in different vehicles in adults with atopic dermatitis To the Editor: Adherence to topical therapy is poor in pediatric atopic dermatitis (AD) patients but not well characterized in adults. 1 Topical medications are available in a variety of vehicles, and patients have varying preferences among vehicles. 2,3 The goal of this study was to assess adherence in adults with AD to a single topical agent in three different vehicles. Methods. Following institutional review board approval, 25 subjects (age $ 18 yrs) with mild to moderate AD (Investigators Global Assessment [IGA], 2 or 3 out of 5; body surface area, 5-30%) were randomized to receive twice daily hydrocor- tisone 17-butyrate 0.1% (Locoid; Ferndale Laboratories, Ferndale, MI) in one of three vehi- cles: cream, lipocream, or ointment. Adherence was monitored electronically (MEMS; Aardex Corp, Fremont, CA). Disease severity was evaluated at baseline and week 2 using the Eczema Area Severity Index (EASI), IGA, and target lesion assessments (TLA). Mean change in IGA, EASI, and target lesion scores from baseline to week 2 were compared using t tests. Kruskal-Wallis and analysis of variance tests were performed to com- pare outcomes across vehicles. The relationship between adherence and treatment group was tested using a mixed model adjusting for within patient correlation. Results. Twenty subjects 19 to 74 years of age completed the study (Fig 1). Overall adherence across all subjects was 70% (standard deviation 5 0.23). Mean adherence was not statistically different between the three vehicle groups (F test; P 5 .39). Mean IGA, EASI, and target lesion assessment scores significantly improved in all three groups after 2 weeks of treatment (Table I). The ointment group had a larger improvement in IGA, EASI, and TLA than the other vehicles; however, this difference was only significant between ointment and cream for im- provement in IGA mean scores (P 5 .05). There were no reported adverse events related to the medication. Discussion. The major finding in this small study is the tremendous variation in use between different individuals. Patients took medications in- consistently, frequently missing doses. Some used the medication more than twice per day. However, nearly all patients reported near perfect usage of the medication. Physicians should expect their patients to misuse topical medications regardless of what they report. Differences in both mean adherence and mean outcomes between vehicle groups were insignifi- cant, perhaps because of the small study size. We had hoped that outcome would not effect adherence over the short study interval, but the rapidity of action of hydrocortisone 17-butyrate 0.1% on AD is so fast that improvement in the disease complicates studies of adherence even over just 2 weeks. JAM ACAD DERMATOL JANUARY 2009 166 Letters

Transcript of Adherence to topical hydrocortisone 17-butyrate 0.1% in different vehicles in adults with atopic...

Page 1: Adherence to topical hydrocortisone 17-butyrate 0.1% in different vehicles in adults with atopic dermatitis

The efficacy of MTX is mainly related to its effecton epidermal cell proliferation. However, in vitrostudies demonstrate that MTX has a more signifi-cant effect on lymphoid cells.2 Nylander Lundqvistet al3 treated four patients with erosive LP withMTX (10-15 mg/wk) in combination of topicalcorticosteroids for 17 months and concluded thatMTX was a well tolerated and effective treatmentfor severe erosive LP. To our knowledge, no clinicaltrials for MTX in generalized LP have been reportedpreviously. The results of this small retrospectivecase series suggest that use of weekly oral MTX canbe a highly effective and tolerable treatmentalternative to systemic corticosteroids. Larger pro-spective controlled trials are needed to establish theoptimal dosage and duration of MTX therapy forgeneralized LP.

Hakan Turan, MD, Emel Bulbul Baskan, MD,Sukran Tunali, MD, Serkan Yazici, MD, andHayriye Saricaoglu, MD

Department of Dermatology, Uludag UniversityMedical Faculty, Bursa, Turkey

Funding sources: None.

Conflicts of interest: None declared.

Correspondence to: Hakan Turan, MD, Depart-ment of Dermatology, Uludag University MedicalFaculty, Gorukle 16059, Bursa, Turkey

E-mail: [email protected]

REFERENCES

1. Gallant C, Kenny P. Oral glucocorticoids and their complica-

tions. A review. J Am Acad Dermatol 1986;14(2 pt 1):161-77.

2. Jeffes EW 3rd, McCullough JL, Pittelkow MR, McCormick A,

Almanzor J, Liu G, et al. Methotrexate therapy of psoriasis:

differential sensitivity of proliferating lymphoid and epithelial

cells to cytotoxic and growth inhibitory effects of methotrexate.

J Invest Dermatol 1995;104:183-8.

3. Nylander Lundqvist E, Wahlin YB, Hofer PA. Methotrexate

supplemented with steroid ointments for the treatment of

severe erosive lichen ruber. Acta Derm Venereol 2002;82:

63-64.

doi:10.1016/j.jaad.2008.09.054

J AM ACAD DERMATOL

JANUARY 2009

166 Letters

Adherence to topical hydrocortisone17-butyrate 0.1% in different vehicles inadults with atopic dermatitis

To the Editor: Adherence to topical therapy is poor inpediatric atopic dermatitis (AD) patients but notwell characterized in adults.1 Topical medicationsare available in a variety of vehicles, and patients

have varying preferences among vehicles.2,3 Thegoal of this study was to assess adherence in adultswith AD to a single topical agent in three differentvehicles.

Methods. Following institutional review boardapproval, 25 subjects (age $ 18 yrs) with mild tomoderate AD (Investigators Global Assessment[IGA], 2 or 3 out of 5; body surface area, 5-30%)were randomized to receive twice daily hydrocor-tisone 17-butyrate 0.1% (Locoid; FerndaleLaboratories, Ferndale, MI) in one of three vehi-cles: cream, lipocream, or ointment. Adherencewas monitored electronically (MEMS; Aardex Corp,Fremont, CA). Disease severity was evaluated atbaseline and week 2 using the Eczema AreaSeverity Index (EASI), IGA, and target lesionassessments (TLA). Mean change in IGA, EASI,and target lesion scores from baseline to week 2were compared using t tests. Kruskal-Wallis andanalysis of variance tests were performed to com-pare outcomes across vehicles. The relationshipbetween adherence and treatment group wastested using a mixed model adjusting for withinpatient correlation.

Results. Twenty subjects 19 to 74 years of agecompleted the study (Fig 1). Overall adherenceacross all subjects was 70% (standard deviation 5

0.23). Mean adherence was not statistically differentbetween the three vehicle groups (F test; P 5 .39).Mean IGA, EASI, and target lesion assessment scoressignificantly improved in all three groups after 2weeks of treatment (Table I). The ointment grouphad a larger improvement in IGA, EASI, and TLA thanthe other vehicles; however, this difference was onlysignificant between ointment and cream for im-provement in IGA mean scores (P 5 .05). Therewere no reported adverse events related to themedication.

Discussion. The major finding in this smallstudy is the tremendous variation in use betweendifferent individuals. Patients took medications in-consistently, frequently missing doses. Some usedthe medication more than twice per day. However,nearly all patients reported near perfect usage of themedication. Physicians should expect their patientsto misuse topical medications regardless of whatthey report.

Differences in both mean adherence and meanoutcomes between vehicle groups were insignifi-cant, perhaps because of the small study size. We hadhoped that outcome would not effect adherenceover the short study interval, but the rapidity ofaction of hydrocortisone 17-butyrate 0.1% on AD isso fast that improvement in the disease complicatesstudies of adherence even over just 2 weeks.

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J AM ACAD DERMATOL

VOLUME 60, NUMBER 1

Letters 167

Fig 1. Flow of participants.

Adherence may have dropped as a result of the earlydisease improvement.

If AD does not improve with a topical corticoste-roid in the clinical setting, poor compliance shouldbe strongly considered as the cause of treatment

Table I. Overall efficacy (n ¼ 20)

Baseline (6 SD) Week 2 ( 6 SD) P

IGA (0, clear; 5,severe)

2.52 (0.51) 1.57 (0.60) \.001

EASI (0, clear; 72,severe)

8.30 (8.38) 3.44 (4.65) \.001

TLA (0, clear; 12,severe)

7.38 (2.09) 2.76 (2.07) \.001

There was significant improvement in mean scores by week 2.

EASI, Eczema Area Severity Index; IGA, Investigators Global

Assessment; TLA, target lesion assessments.

failure. When multiple medication vehicle optionsare available, it may be best to involve patients in thechoice and choose one they would be most likely touse.

Rebekah Wilson, BS,a Fabian Camacho, MS,a AdeleR. Clark, PA-C,a Trudye Young, MD,a RobinInabinet, LPN, CCRC,a Brad A. Yentzer, MD,a

and Steven R. Feldman, MD, PhDa,b,c

Departments of Dermatology,a Pathology,b andPublic Health Sciences,c Center for DermatologyResearch, Wake Forest University School of Med-icine, Winston-Salem, North Carolina

Supported by Ferndale Laboratories.

Conflicts of interest: None declared.

Reprint requests: Steven R. Feldman, MD, PhD,Department of Dermatology, Wake Forest

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JANUARY 2009

168 Letters

University School of Medicine, Medical CenterBlvd, Winston-Salem, NC 27157-1071

E-mail: [email protected]

REFERENCES

1. Krejci-Manwaring J, Tusa MG, Carroll C, Camacho F, Kaur M, Carr

D, et al. Stealth monitoring of adherence to topical medication:

CASE L

Solitary fixed drug eruption caused byfinasteride

To the Editor: We herein describe a patient with asolitary fixed drug eruption (FDE) appearing on thepenile shaft. An oral challenge test with finasteride(Propecia; Merck & Co, Whitehouse Station, NJ),which has been used for the treatment of androgenicalopecia, reproduced the symptomatic eruption atthe previously affected skin site. To our knowledge,this is the first report of FDE caused by finasteride.

A 39-year-old Japanese male had a 2-monthhistory of a pruritic, sore spot of erythema on thedorsal surface of the shaft of the penis. Reportedly,he had received a topical steroid, but the eruptionremained almost unchanged. The physical examina-tion revealed a tip of the thumbesize, solitary viola-ceous erythematous macule (Fig 1). No obviouserosions or blisters were evident. His medical historyincluded androgenic alopecia that was treated withthe oral administration of 1 mg/day finasteride(Propecia) until the onset of the eruption. He wasotherwise healthy and denied abnormal sexualhistory. Laboratory workup, including a serologicscreening for syphilis, was unremarkable.Microscopically, a biopsy of the lesion revealed scantperivascular infiltrates consisting of lymphocytes andeosinophils (Fig 2). Of note, melanophages weredeposited abruptly in the papillary dermis. Theepidermis was almost normal. On the basis of clin-icopathologic findings, FDE was suspected. Nomedication other than oral finasteride had beeninitiated before the onset of the eruption. Aftercessation of the finasteride use and restarting atopical steroid therapy, the symptomatic erythemarapidly resolved, leaving a mild pigmentation.Subsequently, a closed patch test on the upper armwith 10% to 20% finasteride in petrolatum (wt/vol),with or without tape stripping, yielded negativeresults. He refused a topical provocation test, and

adherence is very poor in children with atopic dermatitis. J Am

Acad Dermatol 2007;56:211-6.

2. Richards HL, Fortune DG, O’Sullivan TM, Main CJ, Griffiths CE.

Patients with psoriasis and their compliance with medication.

J Am Acad Dermatol 1999;41:581-3.

3. Feldman SR, Housman TS. Patients’ vehicle preference for

corticosteroid treatments of scalp psoriasis. Am J Clin Dermatol

2003;4:221-4.

doi:10.1016/j.jaad.2008.09.031

ETTERS

therefore underwent an oral provocation challengewith finasteride, which was capable of reproducingthe sore erythematous patch at the previouslyaffected penis shaft skin by the following day.

FDE is a unique skin reaction characterized byreappearing, well defined lesions at exactly the samesite when the causative medication is repeated. Thepathogenesis of the disease remains enigmatic,

Fig 1. A symptomatic violaceous erythematous patch onthe dorsal surface of the penis.

Fig 2. Histologically, the lesional skin showed perivascu-lar inflammatory infiltrates consisting of lymphocytes andeosinophils in the dermis. Note the melanophage depositsin the papillary dermis. (Hematoxylineeosin stain; originalmagnification: 3200.)