Long-term Adherence to Topical Psoriasis Treatment Can Be Abysmal

A 1-year Randomized Intervention Study Using Objective Electronic Adherence Monitoring

H. Alinia; S. Moradi Tuchayi; J.A. Smith; I.M. Richardson; N. Bahrami; S.C. Jaros; L.F. Sandoval; M.E. Farhangian; K.L. Anderson; K.E. Huang; S.R. Feldman

Disclosures

The British Journal of Dermatology. 2017;176(3):759-764. 

In This Article

Methods

A 12-month, investigator-blinded, prospective study of subjects with mild-to-moderate psoriasis was conducted (trial registration number: NCT01802580). Approval was obtained from the Wake Forest University Institutional Review Board, and written informed consent was obtained from all patients. Adult subjects (aged at least 18 years) who were considered good candidates for topical treatment with fluocinonide ointment were recruited from the dermatology clinic at Wake Forest School of Medicine (WFSM). Individuals were excluded if they had a known sensitivity to topical fluocinonide, were unable to complete all study-related visits, had inadequate internet access, were started on any other prescription medication (topical or systemic) for psoriasis while participating in the study, had extensive disease not amenable to topical treatment, were reluctant to be treated with ointment or were on systemic anti-inflammatory psoriasis treatments for less than 3 months.

Subjects were randomized in a 1 : 1 ratio to standard-of-care or to an intervention group that reported their impression of the state of their psoriasis over the internet on a weekly basis (see Fig. 1). Subjects in both the control and intervention groups received topical fluocinonide 0·05% ointment to be applied twice daily, excluding body sites (face, axillae and genitals) for which treatment with fluocinonide is contraindicated. Fluocinonide was used in this study as it is a commonly prescribed psoriasis treatment and could be prescribed for regular use for a full year (as opposed to clobetasol, which cannot be used continuously for more than 2–4 weeks). Adherence to fluocinonide was assessed using Medication Event Monitoring System (MEMS®) caps, electronic monitors affixed to the medication containers. Investigators and subjects were blinded to the adherence data until the final (month 12) visit.

Figure 1.

CONSORT diagram. Yes: received internet survey, No: control group.

At the initial study visit, subjects were given fluocinonide in a jar with a MEMS® cap and given instructions on its use; the medication could be refilled whenever they ran out. Subjects were told to bring their medication jars to be weighed at every return visit, but they were not told about the use of the electronic adherence monitors until the final visit.

Return visits were scheduled for months 1, 3, 6 and 12, at which times study staff reviewed concomitant medications and adverse events, assessed efficacy outcomes [Investigator's Global Assessment (IGA) scale and Psoriasis Area and Severity Index (PASI)], collected and weighed medication containers, and downloaded data from the MEMS® caps. If the subject discontinued treatment prior to month 12, an early termination evaluation, following the protocol for the last study visit, was conducted as soon as possible.

Statistical Analyses

The adherence population consisted of all subjects with usable MEMS® data for the given analysis window. Subjects were excluded from analysis if MEMS® data were not recorded due to malfunction or error. MEMS® events recorded after 03.00 h on the final visit day were excluded, and events recorded within 30 min of each other (e.g. 17.00 h and 17.15 h) were counted as one event. Excluded events were deleted before data were exported from PowerView software.

Adherence rates were determined as previously described.[7] Analysis was performed using SAS 9.2 (SAS Institutes, Cary, NC, U.S.A.) with type I error rate controlled at 0·05. Descriptive statistics were generated with mean ± SD or median (interquartile range) for continuous measures depending on the distribution of the data and frequency distribution for categorical variables. Estimates for adherence rates were obtained as the mean adherence rate along with the corresponding 95% confidence interval. Because smoking and alcohol consumption may modify adherence among patients with psoriasis, these habits were noted among patients and assessed in the statistical models.[9] Group multivariate analysis of variance (manova) analysis was used to compare the IGA and PASI scores at baseline to confirm that there was no significant difference between the internet survey group and the control group. Once confirmed, the pair-test analysis was used to analyse changes in severity over the study period.

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