To increase successful initiation and completion rates among patients with acne who are treated with isotretinoin, improved screening and/or education among those who may be unable to comply with the requirements of iPLEDGE™ — a special restricted distribution program for dispensing isotretinoin — is recommended, according to the results of a retrospective cohort study published in the Journal of the American Academy of Dermatology.
The researchers sought to examine isotretinoin treatment compliance and to investigate common reasons associated with nonadherence.
They conducted a retrospective chart review of 544 patients from the University of California, Los Angeles, who received a prescription for isotretinoin between 2010 and 2015.
Adherence was defined as reaching a cumulative isotretinoin dose of 120 to 150 mg/kg and/or completion of therapy, per determination by the treating clinician. According to this definition, patients were divided into 1 of 6 major categories: completed, likely completed, lost to follow-up (LTFU), patient stopped, physician stopped, or never started. Exclusion criteria were incomplete medical records or access restriction, chronic low-dose or alternative treatment, and non-acne diagnosis.
A total of 458 patients were included in the analysis, of whom 50.4% were women. Of the participants, 53.9% completed treatment, 18.3% likely completed therapy, 15.5% were LTFU, 5.9% stopped treatment on physician orders, 4.2% self-discontinued, and 3.1% never began therapy. When the never-started group and the physician-stopped group were excluded from the total study population, an overall adherence rate of 78.6% was reported, which counted the completed and likely completed groups as adherent and the LFTU and patient-stopped groups as nonadherent.
There were no statistically significant differences reported with respect to age, gender, or prior isotretinoin course(s) status between those who were adherent and those who were nonadherent. When LFTU vs adherent patients were compared, however, significantly more patients LFTU were men and had received prior course(s) of isotretinoin (P =.03 and P =.04, respectively). Overall, the majority of patients who were nonadherent did not complete treatment because of failure to return to the clinic for follow-up appointments. Moreover, >33% of these participants failed to complete their initial follow-up appointment after beginning treatment.
The most frequently cited reason for physician and self-discontinuation was mood changes. Additional reasons for self-discontinuation were travel/moving and unwillingness to reduce alcohol intake. Difficulties with iPLEDGE were cited as the most common reason for not initiating therapy. Of note, of the 133 female patients who completed treatment, only 67% of them had a documented 30-day post-pregnancy test.
The investigators concluded that the retrospective nature of this study limited their ability to capture why patients were LTFU. They recommend close attention to first month follow-up by telephone and message reminders as ways to increase the successful initiation and completion of isotretinoin treatment.
Kazemi T, Sachsman SM, Wilhalme HM, Goh C. Isotretinoin therapy: a retrospective cohort analysis of completion rates and factors associated with non-adherence. [published online February 22, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.02.032