INTRODUCTION
Adherence to topical acne therapies in dermatology is relatively low with a reported mean adherence to non-isotretinoin treatments at just 35%, ultimately resulting in poor patient outcomes.1 As a result, unnecessary additional visits or exposure to higher doses as well as other medications altogether may follow serving as a source of continued patient frustration, economic burden, and potential risk to the patient.2 Multiple factors have been reported to contribute to nonadherence
including lack of perceived efficacy, fear of side effects, difficulty incorporating the treatment routine, and costs of treatment.3,4 Adherence to topical medications is complex and is influenced by patient-physician relationships, patient education,
and the medications themselves.5
While successful adherence to topical medications is multifactorial,
topical medications that provide a quicker onset of action and are well tolerated, addressing two of these issues, may help to improve adherence and ultimately treatment outcomes. Data on a fixed-dose combination of adapalene/benzoyl peroxide
gel, 0.1%/2.5% (A-BPO) demonstrated that this formulation is safe and effective throughout a range of acne severities and in patients as young as 9 years old.6-10 While assessments during
these studies were made at multiple time points up to 12 weeks, the overall impact across the studies early in treatment was not elucidated. Therefore, we conducted a meta-analysis of 14 clinical studies using A-BPO to assess the 4-week efficacy and overall tolerability.
METHODS
Data were pooled from 14 clinical studies for the meta-analysis and data from these studies that contained a vehicle control arm were pooled and assessed. Lesion counts were summarized
at each visit. The change from baseline was calculated as post-baseline count minus baseline count so that a negative change from baseline represented an improvement. Subjects who did not have inflammatory lesions at baseline were excluded
from the percent change calculations for inflammatory lesions. Frequencies and percentages were calculated for investigator
global assessment (IGA) scores (scale of 0 [clear] to 4 [very severe]).
Tolerability assessments were assessed by the investigator,
which included dryness, erythema, scaling, and stinging/burning, and assessed on 4 point scales of none to severe. Frequencies and percentages of each tolerability assessment were calculated at each study visit and the worst post-baseline scores were summarized. If no post-baseline data existed for a subject, then the worst post-baseline data was set equal to the baseline values.
Not all studies included all measurements. Within each study protocol, the last observation carried forward was performed for missing efficacy data according to the visit schedule in the protocol. If a protocol had no scheduled visit at week 4, then no imputations were performed at week 4. Therefore, the number of subjects at each study visit varied in the meta-analysis. No
