DISCUSSION
In addition to efficacy, tolerability is important to consider when choosing a therapy for multiple AKs or clinical evidence of field cancerization. Foley et al found common reasons for non-adherence or non-persistence to topical regimens to be length of treatment, local skin reaction severity and duration, and uncertainty regarding the treatment regimen.39 For example, topical preparations of 5-FU, especially in the potent 5% formulation, traditionally have carried unfavorable tolerability profiles; 14.9% of patients discontinued 5% 5-FU cream when applied twice daily for 4 weeks.16 Other topical agents with harsher tolerability profiles, such as 5% imiquimod applied daily 3 times per week for 16 weeks, saw 13.2% of participants discontinue therapy in the treatment group.24
This is in contrast to patients in the treatment arm of phase III studies evaluating safety/efficacy of tirbanibulin 1%, in which no patients discontinued due to treatment-related adverse events.10 The severity of local skin reactions and duration of treatment matched discontinuation data as well: severe erythema, scabbing/crusting, and flaking/scaling/dryness were experienced in 33.2%, 27.4%, and 8.7% of patients in the 5% imiquimod study, respectively, versus 6%, 2%, and 9% in the tirbanibulin 1% study.10,24 Additionally, compared to the months-long duration of treatment for imiquimod, tirbanibulin only requires once daily application for 5 days, limiting both the duration of potential local skin reactions and increasing ease of use.
This is in contrast to patients in the treatment arm of phase III studies evaluating safety/efficacy of tirbanibulin 1%, in which no patients discontinued due to treatment-related adverse events.10 The severity of local skin reactions and duration of treatment matched discontinuation data as well: severe erythema, scabbing/crusting, and flaking/scaling/dryness were experienced in 33.2%, 27.4%, and 8.7% of patients in the 5% imiquimod study, respectively, versus 6%, 2%, and 9% in the tirbanibulin 1% study.10,24 Additionally, compared to the months-long duration of treatment for imiquimod, tirbanibulin only requires once daily application for 5 days, limiting both the duration of potential local skin reactions and increasing ease of use.
