DISCUSSION
Pooled data from two phase 3 studies indicate that participants with moderate-to-severe acne experienced improved qualityof- life with tazarotene 0.045% lotion, applied once daily for 12 weeks. In the pooled population, significant differences between tazarotene 0.045% lotion and vehicle lotion were found in the acne symptoms domain of the Acne-QoL, along with 3 items from that domain (bumps on face, bumps full of pus, and concerned with scarring). These results were consistent with the previously reported clinician-rated symptom assessments in the pooled population, which showed significantly greater reductions from baseline to week 12 with tazarotene 0.045% in inflammatory lesions (-57.9% vs -47.8% [tazarotene 0.045% vs vehicle]; P<0.001) and noninflammatory lesions (-56.0% vs -42.0%; P<0.001).10
To understand the potential effects of symptom severity on quality of life, Acne-QoL outcomes were analyzed in participants who had an EGSS score=3 (“moderate”) or score=4 (“severe”) at baseline. In participants treated with tazarotene 0.045% lotion, the magnitude of Acne-QoL score improvements was comparable between EGSS subgroups. However, statistical comparisons between tazarotene 0.045% lotion and vehicle lotion within each subgroup revealed some potential differences. The EGSS score=4 subgroup had significantly greater improvements with tazarotene 0.045% lotion (P<0.05 versus vehicle lotion) in 3 role-social items (meeting new people, going out in public, and interacting with the opposite sex or same sex if applicable), none of which were statistically significant in the EGSS score=3 subgroup. Mean improvements for the acne symptoms domain was significantly greater for tazarotene 0.045% lotion in the EGSS score=3 subgroup (P<0.05 vs vehicle lotion) but not the EGSS score=4 subgroup. Moreover, acne symptoms items that were significant the EGSS score=3 subgroup (bumps on face, bumps full of pus, concerned with scarring) were different from those that were significant in the EGSS score=4 subgroup (scabbing from acne, oily skin). Together, these results suggest that patients with either moderate or severe acne symptoms will likely experience improved quality of life with tazarotene 0.045% lotion. However, patients with more severe symptoms may have greater concerns about social situations and may differ as to which acne symptoms have negative effects on quality of life than those with moderate symptoms.
It was expected that segregating the pooled ITT population by the median Acne-QoL total score at baseline would show greater improvements in the subgroup with worse quality of life (total score <60). However, the magnitude of difference between these participants and those with better quality of life (total score ≥60) was somewhat surprising. No statistical testing was conducted between the Acne-QoL subgroups, but mean improvements in all 4 domains were markedly different between subgroups (score <60 vs ≥60): self-perception (12.1 vs 3.0); role-emotional (10.1 vs 2.0); role-social (8.2 vs 1.2); acne symptoms (9.2 vs 3.7; Figure 3). Some participants in the Acne- QoL score ≥60 subgroup might have experienced a ceiling effect (ie, domain score improved to the maximum possible score), but mean scores at week 12 in this subgroup were below the maximum possible score in all 4 domains (mean, maximum): self-perception (25.5, 30); role-emotional (24.3, 30); role-social (22.1, 24); acne symptoms (22.0, 30); data for mean scores at week 12 not shown in figures.
Both Acne-QoL subgroups had significantly greater improvements with tazarotene 0.045% lotion in the acne symptoms domain and in 2 acne symptoms items (bumps on face, bumps full of pus; P<0.05 vs vehicle lotion). However, the Acne-QoL score <60 subgroup had significant improvements with tazarotene 0.045% lotion in 4 additional items (not looking my best, meeting new people, interacting with the opposite sex, concerned with scarring) that were not significant in the Acne-QoL score ≥60 subgroup. In conjunction with the Acne- QoL domain results, these findings strongly suggest that in patients who report poor quality of life due to acne, evaluations should not be limited to clinical assessments of lesions and skin condition. For these patients, issues of social and emotional wellbeing may be equally important, and it is critical to understand whether improvements in the physical symptoms of acne are coinciding with quality-of-life improvements.
Other studies have shown the negative impact of acne on quality life in female and non-White patients.11-13 Therefore, demographic factors may also need to be considered when assessing quality of life in patients with moderate-to-severe acne. At baseline in participants who were randomized to tazarotene 0.045%, the Acne-QoL subgroup with worse quality of life (score <60) had a higher percentage of participants who were female or Black versus those with better quality of life (score ≥60): female (81.8% vs 50.9%); Black (19.2% vs 11.8%). In addition, results from the exploratory analyses indicated greater improvements for females versus males in all 4 Acne-QoL domains, with the largest differences in self-perception (9.2 vs 4.3) and role-emotional (7.6 vs 2.9). Black participants also had greater mean improvements versus White participants in all 4 domains, particularly in the domains of self-perception (10.3 vs 7.2) and role-social (7.2 vs 4.4). Given the clinical improvements that have been demonstrated in both of these subgroups,14,15 tazarotene 0.045% lotion may be an attractive treatment option for female and/or Black patients who express negative feelings about their appearance, self-confidence, or ability/willingness to socialize.
These post hoc analyses are limited by the study designs. Acne-QoL was not a primary endpoint in either study, with no Acne-QoL criteria required for eligibility. In addition, the studies were limited to patients with moderate-to-severe acne and therefore, the results of this post hoc analysis may not be
To understand the potential effects of symptom severity on quality of life, Acne-QoL outcomes were analyzed in participants who had an EGSS score=3 (“moderate”) or score=4 (“severe”) at baseline. In participants treated with tazarotene 0.045% lotion, the magnitude of Acne-QoL score improvements was comparable between EGSS subgroups. However, statistical comparisons between tazarotene 0.045% lotion and vehicle lotion within each subgroup revealed some potential differences. The EGSS score=4 subgroup had significantly greater improvements with tazarotene 0.045% lotion (P<0.05 versus vehicle lotion) in 3 role-social items (meeting new people, going out in public, and interacting with the opposite sex or same sex if applicable), none of which were statistically significant in the EGSS score=3 subgroup. Mean improvements for the acne symptoms domain was significantly greater for tazarotene 0.045% lotion in the EGSS score=3 subgroup (P<0.05 vs vehicle lotion) but not the EGSS score=4 subgroup. Moreover, acne symptoms items that were significant the EGSS score=3 subgroup (bumps on face, bumps full of pus, concerned with scarring) were different from those that were significant in the EGSS score=4 subgroup (scabbing from acne, oily skin). Together, these results suggest that patients with either moderate or severe acne symptoms will likely experience improved quality of life with tazarotene 0.045% lotion. However, patients with more severe symptoms may have greater concerns about social situations and may differ as to which acne symptoms have negative effects on quality of life than those with moderate symptoms.
It was expected that segregating the pooled ITT population by the median Acne-QoL total score at baseline would show greater improvements in the subgroup with worse quality of life (total score <60). However, the magnitude of difference between these participants and those with better quality of life (total score ≥60) was somewhat surprising. No statistical testing was conducted between the Acne-QoL subgroups, but mean improvements in all 4 domains were markedly different between subgroups (score <60 vs ≥60): self-perception (12.1 vs 3.0); role-emotional (10.1 vs 2.0); role-social (8.2 vs 1.2); acne symptoms (9.2 vs 3.7; Figure 3). Some participants in the Acne- QoL score ≥60 subgroup might have experienced a ceiling effect (ie, domain score improved to the maximum possible score), but mean scores at week 12 in this subgroup were below the maximum possible score in all 4 domains (mean, maximum): self-perception (25.5, 30); role-emotional (24.3, 30); role-social (22.1, 24); acne symptoms (22.0, 30); data for mean scores at week 12 not shown in figures.
Both Acne-QoL subgroups had significantly greater improvements with tazarotene 0.045% lotion in the acne symptoms domain and in 2 acne symptoms items (bumps on face, bumps full of pus; P<0.05 vs vehicle lotion). However, the Acne-QoL score <60 subgroup had significant improvements with tazarotene 0.045% lotion in 4 additional items (not looking my best, meeting new people, interacting with the opposite sex, concerned with scarring) that were not significant in the Acne-QoL score ≥60 subgroup. In conjunction with the Acne- QoL domain results, these findings strongly suggest that in patients who report poor quality of life due to acne, evaluations should not be limited to clinical assessments of lesions and skin condition. For these patients, issues of social and emotional wellbeing may be equally important, and it is critical to understand whether improvements in the physical symptoms of acne are coinciding with quality-of-life improvements.
Other studies have shown the negative impact of acne on quality life in female and non-White patients.11-13 Therefore, demographic factors may also need to be considered when assessing quality of life in patients with moderate-to-severe acne. At baseline in participants who were randomized to tazarotene 0.045%, the Acne-QoL subgroup with worse quality of life (score <60) had a higher percentage of participants who were female or Black versus those with better quality of life (score ≥60): female (81.8% vs 50.9%); Black (19.2% vs 11.8%). In addition, results from the exploratory analyses indicated greater improvements for females versus males in all 4 Acne-QoL domains, with the largest differences in self-perception (9.2 vs 4.3) and role-emotional (7.6 vs 2.9). Black participants also had greater mean improvements versus White participants in all 4 domains, particularly in the domains of self-perception (10.3 vs 7.2) and role-social (7.2 vs 4.4). Given the clinical improvements that have been demonstrated in both of these subgroups,14,15 tazarotene 0.045% lotion may be an attractive treatment option for female and/or Black patients who express negative feelings about their appearance, self-confidence, or ability/willingness to socialize.
These post hoc analyses are limited by the study designs. Acne-QoL was not a primary endpoint in either study, with no Acne-QoL criteria required for eligibility. In addition, the studies were limited to patients with moderate-to-severe acne and therefore, the results of this post hoc analysis may not be
