Investigator global assessment (IGA) of Acne Vulgaris and IGA Success among patients with moderate to severe non-nodular Acne Vulgaris (AV) administered sarecycline in community practices across the U.S in PROSES study: Analysis by concomitant medication

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Hilary Baldwin
James Del Rosso
Leon Kircik
Linda Stein Gold
Adelaide Hebert
Evan A. Rieder
Andrew F. Alexis
Julie C. Harper
Richard G. Fried
Siva Narayanan
Volker Koscielny
Ismail Kasujee
Emmy Graber


Acne, IGA, PROSES, sarecycline, Real World Evidence, RWE


Introduction: The objective of this analysis was to evaluate facial IGA and the associated IGA success, stratified by the use of concomitant acne medications, among AV patients administered sarecycline in community practices across the U.S.

Methods: A single-arm, prospective cohort study (PROSES) was conducted with moderate-to-severe non-nodular AV patients >9 years who were prescribed sarecycline in real-world community practices in the US. Facial IGA of AV status was collected on a five-point adjectival response scale (0(clear)-4(severe)). IGA success at week-12 was defined as >2-grade improvement and score 0-clear or 1-almost clear at week-12. Proportion of patients achieving IGA success was analyzed, stratified by the use of any concomitant AV medication during the study (Yes vs. No (monotherapy)).

Results: A total of 253 AV patients completed the study (adults 60.08% (mean age 26.63); pediatric 39.92% (mean age 14.81); female: 66.40%; white/caucasian: 68.38%, african-american: 8.70%; other races: 22.92%). Per IGA at baseline, 86.56% & 13.44% had moderate and severe AV, respectively. Key concomitant treatments for AV observed during the study included: topical retinoids (24.51%), topical antibiotics (13.44%), benzoyl peroxide (5.93%), topical dapsone (5.14%) and other (17.00%; predominantly adapalene/benzoyl peroxide). Half of the patients (49.80%) were on sarecycline monotherapy (i.e., did not use any concomitant treatments for AV). For the overall study cohort, IGA success at week-12 was 58.89%. At week-12, IGA success was 59.84% among patients using concomitant AV medications, and 57.94% among patients using no concomitant AV medications (i.e., on sarecycline monotherapy).

Conclusion: Within the study cohort administered sarecycline, a narrow-spectrum, tetracycline-derived antibiotic, for 12 weeks, majority of patients achieved IGA success at week-12, and the outcomes were similar among patients on sarecycline monotherapy and those on concomitant AV medications.



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