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

Abstract

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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Hilary Baldwin,1James Del Rosso,2Leon Kircik,3Linda Stein Gold,4Adelaide Hebert,5Evan A Rieder,6Andrew F. Alexis,7Julie C. Harper,8Richard G. Fried,9
Siva Narayanan,10 Volker Koscielny,11 Ismail Kasujee,11 Emmy Graber12
1Acne Treatment and Research Center, Brooklyn, NY; 2JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 3Icahn School of Medicine, Mount Sinai, New York, NY;
4Henry Ford Health System, Bloomfield, MI; 5UTHealth McGovern Medical School, Houston, TX; 6New York University Grossman School of Medicine, New York, NY;
7Weill Cornell Medical College, New York, NY; 8The Dermatology and Skin Care Center of Birmingham, Birmingham, A L; 9Yardley Dermatology Associates, Yardley, PA;
10Avant Health LLC, Bethesda, MD; 11Almirall SA, Barcelona, Spain; 12The Dermatology Institute of Boston and Northeastern University, Boston, MA.
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 USE
Introduction: Objective of the 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. 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.
SYNOPSIS
CONCLUSIONS
• Within the study cohort administered sarecycline, a
narrow-spectrum, tetracycline-derive d antibiotic, for 12
weeks, majority of patients achieved IGA success at
week-12, and the outcomes were similar among
patients on sarecycline m onotherapy and those on
concomitant AV medications.
Sponsored by Almirall, S.A.
METHODS
• A single-arm, prospective cohort study (PROSES) was
conducted with moderate-to-se vere non-nodular AV
patients >9 years who were prescribed sarecycline i n
real-world community practices in the US.
• A total of 300 subjects were enrolled from 30 community
practices across the U.S .
• Patients and clinicians c ompleted surveys and
clinical assessments at baseline and weeks 4, 8 &
12. Concomitant medication use was collected at
baseline and week-12.
• 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.
• Last observation carried forward (LOCF) imput ation
was considered for imput ing missing data for the
calculation of IGA and IGA success; however, there
was no missing data at week-12, within the analytic
population.
• Proportion of patients achieving IGA success was
analyzed, stratified by t he use of any concomitant AV
medication during the s tudy (Yes vs. No
(monotherapy)).
OBJECTIVE
• The objective of this analysis was to evaluate facial IGA
and the associated IGA success, s tratified by the use of
concomitant acne medications , among AV patients
administered sarecycline in com munity practices across
the U.S.
RESULTS
Table 1: Patient Demographics (N=253)
Demographic Group Proportion of
Patients
Age Group, % Pediatric (<18 yrs) 39.92
Adult (≥18 yrs) 60.08
Age Group, Mean Pediatric (<18 yrs) 26.63
Adult (≥18 yrs) 14.81
Gender, % Male 33.60
Female 66.40
Race,%
White 66.80
Other 15.81
Black/African
American 9.88
Asian 5.93
Prefer not to answer 3.16
American Indian or
Alaskan 0.79
Native
Hawaiian/Pacific
Islander
0.40
Ethnicity,%
(Hispanic, Latino or
of Spanish Origin)
Yes 33.99
No 66.01
Baseline IGA, % Moderate 86.56
Severe 13.44
Table 2: Concomitant Medication Use (N=253)
Medication Class n(%)
Has not used any acne medication 126 (49.80)
Topical medication
Topical retinoids 62 (24.51)
Salicylic acid 3 (1.19)
Benzoyl peroxide 15 (5.93)
Topical antibiotics 34 (13.44)
Topical Dapsone 13 (5.14)
Azelaic acid 7 (2.77)
Topical Clascoterone 2 (0.79)
Other* 43 (17.00)
Oral Medication^ 12 (4.74)
• A total of 253 AV patients completed the study, demographics shown in table 1.
• Key concomitant treatments for AV observed during the study included: topical retinoids,
topical antibiotics, benzoyl peroxide, topical dapsone, and adapalene/benzoyl peroxide.
• For the overall study cohort , IGA success at week-12 was 58.89%.
• There was no statistically signif icant difference between the facial IGA of the group of
patients on concomitant AV treatments and those patients only on sarecycline
monotherapy (figure 2).
*28 patients were on adapalene/benzoyl peroxide among others; ^11 were on spironolactone
0.00%
9.09%
33.99%
58.89%
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
Baseline Week 4 Week 8 Week 12
% Patients with IGA Success: Clear/Almost Clear
Figure 1: Proportion of Patients with a Facial IGA of “Clear/Almost
Clear” Significantly Increased Over 12-Week Study Period.
All Patients (N=253)
p<.0001
p<.0001
P-values for 4,8,12 refers statistical significance of change from baseline.
0%
11.0 2%
38.58%
59.84%
0%
7.14%
29.37%
57.94%
0%
10%
20%
30%
40%
50%
60%
Baseline Week 4 Week 8 Week 12
% Patients with IGA Success: Clear/Almost Clear
Figure 2: Facial IGA Success Did Not Differ Significantly between
The Concomitant AV Treatment Group and The Monotherapy
Group
Patients on Concomitant AV Treatments (N=127) Patients on Monotherapy (N=126)
IGA Success
p>0.05
p>0.05
p>0.05
RESULTS
p<.0001