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CIBINQO Clinical Studies (abrocitinib)

14 CLINICAL STUDIES

The efficacy of CIBINQO as monotherapy and in combination with background topical corticosteroids were evaluated in 3 randomized, double-blind, placebo-controlled trials [Trial-AD-1 (NCT03349060), Trial-AD-2 (NCT03575871), and Trial-AD-3 (NCT03720470)] in 1615 subjects 12 years of age and older (CIBINQO is not approved for use in pediatric patients) with moderate-to-severe atopic dermatitis as defined by Investigator's Global Assessment (IGA) score ≥3, Eczema Area and Severity Index (EASI) score ≥16, body surface area (BSA) involvement ≥10%, and Peak Pruritus Numerical Rating Scale (PP-NRS) ≥4 at the baseline visit prior to randomization.

Overall, 53% of subjects were male, 69% of subjects were white, 64% of subjects had a baseline IGA score of 3 (moderate AD), and 36% of subjects had a baseline IGA score of 4 (severe AD). The baseline mean EASI score was 30. The baseline mean age was 36 years old with 8% of subjects 12 to less than 18 years old and 92% of subjects 18 years of age or older. Subjects in these trials were those who had inadequate response to previous topical therapy, or were subjects for whom topical treatments were medically inadvisable, or who had received systemic therapies including dupilumab. In each of the trials, over 40% of subjects had prior exposure to systemic therapy. In Trial-AD-1 and Trial-AD-2, 6% of the subjects had received dupilumab, whereas prior use of dupilumab was not allowed in Trial-AD-3.

Trial-AD-1, Trial-AD-2, and Trial-AD-3 assessed the co-primary endpoints of IGA and EASI-75 responses at Week 12. The designs of the trials are summarized in Table 8.

Table 8. Summary of Clinical Study Designs
Study Name
(regimen type)
Treatment Duration
Population
(number of randomized and dosed subjects)
Treatment ArmsCo-Primary Endpoints
Abbreviations: EASI=Eczema Area and Severity Index; IGA=Investigator's Global Assessment; QD=once daily; Q2W=once every 2 weeks.
*
Pediatric subjects 12 years of age and older were included in the trial population; however, CIBINQO is not approved for use in pediatric patients.
IGA response was based on IGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points.
EASI-75 was based on ≥75% improvement in EASI from baseline.
§
Dupilumab treatment in Trial-AD-3: An initial dose of 600 mg on day 1, followed by 300 mg Q2W.
Trial-AD-1
(monotherapy)
12 weeks
*Subjects 12 years of age or older (387)Oral administration of:
  • CIBINQO 200 mg QD
  • CIBINQO 100 mg QD
  • Placebo
  • IGA response at Week 12
  • EASI-75 at Week 12
Trial-AD-2
(monotherapy)
12 weeks
*Subjects 12 years of age or older (391)Oral administration of:
  • CIBINQO 200 mg QD
  • CIBINQO 100 mg QD
  • Placebo
Trial-AD-3
(combination therapy)
16 weeks
Subjects 18 years of age or older (837)Oral administration of:
  • CIBINQO 200 mg QD
  • CIBINQO 100 mg QD
  • Placebo
Subcutaneous administration of:
  • Dupilumab 300 mg Q2W SC§
All subjects received background topical corticosteroids

Clinical Response

Monotherapy Trials

The results of the CIBINQO monotherapy trials (Trial-AD-1 and Trial-AD-2) are presented in Table 9.

Table 9. Efficacy Results of CIBINQO Monotherapy at Week 12 in Subjects with Moderate-to-Severe AD (Trial-AD-1 and Trial-AD-2)
Trial-AD-1Trial-AD-2
CIBINQOPlacebo
N=77
CIBINQOPlacebo
N=78
200 mg QD
N=154
100 mg QD
N=156
200 mg QD
N=155
100 mg QD
N=158
Abbreviations: CI=confidence interval; EASI=Eczema Area and Severity Index; IGA=Investigator Global Assessment; QD=once daily.
*
IGA responders were subjects with IGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points.
EASI -75 responders were patients with ≥75% improvement in EASI from baseline.
IGA 0 or 1*44%24%8%
38%
28%9%
  Difference from Placebo
(95% CI)
36%
(26%, 46%)
16%
(7%, 25%)
-29%
(19%, 39%)
19%
(9%, 29%)
-
EASI-7562%
40%
12%
61%44%10%
  Difference from Placebo
(95% CI)
51%
(40%, 61%)
28%
(18%, 39%)
-50%
(40%, 61%)
33%
(23%, 44%)
-

The proportion of subjects achieving PP-NRS4 at Week 2 (defined as an improvement of ≥4 points from baseline in PP-NRS) was higher in subjects treated with CIBINQO monotherapy 200 mg once daily (28% in Trial-AD-1 and 24% in Trial-AD-2) and 100 mg once daily (11% in both trials) compared to placebo (2% in both trials).

A higher proportion of subjects in the CIBINQO monotherapy 100 mg or 200 mg once daily arm compared to placebo achieved improvement in itching at Week 12.

Combination Therapy Trial

The results of CIBINQO in combination with background topical corticosteroids (Trial-AD-3) are presented in Table 10.

Table 10. Efficacy Results of CIBINQO with Concomitant Topical Corticosteroids at Week 12 in Subjects with Moderate-to-Severe AD (Trial-AD-3)
% RespondersCIBINQOPlacebo
N=131
200 mg QD
N=226
100 mg QD
N=238
Abbreviations: CI=confidence interval; EASI=Eczema Area and Severity Index; IGA=Investigator Global Assessment; QD=once daily.
*
IGA responders were subjects with IGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points.
EASI-75 responders were subjects with ≥75% improvement in EASI, from baseline.
IGA 0 or 1*at Week 1247%36%14%
  Difference from Placebo
(95% CI)
34%
(25%, 42%)
23%
(15%, 31%)
-
EASI-75 at Week 1268%58%27%
  Difference from Placebo
(95% CI)
41%
(32%, 51%)
32%
(22%, 41%)
-

The proportions of subjects achieving PP-NRS4 at Week 2 was higher in subjects treated with CIBINQO 200 mg once daily (30%) and 100 mg once daily (14%) in combination with background medicated topical therapies compared to placebo (8%).

Examination of age, gender, race, weight and previous systemic AD therapy treatment did not identify differences in response to CIBINQO 100 mg or 200 mg once daily among these subgroups in Trial-AD-1, Trial-AD-2, and Trial-AD-3.

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