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Drug Trials Snapshots: DUPIXENT

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to DUPIXENT Prescribing Information for complete information.

DUPIXENT (dupilumab)
(DU-pix’-ent)
Regeneron Pharmaceuticals, Inc.
Approval date: March 28, 2017


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

DUPIXENT is used for treatment of moderate to severe atopic dermatitis in adult patients whose disease is not well controlled with topical therapies, or who cannot use topical therapies (topical therapies are applied directly to the affected areas of the skin).

How is this drug used?

DUPIXENT is an injection that is given under the skin (subcutaneous). Two injections of DUXIPENT are given on the first day followed by one injection every two weeks. DUPIXENT may be used with or without additional corticosteroid topical therapy.

What are the benefits of this drug?

More participants achieved clear or almost clear skin and a reduction in itch after treatment with DUPIXENT in comparison to those who were treated with placebo.

What are the benefits of this drug (results of trials used to assess efficacy)?

The table below summarizes efficacy results for the clinical trials based on the primary efficacy endpoint defined as the proportion of participants at Week 16 who achieved success. Success was defined as an IGA grade of Clear (score of 0) or Almost Clear (score of 1) with a 2-grade or greater improvement from baseline, comparing DUPIXENT-treated participants to placebo-treated participants.

Table 2. Primary Efficacy Outcomes in Participants with Moderate to Severe Atopic Dermatitis at Week 16

 Trial 1Trial 2Trial 3
DUPIXENTPlaceboDUPIXENTPlaceboDUPIXENT + TCSPlacebo + TCS
Number of participants randomized (FAS)a224224233236106315
IGA 0 or 1b,c38%10%36%9%39%12%
EASI-75)c51%15%44%12%69%23%
EASI-90c36%8%30%7%40%11%
Number of participants with baseline Peak Pruritus NRS score ≥4213212225221102299
Peak Pruritus NRS (≥4-point improvement)c41%12%36%10%59%20%

a Full Analysis Set (FAS) includes all participants randomized.
b Responder was defined as a participant with IGA 0 or 1 (“clear” or “almost clear”) with a reduction of ≥2 points on a 0-4 IGA scale.
c Participant who received rescue treatment or with missing data were considered as non-responders.

DUPIXENT Prescribing Information

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: DUPIXENT worked similarly in men and women.
  • Race: DUPIXENT worked similarly in White and Asian participants. The number of participants in other races was limited; therefore, differences in response among all races could not be determined.
  • Age: DUPIXENT worked similarly in different age groups. The number of participants above 65 years of age was limited; therefore, differences in response between participants above and below 65 years of age could not be determined.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?

The table below summarize efficacy results at Week 16 by subgroup for pooled Trials 1 and 2 based on the Full analysis set (FAS) population.

Table 4. Proportion of Responders by Sex, Race, and Age for Pooled Trials 1 and 2 (FAS population)

 Responders* at Week 16
DUPIXENT
 n/N (%)
Placebo
 n/N (%)
Difference DUPIXENT vs. Placebo
 % (95% CI**)
Sex
Men87/267 (33)16/250 (6)26 (17.73,34.36)
Women82/190 (43)27/210 (13)30 (20.73, 39.43)
Race
White128/320 (40)34/302 (11)29 (21.09, 36.13)
Black or African American5/23 (22)4/36 (11)11 (-15.56, 35.97)
Asian29/98 (30)3/106 (3)27 (13.21, 39.60)
Age Group
18-40 years101/267 (38)29/254 (11)26 (17.98, 34.56)
40 - <65>56/164 (34)13/189 (7)27 (16.99, 37.06)
≥65 years12/26 (46)1/17 (6)40 (10.67, 65.43)

*Responder=Participant with IGA 0 or 1 (“clear” or “almost clear”) with a reduction of ≥2 points on a 0-4 IGA scale. Participant was consider non-responder after rescue treatment use
** CI=confidence interval

Clinical trial report

What are the possible side effects?

DUPIXENT may cause serious side effects including allergic reactions and eye inflammation.

The most common side effects of DUPIXENT are injection site reactions, eye and eye lid inflammation and cold sores in the mouth.

What are the possible side effects?

The table below summarizes adverse reactions that occurred in clinical trials. Presented is the safety population that includes all participants who applied the treatment at least once according to the approved dosing regimen.

Table 5. Adverse Reactions Occurring in ≥1% of Participants in Atopic Dermatitis Trials through Week 16 (safety population)

 DUPIXENT MonotherapyaDUPIXENT + TCSb
Adverse ReactionDUPIXENT

N=529
n (%)
Placebo

N=517
n (%)
DUPIXENT+ TCS

N=110
 n (%)
Placebo + TCS

N=315
n (%)
Injection site reactions51 (10)28 (5)11 (10)18 (6)
Conjunctivitisd51 (10)12 (2)10 (9)15 (5)
Blepharitis2 (<>1 (<>5 (5)2 (1)
Oral herpes20 (4)8 (2)3 (3)5 (2)
Keratitise1 (<>04 (4)0
Eye pruritus3 (1)1 (<>2 (2)2 (1)
Other herpes simplex virus infectionf10 (2)6 (1)1 (1)1 (<>
Dry eye1 (<>02 (2)1 (<>

a pooled analysis of Trials 1, 2, and from one Phase 2 trial with the same dosing regimen
b analysis of Trial 3 where participants were on background concomitant topical corticosteroids (TCS) therapy
c DUPIXENT 600 mg at Week 0, followed by 300 mg every two weeks
d Conjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.
e Keratitis cluster includes keratitis, ulcerative keratitis, allergic keratitis, atopic keratoconjunctivitis, and ophthalmic herpes simplex.
f Other herpes simplex virus infection cluster includes herpes simplex, genital herpes, herpes simplex otitis externa, and herpes virus infection, but excludes eczema herpeticum.

DUPIXENT Prescribing Information

Were there any differences in side effects among sex, race and age?

  • Sex: The risk of side effects was higher in women than men.
  • Race: The majority of participants who reported side effects were White. The number of participants in other races who reported side effects was limited; therefore, differences in side effects among races could not be determined.
  • Age: The risk of side effects was similar in different age groups. The number of participants above 65 years of age was limited; therefore, differences in side effects between participants above and below 65 years of age could not be determined.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The table below summarizes subgroups of participants who reported an injection site reaction during clinical trials in pooled DUPIXENT monotherapy trials-safety population.

Table 6. Subgroup Analysis of Injection Site Reaction (safety population*)

SubgroupDUPIXENT
 n/N** (%)
Placebo
 n/N** (%)
Sex
Men18/314 (6)11/289 (4)
Women33/215 (15)17/228 (8)
Age Group (years)
18-4032/300 (11)16/289 (6)
40-6519/201 (10)10/209 (5)
≥650/28 (0)2/19 (11)
Race
White36/365 (10)24/341 (7)
Black or African American1/32 (3)2/40 (5)
Asian9/114 (8)2/120 (2)

*safety population includes participants who received DUPIXENT monotherapy from Trial 1, 2 and patients from one Phase 2 trial with the same dosing regimen
**n/N= number of participants with adverse reaction (n) in the subgroup (N)

Clinical trial report

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved DUPIXENT based primarily on evidence from three clinical trials of 1338 participants with moderate to severe atopic dermatitis. The trials were conducted in 427 centers in North America, Europe, Asia, and Australia.

The figure below summarizes how many men and women were in the clinical trials.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trials of the drug DUPIXENT. In total, 772 men (58%) and 566 (42%) participated in the clinical trials.

Adapted from FDA Statistical review

Figure 2 and Table 1 below summarize the percentage of participants by race in the clinical trials.

Figure 2. Baseline Demographics by Race

Pie chart summarizing the percentage of patients by race in DUPIXENT clinical trials. In total, 904 Whites (67%), 316 Asians (24%), 80 African Americans  (6%), and 38 Other (3%), participated in the clinical trials.

Adapted from FDA Statistical review

Table 1. Baseline Demographics by Race

RaceNumber of ParticipantsPercentage
White90467
Black or African American806
Asian31624
Other383

Adapted from FDA Statistical review

Figure 3 summarizes the percentage of participants by age in the clinical trials.

Figure 3. Baseline Demographics by Age

Pie charts summarizing how many individuals of certain age groups were in the clinical trials. In total, 1281 were younger than 65 years (96%), and 57 patients were 65 years and older (4%).

Adapted from FDA Statistical review

Who participated in the trials?

The table below summarizes participants by subgroup for the randomized population (FAS population) in the clinical trials.

Table 5. Baseline Demographics of Participants in the Clinical Trials (randomized population)

 Trial 1Trial 2Trial 3
 DUPIXENTPlaceboDUPIXENTPlaceboDUPIXENT
 +
TCS
Placebo
 +
TCS
Randomized224224233236106315
Sex
Men130 (58%)118 (53%)137 (59%)132 (56%)62 (59%)193 (61%)
Women94 (42%)106 (47%)96 (42%)104 (44%)44 (41%)122 (39%)
Age
Mean39.839.536.937.439.636.6
SD14.713.914.014.114.013.0
Range18-8518-8418-8818-8318-7318-76
Median383934354134
Age Group
<>208 (93%)216 (96%)223 (96%)227 (96%)101 (95%)306 (97%)
≥6516 (7%)8 (4%)10 (4%)9 (4%)5 (5%)9 (3%)
Race
White155 (69%)146 (65%)165 (71%)156 (66%)74 (70%)208 (66%)
Black or African American10 (5%)16 (7%)13 (6%)20 (9%)2 (2%)19 (6%)
Asian54 (24%)56 (25%)44 (19%)50 (21%)29 (27%)83 (26%)
Other5 (2%)6 (3%)11 (5%)10 (4%)1 (1%)5 (2%)

Adapted from FDA Statistical review

How were the trials designed?

The benefit and side effects of DUPIXENT were evaluated in three clinical trials of adult participants with moderate to severe atopic dermatitis. In two trials participants received treatment with either DUPIXENT or placebo injections every two weeks for 16 weeks. Neither the participants nor the health care providers knew which treatment was being given until after the trials were completed.

In the third trial, in addition to DUPIXENT or placebo injections, participants applied topical corticosteroids (TCS) to affected areas of the skin. This trial lasted 52 weeks. Neither the participants nor the health care providers knew which injection treatment was being given until after the trials were completed but they knew which TCS was being given.

Participants were evaluated for improvement of atopic dermatitis from the first to the last day of treatment. The improvement was measured for all three trials at Week 16 using the Investigator’s Global Assessment [IGA] score that measures the severity of disease on a scale from 0 to 4.

How were the trials designed?

The safety and efficacy of DUPIXENT were established in 3 randomized, double-blind, placebo-controlled trials. All participants had moderate to severe atopic dermatitis defined as a score of ≥3 using an Investigator’s Global Assessment [IGA] severity scale of 0 to 4, an Eczema Area and Severity Index (EASI) score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.

In Trials 1 and 2, participants received DUPIXENT or placebo injection every two weeks for 16 weeks.

In Trial 3, participants received DUPIXENT or placebo injection every two weeks with concomitant topical corticosteroids (TCS) and as needed topical calcineurin inhibitors for problem areas only. This trial lasted 52 weeks.

The primary efficacy outcome measure for all three trials was the proportion of participants at Week 16 who achieved success, defined as an IGA grade of Clear (score of 0) or Almost Clear (score of 1) with a 2-grade or greater improvement from baseline, comparing DUPIXENT-treated participants to vehicle-treated participants.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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