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Clinical Data

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Clearer skin is within sight1

Clearer skin is within sight1

ADvocate 1: EBGLYSS monotherapy through week 16 (N=424)2

Start strong: Patients taking EBGLYSS showed significant improvement in IGA* (0,1)1

43% of patients who received EBGLYSS monotherapy achieved clear or almost-clear skin (IGA 0 or 1) at week 16 vs 13% of patients who received placebo in ADvocate 1 (P<0.001).1,2

Primary endpoint: IGA (0,1) responders through week 16 in ADvocate 1 (N=424)1,2,a,b,c

aResponder was defined as a patient with an IGA 0 or 1 (“clear” or “almost-clear”) and a reduction of ≥2-points on a 0-4 IGA scale.1

bPatients received 500 mg of EBGLYSS at week 0 and week 2, and 250 mg Q2W through week 16.1

cPatients who received rescue therapy or discontinued treatment due to lack of efficacy were analyzed as nonresponders. Data after treatment discontinuation due to any other reason were considered missing. Any missing data were imputed using MCMC-MI.1

ADvocate 2 (N=427): 33% of patients who received EBGLYSS monotherapy achieved IGA 0 or 1 vs 11% with placebo at week 16 (P<0.001).1

Primary endpoint was the proportion of patients who achieved IGA 0 or 1 with a ≥2-point change from baseline at week 16.1

*IGA: A 5-point clinical assessment measure of atopic dermatitis (AD) severity in which 0=“clear,” 1=“almost-clear,” 2=“mild,” 3=“moderate,” and 4=“severe.”3

MCMC-MI=Markov chain Monte Carlo multiple imputation; Q2W=every 2 weeks; IGA=Investigator’s Global Assessment.

Start strong: EBGLYSS delivered clinically meaningful skin clearance1

59% of patients who received EBGLYSS monotherapy achieved a ≥75% improvement in EASI* score from baseline through week 16 vs 16% of patients who received placebo in ADvocate 1.1

Secondary endpoint: EASI 75 responders through week 16 in ADvocate 1 (N=424)1,2,4,a

aPatients who received rescue therapy or discontinued treatment due to lack of efficacy were analyzed as nonresponders. Data after treatment discontinuation due to any other reason were considered missing. Any missing data were imputed using MCMC-MI.1

ADvocate 2 (N=427): 52% of patients who received EBGLYSS monotherapy achieved EASI 75 vs 18% with placebo through week 16 (P<0.001).1,2

Primary endpoint was the proportion of patients who achieved IGA 0 or 1 with ≥2-point change from baseline at week 16.1

The response rate at week 2 was a non-ranked endpoint that was not controlled for multiplicity. No statistical significance can be derived from this result.2

*EASI: A composite index assessing the extent and severity of AD with scores ranging from 0 to 72, with the higher values indicating more severe and/or extensive disease. EASI 75 indicates an improvement of at least 75% in lesion extent and severity.5

EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; MCMC-MI=Markov chain Monte Carlo multiple imputation; Q2W=every 2 weeks.

START STRONG
Extensive skin clearance for patients with moderate-to-severe AD through week 161

Visible improvement through week 16 with EBGLYSS monotherapy1

Patients achieved clear or almost-clear skin1

Patient who achieved IGA 0,1 at 16 weeks from baseline6,a

Before Treatment

After Treatment

Images of patient who achieved IGA 0,1 at week 16 from baseline
Images of patient who achieved IGA 0,1 at week 16 from baseline

Clinical trial patient treated with EBGLYSS. Individual results may vary.

White background added for a consistent presentation across treatment time periods.

aIGA: A 5-point clinical assessment measure of AD severity in which 0=“clear,” 1=“almost-clear,” 2=“mild,” 3=“moderate,” and 4=“severe.”2

IGA=Investigator’s Global Assessment.

SELECT IMPORTANT SAFETY INFORMATION

Conjunctivitis and Keratitis

Conjunctivitis and keratitis adverse reactions have been reported in clinical trials. Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received EBGLYSS compared to those who received placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered during the treatment period. Advise patients to report new onset or worsening eye symptoms to their healthcare provider.

Long-lasting skin clearance at one year1

Efficacy maintained in patients who achieved results at week 161

Long-lasting skin clearance with monthly dosing1

Almost 3 out of 4 patients in ADvocate 1 who achieved IGA* 0 or 1† at week 16 maintained that score at 1 year with monthly EBGLYSS1

Long-lasting clearance: IGA (0,1) responders at week 521,a

  1. Patients who received systemic rescue therapy or discontinued treatment due to lack of efficacy were analyzed as nonresponders. Data after topical rescue medication or after treatment discontinuation due to any other reason were considered missing. Any missing data were imputed using MCMC-MI.1

ADvocate 2: 81% of patients who achieved clear or almost-clear skin (IGA 0 or 1) at week 16 maintained clearance at 1 year with monthly EBGLYSS (n=32); 50% with EBGLYSS withdrawal (placebo)(n=16).1

Primary endpoint was the proportion of subjects who achieved IGA 0 or 1 with ≥2-point change from baseline at week 16.1

The recommended dosage of EBGLYSS is an initial dose of 500 mg (two 250-mg injections) at week 0 and week 2, followed by 250 mg every 2 weeks until week 16 or later, when adequate clinical response is achieved. The maintenance dose is 250 mg every 4 weeks.

*IGA: A 5-point clinical assessment measure of AD severity in which 0=“clear,” 1=“almost-clear,” 2=“mild,” 3=“moderate,” and 4=“severe.”7

†Responder was defined as a patient with an IGA 0 or 1 (“clear” or “almost-clear”) and a reduction of ≥2 points on a 0-4 scale IGA scale.1

MCMC-MI=Markov chain Monte Carlo multiple imputation; Q4W=every 4 weeks; IGA=Investigator’s Global Assessment.

Long-lasting skin clearance is possible1

Almost 8 out of 10 patients in ADvocate 1 who achieved EASI* 75 at week 16 maintained this level of clearance at 1 year with once-monthly EBGLYSS.1

Maintained clearance: EASI 75 at week 52 in ADvocate 1 (n=62)1,7,a

  1. Patients who received systemic rescue therapy or discontinued treatment due to lack of efficacy were analyzed as nonresponders. Data after topical rescue medication or treatment discontinuation due to any other reason were considered missing. Any missing data were imputed using MCMC-MI.1

ADvocate 2: 85% of patients who achieved EASI 75 at week 16 maintained EASI 75 at 1 year with once-monthly EBGLYSS (n=53); 72% with EBGLYSS withdrawal (placebo) (n=27).1

Primary endpoint was the proportion of subjects who achieved IGA† 0 or 1 with ≥2-point change from baseline at week 16.1

  1. EASI: A composite index assessing the extent and severity of AD with scores ranging from 0 to 72, with the higher values indicating more severe and/or extensive disease. EASI 75 indicates an improvement of at least 75% in lesion extent and severity.5
  1. IGA: A 5-point clinical assessment measure of AD severity in which 0=“clear,” 1=“almost-clear,” 2=“mild,” 3=“moderate,” and 4=“severe.”3

EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; MCMC-MI=Markov chain Monte Carlo multiple imputation; Q2W=every 2 weeks; Q4W=every 4 weeks.

LAST LONG
Lasting skin clearance with monthly injections1

SELECT IMPORTANT SAFETY INFORMATION

Parasitic (Helminth) Infections

Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if EBGLYSS will influence the immune response against helminth infections by inhibiting IL-13 signaling. Treat patients with pre-existing helminth infections before initiating treatment with EBGLYSS. If patients become infected while receiving EBGLYSS and do not respond to antihelminth treatment, discontinue treatment with EBGLYSS until the infection resolves.

Start strong: 90% improvement in skin lesion extent and severity is possible1

38% of patients who received EBGLYSS monotherapy achieved ≥90% improvement in EASI* score at week 16 vs 9% of patients who received placebo in ADvocate 1.1

Secondary endpoint: EASI 90 responders through week 16 in ADvocate 1 (N=424)1,2,8,a

aPatients who received rescue therapy or discontinued treatment due to lack of efficacy were analyzed as nonresponders. Data after treatment discontinuation due to any other reason were considered missing. Any missing data were imputed using MCMC-MI.1

ADvocate 2 (N=427): 31% of patients who received EBGLYSS monotherapy achieved EASI 90 vs 10% with placebo at week 16 (P<0.001).1,2

Primary endpoint was the proportion of subjects who achieved IGA 0 or 1 with ≥2-point change from baseline at week 16.1

The response rate at week 4 was a non-ranked endpoint that was not controlled for multiplicity. No statistical significance can be derived from this result.2

  1. EASI: A composite index assessing the extent and severity of AD with scores ranging from 0 to 72, with the higher values indicating more severe and/or extensive disease. EASI 90 indicates an improvement of at least 90% in lesion extent and severity.5

EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; MCMC-MI=Markov chain Monte Carlo multiple imputation; Q2W=every 2 weeks.

START STRONG
90% or higher skin clearance is possible with EBGLYSS1

EASI* 90 results at 1 year9,10

Post hoc analysis: 78% of patients in ADvocate 1 who achieved EASI 90 at week 16 and then received monthly EBGLYSS maintained ≥90% skin clearance at 1 year9

Maintained clearance: EASI 90 at week 52 in ADvocate 1 (n=60)9,a

aPatients who received systemic rescue therapy or discontinued treatment due to lack of efficacy were analyzed as nonresponders. Data after topical rescue medication or treatment discontinuation due to any other reason were considered missing. Any missing data were imputed using MCMC-MI.1

ADvocate 2: 75% of patients (n=30) who achieved EASI 90 at week 16 and then received monthly EBGLYSS maintained EASI 90 at 1 year (46% with EBGLYSS withdrawal [placebo], n=15).10

Primary endpoint was the proportion of patients who achieved IGA† 0 or 1 with ≥2-point change from baseline at week 16.1

Data represent a post hoc analysis of non-ranked endpoints that were not controlled for multiplicity. No statistical significance can be derived from these results.

*EASI: A composite index assessing the extent and severity of AD with scores ranging from 0 to 72, with the higher values indicating more severe and/or extensive disease. EASI 90 indicates an improvement of at least 90% in lesion extent and severity.5
†IGA: a 5-point clinical assessment measure of AD severity in which 0=“clear,” 1=“almost clear,” 2=“mild,” 3=“moderate,” and 4=“severe.”3

EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; MCMC-MI=Markov chain Monte Carlo multiple imputation; Q4W=every 4 weeks.

Provide relief from intolerable itch

Almost half of patients* in ADvocate 1 experienced clinically meaningful itch reduction,† with some patients seeing reduction as early as week 21

Secondary endpoint: Pruritus NRS responders through week 16 in ADvocate 1 (N=393)1,2,a

ADvocate 2 (N=387): 40% of patients* who received EBGLYSS monotherapy experienced meaningful itch relief vs 12% with placebo at week 16 (P<0.001).1,2

Primary endpoint was the proportion of patients who achieved IGA 0 or 1 with ≥2-point change from baseline at week 16.1

  1. Patients analyzed had a baseline Pruritus NRS score of ≥4 points.2
  1. Pruritus NRS: A participant-reported, single-item, daily, 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating “No itch” and 10 indicating “Worst itch imaginable”. Pruritus NRS response was defined by a ≥4 point improvement from baseline. A change of ≥3 points is considered clinically meaningful.2,11

IGA=Investigator’s Global Assessment; NRS=Numeric Rating Scale; Q2W=every 2 weeks.

Patients achieving ≥4-point improvement on the Pruritus NRS at 1 year

80% of responders in ADvocate 1* who had a ≥4-point improvement on the Pruritus NRS† at week 16 maintained that level of improvement at week 52 with once-monthly EBGLYSS7

Pruritus NRS responders at week 52 in ADvocate 17,a

aPatients who received rescue therapy or discontinued treatment due to lack of efficacy were analyzed as nonresponders. Data after treatment discontinuation for any other reason was considered missing. Any missing data were imputed using MCMC-MI.1

*Patients had a Pruritus NRS score of ≥4 points at baseline and had a ≥4-point improvement on the Pruritus NRS at week 16.7
†Pruritus NRS: A participant-reported, single-item, daily, 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating “No itch” and 10 indicating “Worst itch imaginable.” A change of ≥3 points is considered clinically meaningful.11

ADvocate 2: Of the patients who had a ≥4-point improvement on the Pruritus NRS at week 16, 88% maintained that level of improvement at week 52 with once-monthly EBGLYSS (n=36); 68% with EBGLYSS withdrawal (placebo) (n=11).7

Primary endpoint was the proportion of patients who achieved IGA 0 or 1 with ≥2-point change from baseline at week 16.1

Data represents a prespecified endpoint. These results were not adjusted for multiplicity and no statistical significance can be derived.

IGA=Investigator’s Global Assessment; MCMC-MI=Markov chain Monte Carlo multiple imputation; NRS=Numeric Rating Scale; Q4W=every 4 weeks.

START STRONG
EBGLYSS provided clinically meaningful itch reduction1

SELECT IMPORTANT SAFETY INFORMATION

VACCINATIONS

EBGLYSS may alter a patient’s immunity and increase the risk of infection following administration of live vaccines. Prior to therapy with EBGLYSS, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines immediately prior to or during treatment with EBGLYSS. No data are available on the response to live vaccines.

EBGLYSS in combination with TCS

The efficacy and safety of EBGLYSS + TCS were evaluated vs placebo + TCS over the course of 16 weeks in the ADhere clinical trial12

ADhere study design12

aTCIs were permitted for sensitive areas only, such as the face, neck, intertriginous, and genital areas.12
b500 mg loading dose at week 0 and week 2.12
cThis included 53 pediatric patients.12
dPatients who completed the ADhere trial were offered open-label treatment in ADjoin; otherwise patients participated in a safety follow-up 12 weeks after their last dose.12
ePediatric patients between ages 12 and 18 had to weigh ≥40 kg.12
fPrimary endpoint was IGA (0,1) with ≥2-point improvement from baseline.12

Patients were allowed to taper or stop TCS use as needed. If AD lesions returned or a patient experienced a flare, TCS treatment could be resumed at the patient’s discretion. A mid-potency TCS, triamcinolone acetonide 0.1% cream, and a low-potency TCS, hydrocortisone 1% cream (for use on sensitive skin areas), were provided to all patients.12

ADhere efficacy and safety analyses were performed on a modified population, excluding 17 patients (from a single study site) whose eligibility criteria related to the severity of AD at baseline could not be confirmed.12

BSA=body surface area; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; LD=loading dose; LTE=long-term extension study; Q2W=every 2 weeks; TCI=topical calcineurin inhibitors; TCS=topical corticosteroid.

Efficacy results with EBGLYSS + TCS

EBGLYSS + TCS compared with placebo + TCS at week 16 in ADhere

  1. Patients who received rescue therapy or discontinued treatment due to lack of efficacy were analyzed as nonresponders. Data after treatment discontinuation due to any other reason were considered missing. Any missing data were imputed using MCMC-MI.1
  1. Patients analyzed had a baseline Pruritus NRS score of ≥4 points.12

Primary endpoint was the proportion of patients who achieved IGA 0 or 1 with ≥2-point change from baseline at week 16.1,12

*IGA: A 5-point clinical assessment measure of AD severity in which 0=“clear,” 1=“almost-clear,” 2=“mild,” 3=“moderate,” and 4=“severe.”12
†EASI: A composite index assessing the extent and severity of AD. EASI 75 and EASI 90 indicate an improvement of at least 75% and 90% in skin lesion extent and severity, respectively.12
‡Pruritus NRS: A participant-reported, single-item, daily, 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating “No itch” and 10 indicating “Worst itch imaginable.” A change of ≥3 points is considered clinically meaningful.13

EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; MCMC-MI=Markov chain Monte Carlo multiple imputation; NRS=Numeric Rating Scale; Q2W=every 2 weeks; TCS=topical corticosteroid.

SELECT IMPORTANT SAFETY INFORMATION

Adverse Reactions

The most common (≥1%) adverse reactions are conjunctivitis, injection site reactions, and herpes zoster.

IGA (0,1)* results and EASI 75† response rates for pediatric patients ages 12 and older who weigh ≥ 40kg1

ADvocate 1 + ADvocate 2: Pooled subgroup analysis of EBGLYSS monotherapy results through week 16

*IGA: A 5-point clinical assessment measure of AD severity in which 0=“clear,” 1=“almost clear,” 2=“mild,” 3=“moderate,” and 4=“severe.”

†EASI: A composite index assessing the extent and severity of AD with scores ranging from 0 to 72, with the higher value indicating more severe and/or extensive disease. EASI 75 indicates an improvement of at least 75% in lesion extent and severity.

EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment.

IGA* (0,1) results through week 16 for pediatric patients 12 and older who weigh ≥ 40kg1

47% of pediatric patients who received EBGLYSS monotherapy achieved IGA (0,1) at week 16 vs 14% who received placebo14

aResponder was defined as a patient with an IGA (0,1) (“clear” or “almost-clear”) and a reduction of ≥2 points on a 0-4 IGA scale.1
bPatients who received rescue therapy or discontinued treatment due to lack of efficacy were analyzed as nonresponders. Data after treatment discontinuation due to any other reason were considered missing. Any missing data were imputed using MCMC-MI.1
cPatients received 500 mg of EBGLYSS at week 0 and week 2, and 250 mg Q2W through week 16.1

*IGA: A 5-point clinical assessment measure of AD severity in which 0=“clear,” 1=“almost-clear,” 2=“mild,” 3=“moderate,” and 4=“severe.”3

Data represent a prespecified pooled subgroup analysis of pediatric patients from ADvocate 1 and ADvocate 2. These results were not adjusted for multiplicity and no statistical significance can be derived.15

Pediatric patients were defined as 12 years to less than 18 years of age and weighing ≥40 kg.1

Primary endpoint in ADvocate 1 and ADvocate 2 was the proportion of total population who achieved IGA (0,1) with ≥2-point change from baseline at week 16.1

aPatients who received rescue therapy or discontinued treatment due to lack of efficacy were analyzed as nonresponders. Data after treatment discontinuation due to any other reason were considered missing. Any missing data was imputed using MCMC-MI.1
bPatients received 500 mg of EBGLYSS at week 0 and week 2, and 250 mg Q2W through week 16.1

Data represent a prespecified pooled subgroup analysis of pediatric patients from ADvocate 1 and ADvocate 2. These results were not adjusted for multiplicity and no statistical significance can be derived.16

Pediatric patients were defined as between 12 years and less than 18 years of age and weighing ≥40 kg.1

Primary endpoint in ADvocate 1 and ADvocate 2 was the proportion of total population who achieved IGA† (0,1) with ≥2- point change from baseline at week 16.1

*EASI: A composite index assessing the extent and severity of AD with scores ranging from 0 to 72, with the higher values indicating more severe and/or extensive disease. EASI 75 indicates an improvement of at least 75% in lesion extent and severity.5

†IGA: A 5-point clinical assessment measure of AD severity in which 0=“clear,” 1=“almost clear,” 2=“mild,” 3=“moderate,” and 4=“severe.”3

EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; MCMC-MI=Markov chain Monte Carlo multiple imputation; Q2W=every 2 weeks.

IGA (0,1)* results and EASI† 75 response rates for pediatric patients ages 12 and older who weigh ≥ 40kg

ADvocate 1 + ADvocate 2: Pooled subgroup analysis of EBGLYSS monotherapy results at week 52

*IGA: A 5-point clinical assessment measure of atopic dermatitis (AD) severity in which 0=“clear,” 1=“almost clear,” 2=“mild,” 3=“moderate,” and 4=“severe.”

†EASI: A composite index assessing the extent and severity of AD with scores ranging from 0 to 72, with the higher value indicating more severe and/or extensive disease. EASI 75 indicates an improvement of at least 75% in lesion extent and severity.

aPatients who received systemic rescue therapy or discontinued treatment due to lack of efficacy were analyzed as nonresponders. Data after topical rescue medication or treatment discontinuation due to any other reason were considered missing. Any missing data were imputed using MCMC-MI.1
bPatients received EBGLYSS 500 mg at weeks 0 and 2 followed by EBGLYSS 250 mg Q2W from week 4 to week 16 and met IGA (0,1) or EASI 75 response criteria, respectively, at week 16 and were then rerandomized to EBGLYSS 250 mg Q4W in the maintenance phase.1

Data represent a prespecified pooled subgroup analysis of pediatric patients from ADvocate 1 and ADvocate 2. These results were not adjusted for multiplicity and no statistical significance can be derived.17,18

Pediatric patients were defined as between 12 years to less than 18 years of age and weighing ≥40 kg.1

Primary endpoint in ADvocate 1 and ADvocate 2 was the proportion of total population who achieved an IGA score of 0 or 1 with ≥2-point change from baseline at week 16.1

*IGA: A 5-point clinical assessment measure of AD severity in which 0=“clear,” 1=“almost clear,” 2=“mild,” 3=“moderate,” and 4=“severe.”7
†Responder was defined as a patient with IGA (0,1) (”clear“ or ”almost clear“) and a reduction of >=2 points on a 0-4 IGA scale or EASI 75, respectively.1
‡EASI: A composite index assessing the extent and severity of atopic dermatitis (AD) with scores ranging from 0 to 72, with the higher values indicating more severe and/or extensive disease. EASI 75 indicates an improvement of at least 75% in lesion extent and severity.7

EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; MCMC-MI=Markov chain Monte Carlo multiple imputation; Q2W=every 2 weeks; Q4W=every 4 weeks.

Pruritus NRS* ≥4-point improvement at week 16 and through week 52 for pediatric patients ages 12 and older who weigh ≥ 40kg†

ADvocate 1 + ADvocate 2: Pooled subgroup analysis of EBGLYSS monotherapy

*Pruritus NRS: A participant-reported, single-item, daily, 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating “No itch” and 10 indicating “Worst itch imaginable.” A change of ≥3 points is considered clinically meaningful.
†Patients analyzed had a baseline Pruritus NRS score of ≥4 points.

IGA=Investigator’s Global Assessment; NRS=Numeric Rating Scale.

Pruritus NRS* results through week 16 for pediatric patients ages 12 and older who weigh ≥ 40kg19

49% of pediatric patients who received EBGLYSS monotherapy achieved a ≥4-point improvement on the Pruritus NRS at week 16 vs 13% of patients who received placebo19†

aPatients who received rescue therapy or discontinued treatment due to lack of efficacy were analyzed as nonresponders. Data after treatment discontinuation due to any other reason were considered missing. Any missing data was imputed using MCMC-MI.1
bPatients received 500 mg of EBGLYSS at week 0 and week 2, and 250 mg Q2W through week 16.1

Data represent a prespecified pooled subgroup analysis of pediatric patients from ADvocate 1 and ADvocate 2. These results were not adjusted for multiplicity and no statistical significance can be derived.19

Pediatric patients were defined as 12 years to less than 18 years of age and weighing ≥40 kg.1

Primary endpoint in ADvocate 1 and ADvocate 2 was the proportion of total population who achieved IGA (0,1) with ≥2-point change from baseline at week 16.1

*Pruritus NRS: A participant-reported, single-item, daily, 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating “No itch” and 10 indicating “Worst itch imaginable.” A change of ≥3 points is considered clinically meaningful.13

†Patients analyzed had a baseline Pruritus NRS score of ≥4 points.14

IGA=Investigator’s Global Assessment; MCMC-MI=Markov chain Monte Carlo multiple imputation; NRS=Numeric Rating Scale; Q2W=every 2 weeks.

Pruritus NRS results maintained at week 52 for pediatric patients ages 12 and older who weigh ≥ 40kg20

91% of patients who achieved ≥4-point improvement on the Pruritus NRS at week 16 and then received EBGLYSS monthly maintained improvement at 1 year vs 50% of patients who received EBGLYSS withdrawal (placebo) maintained that level of improvement through week 52 (n=2).20†

aPatients who received systemic rescue therapy or discontinued treatment due to lack of efficacy were analyzed as nonresponders. Data after topical rescue medication or treatment discontinuation due to any other reason were considered missing. Any missing data were imputed using MCMC-MI.1
bPatients received EBGLYSS 500 mg at weeks 0 and 2 followed by EBGLYSS 250 mg Q2W from weeks 4 to 16 and met IGA (0,1) or EASI 75 response criteria, respectively, at week 16 and were then rerandomized to EBGLYSS 250 mg Q4W in the maintenance phase.1

Data represent a prespecified pooled subgroup analysis of pediatric patients from ADvocate 1 and ADvocate 2. These results were not adjusted for multiplicity and no statistical significance can be derived.20

Pediatric patients were defined as between 12 years to less than 18 years of age and weighing ≥40 kg.1

Primary endpoint in ADvocate 1 and ADvocate 2 was the proportion of total population who achieved an IGA score of 0 or 1 with ≥2-point change from baseline at week 16.1

*Pruritus NRS: A participant-reported, single-item, daily, 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating “No itch” and 10 indicating “Worst itch imaginable.” A change of ≥3 points is considered clinically meaningful.13
†Patients had a Pruritus NRS score of ≥4 points at baseline and had a ≥4-point improvement on the Pruritus NRS at week 16.1

IGA=Investigator’s Global Assessment; MCMC-MI=Markov chain Monte Carlo multiple imputation; NRS=Numeric Rating Scale; Q2W=every 2 weeks; Q4W=every 4 weeks.

EBGLYSS: most common adverse reactions

Adverse reactions occurring in ≥1% of EBGLYSS-treated patients vs placebo through week 161

aIntegrated analysis of ADvocate 1, ADvocate 2, and the phase 2 dose-finding trial (KGAF).1
bAnalysis of TCS concomitant therapy trial ADhere.1
cEBGLYSS 500 mg at week 0 and week 2, followed by 250 mg every 2 weeks.1
dConjunctivitis cluster includes conjunctivitis, conjunctivitis allergic, and conjunctivitis bacterial.1
eInjection site reactions cluster includes injection site-related: pain, erythema, reaction, discomfort, dermatitis, pruritus, swelling, and rash.1

In the monotherapy trials (ADvocate 1, ADvocate 2, and KGAF) through week 16, the proportion of subjects who discontinued due to adverse events was 2.4% in the EBGLYSS 250 mg every 2 weeks group and 1.8% in the placebo group. In the TCS trial (ADhere) through week 16, the proportion of subjects who discontinued treatment due to adverse events was 2.1% in the EBGLYSS 250 mg every 2 weeks + TCS group and 0% in the placebo + TCS group. The most common adverse reactions leading to discontinuation of EBGLYSS compared to the placebo group were conjunctivitis and keratitis (0.6% vs 0.3%) and injection site reactions (0.2% vs 0%) in the monotherapy trials; and conjunctivitis (0.7% vs 0%), and injection site reactions (0.7% vs 0%) in the TCS trial.1

Eosinophilia1
Increased post-baseline blood eosinophils were observed at a higher frequency in EBGLYSS-treated subjects compared to placebo. During the first 16 weeks, eosinophilia (>5000 cells/mcL) was observed in 0.4% in the EBGLYSS-treated subjects and 0% in subjects receiving placebo. Blood eosinophil elevations were generally transient and did not result in discontinuation.

Conjunctivitis and keratitis1
Conjunctivitis was the most frequently reported eye disorder. Most cases of conjunctivitis and keratitis were mild or moderate in severity and recovered or resolved without treatment interruption or discontinuation.

Injection site reactions1
Injection site reactions were reported by 3% of the EBGLYSS group and 1% of the placebo group in the first 16 weeks of the monotherapy trials. Incidence of injection site reactions declined with continued treatment. Most events were mild or moderate and recovered without treatment discontinuation.

Q2W=every 2 weeks; TCS=topical corticosteroid.

EBGLYSS Safety Considerations

EBGLYSS1,21:
Box with a slash icon

No boxed warning

Vial with a slash through icon

No lab monitoring

Circle with a slash icon

Not an immunosuppressant or steroid

Adult embracing adolescent icon

Safety profile for pediatric patients (12 years and older and ≥40 kg) was generally consistent with the overall population

Two drug containers with swapping arrows icon

No expected drug-drug interactions. No significant hepatic metabolism or renal elimination.

Additionally, the 52-week safety profile was generally consistent with the 16-week safety profile

Most common TEAEs occurring in ≥1% of patients from weeks 0–52/5622

aPooled data from four phase 3 trials (ADvocate 1, ADvocate 2, ADhere, ADjoin).22
bIncludes all patients who received EBGLYSS 250 mg Q2W as induction treatment and/or EBGLYSS 250 mg Q4W as maintenance treatment regimen. For patients on EBGLYSS 250 mg Q2W longer than 16 weeks, only the first 16 weeks of EBGLYSS 250 mg Q2W is included in analyses. For patients who required open label EBGLYSS Q2W after receiving EBGLYSS Q4W, data from open label/Q2W was not included in the analysis.22

At one year, 25 patients (2.5%; N=991) discontinued treatment due to adverse events.22

IR=incidence rate; Q2W=every 2 weeks; Q4W=every 4 weeks; TEAE=treatment-emergent adverse event.

Adverse events of clinical interest23,24

aPooled data from three phase 3 trials (ADvocate 1, ADvocate 2, ADhere) and one phase 2 dosing range trial (KGAF).23
b‘EBGLYSS weeks 0-16’ includes all patients who received EBGLYSS 250 mg Q2W from weeks 0-16. ‘EBGLYSS weeks 0-52/56’ includes all patients who received EBGLYSS 250 mg Q2W as induction treatment and/or EBGLYSS 250 mg Q4W as maintenance treatment regimen. For patients on EBGLYSS 250 mg Q2W longer than 16 weeks, only the first 16 weeks of EBGLYSS 250 mg Q2W is included in analyses. For patients who required open label EBGLYSS Q2W after receiving EBGLYSS Q4W, data from open label/Q2W was not included in the analysis.24
cPooled data from four phase 3 trials (ADvocate 1, ADvocate 2, ADhere, ADjoin).24
dKeratitis cluster included a search for the preferred terms keratitis, atopic keratoconjunctivitis, allergic keratitis, ulcerative keratitis, and vernal keratoconjunctivitis.23
eHerpes infections were defined using the MedDRA HLT of “herpes infection” and included the following preferred terms: oral herpes, herpes zoster, herpes simplex, and eczema herpeticum.23
fSkin infections were defined using the MedDRA HLT of “skin structures and soft tissue infections” and included the following preferred terms: cellulitis, eczema impetiginous, folliculitis, staphylococcal skin infection, cellulitis staphylococcal, furuncle, erysipelas, and fungal skin infection.23
HLT=High-Level Term; IR=incidence rate; MedDRA=Medical Dictionary for Regulatory Activities; NMSC=non-melanoma skin cancer; Q2W=every 2 weeks; Q4W=every 4 weeks.

References:

  1. EBGLYSS (lebrikizumab-lbkz). Prescribing Information. Lilly USA, LLC.
  2. Silverberg JI, Guttman-Yassky E, Thaçi D, et al; for ADvocate1 and ADvocate2 Investigators. Two phase 3 trials of lebrikizumab for moderate-to-severe atopic dermatitis. N Engl J Med. 2023;388(12):1080-1091. doi:10.1056/NEJMoa2206714
  3. Data on File. Lilly USA, LLC. DOF-LK-US-0007.
  4. Data on File. Lilly USA, LLC. DOF-LK-US-0005.
  5. Data on File. Lilly USA, LLC. DOF-LK-US-0004.
  6. Data on File. Lilly USA, LLC. DOF-LK-US-0037.
  7. Blauvelt A, Thyssen JP, Guttman-Yassky E, et al. Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: 52-week results of two randomized double-blinded placebo-controlled phase III trials. Br J Dermatol. 2023;188(6):740-748. doi:10.1093/bjd/ljad022
  8. Data on File. Lilly USA, LLC. DOF-LK-US-0008.
  9. Data on File. Lilly USA, LLC. DOF-LK-US-0021.
  10. Data on File. Lilly USA, LLC. DOF-LK-US-0022.
  11. Rams A, Baldasaro J, Bunod L, et al. Assessing itch severity: content validity and psychometric properties of a patient-reported pruritus numeric rating scale in atopic dermatitis. Adv Ther. 2024;41(4):1512-1525. doi:10.1007/s12325-024-02802-3
  12. Simpson EL, Gooderham M, Wollenberg A, et al; for ADhere Investigators. Efficacy and safety of lebrikizumab in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis: a randomized clinical trial (ADhere). JAMA Dermatol. 2023;159(2):182-191. doi:10.1001/jamadermatol.2022.5534
  13. Yosipovitch G, Rams A, Baldasaro J, et al. Content validity and assessment of the psychometric properties and score interpretation of a pruritus numeric rating scale in atopic dermatitis. Poster presented at: Annual Revolutionizing Atopic Dermatitis (RAD) Conference; December 11-13, 2021; Chicago, IL.
  14. Hebert A, Flohr C, Hong HC, et al. Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials. Poster presented at: American Academy of Dermatology (AAD); March 17-21, 2023; New Orleans, LA.
  15. Data on File. Lilly USA, LLC. DOF-LK-US-0017.
  16. Data on File. Lilly USA, LLC. DOF-LK-US-0015.
  17. Data on File. Lilly USA, LLC. DOF-LK-US-0019.
  18. Data on File. Lilly USA, LLC. DOF-LK-US-0016.
  19. Data on File. Lilly USA, LLC. DOF-LK-US-0018.
  20. Data on File. Lilly USA, LLC. DOF-LK-US-0025.
  21. Data on File. Lilly USA, LLC. DOF-LK-US-0028.
  22. Data on File. Lilly USA, LLC. DOF-LK-US-0012.
  23. Stein Gold L, Thaçi D, Thyssen JP, et al. Safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis: an integrated analysis of eight clinical trials. Am J Clin Dermatol. 2023;24(4):595-607. doi:10.1007/s40257-023-00792-6
  24. Data on File. Lilly USA, LLC. DOF-LK-US-0034.

IMPORTANT SAFETY INFORMATION

Contraindication: EBGLYSS is contraindicated in patients with prior serious hypersensitivity to lebrikizumab-lbkz or any excipients of EBGLYSS.

Warnings and Precautions

Hypersensitivity
Hypersensitivity reactions, including angioedema and urticaria, have been reported with use of EBGLYSS. If a serious hypersensitivity reaction occurs, discontinue EBGLYSS and institute appropriate therapy.

Conjunctivitis and Keratitis
Conjunctivitis and keratitis adverse reactions have been reported in clinical trials. Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received EBGLYSS compared to those who received placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered during the treatment period. Advise patients to report new onset or worsening eye symptoms to their healthcare provider.

Parasitic (Helminth) Infections
Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if EBGLYSS will influence the immune response against helminth infections by inhibiting IL-13 signaling. Treat patients with pre-existing helminth infections before initiating treatment with EBGLYSS. If patients become infected while receiving EBGLYSS and do not respond to antihelminth treatment, discontinue treatment with EBGLYSS until the infection resolves.

Vaccinations
EBGLYSS may alter a patient’s immunity and increase the risk of infection following administration of live vaccines. Prior to therapy with EBGLYSS, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines immediately prior to or during treatment with EBGLYSS. No data are available on the response to live vaccines.

Adverse Reactions

The most common (≥1%) adverse reactions are conjunctivitis, injection site reactions, and herpes zoster.

EBGLYSS is available as a 250mg/2mL subcutaneous injection prefilled pen or prefilled syringe.

Please click to access Prescribing Information and Patient Information.
Please see Instructions for Use included with the device.

LK HCP ISI AD APP

INDICATION

EBGLYSS is indicated for the treatment of adults and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.