Adbry Drug Information
Generic name: TRALOKINUMAB-LDRM
Interleukin-13 Antagonist [EPC]
Uses of Adbry
is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids. ADBRY is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
ADBRY can be used with or without topical corticosteroids.
Dosage & Administration of Adbry
| Prefilled syringe | 600 mg (four 150 mg injections) |
|---|---|
| Autoinjector | 600 mg (two 300 mg injections) |
Side Effects of Adbry
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions from Clinical Trials in Adults The safety of ADBRY was evaluated in a pool of 5 randomized, double-blind, placebo-controlled trials in subjects with moderate-to-severe atopic dermatitis including three phase 3 Eczema Tralokinumab trials (ECZTRA 1, ECZTRA 2, and ECZTRA 3), a dose-finding trial, and a vaccine response trial. The safety population had a mean age of 37 years; 43% of subjects were female, 67% were White, 21% were Asian, and 9% were Black.
In terms of co-morbid conditions, 39% of the subjects had asthma, 49% had hay fever, 36% had food allergy, and 21% had allergic conjunctivitis at baseline. In these 5 atopic dermatitis trials, 1964 subjects were treated with subcutaneous injections of ADBRY, with or without concomitant topical corticosteroids (TCS). A total of 807 subjects were treated with ADBRY for at least 1 year. ECZTRA 1 and ECZTRA 2 compared the safety of ADBRY monotherapy to placebo through Week 52. ECZTRA 3 compared the safety of ADBRY + TCS to placebo + TCS through Week 32. Weeks 0 to 16 (ECZTRA 1, ECZTRA 2, and ECZTRA 3): Table 1 summarizes the adverse reactions identified in the pool of 3 trials (ECZTRA 1, ECZTRA 2, and ECZTRA 3) and that occurred at a rate of at least 1% in the ADBRY 300 mg every other week monotherapy group, and in the ADBRY 300 mg every other week + TCS trial, all at a higher rate than placebo during the first 16 weeks of treatment.
Table 1: Adverse Reactions Occurring in ≥1% of the ADBRY Monotherapy Group or the ADBRY + TCS Group in the Atopic Dermatitis Trials through Week 16 Adverse Reaction ADBRY Monotherapy Pooled analysis of ECZTRA 1 and ECZTRA 2. ADBRY + TCS Analysis of ECZTRA 3 where subjects were on background TCS therapy. ADBRY 300 mg Q2W ADBRY 600 mg at Week 0, followed by 300 mg every other week. PLACEBO ADBRY 300 mg Q2W + TCS PLACEBO + TCS N=1180 n (%) N=388 n (%) N=243 n (%) N=123 n (%) Upper respiratory tract infections Upper respiratory tract infections cluster includes upper respiratory tract infection, viral upper respiratory tract infection, pharyngitis, and nasopharyngitis; mainly reported as common cold. 281 79 73 19 Conjunctivitis Conjunctivitis cluster includes conjunctivitis and allergic conjunctivitis. 88 12 33 6 Injection site reactions Injection site reactions cluster includes pain, erythema, and swelling. 87 16 27 1 Eosinophilia Eosinophilia cluster includes eosinophilia and eosinophil count increased. 17 2 3 0 In the monotherapy trials (ECZTRA 1 and ECZTRA 2) through Week 16, the proportion of subjects who discontinued treatment due to adverse reactions was 0.7% in the ADBRY 300 mg every other week group and 0% of the placebo group.
In the concomitant TCS trial (ECZTRA 3) through Week 16, the proportion of subjects who discontinued treatment due to adverse reactions was 0.8% in the ADBRY 300 mg every other week +TCS group and 0% of the placebo + TCS group. The most common adverse reactions leading to discontinuation in the ADBRY group compared to the placebo group were injection site reaction (0.3% v. 0) and eosinophilia (0.3% v. 0) in ECZTRA 1 and ECZTRA 2; and injection site reaction (0.4% v. 0) and conjunctivitis (0.4% v. 0) in ECZTRA 3. Weeks 16-52 (ECZTRA 1 and ECZTRA 2) and Weeks 16-32 (ECZTRA 3): The safety profile of ADBRY 300 mg every other week with or without TCS during maintenance treatment was consistent with that in the initial 16-week treatment period. In addition, the frequency of adverse reactions with ADBRY 300 mg every other week and every 4 weeks in ECZTRA 1 and ECZTRA 2 was 44% and 34%, respectively, and 43% and 26% with ADBRY 300 mg + TCS every other week and every 4 weeks in ECZTRA 3, respectively.
Adverse Reactions from Clinical Trials in Pediatric Subjects 12 Years of Age and Older The safety of tralokinumab was assessed in a trial of 289 subjects 12 to 17 years of age with moderate-to-severe atopic dermatitis (ECZTRA 6). Of the 289 subjects, 195 were treated with ADBRY and 94 were treated with matching placebo. The safety profile of ADBRY in these subjects, assessed through the initial treatment period of 16 weeks and the long-term period of 52 weeks, was comparable to the safety profile from trials in adults with atopic dermatitis. Safety through 268 weeks (ECZTEND) ECZTEND was an open-label, multicenter, long-term extension trial that further assessed the safety of ADBRY for up to 5 years of treatment in adults and pediatric subjects 12 years of age and older with moderate-to-severe atopic dermatitis who had previously participated in ADBRY trials.
The safety data in ECZTEND reflect exposure to ADBRY in 1672 subjects who received 300 mg of ADBRY every two weeks (Q2W), including 1422 exposed for at least 52 weeks, 1184 exposed for at least 104 weeks, 701 exposed for at least 156 weeks, and 33 exposed for at least 264 weeks. The long-term safety profile was consistent with the safety profile observed up to week 16. Specific Adverse Reactions Conjunctivitis and Keratitis Conjunctivitis, including allergic conjunctivitis, was reported in 7.5% of subjects treated with ADBRY 300 mg every other week (29 events per 100 subject-years of exposure) and in 3.1% of subjects treated with placebo (12 events per 100 subject-years of exposure) in the initial treatment period of up to 16 weeks in the pool of 5 trials. In the ADBRY group, 126 subjects reported 145 events of conjunctivitis, with 114 events resolved at the end of initial treatment period.
Conjunctivitis led to discontinuation of treatment in 2 subjects. During the initial treatment period of the monotherapy trials (ECZTRA 1 and ECZTRA 2), conjunctivitis was reported in 7.7% of subjects treated with ADBRY 300 mg every other week (30 events per 100 subject-years of exposure). During the maintenance treatment period of the monotherapy trials (ECZTRA 1 and ECZTRA 2) from 16 to 52 weeks, conjunctivitis was reported in 14 (8.9%) subjects treated with ADBRY 300 mg every other week (20 events per 100 subject-years of exposure) and in 10 (6.3%) subjects treated with ADBRY 300 mg every 4 weeks (14 events per 100 subject-years of exposure); and included no serious events, 1 severe event, and 1 event that led to discontinuation. A comparable pattern was seen during the continuation treatment period of an additional 16 weeks in the ADBRY combination trial ECZTRA 3. Keratoconjunctivitis (including 1 atopic keratoconjunctivitis (0.1%)) was reported in 5 (0.3%) subjects (1.2 events per 100 subject-years of exposure) treated with ADBRY and 0% of subjects treated with placebo during the initial treatment period of up to 16 weeks in the pool of 5 trials.
Keratoconjunctivitis was reported as resolved in 2 out of 5 subjects by the end of trials. Keratitis (including 1 ulcerative keratitis (0.1%)) was reported in 4 (0.2%) subjects treated with ADBRY (0.9 events per 100 subject-years of exposure) and 1 (0.2%) subject (viral keratitis) treated with placebo (0.6 events per 100 subject-years of exposure) during the initial treatment period of up to 16 weeks in the pool of 5 trials. Keratitis was reported as resolved in all but 1 subject by the end of trials.
None of the events were serious or led to treatment discontinuation. During the initial treatment period of the monotherapy trials (ECZTRA 1 and ECZTRA 2), keratitis event rate of 2 per 100 subject-years was reported for ADBRY 300 mg every other week. During the maintenance treatment period of the monotherapy trials (ECZTRA 1 and ECZTRA 2) from 16 to 52 weeks in the ADBRY 300 mg every other week group, keratitis was reported in 1 (0.6%) subject (ulcerative, severe, resolved after discontinuation) at an exposure-adjusted event rate of 1.2 per 100 subject-years, and keratoconjunctivitis (not serious or severe, resolved, not led to discontinuation) was reported in 3 (1.9%) subjects (3.6 events per 100 subject-years of exposure). No events of keratitis or keratoconjunctivitis was reported in ADBRY every 4 weeks or placebo groups.
In the continuation treatment period of ECZTRA 3 (from 16 to 32 weeks), there were no additional events of keratitis reported for subjects randomized to ADBRY 300 mg + TCS. Eosinophil Counts ADBRY-treated subjects had a greater mean initial increase from baseline in eosinophil count compared to subjects treated with placebo. The mean and median increases in blood eosinophils from baseline to Week 4 were 190 and 100 cells/mcL, respectively. The increase in the ADBRY-treated subjects declined to baseline level with continued treatment.
Eosinophilia (> 5000 cells/mcL) in the initial treatment period of up to 16 weeks was reported in 1.2% in the ADBRY-treated subjects and 0.3% in the placebo-treated subjects. The safety profile for subjects with eosinophilia was comparable to the safety profile for all subjects included in the pool of 5 atopic dermatitis trials.
Warnings & Cautions for Adbry
Hypersensitivity Hypersensitivity reactions including anaphylaxis and angioedema have been reported with use
of ADBRY. If a serious hypersensitivity reaction occurs, discontinue ADBRY immediately and initiate appropriate therapy.
Conjunctivitis and Keratitis Conjunctivitis and keratitis occurred more frequently in atopic dermatitis
subjects who received ADBRY. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering 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 ADBRY will influence the immune response against helminth infections by inhibiting IL-13 signaling. Treat patients with pre-existing helminth infections before initiating treatment with ADBRY. If patients become infected while receiving ADBRY and do not respond to antihelminth treatment, discontinue treatment with ADBRY until the infection resolves.
Risk of Infection with Live Vaccines
ADBRY may alter a patient's immunity and increase the risk of infection following administration of live vaccines. Prior to initiating therapy with ADBRY, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines during treatment with ADBRY. Limited data are available regarding coadministration of ADBRY with non-live vaccines.
Pregnancy Safety for Adbry
Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADBRY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/. Risk Summary There are limited data from the use of ADBRY in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations ). In an enhanced pre-and post-natal developmental study, no adverse developmental effects were observed in offspring born to pregnant monkeys after intravenous administration of tralokinumab-ldrm during organogenesis through parturition at doses up to 10 times the maximum recommended human dose (MRHD). The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses and peaks during the third trimester.
Therefore, ADBRY may be present in infants exposed in utero. The potential clinical impact of tralokinumab-ldrm exposure in infants exposed in utero should be considered. Data Animal Data In a pre- and post-natal development study, intravenous doses up to 100 mg/kg tralokinumab-ldrm were administered to pregnant cynomolgus monkeys once every week from gestation day 20 to parturition.
No maternal or developmental toxicity was observed at doses up to 100 mg/kg/week (10 times the MRHD on a mg/kg basis of 10 mg/kg/week). In an enhanced pre- and post-natal development study, intravenous doses up to 100 mg/kg tralokinumab-ldrm (10 times the MRHD on a mg/kg basis of 10 mg/kg/week) were administered to pregnant cynomolgus monkeys once every week from the beginning of organogenesis to parturition. No treatment-related adverse effects on embryofetal toxicity or malformations, or on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age.
Pediatric Use of Adbry
Pediatric Use The safety and effectiveness of ADBRY have been established for the treatment of moderate-to-severe atopic dermatitis in pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Use of ADBRY in this age group is supported by a multicenter, randomized, double-blind, placebo-controlled trial (ECZTRA 6) in 289 subjects 12 to 17 years of age with moderate-to-severe atopic dermatitis. Of the 289 subjects, 195 were treated with ADBRY and 94 were treated with matching placebo.
The safety and effectiveness were consistent between subjects 12 to 17 years of age and adult subjects . Safety and effectiveness of ADBRY have not been established in pediatric patients younger than 12 years of age.
Contraindications for Adbry
is contraindicated in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY . Known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY.
Overdosage Information for Adbry
There is no specific treatment for ADBRY overdose. In the event of overdosage, contact Poison Control (1-800-222-1222) for latest recommendations and monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.
Clinical Studies of Adbry
Adults The efficacy of ADBRY was assessed in three randomized, double-blind, placebo-controlled trials. Efficacy was assessed in a total of 1934 subjects 18 years of age and older with moderate-to-severe atopic dermatitis (AD) not adequately controlled by topical medication(s). Disease severity was defined by an Investigator's Global Assessment (IGA) score ≥ 3 in the overall assessment of AD lesions on a 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 (BSA) involvement of ≥10%. At baseline, 58% of subjects were male, 69% of subjects were White, 50% of subjects had a baseline IGA score of 3 (moderate AD), and 50% of subjects had a baseline IGA score of 4 (severe AD). The baseline mean EASI score was 32 and the baseline weekly averaged Worst Daily Pruritus Numeric Rating Scale (NRS) was 8 on a scale of 0-10. In all three trials, subjects received subcutaneous injections of ADBRY 600 mg or placebo on Day 0, followed by 300 mg every other week or placebo for 16 weeks. Responders were defined as achieving an IGA 0 or 1 ("clear" or "almost clear") or EASI-75 (improvement of at least 75% in EASI score from baseline) at Week 16. To evaluate maintenance of response in the monotherapy trials (ECZTRA 1 and ECZTRA 2), subjects responding to initial treatment with ADBRY 300 mg every other week were re-randomized to ADBRY 300 mg every other week, ADBRY 300 mg every 4 weeks or placebo every other week for another 36 weeks following first dose administration.
Subjects randomized to placebo in the initial treatment period who achieved a clinical response at Week 16 continued to receive placebo every other week for another 36 weeks. Non-responders at Week 16, and subjects who lost clinical response during the maintenance period were placed on open-label treatment with ADBRY 300 mg every other week and optional use of TCS. In the combination therapy trial (ECZTRA 3), subjects received either ADBRY 300 mg every other week with TCS or placebo with TCS and as needed topical calcineurin inhibitors (TCI) until Week 16. Subjects in the ADBRY 300 mg with TCS group who achieved clinical response at Week 16 were re-randomized to ADBRY 300 mg every other week with TCS or ADBRY every 4 weeks with TCS for another 16 weeks following first dose administration. Subjects in the placebo with TCS group who achieved clinical response at Week 16 continued on placebo with TCS for another 16 weeks.
Subjects who did not achieve clinical response at Week 16 received ADBRY 300 mg every other week for another 16 weeks. A mid-potency TCS (i.e., mometasone furoate 0.1% cream) was dispensed at each dosing visit. Subjects were instructed to apply a thin film of the dispensed TCS as needed once daily to active lesions from Week 0 to Week 32 and were to discontinue treatment with TCS when control was achieved.
An additional, lower potency TCS or TCI could be used at the investigator's discretion on areas of the body where use of the supplied TCS was not advisable, such as areas of thin skin. All three trials assessed the primary endpoints of the proportion of subjects with an IGA 0 or 1 at Week 16 and the proportion of subjects with EASI-75 at Week 16. Secondary endpoints included the reduction of Worst Daily Pruritus NRS (weekly average) of at least 4 points on the 11-point itch NRS from baseline to Week 16. Clinical Response at Week 16 (ECZTRA 1, ECZTRA 2, and ECZTRA 3) The results of the ADBRY monotherapy trials (ECZTRA 1 and ECZTRA 2) and the ADBRY with TCS trial (ECZTRA 3) are presented in Table 2. Table 2: Efficacy Results of ADBRY With or Without TCS at Week 16 (ECZTRA 1, ECZTRA 2, and ECZTRA 3) in Subjects with Moderate-to-Severe AD ECZTRA 1 ECZTRA 2 ECZTRA 3 ADBRY 300 mg every other week Placebo ADBRY 300 mg every other week Placebo ADBRY 300 mg every other week + TCS Placebo + TCS Abbreviations: AD = Atopic Dermatitis CI = Confidence Interval. Note: Difference and 95% CI are based on the CMH test stratified by region and baseline IGA score.
Number of subjects randomized and dosed (FAS) Full Analysis Set (FAS) includes all subjects randomized and dosed. 601 197 577 193 243 123 IGA 0 or 1 Responders was defined as a subject with an IGA 0 or 1 ("clear" or "almost clear")., Subjects who received rescue treatment or with missing data were considered as non-responders. 16% 7% 21% 9% 38% 27% Difference from Placebo 9% 12% 11% (95% CI) (4%, 13%) (7%, 17%) (1%, 21%) EASI-75 25% 13% 33% 10% 56% 37% Difference from Placebo 12% 22% 20% (95% CI) (6%, 18%) (17%, 28%) (9%, 30%) Number of subjects with baseline Worst Daily Pruritus NRS (weekly average) score ≥4 594 194 563 192 240 123 Worst Daily Pruritus NRS (≥4 point reduction) 20% 10% 25% 9% 46% 35% Difference from Placebo 10% 16% 11% (95% CI) (4%, 15%) (11%, 21%) (1%, 22%) A higher proportion of subjects in the ADBRY 300 mg every other week arm achieved EASI-90 compared to placebo in the three pivotal trials. Examination of age, gender, race, body weight, and previous treatment, including immunosuppressants, did not identify differences in response to ADBRY 300 mg every other week among these subgroups. Monotherapy Trials (ECZTRA 1 and ECZTRA 2) – Maintenance Period (Week 16-52 ) In ECZTRA 1, 179 ADBRY 300 mg every other week responders (IGA 0/1 or EASI-75) were re-randomized (and dosed) at Week 16 to ADBRY 300 mg every other week (68 subjects), ADBRY 300 mg every 4 weeks (76 subjects) or placebo (35 subjects). Among these subjects, 39 subjects in ADBRY 300 mg every other week arm, 36 subjects in ADBRY 300 mg every 4 weeks arm and 19 subjects in placebo arm were IGA 0/1 responders at Week 16. Maintenance of IGA 0/1 response at Week 52 was as follows: 20 subjects (51%) in every other week arm, 14 subjects (39%) in every 4 weeks arm and 9 subjects (47%) in the placebo arm.
Among the re-randomized subjects, 47 subjects in ADBRY 300 mg every other week arm, 57 subjects in ADBRY 300 mg every 4 weeks arm and 30 subjects in placebo arm were EASI-75 responders at Week 16. Maintenance of EASI-75 response at Week 52 was as follows: 28 subjects (60%) in every other week arm, 28 subjects (49%) in every 4 weeks arm and 10 subjects (33%) in the placebo arm. In ECZTRA 2, 218 ADBRY 300 mg every other week responders (IGA 0/1 or EASI-75) were re-randomized (and dosed) at Week 16 to ADBRY 300 mg every other week (90 subjects), ADBRY 300 mg every 4 weeks (84 subjects) or placebo (44 subjects). Among these subjects, 53 subjects in ADBRY 300 mg every other week arm, 44 subjects in ADBRY 300 mg every 4 weeks arm and 26 subjects in placebo arm were IGA 0/1 responders at Week 16. Maintenance of IGA 0/1 response at Week 52 was as follows: 32 subjects (60%) in every other week arm, 22 subjects (50%) in every 4 weeks arm and 6 subjects (23%) in the placebo arm. Among the re-randomized subjects, 76 subjects in ADBRY 300 mg every other week arm, 69 subjects in ADBRY 300 mg every 4 weeks arm and 40 subjects in placebo arm were EASI-75 responders at Week 16. Maintenance of EASI-75 response at Week 52 was as follows: 43 subjects (57%) in every other week arm, 38 subjects (55%) in every 4 weeks arm and 8 subjects (20%) in the placebo arm.
Concomitant TCS Trial (ECZTRA 3) – Maintenance Period (Week 16-32) In ECZTRA 3, 131 ADBRY 300 mg every other week + TCS responders (IGA 0/1 or EASI-75) were re-randomized (and dosed) at Week 16 to ADBRY 300 mg every other week + TCS (65 subjects) or ADBRY 300 mg every 4 weeks + TCS (66 subjects). Among these subjects, 45 subjects in ADBRY 300 mg every other week + TCS arm and 46 subjects in ADBRY 300 mg every 4 weeks + TCS arm were IGA 0/1 responders at Week 16. Maintenance of IGA 0/1 response at Week 32 was as follows: 40 subjects (89%) in every other week arm and 35 subjects (76%) in every 4 weeks arm. Among the re-randomized subjects, 65 subjects in ADBRY 300 mg every other week arm and 62 subjects in ADBRY 300 mg every 4 weeks arm were EASI-75 responders at Week 16. Maintenance of EASI-75 response at Week 32 was as follows: 60 subjects (92%) in every other week arm and 56 subjects (90%) in every 4 weeks arm. Pediatric Subjects 12 Years of Age and Older The efficacy of ADBRY monotherapy in pediatric subjects 12 years of age and older was assessed in a multicenter, randomized, double-blind, placebo-controlled trial (ECZTRA 6; NCT03526861) in 289 subjects 12 to 17 years of age with moderate-to-severe AD defined by IGA score ≥ 3 in the overall assessment of AD lesions on a severity scale of 0 to 4, an EASI score ≥ 16 at baseline, and a minimum BSA involvement of ≥10%. Eligible subjects enrolled into this trial had previous inadequate response to topical medication.
A total of 98 subjects received an initial dose of ADBRY 300 mg followed by 150 mg every other week up to Week 16. Subjects who met the clinical response criteria (IGA of 0 or 1 or EASI-75) at Week 16 without the use of rescue medication were re-randomized in a 1:1 ratio to either ADBRY every other week or every 4 weeks up to Week 52, receiving the same dose as during the initial 16-week treatment period. Subjects who did not meet the clinical response criteria at Week 16 or did not maintain the response during the maintenance treatment period, or used rescue medication during the initial treatment period were transferred to open-label treatment with ADBRY 300 mg every other week with optional use of topical corticosteroids. Subjects randomized to placebo in the initial treatment period who achieved a clinical response at Week 16 continued to receive placebo every other week in the maintenance treatment period.
In this trial, the mean subject age was 14.6 years (range: 12 to 17 years), the mean weight was 61.5 kg, 48% of subjects were female, 57% were White, 25% were Asian, and 11% were Black. For ethnicity, 91.3% of subjects identified as non-Hispanic/Latino and 8.7% identified as Hispanic/Latino. At baseline, 53% of subjects had a baseline IGA score of 3 (moderate AD), 47% of subjects had a baseline IGA score of 4 (severe AD), the mean BSA involvement was 51%, and 21% of subjects had received prior systemic immunosuppressants (cyclosporine, methotrexate, azathioprine and mycophenolate). Also, at baseline the mean EASI score was 32, the baseline Adolescent Worst Pruritus NRS score was 8. Overall, 84% of subjects had at least one co-morbid allergic condition; 68% had allergic rhinitis, 51% had asthma, and 57% had food allergies.
The primary endpoints were the proportion of subjects with IGA 0 or 1 at Week 16 ("clear" or "almost clear") and the proportion of patients with EASI-75 (improvement of at least 75% in EASI from baseline) at Week 16. Secondary endpoints included the reduction in itch, as measured by the proportion of subjects with ≥4 point improvement in Adolescent Worst Pruritus NRS from baseline. The efficacy results at Week 16 for subjects 12 to 17 years of age are presented in Table 3. Table 3: Efficacy Results of ADBRY Monotherapy in Subjects 12 to 17 Years of Age at Week 16 in Subjects with Moderate-to-Severe AD (ECZTRA 6) ADBRY 150 mg every other week Placebo Abbreviations: AD = Atopic Dermatitis, CI = Confidence Interval Number of subjects randomized and dosed (FAS) Full Analysis Set (FAS) includes all subjects randomized and dosed. 98 94 IGA 0 or 1 Subjects who received rescue treatment from week 2 to week 16 or had missing data were considered non-responders., Responder was defined as a subject with IGA 0 or 1 ("clear" or "almost clear" on a 0-4 IGA scale). 21% 4% Difference from Placebo 18% (95% CI) (8%, 27%) EASI-75 29% 6% Difference from Placebo 23% (95% CI) (12%, 33%) Number of subjects with baseline Worst Daily Pruritus NRS (weekly average) score ≥4 95 90 Worst Daily Pruritus NRS( ≥4 point reduction), The percentage is calculated relative to the number of subjects with a baseline value ≥4. 23% 3% Difference from Placebo 20% (95% CI) (11%, 29%) In ECZTRA 6, a higher proportion of subjects in the ADBRY 150 mg every other week group achieved EASI-90 compared to placebo.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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