Medical Editor: John P. Cunha, DO, FACOEP
What Is Adbry?
Adbry (tralokinumab-ldrm) is a human IgG4 monoclonal antibody indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
What Are Side Effects of Adbry?
Side effects of Adbry include:
- upper respiratory infections,
- injection site reactions (pain, redness, swelling), and
- high white blood cell count (eosinophilia).
Adbry may cause serious side effects including:
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- severe dizziness,
- skin rash, and
- changes in vision
Get medical help right away, if you have any of the symptoms listed above.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Adbry
The recommended dosage of Adbry is an initial dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered every other week. A dosage of 300 mg every 4 weeks may be considered for patients below 100 kg who achieve clear or almost clear skin after 16 weeks of treatment.
Adbry In Children
The safety and effectiveness of Adbry have not been established in pediatric patients.
What Drugs, Substances, or Supplements Interact with Adbry?
Adbry may interact with other medicines.
Tell your doctor all medications and supplements you use.
Adbry During Pregnancy and BreastfeedingTell your doctor if you are pregnant or plan to become pregnant before using Adbry; it is unknown how it might affect a fetus. Human IgG antibodies are known to cross the placental barrier; therefore, Adbry may be transmitted from the mother to the developing fetus. It is unknown if Adbry passes into breast milk. Maternal IgG is present in breast milk. The effects of local gastrointestinal exposure and limited systemic exposure to Adbry on the breastfed infant are unknown. Consult your doctor before breastfeeding.
Additional InformationOur Adbry (tralokinumab-ldrm) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following adverse reactions are discussed in greater detail elsewhere in the labeling:
- Hypersensitivity [see WARNINGS AND PRECAUTIONS]
- Conjunctivitis and Keratitis [see WARNINGS AND PRECAUTIONS]
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.
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, and9% 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 ofADBRY + 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 study, 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 AtopicDermatitis Trials through Week 16
|Adverse Reaction||ADBRY Monotherapy*||ADBRY + TCS†|
|ADBRY 300 mg Q2W‡
|ADBRY 300 mg Q2W‡ + TCS
|PLACEBO + TCS
|Upper respiratory tract infections§||281(23.8)||79 (20.4)||73 (30.0)||19 (15.4)|
|Conjunctivitis¶||88 (7.5)||12 (3.1)||33 (13.6)||6 (4.9)|
|Injection site reactions#||87 (7.4)||16 (4.1)||27 (11.1)||1 (0.8)|
|EosinophiliaÞ||17 (1.4)||2 (0.5)||3 (1.2)||0|
|* Pooled analysis of ECZTRA 1 and ECZTRA 2.
† Analysis of ECZTRA 3 where subjects were on background TCS therapy.
‡ ADBRY 600 mg at Week 0, followed by 300 mg every other week.
§ Upper respiratory tract infections cluster includes upper respiratory tract infection, viral upper respiratory tract infection, pharyngitis, and nasopharyngitis; mainly reported as common cold.
¶ Conjunctivitis cluster includes conjunctivitis and allergic conjunctivitis.
# Injection site reactions cluster includes pain, erythema, and swelling.
Þ Eosinophilia cluster includes eosinophilia and eosinophil count increased.
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.
Safety 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 initial16-week treatment period. In addition, the frequency of adverse reactions with ADBRY 300 mg every other week and every 4 weeks inECZTRA 1 and ECZTRA 2 was 44% and 34%, respectively, and 43% and 26% with ADBRY 300 mg + TCS every other week and every 4weeks in ECZTRA 3, respectively.
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 per100 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 maintenance treatment period of the monotherapy trials (ECZTRA 1 and ECZTRA 2) from 16 to 52 weeks, conjunctivitis was reported in 8.9% of subjects treated with ADBRY 300 mg every other week (20 events per 100 subject-years of exposure) and in 6.3% of subjects treated with ADBRY 300 mg every 4 weeks (14 events per 100 subject-years of exposure) compared to 7.7% of subjects treated withADBRY 300 mg every other week in the initial treatment period (30 events per 100 subject-years of exposure). Conjunctivitis (including no serious events, 1 severe event, and 1 event that led to discontinuation) was reported in 24 subjects in the combined (every other week and every4 weeks) ADBRY groups. A similar pattern was seen during the continuation treatment period of an additional 16 weeks in the ADBRYcombination ECZTRA 3.
Keratitis (including kerato conjunctivitis) was reported in 0.5% of subjects treated with ADBRY and 0% treated with placebo during the initial treatment period of up to 16 weeks in the pool of 5 trials. Keratitis (including 1 ulcerative keratitis) was reported in 0.2% of subjects treated withADBRY (0.9 events per 100 subject-years of exposure) and 0.2% of subjects treated with placebo (0.6 events per 100 subject-years of exposure).kerato conjunctivitis (including 1 atopic kerato conjunctivitis) was reported in 0.3% of subjects treated with ADBRY (1.2 events per 100 subject-years of exposure), and in no subjects treated with placebo. In the ADBRY group, 9 subjects reported 10 events of keratitis or kerato conjunctivitis, with 5 events resolved during the trial following the initial treatment period. None of the events were serious or led to treatment discontinuation.
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 kerato conjunctivitis (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 kerato conjunctivitis was reported in ADBRY every 4weeks or placebo groups, compared to keratitis event rate of 2 per 100 subject-years for ADBRY 300 mg every other week in the initial treatment period.
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.
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 theADBRY-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.
As with all therapeutic proteins, there is a potential for immunogenicity with ADBRY. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other tralokinumab products may be misleading.
In ECZTRA 1, ECZTRA 2, and ECZTRA 3, and the vaccine-response trial, the incidence of Anti-Drug-Antibodies (ADA) during the initial 16-week treatment period was 1.4% for subjects treated with ADBRY 300 mg every other week and in 1.3% for subjects treated with placebo; neutralizing antibodies were seen in 0.1% of subjects treated with ADBRY and 0.2% of subjects treated with placebo.
Across all trial periods, the ADA incidence for subjects who received ADBRY was 4.6%; 0.9% had persistent ADA and 1.0% had neutralizing antibodies.
No clinically meaningful differences in the pharmacokinetics, safety, or efficacy of tralokinumab-ldrm were observed in patients who tested positive for anti-tralokinumab-ldrm antibody (including neutralizing antibodies).
No Information Provided
Read the entire FDA prescribing information for Adbry (Traokinumab-ldrm for Injection)
© Adbry Patient Information is supplied by Cerner Multum, Inc. and Adbry Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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