For HDM-induced AR, with or without conjunctivitis...

ODACTRA has been proven effective in mono- and polysensitized patients1,2

Environmental Exposure
Chamber Study (Study 3)

pie charts showing percentage of polysensitized patients: 84% in Environmental Exposure Chamber Study; 76% in North American Study; 67% in European Study

of patients were
polysensitized3

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North American Study
(Field Study 1)

pie charts showing percentage of polysensitized patients: 84% in Environmental Exposure Chamber Study; 76% in North American Study; 67% in European Study

of patients were
polysensitized3

Show details

European Study
(Field Study 2)

pie charts showing percentage of polysensitized patients: 84% in Environmental Exposure Chamber Study; 76% in North American Study; 67% in European Study

of patients were
polysensitized3

Show details

Environmental Exposure
Chamber Study (Study 3)

pie charts showing percentage of polysensitized patients: 84% in Environmental Exposure Chamber Study; 76% in North American Study; 67% in European Study

of patients were polysensitized3

Show details

In the Environmental Exposure Chamber Study...
Proven efficacy that starts to work as early as week 84
  • The efficacy of ODACTRA in monosensitized and polysensitized patients was demonstrated in a chamber study in which patients underwent 6-hour exposure challenges to determine the average TNSS at week 244

Reduction in TNSS

arrow charts showing 20.4% reduction in Total Nasal Symptom Score at week 8, the secondary end point, and 48.6% reduction at week 24, the primary end point arrow charts showing 20.4% reduction in Total Nasal Symptom Score at week 8, the secondary end point, and 48.6% reduction at week 24, the primary end point

Significantly reduced ocular symptoms4

Reduction in TOSS

arrow chart showing 67.9% reduction in Total Ocular Symptom Score at week 24

Study design: A randomized, single-site, placebo-controlled, double-blind, onset-of-action trial was conducted for 24 weeks in adults aged ≥18 years with HDM-induced AR/conjunctivitis, with or without asthma (N=83; ODACTRA=42, placebo=41), using the Vienna Challenge Chamber. Mean age (years/range) was 28 (18-58) for the ODACTRA patients and 27 (19-43) for placebo patients. Mean duration of AR/conjunctivitis was 16 years and 17 years for ODACTRA and placebo patients, respectively. Of ODACTRA patients, 88% were polysensitized. Patients received ODACTRA or placebo and symptoms were scored every 15 minutes during exposure challenges, which occurred at screening and at weeks 8, 16, and 24. The primary efficacy end point was the average TNSS at week 24, which was the sum of the 4 nasal symptoms (runny nose, blocked nose, sneezing, and itchy nose), with a maximum score of 12. A key secondary end point was the average TOSS at weeks 8, 16, and 24. The TOSS was the sum of the 2 ocular symptoms (gritty/red/itchy eyes and watery eyes). There were 10 patients and 9 patients with asthma (ODACTRA and placebo, respectively).4


AR=allergic rhinitis; HDM=house dust mite; TNSS=total nasal symptom score; TOSS=total ocular symptom score.

*TNSS is defined as a total score comprising the following: rhinorrhea, nasal congestion, nasal itching, and sneezing.

References: 1. Nolte H, Bernstein DI, Nelson HS, et al. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016;138(6):1631-1638. 2. Demoly P, Emminger W, Rehm D, Backer V, Tommerup L, Kleine-Tebbe J. Effective treatment of house dust mite−induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: results from a randomized, double-blind, placebo-controlled phase III trial. J Allergy Clin Immunol. 2016;137(2):444-451. 3. ODACTRA [prescribing information]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp; 2017. 4. Nolte H, Maloney J, Nelson HS, et al. Onset and dose-related efficacy of house dust mite sublingual immunotherapy tablets in an environmental exposure chamber. J Allergy Clin Immunol. 2015;135(6):1494-1501.e6.


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North American Study
(Field Study 1)

pie charts showing percentage of polysensitized patients: 84% in Environmental Exposure Chamber Study; 76% in North American Study; 67% in European Study

of patients were polysensitized3

Show details

In the North American Field Efficacy Study...
Statistically significant effects on HDM-induced AR1
  • During the last 8 weeks of the 52-week treatment period, ODACTRA produced statistically significant reductions in the symptoms of AR1

Reduction in TCRS

This study was designed to prove clinically significant reduction in symptoms and medication use by 15%, as defined by the FDA3

arrow chart showing 17.2% reduction in Total Combined Rhinitis Score

ODACTRA was effective regardless of sensitization status1

Reduction in TCRS in patient subgroups

arrow charts showing 17% reduction in Total Combined Rhinitis Score in monosensitized patients and 18% reduction in polysensitized patients arrow charts showing 17% reduction in Total Combined Rhinitis Score in monosensitized patients and 18% reduction in polysensitized patients

Study design: A randomized, multicenter, placebo-controlled, double-blind trial was conducted for 52 weeks in patients aged ≥12 years with HDM-induced AR/conjunctivitis, with or without asthma (N=1482; ODACTRA=741, placebo=741). Mean age (years ± SD) was 35 ± 14 for ODACTRA patients and 35 ± 14 for placebo patients. Mean duration of AR was 18 ± 13 years and 19 ± 13 years for ODACTRA and placebo patients, respectively. Of ODACTRA patients, 75% were polysensitized. Patients received ODACTRA or placebo, with the efficacy assessment occurring during the last 8 weeks of treatment, when HDM exposure per physician judgment was expected to be at its peak. The primary efficacy end point was the average TCRS during the last 8 weeks of treatment. The TCRS was the sum of the rhinitis DSS and rhinitis DMS. The rhinitis DSS was the sum of 4 nasal symptoms (runny nose, stuffy nose, sneezing, and itchy nose) scored on a scale of 0 (none) to 3 (severe). The rhinitis DMS was calculated based on daily use of symptom-relieving medications for nasal symptoms.1,3


AR=allergic rhinitis; DMS=daily medication score; DSS=daily symptom score; HDM=house dust mite; TCRS=total combined rhinitis score.

*TCRS is defined as the sum of the rhinitis DSS and rhinitis DMS.

References: 1. Nolte H, Bernstein DI, Nelson HS, et al. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016;138(6):1631-1638. 2. Demoly P, Emminger W, Rehm D, Backer V, Tommerup L, Kleine-Tebbe J. Effective treatment of house dust mite−induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: results from a randomized, double-blind, placebo-controlled phase III trial. J Allergy Clin Immunol. 2016;137(2):444-451. 3. ODACTRA [prescribing information]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp; 2017.


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European Study
(Field Study 2)

pie charts showing percentage of polysensitized patients: 84% in Environmental Exposure Chamber Study; 76% in North American Study; 67% in European Study

of patients were polysensitized3

Show details

In the European Efficacy Study...
Demonstrated efficacy throughout the year, including polysensitized patients2
  • The efficacy of ODACTRA in monosensitized and polysensitized patients was demonstrated despite the use of pharmacotherapy, with proven clinical relevance according to a predefined criterion2,3
  • Statistically significant reduction in combined nasal symptom and medication usage scores occurred as early as week 14 and continued throughout the year2

Reduction in TCRS over 52 weeks

line graph showing reduction in Total Combined Rhinitis Score over 52 weeks

Adapted from Demoly P et al. J Allergy Clin Immunol. 2016;13(2):444-451.

nose icon

Statistically significant reduction in AR symptoms as well as in individual symptoms2,3

  • 14.1% reduction in rhinitis DSS compared with placebo (95% CI: −23.8%, −3.9%; P=.003)2,3
  • AR symptoms in rhinitis DSS compared with placebo that were measured included runny nose, blocked nose, sneezing, and itchy nose2
medications icon

Statistically significant reduction in AR medications

  • 18.9% reduction in rhinitis DMS compared with placebo (95% CI: −34.7%, −1.3%; P=.024)3
  • AR medications that were measured included an oral antihistamine (desloratadine tablets, 5 mg) and a nasal steroid (budesonide nasal spray, 64 mcg/dose)2

Study design: A randomized, multinational, multicenter, placebo-controlled, double-blind trial was conducted for 52 weeks in patients aged 18 to 66 years with HDM-induced AR, with or without asthma, and conjunctivitis (N=656). Mean age (years) was 32.1 ± 10.6 for ODACTRA patients and 32.2 ± 10.9 for placebo patients. There were 152 patients with HDM-induced allergic asthma for both ODACTRA and placebo. Mean duration of AR/conjunctivitis was 9.8 years and 10.0 years for ODACTRA and placebo patients, respectively. Of ODACTRA patients, 66% were polysensitized. Patients received ODACTRA or placebo, with the efficacy assessment occurring during the last 8 weeks of treatment (October 1 through March 15) to avoid overlapping symptoms caused by pollen allergy. The primary efficacy end point was the average TCRS during the last 8 weeks of treatment. The TCRS was the sum of the rhinitis DSS and rhinitis DMS. The rhinitis DSS was the sum of 4 nasal symptoms (runny nose, stuffy nose, sneezing, and itchy nose) scored on a scale of 0 (none) to 3 (severe). The rhinitis DMS was calculated based on daily use of symptom-relieving medications for nasal symptoms.2,3

AR=allergic rhinitis; DMS=daily medication score; DSS=daily symptom score; HDM=house dust mite; TCRS=total combined rhinitis score.

References: 1. Nolte H, Bernstein DI, Nelson HS, et al. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016;138(6):1631-1638. 2. Demoly P, Emminger W, Rehm D, Backer V, Tommerup L, Kleine-Tebbe J. Effective treatment of house dust mite−induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: results from a randomized, double-blind, placebo-controlled phase III trial. J Allergy Clin Immunol. 2016;137(2):444-451. 3. ODACTRA [prescribing information]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp; 2017.


Hide details X

AR=allergic rhinitis; HDM=house dust mite.

References: 1. Nolte H, Bernstein DI, Nelson HS, et al. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016;138(6):1631-1638. 2. Demoly P, Emminger W, Rehm D, Backer V, Tommerup L, Kleine-Tebbe J. Effective treatment of house dust mite−induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: results from a randomized, double-blind, placebo-controlled phase III trial. J Allergy Clin Immunol. 2016;137(2):444-451. 3. ODACTRA [prescribing information]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp; 2017.

Indication

ODACTRA is an allergen extract indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts. ODACTRA is approved for use in adults 18 through 65 years of age. ODACTRA is not indicated for the immediate relief of allergic symptoms.

Important Safety Information

WARNING: SEVERE ALLERGIC REACTIONS

ODACTRA can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer ODACTRA to patients with severe, unstable or uncontrolled asthma. Observe patients in the office for at least 30 minutes following the initial dose. Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. ODACTRA may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. ODACTRA may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.

ODACTRA is contraindicated in patients with:

  • Severe, unstable, or uncontrolled asthma
  • A history of any severe systemic allergic reaction
  • A history of any severe local reaction after taking any sublingual allergen immunotherapy
  • A history of eosinophilic esophagitis
  • Hypersensitivity to any of the inactive ingredients [gelatin, mannitol and sodium hydroxide] contained in this product

ODACTRA can cause systemic allergic reactions including anaphylaxis which may be life-threatening. In addition, ODACTRA can cause severe local reactions, including laryngopharyngeal swelling, which can compromise breathing and be life-threatening. Educate patients to recognize the signs and symptoms of these allergic reactions and instruct them to seek immediate medical care and discontinue therapy should any of these occur. Allergic reactions may require treatment with epinephrine.

Prescribe auto-injectable epinephrine to patients receiving ODACTRA. Instruct patients to recognize the signs and symptoms of a severe allergic reaction and in the proper use of emergency auto-injectable epinephrine. Instruct patients to seek immediate medical care upon use of auto-injectable epinephrine and to stop treatment with ODACTRA. Review the epinephrine package insert for complete information.

Administer the initial dose of ODACTRA in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases and prepared to manage a life-threatening systemic or local allergic reaction. Observe patients in the office for at least 30 minutes following the initial dose of ODACTRA.

Patients who have persistent and escalating adverse reactions in the mouth or throat should be considered for discontinuation of ODACTRA.

Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy. Discontinue ODACTRA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastro-esophageal symptoms including dysphagia or chest pain.

Withhold immunotherapy with ODACTRA if the patient is experiencing an acute asthma exacerbation. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of ODACTRA.

ODACTRA has not been studied in subjects who are receiving concomitant allergen immunotherapy. Concomitant dosing with other allergen immunotherapy may increase the likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy.

Stop treatment with ODACTRA to allow complete healing of the oral cavity in patients with oral inflammation (e.g., oral lichen planus, mouth ulcers, or thrush) or oral wounds, such as those following oral surgery or dental extraction.

The most common solicited adverse reactions reported in clinical studies for subjects 18 through 65 years of age treated with ODACTRA vs placebo included throat irritation/tickle (67.0% vs 20.8%), itching in the mouth (61.3% vs 14.1%), itching in the ear (51.7% vs 11.7%), and swelling of the uvula/back of the mouth (19.8% vs 2.4%).

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Available data on ODACTRA administered to pregnant women are insufficient to inform associated risks in pregnancy.

Before prescribing ODACTRA, please read the Boxed WARNING, full Prescribing Information, and Medication Guide, for additional Important Safety Information.

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Important Safety Information

WARNING: SEVERE ALLERGIC REACTIONS

ODACTRA can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer ODACTRA to patients with severe, unstable or uncontrolled asthma. Observe patients in the office for at least 30 minutes following the initial dose. Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. ODACTRA may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. ODACTRA may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.

ODACTRA is contraindicated in patients with:

  • Severe, unstable, or uncontrolled asthma
  • A history of any severe systemic allergic reaction
  • A history of any severe local reaction after taking any sublingual allergen immunotherapy
  • A history of eosinophilic esophagitis
  • Hypersensitivity to any of the inactive ingredients [gelatin, mannitol and sodium hydroxide] contained in this product

ODACTRA can cause systemic allergic reactions including anaphylaxis which may be life-threatening. In addition, ODACTRA can cause severe local reactions, including laryngopharyngeal swelling, which can compromise breathing and be life-threatening. Educate patients to recognize the signs and symptoms of these allergic reactions and instruct them to seek immediate medical care and discontinue therapy should any of these occur. Allergic reactions may require treatment with epinephrine.

Prescribe auto-injectable epinephrine to patients receiving ODACTRA. Instruct patients to recognize the signs and symptoms of a severe allergic reaction and in the proper use of emergency auto-injectable epinephrine. Instruct patients to seek immediate medical care upon use of auto-injectable epinephrine and to stop treatment with ODACTRA. Review the epinephrine package insert for complete information.

Administer the initial dose of ODACTRA in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases and prepared to manage a life-threatening systemic or local allergic reaction. Observe patients in the office for at least 30 minutes following the initial dose of ODACTRA.

Patients who have persistent and escalating adverse reactions in the mouth or throat should be considered for discontinuation of ODACTRA.

Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy. Discontinue ODACTRA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastro-esophageal symptoms including dysphagia or chest pain.

Withhold immunotherapy with ODACTRA if the patient is experiencing an acute asthma exacerbation. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of ODACTRA.

ODACTRA has not been studied in subjects who are receiving concomitant allergen immunotherapy. Concomitant dosing with other allergen immunotherapy may increase the likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy.

Stop treatment with ODACTRA to allow complete healing of the oral cavity in patients with oral inflammation (e.g., oral lichen planus, mouth ulcers, or thrush) or oral wounds, such as those following oral surgery or dental extraction.

The most common solicited adverse reactions reported in clinical studies for subjects 18 through 65 years of age treated with ODACTRA vs placebo included throat irritation/tickle (67.0% vs 20.8%), itching in the mouth (61.3% vs 14.1%), itching in the ear (51.7% vs 11.7%), and swelling of the uvula/back of the mouth (19.8% vs 2.4%).

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Available data on ODACTRA administered to pregnant women are insufficient to inform associated risks in pregnancy.

Before prescribing ODACTRA, please read the Boxed WARNING, full Prescribing Information, and Medication Guide, for additional Important Safety Information.

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