INDICATIONS
ORALAIR IS AN ALLERGEN EXTRACT INDICATED AS IMMUNOTHERAPY FOR THE TREATMENT OF GRASS POLLEN-INDUCED ALLERGIC RHINITIS WITH OR WITHOUT CONJUNCTIVITIS CONFIRMED BY POSITIVE SKIN TEST OR IN VITRO TESTING FOR POLLEN-SPECIFIC IGE ANTIBODIES FOR ANY OF THE FIVE GRASS SPECIES CONTAINED IN THIS PRODUCT. ORALAIR IS APPROVED FOR USE IN PERSONS 10 THROUGH 65 YEARS OF AGE.
ORALAIR IS NOT INDICATED FOR THE IMMEDIATE RELIEF OF ALLERGY SYMPTOMS.
HOW SUPPLIED
DOSAGE FORMS AND STRENGTHS
ORALAIR TABLETS ARE AVAILABLE AS FOLLOWS:
" ORALAIR 100 IR TABLETS ARE ROUND AND BICONVEX, SLIGHTLY SPECKLED WHITE TO BEIGE WITH "100" ENGRAVED ON BOTH SIDES
" ORALAIR 300 IR TABLETS ARE ROUND AND BICONVEX, SLIGHTLY SPECKLED WHITE TO BEIGE WITH "300" ENGRAVED ON BOTH SIDES
STORAGE AND HANDLING
ORALAIR IS AVAILABLE AS A SUBLINGUAL TABLET EQUIVALENT TO 100 IR AND 300 IR OF FIVE GRASS MIXED POLLENS ALLERGEN EXTRACT.
DESCRIPTION NDC NUMBER
CHILDREN AND ADOLESCENTS SAMPLE KIT (10 TO 17 YEARS OF AGE) ONE BOX OF THE 100 IR STARTER PACK TWO BOXES OF THE 300 IR SAMPLE PACKS NDC 59617-0020-1
ADULT SAMPLE KIT (18 TO 65 YEARS OF AGE) ONE BOX OF 300 IR STARTER PACK TWO BOXES OF 300 IR SAMPLE PACKS NDC 59617-0025-1
CHILDREN AND ADOLESCENTS STARTER PACK (10 TO 17 YEARS OF AGE) 1 BLISTER PACK OF THREE 100 IR TABLETS NDC 59617-0010-1
ADULT STARTER PACK (18 TO 65 YEARS OF AGE) 1 BLISTER PACK OF THREE 300 IR TABLETS NDC 59617-0016-1
SAMPLE PACK 1 BLISTER PACK OF THREE 300 IR TABLETS NDC 59617-0015-3
COMMERCIAL PACK 1 BLISTER PACK OF THIRTY 300 IR TABLETS NDC 59617-0015-2
STORAGE: STORE AT CONTROLLED ROOM TEMPERATURE (200C-25Β°C/680F-77Β°F); EXCURSIONS PERMITTED TO 15-30Β°C (59-86Β°F). PROTECT FROM MOISTURE.
MANUFACTURED BY: STALLERGENES S.A., ANTONY, 92183, FRANCE, U.S. LICENSE # 1893. DISTRIBUTED BY: GREER LABORATORIES, INC., LENOIR, N.C. 28645
DOSAGE AND ADMINISTRATION
FOR SUBLINGUAL USE ONLY.
DOSE
FOR ADULTS 18 THROUGH 65 YEARS OF AGE, THE DOSE IS 300 IR (INDEX OF REACTIVITY) DAILY. FOR CHILDREN AND ADOLESCENTS 10 THROUGH 17 YEARS OF AGE, THE DOSE IS INCREASED OVER THE FIRST THREE DAYS AS SHOWN IN TABLE 1.
TABLE 1: DOSAGE FOR ADULTS AND CHILDREN FOR THE DAYS 1-3 (AND FOLLOWING)
AGE (YEARS) DOSE
DAY 1 DAY 2 DAY 3 AND FOLLOWING
10-17 100 IR 2X 100 IR 300 IR
18-65 300 IR 300 IR 300 IR
ADMINISTRATION
ADMINISTER THE FIRST DOSE OF ORALAIR IN A HEALTHCARE SETTING IN WHICH ACUTE ALLERGIC REACTIONS CAN BE TREATED UNDER THE SUPERVISION OF A PHYSICIAN WITH EXPERIENCE IN THE DIAGNOSIS AND TREATMENT OF SEVERE ALLERGIC REACTIONS. AFTER RECEIVING THE FIRST DOSE OF ORALAIR, OBSERVE THE PATIENT FOR AT LEAST 30 MINUTES TO MONITOR FOR SIGNS OR SYMPTOMS OF A SEVERE SYSTEMIC OR A SEVERE LOCAL ALLERGIC REACTION. IF THE PATIENT TOLERATES THE FIRST DOSE, THE PATIENT MAY TAKE SUBSEQUENT DOSES AT HOME.
ADMINISTER ORALAIR TO CHILDREN UNDER ADULT SUPERVISION.
REMOVE THE ORALAIR TABLET FROM THE BLISTER JUST PRIOR TO DOSING.
PLACE THE ORALAIR TABLET IMMEDIATELY UNDER THE TONGUE UNTIL COMPLETE DISSOLUTION FOR AT LEAST 1 MINUTE BEFORE SWALLOWING.
WASH HANDS AFTER HANDLING THE ORALAIR TABLET.
DO NOT TAKE THE ORALAIR TABLET WITH FOOD OR BEVERAGE. TO AVOID SWALLOWING ALLERGEN EXTRACT, FOOD OR BEVERAGE SHOULD NOT BE TAKEN FOR 5 MINUTES FOLLOWING DISSOLUTION OF THE TABLET.
INITIATE TREATMENT 4 MONTHS BEFORE THE EXPECTED ONSET OF EACH GRASS POLLEN SEASON AND MAINTAIN IT THROUGHOUT THE GRASS POLLEN SEASON.
DATA REGARDING THE SAFETY OF STARTING TREATMENT DURING THE POLLEN SEASON OR RESTARTING TREATMENT AFTER MISSING A DOSE OF ORALAIR ARE NOT AVAILABLE.
IT IS RECOMMENDED THAT AUTO-INJECTABLE EPINEPHRINE BE MADE AVAILABLE TO PATIENTS PRESCRIBED ORALAIR. PATIENTS WHO ARE PRESCRIBED EPINEPHRINE WHILE RECEIVING IMMUNOTHERAPY SHOULD BE INSTRUCTED IN THE PROPER USE OF EMERGENCY SELF-INJECTION OF EPINEPHRINE [SEE WARNINGS AND PRECAUTIONS].
SIDE EFFECTS
ADVERSE REACTIONS REPORTED IN ? 5% OF PATIENTS WERE: ORAL PRURITUS, THROAT IRRITATION, EAR PRURITUS, MOUTH EDEMA, TONGUE PRURITUS, COUGH, OROPHARYNGEAL PAIN.
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 RATE OBSERVED IN PRACTICE.
ADULTS
OVERALL, IN 6 PLACEBO-CONTROLLED CLINICAL TRIALS, 1,038 ADULTS 18 THROUGH 65 YEARS OF AGE RECEIVED AT LEAST ONE DOSE OF ORALAIR 300IR, OF WHOM 611 (59%) COMPLETED AT LEAST FOUR MONTHS OF THERAPY. OF STUDY PARTICIPANTS, 56% WERE MALE, 17% HAD A HISTORY OF MILD INTERMITTENT ASTHMA AT STUDY ENTRY, AND 64% WERE POLYSENSITIZED. DATA ON RACE AND ETHNICITY WERE NOT SYSTEMATICALLY CAPTURED IN THE FIVE EUROPEAN STUDIES (N=805). IN THE US STUDY (N=233), A LIMITED NUMBER OF PATIENTS REPORTED THEIR RACE AS OTHER THAN WHITE/CAUCASIAN (BLACK/AFRICAN AMERICAN: 5.6%, ASIAN: 2.6%, OTHER: 2.1%) OR THEIR ETHNICITY AS HISPANIC OR LATINO (3.0%). ADVERSE EVENTS WERE CAPTURED ON A DAILY DIARY CARD THAT DID NOT SOLICIT FOR SPECIFIC ADVERSE EVENTS.
ACROSS THE SIX CLINICAL STUDIES, ADVERSE REACTIONS REPORTED AT AN INCIDENCE OF ? 2% OF ORALAIR RECIPIENTS AND AT A GREATER INCIDENCE THAN THAT IN PARTICIPANTS TREATED WITH PLACEBO ARE LISTED IN TABLE 2.
TABLE 2: ADVERSE REACTIONS REPORTED BY ? 2% OF ADULTS RECEIVING ORALAIR 300 IR AND AT A GREATER INCIDENCE THAN THAT IN PARTICIPANTS TREATED WITH PLACEBO
ADVERSE REACTIONS ORALAIR 300 IR
(N=1,038) PLACEBO
(N=840)
EAR AND LABYRINTH DISORDERS
EAR PRURITUS 8.40% 0.60%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
THROAT IRRITATION 22.00% 3.70%
COUGH 7.30% 5.90%
OROPHARYNGEAL PAIN 5.10% 3.70%
PHARYNGEAL EDEMA 3.80% 0.10%
GASTROINTESTINAL DISORDERS
ORAL PRURITUS 25.10% 5.00%
EDEMA MOUTH 8.20% 0.60%
TONGUE PRURITUS 7.90% 0.70%
LIP EDEMA 4.40% 0.40%
PARAESTHESIA ORAL 4.30% 1.00%
ABDOMINAL PAIN 4.20% 1.30%
DYSPEPSIA 3.90% 0.40%
TONGUE EDEMA 2.70% 0.10%
HYPOAESTHESIA ORAL 2.20% 0.10%
STOMATITIS 2.10% 0.70%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
URTICARIA 2.30% 1.50%
ADDITIONAL ADVERSE REACTIONS OF INTEREST THAT OCCURRED IN < 2% OF ORALAIR RECIPIENTS INCLUDE DYSPHAGIA, NAUSEA, VOMITING, ESOPHAGEAL PAIN, GASTRITIS, AND GASTROESOPHAGEAL REFLUX.
CHILDREN AND ADOLESCENTS
OVERALL, IN PLACEBO-CONTROLLED CLINICAL TRIALS, 154 CHILDREN AND ADOLESCENTS 5 THROUGH 17 YEARS OF AGE RECEIVED ORALAIR 300 IR, OF WHOM 147 WERE EXPOSED FOR MORE THAN 3 MONTHS. OF STUDY PARTICIPANTS, 66% WERE MALE, AND 21% HAD A HISTORY OF MILD INTERMITTENT ASTHMA AT STUDY ENTRY. DATA ON RACE AND ETHNICITY WERE NOT SYSTEMATICALLY CAPTURED.
THE SAFETY PROFILE IN THE PEDIATRIC POPULATION, WAS GENERALLY SIMILAR TO THAT OF ADULTS. IN PEDIATRIC PATIENTS RECEIVING ORALAIR, ADDITIONAL ADVERSE REACTIONS REPORTED AT AN INCIDENCE OF ? 2% AND AT A GREATER INCIDENCE THAN THAT IN PARTICIPANTS TREATED WITH PLACEBO ARE LISTED IN TABLE 3.
TABLE 3: ADDITIONAL ADVERSE REACTIONS REPORTED BY ? 2% OF CHILDREN AND ADOLESCENTS RECEIVING ORALAIR 300 IR AND AT A GREATER INCIDENCE THAN THAT IN PARTICIPANTS TREATED WITH PLACEBO
ADVERSE REACTIONS ORALAIR 300 IR
(N=154) PLACEBO
(N=158)
INFECTIONS AND INFESTATIONS
TONSILLITIS 5.80% 3.20%
UPPER RESPIRATORY TRACT INFECTION 3.90% 1.90%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
ASTHMA 7.10% 3.80%
DYSPHONIA 2.60% 1.30%
GASTROINTESTINAL DISORDERS
LIP PRURITUS 3.20% 0.00%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ATOPIC DERMATITIS 3.20% 0.60%
SERIOUS ADVERSE REACTIONS
AT LEAST 1 SERIOUS ADVERSE EVENT WAS REPORTED IN 22 OF 1514 (1.5%) SUBJECTS WHO RECEIVED ORALAIR AT ANY DOSE, AND 11 OF 840 (1.1%) OF PLACEBO RECIPIENTS. OF THE 22 SERIOUS ADVERSE EVENTS IN THE ORALAIR RECIPIENTS, 2 WERE CONSIDERED "DEFINITELY RELATED" TO ORALAIR.
THE FIRST SUBJECT WAS AN ADULT WHO EXPERIENCED A SEVERE HYPERSENSITIVITY REACTION WHICH BEGAN 5 MINUTES AFTER ADMINISTRATION OF ORALAIR. THE SYMPTOMS WERE VIOLENT COUGHING AND MARKED DYSPNEA. THE SUBJECT WAS TREATED WITH ANTIHISTAMINES, SALBUTAMOL AND PREDNISOLONE AND THE REACTION RESOLVED WITHOUT SEQUELAE.
THE SECOND SUBJECT WAS AN ADULT WHO EXPERIENCED SEVERE LARYNGEAL EDEMA. THE SUBJECT WAS TREATED WITH PREDNISOLONE AND EVENT RESOLVED WITHOUT SEQUELAE.
THERE WAS ALSO ONE CASE OF GASTROENTERITIS WITH AN ONSET ON DAY 93 OF THERAPY THAT WAS POSSIBLY RELATED TO ORALAIR.
POSTMARKETING EXPERIENCE
POST MARKETING SAFETY STUDIES
A TOTAL OF 1728 INDIVIDUALS (808 ADULTS; 920 CHILDREN 5 THROUGH 17 YEARS OF AGE) RECEIVED ORALAIR IN POST MARKETING SAFETY STUDIES. REPORTED ADVERSE REACTIONS INCLUDED: ANAPHYLACTIC REACTION, ORAL ALLERGY SYNDROME, FLUSHING, DYSPNEA, LARYNGEAL EDEMA, AND DIARRHEA.
SPONTANEOUS POSTMARKETING REPORTS
IN ADDITION TO ADVERSE REACTIONS REPORTED IN CLINICAL AND POST MARKETING SAFETY STUDIES, THE FOLLOWING ADVERSE REACTIONS HAVE BEEN IDENTIFIED DURING POST APPROVAL USE OF ORALAIR. BECAUSE THESE REACTIONS ARE REPORTED VOLUNTARILY FROM A POPULATION OF UNCERTAIN SIZE, IT IS NOT ALWAYS POSSIBLE TO RELIABLY ESTIMATE THEIR FREQUENCY OR ESTABLISH A CAUSAL RELATIONSHIP TO DRUG EXPOSURE: AUTOIMMUNE THYROIDITIS, EOSINOPHILIC MYOCARDITIS, EOSINOPHILIC ESOPHAGITIS, PALPITATIONS, TACHYCARDIA, HYPOTENSION, LOSS OF CONSCIOUSNESS, CIRCULATORY COLLAPSE, MALAISE, PALLOR, PERIPHERAL VASCULAR DISORDER, STRIDOR, ANGIOEDEMA, FACE EDEMA, WEIGHT DECREASED, WHEEZING, EXACERBATION OF ASTHMA, CHEST DISCOMFORT, OROPHARYNGEAL BLISTERING, HEADACHE, DIZZINESS, TINNITUS, ASTHENIA, SOMNOLENCE, ANXIETY, RASH, PRURITUS, SALIVARY GLAND ENLARGEMENT AND/OR HYPERSECRETION, DRY MOUTH, DRY EYE, INFLUENZA-LIKE SYNDROME, LYMPHADENOPATHY, EOSINOPHIL COUNT INCREASED.
READ THE ORALAIR (SWEET VERNAL, ORCHARD, PERENNIAL RYE, TIMOTHY, AND KENTUCKY BLUE GRASS MIXED POLLENS ALLERGEN EXTRACT SUBLINGUAL TABLETS) SIDE EFFECTS CENTER FOR A COMPLETE GUIDE TO POSSIBLE SIDE EFFECTS
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
THE MECHANISMS OF ACTION OF ALLERGEN IMMUNOTHERAPY ARE NOT KNOWN.
CLINICAL STUDIES
THE EFFICACY OF ORALAIR FOR THE TREATMENT OF GRASS POLLEN-INDUCED ALLERGIC RHINOCONJUNCTIVITIS WAS INVESTIGATED IN FIVE DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIALS: FOUR NATURAL FIELD STUDIES AND AN ENVIRONMENTAL EXPOSURE CHAMBER STUDY.
THE NATURAL FIELD STUDIES INCLUDED THREE TRIALS, EACH CONDUCTED OVER A SINGLE SEASON (TWO IN ADULTS AND ONE IN ADOLESCENTS AND CHILDREN) AND ONE FIVE-YEAR STUDY (ADULTS). PARTICIPANTS RECEIVED ORALAIR OR PLACEBO DAILY FOR FOUR MONTHS PRIOR TO GRASS POLLEN SEASON AND THROUGHOUT GRASS POLLEN SEASON.
STUDY PARTICIPANTS REPORTED AT LEAST A TWO GRASS POLLEN SEASON HISTORY OF RHINOCONJUNCTIVITIS SYMPTOMS. FOR THE EUROPEAN STUDIES, SUBJECTS HAD A POSITIVE SKIN PRICK TEST TO 5-GRASS POLLEN EXTRACT AND POSITIVE IN VITRO TESTING FOR TIMOTHY GRASS-SPECIFIC SERUM IGE. FOR THE US STUDY, SUBJECTS HAD A POSITIVE SKIN PRICK TEST TO TIMOTHY GRASS POLLEN EXTRACT.
WITH THE EXCEPTION OF THOSE WITH MILD INTERMITTENT ASTHMA, PATIENTS WITH ASTHMA WERE EXCLUDED. APPROXIMATELY 16% HAD ASTHMA AT BASELINE AND 65% WERE POLYSENSITIZED (I.E., SENSITIZED TO THE 5-GRASS POLLEN ALLERGEN EXTRACT AND AT LEAST ONE OTHER UNRELATED ALLERGEN). OVERALL, THE MEAN AGE OF STUDY PARTICIPANTS WAS 28 YEARS AND 56% WERE MALE.
NATURAL FIELD STUDIES
IN THE NATURAL FIELD STUDIES, EFFICACY OF ORALAIR AS IMMUNOTHERAPY TO TREAT SYMPTOMS OF ALLERGIC RHINOCONJUNCTIVITIS DUE TO THE GRASS POLLENS INCLUDED IN ORALAIR WAS ASSESSED VIA DAILY RECORDING OF SYMPTOMS AND RESCUE MEDICATION USE. THE DAILY COMBINED SCORE (CS, RANGE: 0-3) EQUALLY WEIGHTS SYMPTOMS AND RESCUE MEDICATION USE. THE DAILY RHINOCONJUNCTIVITIS TOTAL SYMPTOM SCORE (RTSS, RANGE 0-18) IS THE TOTAL OF THE SIX INDIVIDUAL SYMPTOM SCORES (SNEEZING, RHINORRHEA, NASAL PRURITUS, NASAL CONGESTION, OCULAR PRURITUS AND WATERY EYES) EACH GRADED BY PARTICIPANTS ON A 0 (NO SYMPTOMS) TO 3 (SEVERE SYMPTOMS) SCALE. THE DAILY RESCUE MEDICATION SCORE (RMS, RANGE 0-3) GRADES THE INTAKE OF RESCUE MEDICATION AS 0 = ABSENT, 1 = ANTIHISTAMINE, 2 = NASAL CORTICOSTEROID, 3 = ORAL CORTICOSTEROID. IN CASE OF MULTIPLE MEDICATIONS, THE HIGHER SCORE IS RETAINED. LEAST SQUARES (LS) MEANS ARE WITHIN-GROUP MEANS ADJUSTED FOR THE COVARIATES IN THE STATISTICAL MODELS (I.E., ANALYSES OF COVARIANCE FOR AVERAGE SCORES AND LINEAR MIXED MODELS WITH REPEATED MEASURES FOR DAILY SCORES). THE RELATIVE DIFFERENCE IS THE LS MEAN DIFFERENCE BETWEEN ORALAIR AND PLACEBO DIVIDED BY THE LS MEAN OF PLACEBO, EXPRESSED AS A PERCENTAGE.
US STUDY
IN THIS STUDY, 473 ADULTS AGED 18 THROUGH 65 YEARS RECEIVED ORALAIR OR PLACEBO, STARTING APPROXIMATELY FOUR MONTHS PRIOR TO THE EXPECTED ONSET OF THE GRASS-POLLEN SEASON AND CONTINUING FOR THE DURATION OF THE POLLEN SEASON. THE RESULTS OF THE ANALYSIS OF THE DAILY COMBINED SCORE (CS), DAILY RHINOCONJUNCTIVITIS TOTAL SYMPTOM SCORE (RTSS), AND DAILY RESCUE MEDICATION SCORE (RMS) ARE SUMMARIZED IN TABLE 4.
TABLE 4: DAILY COMBINED SCORE (CS), DAILY RHINOCONJUNCTIVITIS TOTAL SYMPTOM SCORE (RTSS), AND DAILY RESCUE MEDICATION SCORE (RMS) DURING THE GRASS POLLEN PERIOD (US STUDY)
EFFICACY ENDPOINT ORALAIR
(N=208)
LSC MEAN PLACEBO
(N=228)
LS MEAN LS MEAN DIFFERENCE ORALAIR -PLACEBO RELATIVE DIFFERENCE
ESTIMATE 95% CI
DAILY CSA 0.32 0.45 -0.13 -28.20% [-43.4%;-13.0%]
DAILY RTSSB 3.21 4.16 -0.95 -22.90% [-38.2%;-7.5%]
DAILY RMSB 0.11 0.2 -0.09 -46.50% [-73.9%;-19.2%]
A PRIMARY EFFICACY ANALYSIS
B SECONDARY EFFICACY ANALYSIS
C LS: LEAST SQUARES
EUROPEAN STUDY
IN THIS STUDY, ADULTS AGED 18 TO 45 YEARS RECEIVED ONE OF 3 DIFFERENT DOSES OF 5-GRASS POLLEN EXTRACT SUBLINGUAL TABLET OR PLACEBO. A TOTAL OF 311 SUBJECTS RECEIVED ORALAIR OR PLACEBO STARTING APPROXIMATELY 4 MONTHS PRIOR TO THE EXPECTED ONSET OF THE GRASS POLLEN SEASON AND CONTINUING FOR THE DURATION OF THE GRASS POLLEN SEASON. THE RESULTS OF THE ANALYSIS OF THE DAILY CS, DAILY RTSS AND DAILY RMS FOR ORALAIR (300 IR) ARE SHOWN IN TABLE 5.
TABLE 5: DAILY COMBINED SCORE (CS), DAILY RHINOCONJUNCTIVITIS TOTAL SYMPTOM SCORE (RTSS), AND DAILY RESCUE MEDICATION SCORE (RMS) DURING THE GRASS POLLEN PERIOD (EUROPEAN STUDY)
EFFICACY ENDPOINT ORALAIR
(N=136)
LSA MEAN PLACEBO
(N=148)
LS MEAN LS MEAN DIFFERENCE ORALAIR -PLACEBO RELATIVE DIFFERENCE
ESTIMATE 95% CI
DAILY CS 0.5 0.7 -0.21 -29.60% [-43.1%;-16.1%]
DAILY RTSS 3.48 4.91 -1.44 -29.20% [-43.4%;-15.1 %]
DAILY RMS 0.41 0.59 -0.18 -30.10% [-49.5%;-10.6%]
A LS: LEAST SQUARES
LONG TERM STUDY
IN THIS STUDY, ADULTS RECEIVED ORALAIR OR PLACEBO ACCORDING TO TWO DIFFERENT TREATMENT REGIMENS. A TOTAL OF 426 SUBJECTS RECEIVED ORALAIR OR PLACEBO STARTING APPROXIMATELY 4 MONTHS PRIOR TO THE GRASS POLLEN SEASON AND CONTINUING FOR THE ENTIRE SEASON. SUBJECTS WERE TREATED FOR THREE CONSECUTIVE GRASS POLLEN SEASONS (YEAR 1 TO YEAR 3). THE PRIMARY EVALUATION WAS THE YEAR 3 POLLEN PERIOD. PARTICIPANTS THEN ENTERED TWO YEARS OF IMMUNOTHERAPY-FREE FOLLOW-UP (YEAR 4 AND YEAR 5). THE RESULTS OF THE ANALYSIS OF THE DAILY COMBINED SCORE FOR ORALAIR (4M) FOR TREATMENT YEARS 1-3 ARE SUMMARIZED IN TABLE 6. DATA ARE INSUFFICIENT TO DEMONSTRATE EFFICACY FOR ONE OR TWO YEARS AFTER DISCONTINUATION OF ORALAIR.
TABLE 6: ANALYSIS OF DAILY COMBINED SCORE FOR EACH GRASS POLLEN PERIOD (LONG TERM STUDY)
YEAR ORALAIR (4M) PLACEBO LS MEAN DIFFERENCE ORALAIR - PLACEBO RELATIVE DIFFERENCE
N LSA MEAN N LS MEAN ESTIMATE 95% CI
YEAR 1 188 0.56 205 0.67 -0.11 -16.40% [-27.0%;-5.8%]
YEAR 2 160 0.35 172 0.56 -0.21 -38.00% [-53.4%;-22.6%]
YEAR 3 149 0.31 165 0.5 -0.19 -38.30% [-54.7%;-22.0%]
A LS: LEAST SQUARES
PEDIATRIC STUDY
IN THIS STUDY, 278 CHILDREN AND ADOLESCENTS RECEIVED ORALAIR OR PLACEBO STARTING APPROXIMATELY 4 MONTHS PRIOR TO THE GRASS-POLLEN SEASON AND CONTINUING FOR THE DURATION OF THE POLLEN SEASON. THE RESULTS OF THE DAILY CS, DAILY RTSS, AND DAILY RMS ARE SUMMARIZED IN TABLE 7.
TABLE 7: DAILY COMBINED SCORE (CS), DAILY RHINOCONJUNCTIVITIS TOTAL SYMPTOM SCORE (RTSS), DAILY RESCUE MEDICATION SCORE (RMS) DURING THE GRASS POLLEN PERIOD (PEDIATRIC STUDY)
EFFICACY ENDPOINT ORALAIR
(N=131)
LSA MEAN PLACEBO
(N=135)
LS MEAN LS MEAN DIFFERENCE ORALAIR -PLACEBO RELATIVE DIFFERENCE
ESTIMATE 95% CI
DAILY CS 0.44 0.63 -0.19 -30.10% [-46.9%;-13.2%]
DAILY RTSS 2.52 3.63 -1.11 -30.60% [-47.0%;-14.1%]
DAILY RMS 0.46 0.65 -0.19 -29.50% [-50.9%;-8.0%]
A LS: LEAST SQUARES
ALLERGEN ENVIRONMENTAL CHAMBER STUDY
IN AN ALLERGEN ENVIRONMENTAL CHAMBER STUDY, 89 ADULTS WITH GRASS POLLEN-ASSOCIATED ALLERGIC RHINOCONJUNCTIVITIS WERE CHALLENGED WITH FOUR OF THE FIVE GRASS POLLENS CONTAINED IN ORALAIR AT BASELINE AND AFTER 4 MONTHS OF TREATMENT WITH ORALAIR (N=45) OR PLACEBO (N=44). THE AVERAGE RHINOCONJUNCTIVITIS TOTAL SYMPTOM SCORE (RTSS) OF EACH GROUP DURING THE 4 HOURS OF THE ALLERGEN CHALLENGE WAS ASSESSED; USE OF RESCUE MEDICATION WAS NOT PERMITTED. THE RESULTS OF THIS STUDY ARE SHOWN IN TABLE 8.
TABLE 8: AVERAGE RHINOCONJUNCTIVITIS TOTAL SYMPTOM SCORE (RTSS) DURING GRASS POLLEN ALLERGEN CHALLENGE IN AN ENVIRONMENTAL EXPOSURE CHAMBER AFTER 4 MONTHS OF ORALAIR OR PLACEBO
EFFICACY ENDPOINT ORALAIR
(N=45)
LSB MEAN PLACEBO
(N=44)
LS MEAN LS MEAN DIFFERENCE ORALAIR -PLACEBO RELATIVE DIFFERENCE
ESTIMATE 95% CI
AVERAGE RTSSA 4.88 6.84 -1.97 -28.70% [-43.7%;-13.7%]
A PRIMARY EFFICACY ANALYSIS
B LS: LEAST SQUARES