Dymista ® in 90 minutes *Carr et al. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. J Allergy Clin Immunol. 2012; 129(5): 1282-1289. Leung et al. MP29-02: A major advancement in the treatment of allergic rhinitis. J Allergy Clin Immunol. 2012; 129(5): 1216.
60
Embed
Dymista ® in 90 minutes *Carr et al. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. J Allergy Clin Immunol.
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Dymista® in 90 minutes
*Carr et al. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. J Allergy Clin Immunol. 2012; 129(5): 1282-1289. Leung et al. MP29-02: A major advancement in the treatment of allergic rhinitis. J Allergy Clin Immunol. 2012; 129(5): 1216.
Agenda
• Introduction
• Unmet medical need in Allergic Rhinitis and the patient perspective
• Dymista®: the drug of choice for the treatment of Allergic Rhinitis
• Dymista® versus commercially available first line therapy
• Wrap-up and discussion
Unmet medical need with current Allergic Rhinitis therapy: SCUAD
• Up to 20% of Allergic Rhinitis patients receiving an optimal pharmacologic treatment (according to guidelines) still present with severe symptoms
• These patients are ascribed to Severe Chronic Upper Airway Disease (SCUAD)
Bousquet et al, 2009 & 2010
Before
Controlled
SCUAD
n=586
Med
ian
sco
re
Global Sleep Practical Eye Emotions
Unmet medical need with current allergic rhinitis (AR) therapy
• Patients use multiple therapies to achieve AR symptom control
− As many as 90% of patients in a recent survey - despite the fact that there is limited evidence to support this practice
− 60% of all AR patients are “very interested” in finding a new medication and 25% are “constantly” trying different medications to find one that “works”
There is a clear need for a new and more effective therapyThere is a clear need for a new and more effective therapy
Canonica et al, 2007; Schatz, 2007; Mullol et al, 2009; Demoly et al, 2002; Bousquet et al, 2012; Bousquet et al, 2008; Marple et al, 2007
Up to 90% of patients already take 2 or more rhinitis medications
Canonica Schatz BousquetDemolyMullol
% o
f P
atie
nts
Can Dymista® change the landscape of AR management?
• Fast relief: SABA• Sustained relief: LABA• Preventer: ICS• Unmet medical need
− Most patients were taking SABA, LABA and ICS
− Convenient treatment needed to simplify asthma management as per recommendations
• Fast relief: SABA• Sustained relief: LABA• Preventer: ICS• Unmet medical need
− Most patients were taking SABA, LABA and ICS
− Convenient treatment needed to simplify asthma management as per recommendations
• Fast relief: anti-histamines• Sustained & most effective relief:
intranasal corticosteroids• Unmet medical need
− Changing face of the disease− 20% SCUAD− 75% of patients on unproven combination
therapy− More effective therapies urgently needed
• Fast relief: anti-histamines• Sustained & most effective relief:
intranasal corticosteroids• Unmet medical need
− Changing face of the disease− 20% SCUAD− 75% of patients on unproven combination
therapy− More effective therapies urgently needed
….to the same extent as that seen in asthma management
Asthma LandscapeAsthma Landscape
Many asthmatics now on LABA/ICS formulations
Dymista® a new paradigm for Allergic Rhinitis management
6. Frequency of medication (once, twice, three times/day)
7. Monthly out-of-pocket cost (£15, £30, £45). Patients were asked to imagine that they paid the full cost of this prescription medication
• Patients were presented with 19 pairs of ‘potential Allergic Rhinitis products’ (based on the above characteristics) and asked to choose between them
We asked them using a Discrete Choice Experiment (DCE)
An Example Choice Set
Patients were presented with 19 of these and asked to pick ‘A’ or ‘B’
DCE Results: moderate to severe SAR patients
• Patients want more efficacious treatments which provide complete or substantial treatment relief
• Patients where willing to pay £43 to receive such a medication
Carr et al, 2012. Responder rate = % of patients who achieved the specified response
rTNSS (≤1 point for all symptom scores)
Day
Res
po
nd
er R
ate
(%)
AZE
FP
PLA
Start
These results have been published in JACI
• ‘Prior to MP29-02 [Dymista®], no clinical development program has demonstrated additional benefit over two currently recommended first-line AR therapies in moderate-to-severe patients’
• ‘Patients with moderate-to-severe SAR achieved better control and were controlled earlier with MP29-02 [Dymista®] than with recommended medications according to guidelines’
• ‘The results are consistent among different parameters, including ocular symptoms, and across various allergy seasons’
• ‘’MP29-02 [Dymista®]provided benefits for all patients, providing significantly greater symptom relief than Fluticasone propionate or Azelastine monotherapy regardless of disease severity’
Take home messages
Carr et al, 2012JACI: Journal of Allergy & Clinical Immunology; AR: Allergic Rhinitis; SAR: Seasonal Allergic Rhinitis
Editors’ choice J Allergy Clin Immunol
• ‘MP29-02 [Dymista®]: A major advancement in the treatment of Allergic Rhinitis’• ‘MP29-02 [Dymista®]: can be considered the drug of choice for the treatment of
Allergic Rhinitis’
AR: Allergic Rhinitis
Dymista® versus commercially first line therapy
The treatment effect of Dymista® becomes even more striking when comparing it to commercially-available FP – the Meda Fluticasone propionate
preparation masks the ‘real world’ effects of Dymista®
The treatment effect of Dymista® becomes even more striking when comparing it to commercially-available FP – the Meda Fluticasone propionate
preparation masks the ‘real world’ effects of Dymista®
Dymista® versus commercially available first line therapy
The importance of Study MP4001
Hampel et al, 2010; Carr et al, 2012; Price et al, EAACI , 2012FP: fluticasone propionate; ITT: intent to treat
Hampel et al, 2010; Carr et al, 2012AZE: azelastine; FP: fluticasone propionatel; rTNSS: reflective total nasal symptom socre;
Data presented as LS mean change from baseline delta placebo with 95% CI
Dymista® is more effective in reducing nasal AR symptoms compared to commercially available first-line therapy
Not commercial available first line therapy
Commercially available first line therapy
FP AZE
LS
Mea
n C
han
ge
fro
m B
asel
ine
in r
TN
SS
(Del
ta p
lace
bo)
† p<0.0001 vs Dymista®; ‡ p=0.0031 vs Dymista®
Patients treated with Dymista® experience significant relief from all their nasal symptoms
Hampel et al, 2010. Results expressed as LS mean change from baseline (delta placebo) with 95% CI
† p=0.0034 vs Dymista®; ‡ p=0.0001 vs Dymista® † p=0.0240 vs Dymista®; ‡ p=0.0033 vs Dymista®
Nasal Congestion Nasal Itch
LS
Mea
n C
han
ge
fro
m B
asel
ine
(Del
ta p
lace
bo)
AZEFP AZEFP
LS
Mea
n C
han
ge
fro
m B
asel
ine
(Del
ta p
lace
bo)
Patients treated with Dymista® experience significant relief from all their nasal symptoms
Dymista® (n=153) FP: Fluticasone propionate (n=151); AZE: azelastine (n=152) ; Hampel et al, 2010. Results expressed as LS mean change from baseline (delta placebo) with 95% CI
Better than intranasal Fluticasone and Azelastine
† p=0.0678 vs Dymista®; ‡ p<0.0001 vs Dymista® † p=0.0009 vs Dymista®; ‡ p<0.0001 vs Dymista®
Rhinorrhea Sneezing
AZEFP AZEFPL
S M
ean
Ch
ang
e fr
om
Bas
elin
e (D
elta
pla
cebo
)
LS
Mea
n C
han
ge
fro
m B
asel
ine
(Del
ta p
lace
bo)
Dymista® (n=153); FP: Fluticasone propionate (n=151); AZE: azelastine (n=152); rTOSS: reflective Total Ocular Symptom Score; SAR: Seasonal Allergic Rhinitis; Hampel et al, 2010; Data presented as LS mean change from baseline delta placebo with 95% CI
Dymista® is also more effective than intranasal steroids in treating the symptoms of conjunctivitis
• Approx 90% of SAR patients also experience eye symptoms during the season• Patients treated with Dymista® experienced significantly better ocular symptom
relief than those treated with fluticasone with a relative difference of 58%
† p=0.0022 vs Dymista®; ‡ p=0.0706
AZEFP
LS
Mea
n C
han
ge
fro
m B
asel
ine
in r
TO
SS
(D
elta
pla
cebo
)
Hampel et al, 20120Dymista® (n=153); FP: Fluticasone propionate (n=151); AZE: azelastine (n=152); Data presented as LS mean change from baseline delta placebo with 95% CI
Better than intranasal Fluticasone or Azelastine
Patients treated with Dymista® experience significant relief from all their ocular symptoms
† p=0.0001 vs Dymista®
‡ p=0.0127 vs Dymista®
† p=0.0218 vs Dymista®
‡ p=0.2923 vs Dymista®
† p=0.0044 vs Dymista®
‡ p=0.0372 vs Dymista®
Watering Itching Redness
AZEFP AZEFP AZEFP
LS
Mea
n C
han
ge
fro
m B
asel
ine
(Del
ta p
lace
bo)
† p=0.0013 vs Dymista®; ‡ p=0.0004 vs Dymista®;
Dymista® (n=153); FP: Fluticasone propionate (n=151); AZE: azelastine (n=152); Data on file
rT7SS: Total of 7 symptom scores (All nasal pluis all ocular symptoms); Data on file; Results expressed as LS mean change from baseline (delta placebo) with 95% CI
Better than intranasal Fluticasone or Azelastine
Dymista® most effectively treats the entire rhinitis symptom complex (both nasal & ocular symptoms)
AZEFP
rT7S
S L
S M
ean
Ch
ang
e fr
om
Bas
elin
e(D
elta
pla
cebo
)
AR: allergic rhinitis; AZE: Azelastine; FP: Fluticasone propionate; rTNSS: reflective Total Nasal Symptom ScoreData on file; Results expressed as LS mean change from baseline (delta placebo) with 95% CI
Most AR patients have moderate-to-severe disease
Dymista®: the most effective option regardless of severity
Most severe patients Moderate/ severe patients
LS
Mea
n C
han
ge
fro
m B
asel
ine
In r
TN
SS
(Del
ta p
lace
bo)
AZEFP AZEFP
† p=0.0436 vs Dymista®; ‡ p=0.0035 vs Dymista®
Dymista® (n=77); FP (n=64); AZE (n=68)
† p=0.0188 vs Dymista®; ‡ p=0.0002 vs Dymista®
Dymista® (n=76); FP (n=87); AZE (n=84)
Dymista® is also more effective for those patients with moderate/severe ocular symptoms
rTOSS: reflective total ocular symptom score; ITT: intent to treat; AZE: Azelastine; FP: Fluticasone propionate; BL: baseline.
Data on file; Results expressed as LS mean change from baseline (delta placebo) with 95% CI
More severe patients
BI TOSS ≥ 8
ITT
† p=0.0022 vs Dymista®; ‡ p=0.0706 vs Dymista®
Dymista® (n=153); FP (n=151); AZE (n=152)
† p=0.0012 vs Dymista®; ‡ p=0.0456 vs Dymista®
Dymista® (n=128); FP (n=125); AZE (n=118)
LS
Mea
n C
han
ge
fro
m B
asel
ine
In r
TO
SS
(Del
ta p
lace
bo)
AZEFP AZEFP
Dymista®: superior in providing faster and substantial symptom relief (≥ 50% reduction in nasal symptoms)
• More Dymista® patients achieve substantial symptom relief (1 in every 2 patients)
• And achieve this level of control up to 6 days faster than either FP or AZE
• Relevance:
A substantial response with up to 6 day’s time advantage over first-line therapy is relevant since an AR episode lasts 12.5 days on average
Substantial nasal symptom reduction is achieved by more Dymista® patients and up to 6 days earlier than existing first-line therapy
Substantial nasal symptom reduction is achieved by more Dymista® patients and up to 6 days earlier than existing first-line therapy
Bachert et al. EAACI 2011, AZE: Azelastine; FP: Fluticasone propionate; PLA: placebo; AR: allergic rhinitisResponder rate = % of patients with a 50% or more reduction in Total Nasal Symptom Score
Res
po
nd
ers
rate
(%
)
PLA
Day
6 days
AZEFP
Dymista®: More patients will be symptom-free than first-line therapy
• 1 out of 6 Dymista®
patients achieve complete or near-to-complete symptom relief
• Relevance:
Complete symptom relief is what patients want
80 million allergic rhinitis sufferers around the world could become symptom-free with Dymista®
80 million allergic rhinitis sufferers around the world could become symptom-free with Dymista®
Data on file; Responder Rate = % of patients with a score of ≤ 1 for every nasal symptom
AZEFP
PLA
Res
po
nd
ers
rate
(%
)
Day
Dymista® is the drug that patients want
• Patients want more effective therapy and are willing to pay £43 to receive such medication (DCE results)
• Two thirds of all patients incl. in the survey reported using ≥ 2 AR medications
− Faster and more effective reduction of nasal and ocular symptoms was the primary reason for co-medication
Results of the health survey
Dymista® represents the drug which patients wantDymista® represents the drug which patients want
AR: Allergic Rhinitis; DCE: discrete choice experimentPitman et al, 2012
% moderate/severe patients on ≥ 2 AR medications
Total Increased nasal
efficacy
Increased ocular
efficacy
Faster nasal
response
Faster ocular
response
Other
% o
f P
atie
nts
MP4001 Conclusions
• The efficacy of Dymista® is more apparent compared to commercially-available first line therapy (than not commercially available comparators used in studies MP4002, MP4004 and MP4006 [i.e. the JACI publication])
• Dymista® is more effective than commercially first-line therapies in combating overall nasal symptoms (rTNSS), overall ocular symptoms (rTOSS) as well as each of the individual symptoms
• Dymista® provides benefits for all patients, providing significantly greater symptom relief vs FP or AZE regardless of disease severity
• More Dymista® patients achieved substantial nasal relief and achieved it earlier.
• 250 million patients will experience substantial symptom relief while 80 million patients will have no symptoms and feel themselves “cured”
Dymista® versus marketed comparators
AR: Allergic Rhinitis; rTNSS: reflective Total Nasal Symptom Score; rTOSS: reflective total ocular symptom score; FP: Fluticasone propionate; AZE: Azelastine
Wrap up and Discussion
Can Dymista® change the landscape of AR management?
• Fast relief: SABA• Sustained relief: LABA• Preventer: ICS• Unmet medical need
− Most patients were taking SABA, LABA and ICS
− Convenient treatment needed to simplify asthma management as per recommendations
• Fast relief: SABA• Sustained relief: LABA• Preventer: ICS• Unmet medical need
− Most patients were taking SABA, LABA and ICS
− Convenient treatment needed to simplify asthma management as per recommendations
• Fast relief: anti-histamines• Sustained & most effective relief:
intranasal corticosteroids• Unmet medical need
− Changing face of the disease− 20% SCUAD− 75% of patients on unproven combination
therapy− More effective therapies urgently needed
• Fast relief: anti-histamines• Sustained & most effective relief:
intranasal corticosteroids• Unmet medical need
− Changing face of the disease− 20% SCUAD− 75% of patients on unproven combination
therapy− More effective therapies urgently needed
….to the same extent as that seen in asthma management
Asthma LandscapeAsthma Landscape
Many asthmatics now on LABA/ICS formulations
Dymista® a new paradigm for Allergic Rhinitis management