Use of an innovative short-term immunotherapy in daily practice: results from a post marketing surveillance study (PMS)

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Lee Fisher
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Use of an innovative short-term immunotherapy in daily practice: results from a post marketing surveillance study (PMS) Dr.Albert Roger Reig Allergy Unit. H.U. Germans Trias i Pujol

1 Use of an innovative short-term immunotherapy in daily practice: results from a post marketing surveillance study (PMS) Dr.Albert Roger Reig Allergy Unit. H.U. Germans Trias i Pujol Badalona (Spain) Pollinex Quattro Allergoid containig MPL Th1 driving adjuvant 4 injections / weekly (up to 7) Pharmacoeconomic advantages Efficacy / tolerability Demonstrated in DBPC studies 1

2 Controlled and uncontrolled clinical trials: assessing real world significance in allergy What we really want to know, is how a certain drug would help our patients in a real world setting or everyday practice Thus, what we need are real world studies, often referred to as uncontrolled studies, to complete the full clinical picture of a drug Uncontrolled studies are often performed as post-marketing surveillance studies (PMS) Bachert C. AAAAI 2004 Pollinex Quattro PMS Spain Pollen respiratory allergy Under normal clinical practice conditions (open, observational) 2

3 Aim of study: Efficacy & Tolerability Efficacy (1) Antiallergic medication intake during the pollen season... Regular Frequent Occasional No medication... compared to the previous year before starting the treatment 3

4 Efficacy (2) Therapy success Very good / moderate improvement Slight improvement No change Worsened Assessed Physician Patient Tolerability - Adverse events - Acceptance of therapy by patients - Very good / good - Less good -Bad 4

5 3 years: 2001 (1) / 2002 (2) / visits / year Start immunotherapy End immunotherapy, before pollen season (tolerability assessment) Endpollenseason(efficacyassessment) (1) A.Roger. Pollinex Quattro: primeras experiencias en España. Alergol Inmunol Clin 2002; 17(suppl2):189. (2) A.Roger. Pollinex Quattro: eficacia y seguridad en alergia respiratoria. Alergol Inmunol Clin 2004; 19(suppl2):347. Patients Total = 483 Mean age = 30 (minimum 7) Diagnosis: 100% rhinitis 79% conjunctivitis 49% asthma 5

6 Prick test 74% grass pollens 53% olive 13% parietaria Grass pollen 6

7 Olive pollen Parietaria pollen 7

8 Immunotherapy Length of treatment One year = 73% Two / three years = 27% Schedule Four doses = 48% Four / seven doses = 92% Top dose = 2000 SU Grass = 20.8 mcgr major allergen Results (patients) Tolerability = 458 Efficacy = 452 8

9 Therapy success Antiallergic medication 9

10 Tolerability - Ease of administration (physician) - very good / good = 98% - Acceptance of therapy (patients) Acceptance of therapy by age 10

Adverse events Reaction None Local (1) Systemic (3) Patients 442 14 2 Percentage 96.5 3.1 (2) 0.

11 Adverse events Reaction None Local (1) Systemic (3) Patients Percentage (2) 0.4 (1) redness/swelling <10 cm (no treatment) (2) first year 4.3%; consecutive 1.2% (3) general itching; rhinitis/urticaria No anaphylactic reactions Local reactions by age 11

12 Length Immunotherapy: 1 versus 2-3 years Trend towards continuous improvement Medication intake Efficacy assessment Tolerability Occasional / No medication 1 year = 61% 3 years = 68% (p<0.0001) (p=0.0537) 12

13 Length / Efficacy Patient assessment Length / Efficacy Physician assessment 13

14 Length / Tolerability Acceptance by patients Length / Tolerability Acceptance: patients vaccinated 2-3 years 14

15 Pollinex PMS: Discussion Spain / Germany (EAACI 2004) Improvement (patient) = 92% / 93% Antiallergic medication % Regular Occasional Before 34 / /16 After 10 / 8 49 / 52 Pollinex PMS: Discussion Spain / Germany (EAACI 2004) Acceptance of therapy (patient) very good / good = 92% / 93% Local reactions (years) First Last 4% 1% 8% 2% Grasses / Olive / Parietaria Grasses / Birch / Alder / Hazel 15

16 Summary Respiratory allergic adults and children Under normal clinical practice conditions Effective on assessment by both physicians / patients Antiallergic medication use decrease Good tolerability profile Spanish 3-year Pollinex PMS Conclusion Confirmed our encouraging results from the first and second year of therapy Endorses the success of previous DBPC studies High efficacy Good tolerability 16

Allergen immunotherapy: from EBM to doctors and patients need

Allergen immunotherapy: from EBM to doctors and patients need Moscow, Marriott Hotel February 28th, 2019 Dr. Franco Frati Medical Department Milan, Italy From the recognition of the pollen to in vivo tests