Observational study of sublingual specific immunotherapy in persistent and intermittent allergic rhinitis: the EFESO trial

ABSTRACT

Background: Sublingual specific immunotherapy (SLIT) is a valid treatment for allergies. However, there are few data on a large sample size regarding its clinical role in ‘real life’.

Study aim: We performed a multicentre, case-control study to evaluate the effectiveness of SLIT in patients with allergic rhinitis (AR).

Methods: A total of 305 patients with AR were enrolled. Cases (n = 154) were defined as patients with intermittent (64%) or persistent (36%) AR who were treated daily for at least two consecutive years with specific SLIT. Controls (n = 151) were defined as age-, sex- and type of allergen-matched AR subjects who were never treated with specific immunotherapy. The main outcomes of the study were the rhinoconjunctivitis symptom score (SS) and the symptomatic medication score (MS). SS and MS were evaluated at the end of the observational period in relation to the peak of relevant pollen season or during the period of maximum allergen exposure in case of non-seasonal allergens.

Results: SS mean (SD) value was 5.1 (3.0) in cases and 9.3 (3.3) in controls (−43%) ( p = 0.0001). MS mean (SD) value was 2.6 (1.8) and 4.4 (2.6) in the case and control groups, respectively (−41%) ( p = 0.0001). At the end of the observation period, asthma-related symptoms were present in 8.5% of cases and in 20% in the control group ( p = 0.01).

Conclusion: The EFficacia nella rinitE allergica di SlitOne (EFESO) trial shows that SLIT treatment in AR is associated with lower SS and MS in comparison with controls. SLIT is also associated with a lower incidence of asthma and new sensitizations. As this was an observational study, our results need to be confirmed in randomized, double-blind, controlled trials.

Key Words::

• Allergic rhinitis
• Asthma prevention
• Case-control trial
• Sublingual immunotherapy

Acknowledgements

Declaration of interest: This study was funded by ALK-Abellò Italy.

S.B. acted as the Principal Investigator for this trial, has not received any personal financial support from ALK-Abellò and has no relevant conflicts of interest to declare. M.M. and S.P. are both employees of ALK-Abellò Italy; neither was involved in data management and analysis. M.M. and S.B. were involved in the study design and protocol writing of the trial.

The EFESO Investigators are (in alphabetical order): F. Acquistapace, Pediatric Department, Fatebenefratelli e Oftalmico Hospital – Milan; F. Agostinis, Pediatric Specialist and Allergologist, Bergamo; S. Burastero, Allergology Department, San Raffaele del Monte Tabor Hospital – Milan; G. Cadario, Allergology Department, San Giovanni Battista ‘Le Molinette’ Hospital – Turin; V. Castella, Pediatric Department, Santi Antonio and Margherita Hospital – Tortona, Alessandria; G. Di Franco, Pneumology Department, Civil Hospital of Vimercate – Milan; A. Kantar, Pediatric Department, Ponte San Pietro Hospital – Bergamo; G. Manzotti, Internal Medicine Department, Allergology Service, Treviglio-Caravaggio General Hospital – Treviglio, Bergamo; F. Marengo, Allergology Department, San Giovanni Battista ‘Le Molinette’ Hospital – Turin; E. Novembre, Pediatric Department, A. Meyer Pediatric Hospital – Florence; A. Pappacoda, Allergology Services – Azienda Sanitaria Locale Ponte San Pietro – Bergamo; MR Perrone, Specialist in Allergology – Lecce; M. Pietrasanta, Pediatric Department, Civil Hospital of Aqui Terme – Alessandria; A. Rapetti, Allergology Department, Hospital of Tradate– Varese; R. Sambugaro, Pediatric Specialist and Allergologist – Pavia; V.Sillano, Allergology Specialist – Azienda Sanitaria Locale ‘Milano 1’ Milan; M. Zambito, Allergology Specialist – Palermo.

Notes

* SLITone is a registered product of ALK-Abellò