Clinical assessment of tolerability, immunological and cutaneous reactivity effects of an abbreviated schedule with Olea europaea native extract of subcutaneous immunotherapy
Show more: Authors information and Publication history
Authors Information
Show more Authors information and Publication history 1Jaén University Hospital, Allergology Department, Jaén, Spain
2Santa Bárbara Hospital, Allergology Department, Puertollano, Spain
3Costa de la Luz Hospital, Allergology Department, Huelva, Spain
4Infanta Cristina University Hospital, Allergology Department, Badajoz, Spain
5Nisa Hospital, Allergology Department, Seville, Spain
6 ROXALL España, R&D Department, Zamudio, Spain
History
:
Published online: 27 November 2019
Accepted: 25 November 2019
Received: 29 August 2019
SUMMARY
Objectives. To evaluate the tolerability and efficacy of Olea europaea subcutaneous immunotherapy (SCIT) on patients with rhinoconjunctivitis. Methods. In this open clinical trial patients were assigned to an abbreviated build-up scheme. The outcomes were: number, percentage, and severity of adverse reactions. Secondary outcomes included: changes in immunoglobulin titers and changes in dose-response skin prick tests. Results. Only 8 systemic reactions were registered, which represented 7/47 (14.9%) of patients and 8/429 (1.9%) of administered doses. Regarding immunological parameters the significant increases of sIgG and sIgG4 evidenced the changes in the patient immune system. Cutaneous reactivity decreased significantly. Conclusions. Olea europaea SCIT (Allergovac ® depot ROXALL Medicina España S.A.) showed a good safety and tolerability profile. Immunological changes with induction of blocking IgG and decreases in cutaneous reactivity were detected in the patients.