Introduction
The prevalence of allergies is increasing, and the most common
manifestation of this are the respiratory allergic diseases such as
allergic rhinitis (AR) and asthma1,2. Aomg patients
with AR and allergic asthma, allergen-specific immunotherapy (AIT) is
the only treatment option that induces clinical and immunologic
allergen-specific immune tolerance, thus conferring a long-lasting
clinical benefit3,4. Subcutaneous immunotherapy
(SCIT), which is the most common form of AIT, has been demonstrated to
be highly effective for treating patients with a mite allergy, and/or
seasonal pollinosis5. SCIT usually involves
administering a gradually increasing dose of the specific allergen to
allergic patients until the effective dose is reached, which takes
several weeks and is followed by two or more years of maintenance
doses6. Patient compliance and education during
treatment has been shown to play an important role in guaranteeing the
disease-modifying effect of SCIT7. However, the impact
of treatment delays on the condition of SCIT patients with allergic
diseases has not yet been reported.
At the end of 2019, the global community witnessed the outbreak of the
coronavirus disease 2019 (COVID-19) in China, which has subsequently had
a tremendous influence on clinical, educational, research, and community
responsibilities around the world8. In the event of
such a global infectious pandemic, allergy and immunology specialists
have suggested that rapid and drastic measures may be needed, which
limit or require adjustment of ambulatory allergy
services9. Affected by the pandemic, many patients who
were receiving SCIT were forced to discontinue or postpone treatment in
the hospitals, which led us to consider whether these patients
experienced any physical and/or mental impacts because of treatment
delay during this period. Real world evidence (RWE) allows for estimates
of effectiveness rather than efficacy in various typical practice
settings, as well as the examination of clinical outcomes in a diverse
study population, which is representative of patients observed in
clinical practices5. In this research, we follow up on
the physical and mental outcomes on SCIT patients that experienced
treatment delays, based on RWE up to one year. This will enable us to
develop novel strategies for future SCIT management during the COVID-19
pandemic.
According to the recommendations of World Allergy Organization (WAO) and
European Academy of Allergy and Clinical Immunology
(EAACI)10,11, a comprehensive set of end-points were
chosen for our research. To measure symptom and medication (1) these
included visual analogue scale (VAS); daily symptom score (dSS); daily
medication score (dMS); and combined symptom and medication scores
(CSMS). To measure quality of life (QoL) (2), and psychological burden
(3) these included self-rating anxiety scale (SAS); and self-rating
depression scale (SDS). These commonly used indices were selected to
demonstrate the severity of symptoms, use of medication, quality of
life, effect of anxiety and depression related symptoms in patients with
delayed SCIT during the COVID-19 outbreak.