The present survey investigated the current clinical practice scenario of AR management in Italy. In addition to provide an extensive description of Italian HCPs’ prescribing behaviour, thes research discloses clinicians’ perspective about patients’ symptom discomfort and adherence.
AR is characterized by substantial medical and social burden with high use of healthcare resources worldwide (5,6,11,34) This disorder is associated with absenteeism from work, reduced productivity, and poor school performance (34,35). Recent studies indicate not only a global increase in the AR prevalence (3,6,36), but also high rates of underdiagnosis (3) and inadequate treatment (22).
In our survey, allergologist was the main reference specialist for the disease, followed by ENTs. GPs visited more cases suffering from mild AR compared to both allergologists and ENTs. Prescription attitude was similar between HCPs. Attributes related to medication efficacy, safety, and patient adherence were considered more relevant prescription drivers than ease of use and cost-related items.
Consistent with previous Italian studies (31,32), the most prescribed drugs were antihistamines and intranasal corticosteroids. A novel data disclosed by our survey is that allergologists and ENTs recommended fixed-dose combination intranasal Aze/flu to about 20% of the patients they visited. It is well-established that intranasal corticosteroids provide a more effective control of AR symptoms than antihistamines but their effect is relatively slow (hours) (18). Fixed-dose combination of intranasal fluticasone propionate and azelastine hydrochloride was shown to be more efficacious than intranasal corticosteroid monotherapy (37–42) and it offers the additional benefit of faster relief of symptoms (minutes) (39,40,43). This drug is also indicated when monotherapy with either intranasal antihistamines or corticosteroids do not adequately control the symptoms of AR (39,41,42,44). Of note, randomized clinical trials showed that fixed-dose formulation is more effective than loose combinations of corticosteroids and antihistamines in patients with moderate/severe seasonal AR (44). The newest ARIA guidelines based on both Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence (RWE) confirm and emphasize efficacy of fixed-dose combination of intranasal Aze/flu for both nasal and ocular symptom relief, adding this drug to first line therapies for AR patients (45). Of interest, our analysis showed that fixed-dose combination intranasal Aze/flu was used in both monotherapy and polytherapy regimens, with significant differences across clinicians. In fact, Aze/flu was preferentially used in monotherapy by ENTs, whereas it was more frequently recommended in polytherapy regimens by allergologists and GPs. This latter therapeutic strategy involved the simultaneous use of Aze/flu mainly together with antihistamines (ebastine, desloratine, bilastine). Assessing the risk of therapeutic duplication in patients suffering from AR is a crucial question that requires specific investigation.
Another remarkable finding of the present survey is that AR severity is underestimated by physicians, irrespective of the specialty area in which they operate. In fact, about half of the patients assigned to the mild class of severity actually experienced particularly bothersome symptoms. This observation is consistent with data reported by the European survey carried out in Germany, France, Italy, Spain, and UK, in which clinicians not only underestimated the severity of disease but also misdiagnosed the nature and discomfort of symptoms (12). As a correct classification of symptom frequency and severity is essential to select the best treatment option for each patient (13,18,46), an inaccurate patients’ allocation to severity categories can negatively impact AR therapy. The results provided by our analysis of AR pharmacological management according to patients’ severity further supports this concept. Indeed, patients assigned to moderate/severe AR were preferentially recommended a polytherapy-based approach rather than a monotherapy regimen. Based on this, we can speculate that some of the patients improperly assigned to the mild category were undertreated in our sample. AR undertreatment and inadequate management have been extensively documented (20–22), suggesting that this disease is still trivialized in some cases (3,22,23).
With regard to HCPs’ opinions about patient adherence, our investigation disclosed that clinicians believe all the patients will be compliant, even in the cases of severe AR. This perception does not reflect the real scenario of patients’ adherence in the AR settings. In fact, it is widely accepted that adherence in AR patients is very low (25,26,47,48). A recent study, in which compliance was assessed in a real-life setting using a mobile phone App, confirmed that about 70% of the recruited European AR patients are non-adherent to medications (26). HCPs’ misperception of patient adherence in our sample is likely a consequence of low frequency of follow-up visits (once a year) and of lack of patients-clinicians communication (12,49).
According to the interviewed physicians, the main cause of low compliance was relief of AR symptoms, followed by cost-related issues. Lack of efficacy, adverse effects, treatment duration, and costs are generally associated with lower compliance (50). Patient satisfaction with treatment likewise appears to be a relevant factor in determining compliance, even if its contribution still needs to be elucidated. In fact, many researchers reported that dissatisfaction with treatment may cause non-adherence to therapy (51–53), whereas more recent studies revealed that patients discontinue their treatment when they felt better (47,54). In contrast to guidelines recommending the use of multiple drugs to achieve symptom control (45), recent data indicated that most patients experience poor symptom control with increasing medications (26,55). Hence, the use of single drug-based therapy could substantially ameliorate patient compliance. Finally, concerning drug cost, it is widely accepted that affordability of prescription medication has a role in therapy persistence (25). Of interest, clinicians recruited in our survey did not consider cost issues as relevant prescription drivers.