Treatment burden in atopic dermatitis

While atopic dermatitis may spontaneously resolve in patients, it is not curable. Many patients will experience chronic disease and so the aims of treatment are limited to (Thomsen, 2014):

  1. Minimise the number of flares
  2. Reduce the duration and degree of any flares

Interestingly, when 3,846 dermatology patients across 13 countries were asked whether they had treatment-related issues, 63.4% of patients with atopic dermatitis said they did – more than any other skin disease assessed (Balieva et al., 2018).

80% of patients in an online survey were dissatisfied with their atopic dermatitis treatment (George & Makrygeorgou, 2015).

The topical treatments for atopic dermatitis have changed little over the past 15 years, consisting of topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI). The effectiveness of TCS has been demonstrated over the years, however, local and systemic adverse effects limit their use. This is of particular concern in children where a greater surface area to body weight ratio increases the potential for elevated exposure (Zane et al., 2016). 

Table 5: Adverse effects associated with the use of topical corticosteroids (Zane et al., 2016).

Adverse effects associated with the use of topical corticosteroids (Zane et al., 2016).

While many patients are satisfied with the efficacy of TCS treatment, concerns over their use are common. Steroid phobia, or corticophobia, has been observed in over 80% of patients and parents (Aubert-Wastiaux et al., 2011; Lee et al., 2015), impacting treatment compliance and failure (Lee et al., 2015). Interestingly, a study of steroid phobia among French dermatologists, paediatricians and pharmacists identified concerns among all groups, but particularly among pharmacists, which may lead to increased concerns among patients (Aubert-Wastiaux et al., 2014). A separate study also observed concern among French pharmacists around the use of topical corticosteroids in patients with atopic dermatitis, with this lack of trust potentially helping to maintain the fear of corticosteroids among parents and patients (Raffin et al., 2016). A validated questionnaire (TOPICOP©) has now been developed enabling patients’ topical corticosteroid phobia to be assessed in everyday clinical practice, helping to identify patients requiring additional support and education (Moret et al., 2013; Stalder et al., 2017). 

Two TCIs are currently available for patients who are inadequately responsive to, or intolerant of, TCS. However, TCIs are also associated with application site burning and stinging as well as a small increase in the incidence of herpes simplex infection (Werfel, 2009; Zane et al., 2016) although no increased risk of infection was observed versus TCS treatment in a 5-year study of pimecrolimus in mild-to-moderate atopic dermatitis (Sigurgeirsson et al., 2015). Of greater concern has been the historical link between TCI and increased lymphoma risk. In 2006, a boxed warning was added to the tacrolimus and pimecrolimus labels. Recent epidemiologic data suggests that the incidence of lymphoma was no greater in TCI-treated patients than the general population. However, U.S. FDA deemed an association may still exist and kept the boxed warning in place (Zane et al., 2016).

Patient satisfaction with treatment

No new topical treatments for atopic dermatitis have been approved in Europe since the TCIs around the turn of the century. This represents a significant unmet need in treatment where new therapies with improved efficacy and/or safety profiles are needed. Just 46% of 961 patients reported their prescription medications as ‘'moderately’ or ‘very’ effective in one survey (McAlister et al., 2002). This perception of treatment inefficacy can translate into treatment dissatisfaction.

Patients ‘not at all’ or ‘fairly’ satisfied with current treatments (Paller et al., 2002).

Dissatisfaction with current atopic dermatitis treatments.

Figure 16: Dissatisfaction with current atopic dermatitis treatments (Paller et al., 2002). (Dissatisfaction was recorded for a “not-at-all” or “fairly” satisfied patient response).

A Japanese study of 1,327 patients reported treatment dissatisfaction in 43.6% of patients (Murota et al., 2015) while a cross-sectional study of 226 patients using a visual analogue scale score to assess treatment satisfaction (0, very dissatisfied; 100, very satisfied) showed an average score of 59.6 (±30.8) suggesting moderate satisfaction. However, the broad range of scores suggests substantial variability in the levels of patient satisfaction. It is worth noting that disease severity explained only 20% of the variance seen in treatment satisfaction. The most important determinant of treatment satisfaction was actually the perceived competence of the treating physician (Schmitt et al., 2008).

Such concerns around treatment effectiveness do not seem to be shared by many physicians reflecting a disconnect in patient–physician communication. 

Prescription medications for atopic dermatitis regarded as moderately or very effective by patients and physicians.

Figure 17: Prescription medications for atopic dermatitis regarded as moderately or very effective by patients and physicians (McAlister et al., 2002; Paller et al., 2002).

Interestingly, 47% of physicians thought that their patients were not satisfied with their treatment citing a lack of efficacy as the main cause of dissatisfaction (Paller et al., 2002). 

Discordance between patient and physician opinions on treatment are also apparent with different formulations. While nearly two-thirds of physicians preferred ointment products, most physicians believed that patients overwhelmingly preferred creams. However, when patients were asked, there was a near even divide between ointments and creams with older children preferring ointments (Paller et al., 2002).

Current treatment options offer mixed efficacy and significant adverse events. It is apparent from patient satisfaction data that additional therapies are needed to meet this unmet need. Furthermore, some of the concerns surrounding current treatments do not appear to be shared by the treating physicians highlighting a need for greater patient–doctor communication.