Comprehensive dosage monitoring of topical treatments for mild to moderate psoriasis.
In the treatment of many dermatological conditions, one of the significant factors contributing to successful outcomes is the accurate and consistent self-administration of topical medications. Unfortunately, for a variety of reasons, patients do not always use medications as prescribed, with potentially negative impacts on the efficacy of treatment and downstream patient quality of life. Monitoring and identifying poor adherence to topical medications in real-time has been a perennial challenge. However, new technology specifically developed for virtual patient monitoring of topical medications can improve dosage compliance and adherence.
Psoriasis vulgaris, for example, is a chronic, inflammatory skin disorder that afflicts approximately 7.5 million people in the United States. It is associated with significant comorbidities and social trauma, with related negative effects on a patient’s quality of life.
The most common form of psoriasis, affecting about 80 to 90 percent of psoriasis patients, is plaque psoriasis. A majority of cases (80%) are of mild-to-moderate severity and can be effectively managed by topical therapy alone. Fixed combination calcipotriol and betamethasone gel and ointment formulations, for example, are effective and well-tolerated topical therapies. Topical medications are also used concomitantly even in patients receiving systemic therapy.
Treatment of patients with mild to moderate psoriasis requires long-term adherence to topical agents. An adherent patient is one who takes at least a predefined percentage (typically 80%) of the treatment considered sufficient for obtaining measurable benefit. However, adherence to topicals is typically poor. For example, a recent meta-analysis found frequency of applications varying between 50% and 60% of the prescribed targets, and several that found that patients applied between 35% and 72% of the recommended dose during treatment periods ranging from 14 days to 8 weeks. Research has substantiated a strong relationship between treatment adherence and patient outcomes on a variety of metrics including time to 75% PASI (Psoriasis Area and Severity Index), Physician Global Assessment (PGA) scores, reduction in flares, disease severity and associated comorbidities, and an increase quality of life (QoL).
The most frequently mentioned reasons for non-adherence to topical treatment were low efficacy, time consumption and poor cosmetic characteristics of topical agents. Non-adherent patients can become dissatisfied with their topical psoriasis medication due to the time it takes to apply, the physical properties of the ointments/creams (it gets on their clothes; it’s messy, etc.), the unclear directions for use, and cost. These negative feelings directly relate to decreased adherence which, in turn, results in poorer control of the psoriasis.
Therefore, monitoring and identifying suboptimal treatment adherence and designing interventions, both digital and high touch, that can improve adherence is vital to improving the quality of care in psoriasis. Unfortunately, there are few if any specific technologies for monitoring whether patients are properly applying topical medication. For topical psoriasis therapies, in addition to the time of application, a key requirement is to monitor the amount of the topical applied, generally specified in finger-tip units (FTU), and dependent on the amount of the psoriatic scab to be covered. Measurement of the amount dispensed (as weight or volume) in addition to dosage event data is a key dimension of topical adherence, with demonstrated impact on patient outcomes.
Widely available adherence event technologies can only capture the date and time when doses are taken. Dosage monitoring technologies which allow for non-biased, efficient, and dependable monitoring of multiple parameters of topical dosage are severely lacking.
Ambiguous physician instructions for topical medication dosage is a related challenge. Without a clear way for patients to accurately measure the right amount of topical agent per dose, physicians often resort to general or vague directions such as “apply as needed” or “apply a liberal” amount. While the use of “liberal dosing” language does help ameliorate under-application of medication according to some studies, the term “liberal” is subjective and can lead to variations in amounts applied, across patients and over multiple doses. It can also lead to overapplication that can, given the high cost of certain medications, place an additional financial burden on patients.
For example, branded desonide, a corticosteroid, costs upward of $600 per 60 grams at average retail, and branded calcipotriene can cost upward of $800 per 60 grams. Enstilarm foam, a betamethasone and calcipotriene combination, marketed by Leo Pharma costs upward of $1000 for 60 grams. While insurance and manufacturer rebates can help bring prices down, the costs can still be prohibitive. Overapplication of medication can call into question the cost-benefit ratio of medications and undermine utilization rates.
To address these issues, patients and care providers need innovative technology for remotely monitoring medication compliance to topical medications. In particular, there is a need for solutions that can capture the full scope of topical medication adherence, including time of application, amount applied per application (compared to expected or prescribed amounts) and temperature of the stored product to help patients comply with dosage regimens, enhance efficacy of topical medications including emerging innovative therapies and create value for providers and innovative pharma companies.
References
- Osborne JE, Hutchinson PE. The importance of accurate dosage of topical agents: a method of estimating involved area and application to calcipotriol treatment failures. J Eur Acad Dermatol Venereol. 2002;16(4):367-73.
- Carroll CL, Feldman SR, Camacho FT, Manuel JC, Balkrishnan R. Adherence to topical therapy decreases during the course of an 8-week psoriasis clinical trial: commonly used methods of measuring adherence to topical therapy overestimate actual use. J Am Acad Dermatol. 2004;51(2):212-6.
- Psoriasis facts. The Dermatologist. 2016;24(7).
- Ahn CS, Culp L, Huang WW, Davis SA, Feldman SR. Adherence in dermatology. J Dermatolog Treat. 2017;28(2):94-103.
- Takahashi H, Katayama H, Uwajima Y, Koda M, Sasaki H, Tanito K, Hagiwara M, Matsuo K, Nakagawa H. Patient satisfaction and efficacy of calcipotriol plus betamethasone dipropionate gel in plaque psoriasis patients with poor adherence. J Dermatol. 2020;47(11):1249-56.
- Muddasani S, Fleischer AB, Jr., Feldman SR. Treatment practices for psoriasis and how they are changing. J Am Acad Dermatol. 2021;84(2):579-81.
Joanna Billings, Pharm D, is an acute care pharmacy resident at UNC Medical Center, Deepak Sirdeshmukh, MS, PhD, is Co-founder, President, and CEO of Sensal Health
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