Non-adherence and measures to improve adherence in the topical treatment of psoriasis

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1 DOI: /jdv JEADV REVIEW ARTICLE Non-adherence and measures to improve adherence in the topical treatment of psoriasis I. Zschocke, 1 U. Mrowietz, 2 E. Karakasili 1 K. Reich 3, * 1 SCIderm GmbH, Hamburg, Germany 2 Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany 3 Dermatologikum Hamburg, Hamburg, Germany *Correspondence: K. Reich. kreich@dermatologikum.de Abstract Psoriasis is a chronic, recurrent immune-mediated skin disease with a 2 3% prevalence in the Western population, which severely affects patients quality of life and poses a considerable socioeconomic challenge. The majority of individuals have psoriasis in limited areas and topical products are the mainstay of therapy according to existing guidelines. It is known that medication adherence rates are lower for topical treatment than for systemic treatment. Poor medication adherence is a major multidimensional problem for patients with chronic disorders as it is associated with unfavourable treatment outcomes, increased risk for development of concomitant diseases and inefficient use of health resources. Despite four decades of adherence research and the large number of studies that have identified the importance of medication non-adherence, there are relatively few studies reporting and designing effective strategies to improve adherence. The aim of this article was to report and describe non-adherence in the topical treatment of psoriasis, the factors that might contribute to this phenomenon, and which interventions have so far been developed for the management of chronic conditions. This article proposes that given that the barriers to medication adherence are complex and varied, solutions to improve adherence and thus clinical outcomes must be multifaceted and must also provide the possibility to be tailored according to each patient s individual needs. Such an individualized and comprehensive adherence-enhancing intervention would probably enable the successful long-term management of this disabling chronic condition. Received: 21 January 2014; Accepted: 6 February 2014 Conflicts of interest Kristian Reich has received honoraria as consultant and/or advisory board member and/or acted as paid speaker and/or participated in clinical trials sponsored by Abbott, AbbVie, Amgen, Basilea, Biogen-Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, MSD (Essex Pharma, Schering-Plough), Novartis, Ocean Pharma, Pfizer (Wyeth) and UCB. Ulrich Mrowietz has been an advisor and/or received speakers honoraria and/or received grants and/or participated in clinical trials of the following companies: Abbott, AbbVie, Almirall-Hermal, Amgen, BASF, Biogen Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, Galderma, Janssen, LEO Pharma, Medac, MSD, Miltenyi Biotech, Novartis, Pfizer, Teva, VBL and Xenoport. Ina Zschocke and Eleni Karakasili declare that they have no conflict of interest. Funding sources Editorial assistance was funded by LEO Pharma. Introduction Psoriasis is a chronic inflammatory autoimmune disease, resulting in an excessive immuno-inflammatory response in the skin causing keratinocyte hyperproliferation. Although its cause is unknown, studies indicate that the disease results from a complex and dynamic interplay between genetic and environmental factors. 1,2 Psoriasis has a large spectrum of clinical presentations of which psoriasis vulgaris is seen in more than 80% of the patients. 3 The majority of psoriasis patients suffer from mild to moderate disease and are treated with topical agents, which is the mainstay of treatment. Those treated with phototherapy or systemic agents (methotrexate, cyclosporin, acitretin and oral vitamin D), including biologics (adalimumab, etanercept, infliximab, usekinumab) may also use topical agents as adjuvant therapy. 4,5 There is a high disease burden associated with psoriasis, including various psychosocial impairments and a significant reduction in the patient s quality of life (QoL). 4,6 10 With more

2 Topical treatment adherence in psoriasis 5 than 90% of patients having a chronic course and therefore requiring continual control of disease activity 11 adherence to treatment is crucial for the successful management of psoriasis. However, adherence to treatment has proven to be a major challenge in psoriasis. Adherence reflects an important paradigmatic shift from the concept of compliance and deals with the extent to which a treatment following behaviour coincides with what has been decided in concordance with the healthcare provider. 5,12 On the other hand, the term compliance suggests a restricted medical-centred behaviour where the patient is just following the doctor s instructions. Therefore, adherence implies that the patients are more actively involved in defining and following their medical treatment. 13 Problems in adherence arise in all situations where selfadministration of treatment is required, regardless of the type of disease, disease severity and accessibility to healthcare resources. The estimated adherence rate for long-term therapies is 40 50%, whereas for short-term therapies it is much higher (70 80%). 12 Low medication adherence rates are inversely proportional to good clinical outcomes, 14,15 thus resulting in increased direct and indirect costs for the healthcare system. 12,16,17 This article reviews non-adherence to topical therapies in psoriasis, measures to influence adherence and discusses ways in which adherence can be improved in daily life. Psoriasis, its treatment and impact on patients lives Psoriasis vulgaris can develop at any age but most often develops between the ages of 15 and 25 years. It is characterized by erythematous scaly plaques, typically on the scalp, buttocks and the extensor surfaces of the elbows and knees. Scalp psoriasis manifests as localized superficial scales or thick warty plaques covering the entire scalp and sometimes extending beyond the hairline to the face, ears and neck. About 4 6% of patients have intertriginous psoriasis affecting the skin folds, including the axillary, inguinal, inframammary, intergluteal and abdominal folds, as well as the genital areas. 1 3,18 Almost 75 85% of psoriasis patients have limited area involvement, where topical products are the mainstay of therapy. 18 Topical corticosteroids form the basis of therapy for psoriasis with high potency steroids being the most efficacious. 19 Efficacy rates of different class of corticosteroids range from 41 to 92%. Local cutaneous side effects limit their use and it is recommended that they should not be used for longer duration (i.e. for more than 6 weeks) without interruption. 6 Vitamin D analogues (calcipotriol, calcitriol tacalcitol) were as effective as mid-potency steroids but less effective than high potency corticosteroids. A combination of calcipotriol and betamethasone dipropionate ointment was more effective than either agent alone. 20 Corticosteroids, being anti-inflammatory, reduce the irritation of calcipotriol, while calcipotriol serves as steroidsparing agent reducing the side effects of the corticosteroid. 19 A summary of topical agents used in the treatment of psoriasis 21 along with the recommendations by US 22 and German 23 guidelines German guidelines being a representative for Europe is presented in Table 1. Psoriasis presenting on visible body parts leads to social rejection and stigmatization of these patients. 24,25 Associated comorbidities (psoriatic arthritis, Crohn s disease and metabolic syndrome) have also been shown to have a negative impact on patient psychology. 26 The stigma associated with psoriasis imposes a strong psychological burden, impacting multiple aspects of a patient s life, including relationships, social activities, work and emotional wellbeing. 24 Respondents of a National Psoriasis Foundation survey reported negative psychosocial effects of psoriasis on their everyday lives, such as difficulty in sleeping peacefully (48%), interference with sexual activities (29%) and difficulty in using their hands (36%). Several studies have consistently reported the substantial impact of psoriasis on the patient s QoL Many patients find the daily home treatment, hospital or clinic treatment/visits draining in terms of energy and time. Depression occurs in up to 30% of patients irrespective of the disease severity, anxiety reported in over one-third of patients, and suicide ideation evident in up to 10% of patients. 24 Early onset, fluctuating course of illness, absence of permanent cure and psychosocial impairment makes the management of psoriasis crucial and inevitable. Adherence to medication Adherence has increasingly become the focus of attention in clinical trials over the last years: whereas from 1972 to 1974 only 19% of clinical trials attempted assessment of adherence, from 1997 to 1999 this percentage increased to 47% of the trials. 30,31 In total, over the past 50 years, there has been adherence-related citations in PubMed and in PsychLit. 32 Table 1 Topical therapies for psoriasis Agent Level of evidence/recommendation US guidelines German guidelines Corticosteroids I/A 1/Highly recommended Vitamin D analogues I/A 1/Highly recommended Tazarotene I/A 2/Recommended Calcineurin inhibitors 25 II/B 2/Recommended Dithranol III/C 2/Recommended Coal tar II/B 4/Highly inadvisable Anthralin III/C Not specified Corticosteroids and vitamin D analogue I/A 1/Highly recommended Recommendations are ranked as follows for US guidelines: I/A, based on consistent and good quality patient-orientated evidence; II/B, based on inconsistent or limited quality patient-orientated evidence; III/C, based on consensus, opinion, or case studies. The German guidelines rate interventions on a range of 1 (strongest evidence) to 4 (weakest evidence), relating specifically to efficacy.

3 6 Zschocke et al. Two comprehensive reports on adherence 12,33 recognized non-adherence as a worldwide problem of striking magnitude and as a global issue of major public health concern. Low medication adherence is a frequent and widespread phenomenon and can obstruct the patient s benefit from an otherwise highly efficacious treatment; hence, poor adherence is a significant barrier to safe, effective, as well as cost-effective, use of medications and it is one of the major factors contributing to therapeutic partial or non-response. 33 Several studies have attempted to describe, summarize and categorize factors and predictors of non-adherence, as well as medication adherence-enhancing factors 5,17,32,34 41 with the World Health Organization (WHO) report and the ABC project 12,33 providing the most comprehensive listing of them. According to these, adherence is a multidimensional phenomenon determined by the interplay of five sets of factors, which the WHO termed dimensions. These dimensions include social and economical, healthcarerelated, condition-related, treatment-related and patient-related factors. Therefore, non-adherence should be seen as a very complex problem which has to be addressed and should in no way be perceived as the patient s fault alone. 12,33 Several barriers to adherence, although unique to the field of dermatology and topical medication, are presented in Fig. 1 within the framework of WHO s five proposed dimensions. Non-adherence in topical treatment of chronic skin diseases including psoriasis Non-adherence is linked to virtually all chronic skin diseases, including acne, atopic dermatitis and psoriasis. The adherence rate in dermatology varies from 55 to 66%. 42 Furthermore, adherence to topical treatment tends to be lower than other dosage forms. 43 A worldwide acne study found an overall adherence rate of 50% with significantly worse adherence in Europe versus Asia and the USA (58%, 48% and 43% respectively). Poor adherence was reported in 40% of patients with topical therapy. 44 A study investigating adherence to maintenance therapy found that only 27% adhered to treatment. 45 A high percentage of patients (47.8%) stopped using the treatment when the symptoms subsided, whereas others (64.5%) occasionally forgot to use it. 45 A study investigating primary adherence, i.e. the redemption of initial prescription, in outpatients with dermatologic conditions found that 30% of the patients did not redeem their prescriptions. Amongst them, patients with psoriasis were the least adherent with nearly 50% prescriptions being unfilled. 46 In psoriasis studies, adherence rate to topical treatment varied from 60 to 70%. Even worse in patients with severe psoriasis, the treatment adherence rate was 40%. 47 In a study 48 with 103 psoriasis patients overall treatment adherence rate was 75%, whereas in a survey 49 of more than 800 psoriasis patients, only 51% reported use of topical corticosteroids as prescribed. The reasons for non-adherence to treatment amongst psoriasis patients revolve around the treatment formulation and regimen inconvenience, insufficient knowledge and communication gaps with the physician. Specific characteristics of topical medications, such as cosmetic and galenic issues (greasy, sticky vehicles) can hinder adherence in daily life. 50 In a study of 1281 psoriasis patients, the most frequently reported reasons for nonadherence were related to poor cosmetic characteristics (29%), low efficacy (27%), time-consuming (26%) and occurrence of side effects (15%). 47 In another study, the most common Figure 1 The five dimensions of adherence and dermatology-related factors.

4 Topical treatment adherence in psoriasis 7 complaints included slow absorption (44%), application frequency greater than once daily (41%), staining of clothes (34%) and bedding (27%). 50 In a further study of 103 psoriasis patients, the reasons for missing treatment were being busy (25%), being fed-up (22%), inadequate knowledge about their disease and therapy (20%), familial problems (9%), forgetfulness (9%) and financial problems (5%). 48 Essentially, adherence to topical treatment of psoriasis is a major issue and many factors affect adherence, including treatment vehicle, patient physician relationship and patient motivation. The impact of psoriasis on the patient and the health economy is immense and calls for immediate measures to address non-adherence the major barrier of optimal treatment outcome. Despite four decades of adherence research, patients await interventions that address their issues and physicians await interventions that substantiate the treatment regimens. Measures to improve adherence There is a paucity of evidence on measures to improve adherence in the treatment of psoriasis or other chronic skin conditions and their impact on adherence and clinical outcomes. However, many diverse interventions have been studied in other chronic conditions, such as asthma, chronic obstructive pulmonary disease, hypertension, diabetes and rheumatoid arthritis. Haynes et al. 51 found that 36 of 83 interventions in 70 randomized clinical trials in long-term treatments were associated with improvement in adherence, but only 25 interventions led to improvement in at least one treatment outcome. The interventions that were effective for long-term care included combinations of patient information, reminders, self-monitoring, providing convenient patient care, reinforcement, counselling, family therapy, psychological therapies, crisis intervention, manual telephone follow-up and supportive care. The author concluded that current methods of improving adherence for chronic health problems are mostly complex and the improvement observed in adherence and treatment outcome, even with the most effective interventions were not large enough. 51 From 152 studies, Roter et al. 52 identified four types of interventions: educational, behavioural, affective and provider support. Of the 152 interventions categorized, 102 were single-component interventions. Each category of intervention was associated with significant effect upon adherence, with all categories except behavioural conferring at least 20% added benefit. However, it could not be identified which specific components of the interventions were effective and why. The magnitude of effect suggested that the most effective approaches appeared to combine two or more of the approaches. 52 Peterson et al. 53 identified 41 behavioural, 22 educational and 32 combined interventions, each category having significant overall effects upon adherence (4 11%). However, no single intervention was better than the rest. In a systematic review that assessed adherence in long-term care, interventions either that addressed perceptual or practical barriers or those that utilized combined strategy resulted in a significant change in at least one adherence-related outcome measure. 54 However, very few studies in dermatology discuss the effect of interventions to improve adherence and treatment outcomes and there is limited information available regarding dermatologists using such interventions in long-term care to increase adherence in the real-world practice of psoriasis management. A study showed that patients with good knowledge about their condition reported complete satisfaction with their received care more frequently, compared with patients with poor knowledge. 55 In a survey of 248 psoriasis subjects, 71% considered counselling to be important and preferred that this counselling should be delivered by dermatologists or family doctors. 56 A study assessing patients preferences in psoriasis treatment found that patients were willing to accept treatment-related adverse effects as an exchange for obtaining compatible process attributes (treatment duration, frequency, cost, location, delivery method) that matched their personal and professional life. 57 Studies discussing interventions to improve adherence, however, do not provide conclusive evidence of the effectiveness of any one or more measures in improving adherence, or their impact on treatment outcomes. Future outlook: translating interventions into daily practice Considering the prevalence of the condition and its clinical impact, interventions that can specifically address the challenges of non-adherence in psoriasis are needed. The WHO promotes interventions that address all dimensions of adherence, thus making multifaceted interventions a reliable approach to improve adherence. Satisfaction correlates with the perception of patients concerns for their health, the quality of explanations and the quality of the answers to their questions. Considering the time constraints for dermatologists and other health care providers, it is essential to optimize the components of the physician patient communication to ensure effective clinic visits. Dermatologists must build a treatment strategy based on both treatment guidelines and their professional judgement, which aims for complete clearance of skin lesions. 58 The simplest possible therapy, treatment vehicle and dosage regimen should be selected that best suits the patients lifestyle and practical expectations. 59 Specifically for topical treatment, it is important that the chosen medication must have proven efficacy and safety in clinical settings and is presented in a galenic formulation with better tolerance, convenience and patient acceptability. Moreover, the physician patient partnership should be supported by suitable intervention elements. Nurses can also provide effective treatment advice, address patients concerns and give behavioural clues to help with medication adherence and, above all, free up physicians time. In addition, the interventions planned to improve adherence must address knowledge gaps and anxiety

5 8 Zschocke et al. felt by the patient by effective communication and education by the healthcare providers involved in treatment. Some of the several patient education strategies (verbal education, written information, group-based learning, audiotapes, videotapes, computer-assisted education and internet) can be used to disseminate education in routine clinical practice. 60,61 Reminder systems in the form of telephone calls and text messages intrinsically motivate the patient towards adherence. 62 Additional follow-up visits to the clinic may encourage the patient to report any issues they might face. Furthermore, use of patient questionnaires and tools to record patient-reported outcomes (PROs) can lead to the empowerment of patients so that they feel they have to assess not only the severity of their condition but also their satisfaction with, for example, the information and quality of treatment they have received from their physician. Hence, PROs can help to evaluate patient benefit and satisfaction, rather than the conventional approach of assessing adherence just by weighing the returned medication flask. Finally, inclusion of newer approaches such as the use of treatment algorithms, checklists for physician and nurses to ensure successful visits and optimizing the counselling session can help deliver optimum treatment. In summary, the challenge of addressing non-adherence in the treatment of psoriasis can be effectively dealt by a multifaceted intervention, i.e. by encouraging patient participation, providing follow-up and reminders, defining treatment goals, prescribing therapy in line with the patients choice of vehicle and their personal lifestyle, individualization of therapy, providing extensive patient education, enhancing the physician patient relationship and teamwork between the treating physician and the patients. All these approaches will ensure a motivated and treatment adherent patient. During the course of treatment it is essential to assess the patients views to identify any existing/ upcoming adherence issues. Therefore, assessment of PROs should enable the identification of any non-adherence risk factors, hence allowing physicians to tailor the elements of the multifaceted intervention according to the specific needs of individual patients, leading to personalization of treatment for each patient. Such a multidimensional and personalized intervention should be successful in enhancing adherence in psoriasis patients leading to optimal clinical outcomes and the successful longterm management of this chronic condition. References 1 Monteleone G, Pallone F, MacDonald TT, Chimenti S, Costanzo A. Psoriasis: from pathogenesis to novel therapeutic approaches. Clin Sci (Lond) 2011; 120: Mak RK, Hundhausen C, Nestle FO. Progress in understanding the immunopathogenesis of psoriasis. Actas Dermosifiliogr 2009; 100 (Suppl 2): Ayala F. Clinical presentation of psoriasis. 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