Real-World Experience With Apremilast in the Treatment of Adults With Moderate to Severe Plaque Psoriasis in Québec: A Claims-Based Analysis of Drug Utilization and Healthcare Resource Utilization.

BACKGROUND: In Québec, targeted biologic therapies for moderate to severe plaque psoriasis are restricted to patients who have not responded to phototherapy or conventional systemic treatment, primarily due to high drug costs. Apremilast, an oral treatment for plaque psoriasis, was added to the Québec provincial health insurance plan (Régie de l'assurance maladie du Québec; RAMQ) formulary in 2015, making this the only province in Canada with public drug plan reimbursement for apremilast. OBJECTIVES: The aim of this study is to describe patients' characteristics, treatment patterns, healthcare resource utilization (HCRU), and associated costs and to measure real-world budget impact of using apremilast before biologics in plaque psoriasis. METHODS: This study was performed using RAMQ drug claims and medical services data. Patients diagnosed with psoriasis between January 2015 and December 2017 were identified. Medical services and prescription claims were categorized as all-cause and psoriasis-related. Using RAMQ database estimates, a 3-year budget impact analysis was developed comparing treatment cost with and without the addition of apremilast to the formulary. RESULTS: In all, 540 patients were identified (apremilast: n = 92; biologics: n = 448). Comorbidity burden and treatment persistence and adherence were comparable between apremilast and biologic users. The year following the index date, all-cause HCRU was lower for apremilast versus biologic users (CAN$19 763 vs CAN$28 025; P < .01), mainly driven by drug cost. Using apremilast before biologics resulted in an estimated RAMQ net savings of CAN$49 290 (2015), CAN$746 856 (2016), and CAN$1 216 512 (2017), and a total savings of CAN$2 012 658 since apremilast's addition to the formulary. CONCLUSION: Adding apremilast to the drug formulary of other Canadian provinces could result in significant healthcare savings.

Management of Plaque Psoriasis With Biologic Therapies in Women of Child-Bearing Potential Consensus Paper.

BACKGROUND: Plaque psoriasis (PsO) is a chronic inflammatory disease that often presents at peak reproductive age in women of child-bearing potential (WOCBP). With the emergence of biologic therapies to treat PsO, guidance on disease management in WOCBP is needed to inform treatment decisions before, during, and after pregnancy. OBJECTIVES: To develop a practical, up-to-date consensus document, based on available evidence and expert opinion where evidence was lacking, in order to guide both Canadian and international clinicians treating PsO in WOCBP. METHODS: A panel of 9 Canadian dermatologists with extensive clinical experience managing PsO reviewed the relevant literature from the past 25 years in 3 key domains: overview of PsO in WOCBP and clinical considerations, treatment considerations, and postpartum considerations. The structured literature search focused on WOCBP treated with TNF-alpha inhibitors (adalimumab, certolizumab, etanercept, golimumab, infliximab), IL-23 inhibitors (guselkumab, risankizumab, tildrakizumab), IL-12/23 inhibitors (ustekinumab), and IL-17 inhibitors (brodalumab, ixekizumab, secukinumab). This literature review, along with clinical expertise and opinion, was used to develop concise and clinically relevant consensus statements to guide practical management of PsO in WOCBP. Experts voted on the statements using a modified Delphi process and prespecified agreement cut-off of 75%. RESULTS AND IMPLICATIONS: After review, discussion, and voting on 19 draft consensus statements at an in-person meeting and remotely, 12 consensus statements were approved by the expert panel. The statements presented here will guide healthcare providers in practical disease management using biologic therapies for the treatment of PsO in WOCBP.

North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations: Part I: Diagnosis, evaluation, and the use of complementary and procedural management.

Hidradenitis suppurativa is a chronic inflammatory disorder affecting hair follicles, with profoundly negative impact on patient quality of life. Evidence informing ideal evaluation and management of patients with hidradenitis suppurativa is still sparse in many areas, but it has grown substantially in the last decade. Part I of this evidence-based guideline is presented to support health care practitioners as they select optimal management strategies, including diagnostic testing, comorbidity screening, and both complementary and procedural treatment options. Recommendations and evidence grading based on the evidence available at the time of the review are provided.

Checklist for the Systemic Treatment of Psoriasis Using Biologics: A Delphi Study.

BACKGROUND: Despite the complexity of psoriasis treatment using biologic therapy, there does not exist a standardized synoptic reporting form for the initiation of this population. The purpose of this study was to use a modified Delphi approach to develop a standard checklist for the standardized documentation of patients receiving systemic biologic therapy for psoriasis. METHODS: A modified Delphi survey was conducted over 3 rounds (February 2017 through January 2018). An expert panel generated a 51-item checklist that was proposed to participants. Items were rated on an anchored 1-7 Likert scale. Consensus was defined apriori as ≥ 70% agreement by respondents. RESULTS: A total of 58, 17, and 18 dermatologists participated in 3 consecutive Delphi rounds, respectively. Only half of the dermatologists surveyed reported using a checklist for the management of psoriasis. The final checklist comprised 19, 5, 6, and 9 items pertaining to patient history; physical exam and history of systemic therapy; vaccinations; and lab investigations and bloodwork, respectively. CONCLUSIONS: Given the increasing availability and complexity of biologic agents for psoriasis treatment, there is a need to promote standardized documentation for this population. The Checklist for the Systemic Treatment of Psoriasis presents 38 items that should be considered when initiating patients with psoriasis on biologic therapy.

Approach to the Assessment and Management of Adult Patients With Atopic Dermatitis: A Consensus Document. Section IV: Treatment Options for the Management of Atopic Dermatitis.

The objectives of therapy for atopic dermatitis (AD) are to reduce skin inflammation and pruritus, restore skin barrier function, and improve quality of life (QoL). Treatments can be classified as moisturizing and basic care, topical therapy, phototherapy, and systemic therapy. In this review, we summarize the treatments for AD and recommendations for their use.

A Treatment Algorithm for Moderate to Severe Atopic Dermatitis in Adults.

BACKGROUND: Atopic dermatitis (AD) is a common and chronic inflammatory skin disease. Approximately 10% of adults with AD do not respond adequately to topical therapies and require phototherapy and/or systemic therapy. OBJECTIVE: To provide a patient-focused approach to the identification and management of adults with AD who require systemic treatment. METHODS: A working group of clinicians experienced in managing AD was convened to review and discuss current evidence on the identification and clinical management of adults with moderate to severe AD. RESULTS: We propose a set of simple and practical clinical criteria for selecting candidates for systemic treatment of AD based on their response to first-line topical therapy and 4 clinical measures that are easily incorporated into routine practice. We also suggest a framework for evaluating systemic treatments according to attributes that are important from both a clinician's and a patient's perspective. An algorithm was developed proposing a pathway for treatment of moderate to severe AD in adults. CONCLUSION: Adults with moderate to severe AD that does not respond adequately to topical therapies currently have few safe and effective treatment options. A clinical algorithm could help guide treatment decisions.

Canadian Clinical Practice Guidelines for Rosacea.

Rosacea is a chronic facial inflammatory dermatosis characterized by background facial erythema and flushing and may be accompanied by inflammatory papules and pustules, cutaneous fibrosis and hyperplasia known as phyma, and ocular involvement. These features can have adverse impact on quality of life, and ocular involvement can lead to visual dysfunction. The past decade has witnessed increased research into pathogenic pathways involved in rosacea and the introduction of novel treatment innovations. The objective of these guidelines is to offer evidence-based recommendations to assist Canadian health care providers in the diagnosis and management of rosacea. These guidelines were developed by an expert panel of Canadian dermatologists taking into consideration the balance of desirable and undesirable outcomes, the quality of supporting evidence, the values and preferences of patients, and the costs of treatment. The 2015 Cochrane review "Interventions in Rosacea" was used as a source of clinical trial evidence on which to base the recommendations.

Evaluating practice patterns for managing moderate to severe plaque psoriasis: role of the family physician.

OBJECTIVE: To describe practice patterns for care of Canadian patients with moderate to severe plaque psoriasis. DESIGN: Online survey of a consumer panel. SETTING: Participants were drawn from a population-wide Canadian consumer database. PARTICIPANTS: To be eligible to participate, respondents had to have been diagnosed with plaque psoriasis within the past 5 years, and to have had body surface area involvement of 3% or greater in the past 5 years, or to have psoriasis on a sensitive area of the body (hands, feet, scalp, face, or genitals), or to be currently receiving treatment with systemic agents or phototherapy for psoriasis. MAIN OUTCOME MEASURES: Proportion of respondents with psoriasis managed by FPs and other specialists, psoriasis therapies, comorbidities, and patient satisfaction. RESULTS: Invitations were sent to 3845 panelists with self-reported psoriasis, of which 514 qualified to complete the survey. Family physicians were reported to be the primary providers for diagnosis and ongoing care of psoriasis in all provinces except Quebec. Overall physician care was reported to be satisfactory by 62% of respondents. Most respondents receiving over-the-counter therapies (55%) or prescribed topical therapies (61%) reported that their psoriasis was managed by FPs. Respondents receiving prescription oral or injectable medications or phototherapy were mainly managed by dermatologists (42%, 74%, and 71% of respondents, respectively). Ongoing management of respondents with body surface area involvement of 10% or greater was mainly split between dermatologists (47%) and FPs (45%), compared with rheumatologists (4%) or other health care professionals (4%). Of those respondents receiving medications for concomitant health conditions, treatment for high blood pressure was most common (92%), followed by treatment for heart disease (75%) and elevated cholesterol and lipid levels (68%). CONCLUSION: Patient-reported practice patterns for the diagnosis and management of moderate to severe psoriasis vary among provinces and in primary and secondary care settings.

A randomized study comparing the combination of nbUVB and etanercept to etanercept monotherapy in patients with psoriasis who do not exhibit an excellent response after 12 weeks of etanercept.

BACKGROUND: There is a lack of data on the combination of phototherapy with etanercept in patients who have not shown an excellent response to etanercept monotherapy. OBJECTIVES: To study the combination of narrow-band ultraviolet B (nbUVB) phototherapy with etanercept in patients not demonstrating an improvement of 90% in their Psoriasis Area Severity Index (PASI-90) after 12 weeks of etanercept. PATIENTS AND METHODS: Psoriatic patients not reaching PASI-90 after 12 weeks of etanercept therapy were randomized (1:1) to receive either etanercept (50 mg once a week) monotherapy or in combination with nbUVB three times weekly for periods of 4 weeks. RESULTS: Seventy-five patients were randomized. Only 21.6% of patients achieved adherence of 80% or more for nbUVB treatments. At week 24, PASI-90 was reached by 16.2% of patients in the etanercept plus nbUVB group when compared with 15.8% of patients in the etanercept monotherapy group (p = 1.000). In patients with high adherence to nbUVB, the PASI-90 at week 16 was 42.9% for etanercept with nbUVB when compared with 3.4% for etanercept monotherapy (p = 0.018). Both treatments were well tolerated. CONCLUSION: Addition of nbUVB after 12 weeks of etanercept did not significantly improve the clinical response except for a subset of patients with high adherence to nbUVB. CLINICAL TRIALS REGISTRATION NUMBER: NCT00640393.

Switching to adalimumab for psoriasis patients with a suboptimal response to etanercept, methotrexate, or phototherapy: efficacy and safety results from an open-label study.

BACKGROUND: Strategies for transitioning patients with psoriasis from suboptimal therapy have not been delineated. OBJECTIVE: We sought to determine the efficacy and safety of transitioning to adalimumab for the treatment of psoriasis in patients with suboptimal response to prior therapy with etanercept, methotrexate (MTX), or narrowband (NB)-ultraviolet (UV)B phototherapy. METHODS: In this 16-week, open-label, phase IIIb trial, patients with chronic plaque psoriasis discontinued suboptimal therapy between 11 and 17 days (etanercept) or between 4 and 10 days (MTX and NB-UVB) before initiating adalimumab (80 mg at week 0, then 40 mg every other week from week 1). The primary end point was the percentage of patients achieving a Physician Global Assessment of "clear" or "minimal" at week 16. RESULTS: At week 16, Physician Global Assessment of "clear" or "minimal" was achieved by 52% of all enrolled patients (79 of 152) and 49%, 61%, and 48% in the etanercept, MTX, and NB-UVB subgroups, respectively. Four patients (2.6%) experienced at least 125% worsening of Psoriasis Area and Severity Index score relative to screening value at any study visit. The adalimumab safety profile was consistent with results from other psoriasis clinical trials. LIMITATIONS: This study is limited by its relatively short 16-week duration, small patient enrollment, and open-label design. CONCLUSION: Patients who had a suboptimal response to etanercept, MTX, or NB-UVB phototherapy experienced a similar, approximately 50% likelihood of achieving a clinically relevant response to adalimumab. Immediate transition to adalimumab from prior suboptimal therapy, with no dosage tapering or overlap, had a low risk of psoriasis flare.

A Canadian online survey to evaluate awareness and treatment satisfaction in individuals with moderate to severe plaque psoriasis.

BACKGROUND: Psoriasis is a chronic inflammatory disease associated with comorbidities and decreased quality of life. This survey is aimed to better understand the impact of disease on Canadian patients, and to examine awareness and use of available treatment options. METHODS: An online survey was conducted using a consumer panel. Eligible subjects reported diagnoses of psoriasis and moderate/severe/very severe plaque psoriasis within the past 5 years, and either: psoriasis covering ≥ 3% of body surface area; psoriasis on a sensitive area, or current use of systemic and/or phototherapy or light therapy for psoriasis. RESULTS: A total of 514 panelists completed the survey; 65% reported current moderate/severe/very severe psoriasis. Awareness of available treatment options ranged from 98% for prescription topical agents to 75% for photo/light therapy, and < 50% for prescription oral (49%) or injectable (35%) medications. A total of 92% of respondents had been treated with and 61% were currently taking prescription topical agents. Photo/light therapy had been used by 38% and was currently used by 7% of respondents. Prescribed oral medication had been taken by 25% and was currently used by 8%. Few subjects had been treated with injectables in the past (10%) or currently (5%). Overall, 24% of respondents were very satisfied with their current treatment. A total of 63% of respondents taking injectables were very satisfied, compared with 38% of those taking prescribed oral medication and 21% of those receiving photo/light therapy.Conclusions Most respondents with moderate to severe psoriasis were unaware of all treatment options; systemic treatments were not commonly utilized. Treatment satisfaction rates were low, highlighting the need to ensure greater patient education on and use of available therapeutic options.

Canadian hand dermatitis management guidelines.

BACKGROUND: Hand dermatitis (HD) is one of the most common skin conditions; however, it is not a homogeneous disease entity. The severity of HD may range from very mild cases to severe chronic forms, which may result in prolonged disability and, occasionally, refractory HD. Chronic hand dermatitis (CHD) is associated with a high health- economic burden and significant loss of quality of life. OBJECTIVE: Although numerous treatment options are available, the management of CHD is often difficult and unsatisfactory. There is a paucity of well-designed, randomized, controlled clinical trials in support of the efficacy of established treatment modalities. CONCLUSION: These guidelines cover the epidemiology, burden, quality of life, etiology, diagnosis, classification, and prevention of HD and provide guidance on management using an approach that is as evidence based as possible.

A Canadian self-administered online survey to evaluate the impact of moderate-to-severe psoriasis among patients.

BACKGROUND: Few population studies of individuals living with psoriasis have been performed in Canada. OBJECTIVE: The objective of this survey was to understand the severity and impact of psoriasis on the lives of Canadian patients. METHODS: An online survey was conducted using a consumer panel. Eligible subjects reported a diagnosis of psoriasis and provided a self-reported level of severity. In addition, subjects had to either (a) have psoriasis covering at least 3% of their body surface area; (b) have psoriasis on a sensitive area of the body; or (c) be currently undergoing treatment for their psoriasis with systemic medication and/or phototherapy. RESULTS: A total of 514 panelists met the inclusion criteria and completed the survey. Current moderate, severe, or very severe psoriasis was reported by 65% of respondents. Nearly all subjects (96%) had psoriasis affecting a sensitive area of the body. At the time of the survey, 18% were taking systemic medication and/or phototherapy. Comorbidities, such as obesity and high blood pressure, were highly prevalent, with 75% of respondents reporting at least one other diagnosis. Data from the SF-8 and Dermatology Life Quality Index instruments indicated that psoriasis negatively impacted quality of life. CONCLUSION: Moderate-to-severe psoriasis places a burden on Canadian patients, some of whom may be receiving suboptimal treatment or treatment not appropriate for the severity of their condition.

XP-828L in the treatment of mild to moderate psoriasis: randomized, double-blind, placebo-controlled study.

BACKGROUND: XP-828L, a protein extract obtained from sweet whey, has demonstrated potential benefit for the treatment of mild to moderate psoriasis in an open-label study. OBJECTIVE: To study in a randomized, double-blind, placebo-controlled study the safety and efficacy of XP-828L in the treatment of mild to moderate psoriasis. DESIGN: XP-828L 5 g/d (group A, n=42) or placebo (group B, n=42) was given orally for 56 days followed by XP-828L 5 g/d in group A and by XP-828L 10 g/d in group B for an additional 56 days. RESULTS: Patients receiving XP-828L 5 g/d for 56 days had an improved Physician's Global Assessment (PGA) score compared with patients under placebo (p less than 0.05). Considering the data of group A only, the PGA score improved from day 1 to day 56 (p less than 0.01); the Psoriasis Area and Severity Index score improved as well, but to a lesser extent (p less than 0.05). CONCLUSION: Oral administration of 5 g/d XP-828L compared with a placebo significantly improved the PGA score of patients with mild to moderate psoriasis.

Recommendations for incorporating biologicals into management of moderate to severe plaque psoriasis: individualized patient approaches.

Psoriasis is a T-cell mediated skin disease that affects approximately 2% of the population worldwide. Despite the prevalence of the disease and long-standing efforts to develop strategies to treat it, there is a need for safe and effective therapies to treat psoriasis, particularly the more severe forms. Biological agents such as alefacept, efalizumab, etanercept, and infliximab have been recognized as a class of treatment distinct from other forms of therapy in the treatment algorithm of psoriasis. Recent national and international consensus meetings have developed statements that position biological agents as an important addition to the treatment armamentarium for moderate to severe psoriasis, along with phototherapy and traditional systemic agents. There has been consensus that treatment should be individualized to each patient's needs and circumstances. Biological agents offer the hope of safe, effective, long-term management of moderate to severe psoriasis. As new agents receive approval from Health Canada, the available range of therapeutic options for treating this chronic disease will broaden. A Canadian Psoriasis Expert Panel recently convened in February 2005 to analyze, based on a series of clinical case scenarios, the indications, contraindications, and considerations for and against each of the four biological agents, derived from product labelling, where available, and from the efficacy and safety data from phase 3 and earlier clinical trials, as well as post-marketing reports. The Panel has formulated a set of recommendations for incorporating these biological agents into the current treatment paradigm of moderate to severe plaque psoriasis and has identified the preferred biological agents for each patient based on individual needs and circumstances.

Integrating biologic agents into management of moderate-to-severe psoriasis: a consensus of the Canadian Psoriasis Expert Panel. February 27, 2004.

BACKGROUND: Approximately 2% of people worldwide have psoriasis, with as many as 1 million people with psoriasis in Canada alone.1,2 The severity of psoriasis ranges from mild to severe. It can lead to substantial morbidity and psychological stress and have a profound negative impact on patient quality of life.3,4 Although available therapies reduce therapies reduce the extent and severity of the disease and improve quality of life,3 reports have indicated a patient preference for more aggressive therapy and a dissatisfaction with the effectiveness of current treatment options.5 OBJECTIVE: A Canadian Expert Panel, comprising Canadian dermatologists, convened in Toronto on 27 February 2004 to reach a consensus on unmet needs of patients treated with current therapies and how to include the pending biologic agents in and improve the current treatment algorithm for moderate-to-severe psoriasis. Current treatment recommendations suggest a stepwise strategy starting with topical agents followed by phototherapy and then systemic agents.3,6,7 The Panel evaluated the appropriate positioning of the biologic agents, once approved by Health Canada, for the treatment of moderate-to-severe psoriasis. METHODS: The Panel reviewed available evidence and quality of these data on current therapies and from randomized, controlled clinical trials.8-14 Subsequently, consensus was achieved by small-group workshops followed by plenary discussion. RESULTS: The Panel determined that biologic agents are an important addition to therapies currently available for moderate-to-severe psoriasis and proposed an alternative treatment algorithm to the current step wise paradigm. CONCLUSION: The Panel recommended a new treatment algorithm for moderate-to-severe psoriasis whereby all appropriate treatment options, including biologic agents, are considered together and patients' specific characteristics and needs are taken into account when selecting the most appropriate treatment option.