R.J.B. Driessen

Three-year registry data on biological treatment for psoriasis: the influence of patient characteristics on treatment outcome

Background  The course of biological treatment in clinical practice may be highly different from treatment schedules in clinical trials. Treatment modifications and patient characteristics may influence treatment safety and efficacy. So far, long‐term results from the use of biological treatment in clinical practice are lacking.

The economic impact of high-need psoriasis in daily clinical practice before and after the introduction of biologics.

Background  Although costs of biologics are high, effective treatment of patients with psoriasis may reduce the total health care costs, as it may limit the need for hospitalization.

Switching from etanercept to adalimumab is effective and safe: results in 30 patients with psoriasis with primary failure, secondary failure or intolerance to etanercept.

Background  Knowledge on the sequential treatment of psoriasis with biologics with regard to efficacy and safety is sparse. This also applies to the efficacy and safety of adalimumab in patients previously treated with etanercept. The relationship between the reasons for discontinuation of etanercept and the response to adalimumab is not clear in psoriasis.

Determinants of drug survival for etanercept in a long-term daily practice cohort of patients with psoriasis

Long‐term data of etanercept drug survival in patients with psoriasis in daily practice are scarce.

Cardiovascular risk factors in high-need psoriasis patients and its implications for biological therapies

Background: The associations between psoriasis and cardiovascular risk factors are reported to be stronger as psoriasis severity increases. This makes studying cardiovascular risk factors in high-need psoriasis patients, eligible for biological therapy, interesting. Objective: To survey the prevalence of cardiovascular risk factors in high-need psoriasis patients and to compare these data to patients with other dermatological diseases. Furthermore, the implications of these findings for treatment with biologics were outlined. Methods: The prevalence of cardiovascular risk factors was investigated in a high-need psoriatic patient cohort and compared to patients with other skin diseases who filled out a questionnaire about the presence of cardiovascular risk factors. Results: A significantly higher prevalence of obesity, smoking, and hypertension was found for the high-need psoriatic patients’ cohort compared with non-psoriatic controls. Striking differences were found with respect to body mass index and obesity, as 35.5% of all high-need psoriatic patients were obese. Conclusions: High-need psoriatic patients show a high prevalence of cardiovascular risk factors, and may consequently be predisposed to cardiovascular diseases. As this is relevant for therapy management in daily clinical practice, especially biologics, cardiovascular risk should be evaluated for each high-need psoriasis patient before and during systemic treatment.

Adalimumab therapy for psoriasis in real-world practice: efficacy, safety and results in biologic-naive vs. non-naive patients

Background  Patients and the course of treatment in daily practice are different from randomized controlled trials (RCTs).

Appropriate infliximab infusion dosage and monitoring: results of a panel meeting of rheumatologists, dermatologists and gastroenterologists.

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT Infliximab is an effective treatment for rheumatoid arthritis, ankylosing spondylitis, Crohns disease (both adult and paediatric), ulcerative colitis, psoriatic arthritis and plaque psoriasis and national and international guidelines have been developed for each indication. WHAT THIS STUDY ADDS This study is the first study which compared current international, national and local guidelines from the medical specialties involved in the treatment with infliximab on the following topics: indication, dosage, synergy and monitoring of vital signs. AIMS Infliximab, an anti-TNF biologic agent, is currently indicated and reimbursed for rheumatoid arthritis, ankylosing spondylitis, Crohns disease (both adult and paediatric), ulcerative colitis, psoriatic arthritis and plaque psoriasis. Development of national and international guidelines for rheumatology, gastroenterology and dermatology, was mostly based on clinical studies and expert opinion. The aim of this study was to compare available guidelines and local protocols for rheumatology, dermatology and gastroenterology, regarding dosage of infliximab, synergy of infliximab with concomitant medication and monitoring of vital signs during infliximab administration, for achieving optimal care. METHODS Current international, national and local guidelines on the use of infliximab were reviewed and compared, differences and shortcomings were identified, and optimal treatment schedules discussed during a meeting (July 2008) of clinical experts and researchers from three departments of a Dutch university hospital. RESULTS Recommended dosages of infliximab are not equal for different indications. Loss of response to infliximab is a common problem encountered within the three medical specialties, but indications for adjustments in treatment schedules are lacking in all of the guidelines. Monitoring of vital signs (blood pressure, pulse, temperature) during infusion with infliximab is common practice and recommended by some guidelines. Routine measurement of vital signs is not of any value in predicting or recognizing acute infusion reactions, in our experience, and this is confirmed by literature on inflammatory bowel disease. CONCLUSION Different indications encompass different dosing schedules. National and internal guidelines do not provide advice regarding loss of response. Routine measurement of vital signs during infusion is not valuable in detecting acute infusion reactions and should only be performed in case of an acute infusion reaction. These topics need to be studied in future studies and covered in future guidelines.

Long-term efficacy of etanercept for psoriasis in daily practice.

phoea may represent a more systemic inflammatory process. With regards to older age of morphoea onset as a predictor of relapse, possible explanations are medication underdosing (maximum 25 mg was used) and poor compliance, particularly in teens. The linear face subtype also showed a trend towards risk of relapse, with no statistical significance, probably due to the small sample size. While MTX duration was not identified as a statistically significant predictor of disease relapse, relapsers tended to have a shorter MTX course than nonrelapsers, suggesting that longer treatments may help reduce the occurrence of relapse. A longer MTX course may also reduce the incidence of disease flaring after MTX tapering. We noted flaring in only two of 37 patients, while Christen-Zaech et al. found that it was common for patients to flare after tapering after a mean duration of 19Æ9 months of MTX. Concomitant systemic corticosteroids (either as intravenous pulses or oral) did not influence the odds ratio of relapse. The finding was supported by Kroft et al., who reported similar relapse rates in patients who received MTX plus oral steroids vs. MTX alone. Despite limitations due to its retrospective nature, we feel that this study contributes to the existing literature on this rare disease affecting the paediatric population. Prospective, subtype-specific treatment protocols and further work in developing objective outcome measures are critical to advancing current knowledge and improving clinical outcomes.

Effectiveness of Biologic and Conventional Systemic Therapies in Adults with Chronic Plaque Psoriasis in Daily Practice: A Systematic Review

The efficacy of biologic or conventional systemic therapies for psoriasis has been shown in randomized controlled trials. Effectiveness, however, has been studied in daily practice cohorts, and no aggregation of effectiveness data is available. This systematic review searched PubMed and EMBASE and summarized the real-world evidence on effectiveness of biologics (adalimumab, etanercept, infliximab and ustekinumab) and conventional systemic therapies (acitretin, cyclosporine, fumarates and methotrexate) for the treatment of plaque psoriasis in adults. Thirty-two studies were included. Few data were available on infliximab, ustekinumab and conventional systemics. Results show that biologics and conventional systemics were effective in real-life treatment of psoriasis, with large ranges in the percentage of patients reaching 75% improvement in psoriasis area and severity index score compared with baseline, especially for etanercept and adalimumab treatment. Combination therapies of biologics with conventional systemics, and dose adjustments of biologics were frequently applied strategies and may explain the large range in improvements between cohorts.

Relevance of laboratory investigations in monitoring patients with psoriasis on etanercept or adalimumab

Background  Guidelines concerning biological treatment of patients with psoriasis recommend different pretreatment and monitoring laboratory panels in variable frequencies to monitor treatment.