Lidian L. A. Lecluse

How Good Are Clinical Severity and Outcome Measures for Psoriasis?: Quantitative Evaluation in a Systematic Review

A large number of clinical measures of psoriasis are used in clinical trials and daily practice. These measures lack uniformity and validation. However, valid outcome and severity measures for psoriasis are a prerequisite for fully informative clinical research and evidence-based medicine. The purpose of this study was to identify all clinical measures of psoriasis severity and outcome in use and to evaluate the quality of these measures using clinimetric criteria; we identified 53 separate clinical measures, which were regrouped into 11 measures for quality analysis. No measure could be scored on all items used in the clinimetric analysis. The Lattice System Physicians Global Assessment and Physicians Global Assessment were most highly noted. We conclude that none of the psoriasis measures is adequately validated. The Psoriasis Area and Severity Index is the most commonly used clinical measure in research, but it has substantial limitations such as low response distribution, no consensus on interpretability, and low responsiveness in mild disease. Nevertheless, because of its widespread use the Psoriasis Area and Severity Index permits some degree of comparison of results among clinical trials. Overall, no best instrument was identified, and different situations may call for different measures.

Extent and Clinical Consequences of Antibody Formation Against Adalimumab in Patients With Plaque Psoriasis

OBJECTIVES To investigate the extent antibodies to adalimumab are formed in patients with plaque psoriasis and whether these antibodies have clinical consequences. Also, to examine the relationship between antibodies to adalimumab and adalimumab trough titers. DESIGN Prospective observational cohort study. SETTING Two Dutch dermatology departments in university hospitals. PATIENTS All consecutive patients starting a regimen of adalimumab for chronic plaque psoriasis. Patients were screened and fulfilled the Dutch reimbursement criteria for adalimumab to treat psoriasis. INTERVENTION Adalimumab treatment (per label). MAIN OUTCOME MEASURES The titer of antibodies to adalimumab, the adalimumab trough concentration, and the Psoriasis Area and Severity Index at weeks 12 and 24. RESULTS Antibodies to adalimumab were detected in 13 of 29 patients (45%) during 24 weeks of treatment. Differences in response rates among patients with low, high, and no titers of antibodies to adalimumab were significant at weeks 12 and 24 (P = .04 and P < .001, respectively). The median adalimumab trough concentrations varied significantly among patients with low, high, and no titers of antibodies to adalimumab (1.30 [range, 0.01-5.50], 0.0 [range, 0.0-0.0], and 9.6 [range, 0.0-22.6] mg/L, respectively; P < .001). At week 24, the median adalimumab trough concentrations also differed significantly among good responders, moderate responders, and nonresponders (9.7 [range, 0.0-22.6], 8.9 [range, 3.2-12.6], and 0.0 [range, 0.0-13.3] mg/L, respectively; P = .01). CONCLUSION Antibodies to adalimumab are associated with lower serum adalimumab trough concentrations and with nonresponse or loss of response to adalimumab in patients with plaque psoriasis.

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.

The correlation of clinical efficacy, serum trough levels and antidrug antibodies in ustekinumab‐treated patients with psoriasis in a clinical‐practice setting

Several therapeutic antibodies are available for the treatment of chronic plaque type psoriasis. Ustekinumab (a monoclonal IL12/23 antagonist) is one of these antibodies (1) and it is currently being investigated for other indications. For adalimumab (a monoclonal tumour necrosis factor α antagonist) a positive correlation has been observed between adalimumab trough levels and clinical efficacy, both showing a negative correlation with anti-drug antibodies (ADA) to adalimumab (present in 49% of patients) (2). In rheumatoid arthritis, a therapeutic range for adalimumab trough level has been established, which can eventually lead to a more personalised way of administering adalimumab (3). This article is protected by copyright. All rights reserved

Etanercept: An Overview of Dermatologic Adverse Events

OBJECTIVES To provide a comprehensive overview of dermatologic adverse events of etanercept described in the literature (including all study types, case reports, and surveys) and to present information on the occurrence, severity, treatment, and course of these adverse events. DATA SOURCES MEDLINE and EMBASE. STUDY SELECTION All reports on individual patients who developed a dermatologic adverse event associated with systemic etanercept treatment for any indication in any type of original article were included. DATA EXTRACTION All data were independently extracted by 2 reviewers. Disagreements were resolved by consensus. All articles included (except for case reports/case series) were assessed regarding level of evidence. DATA SYNTHESIS In 126 included study reports, a total of 72 separate specific dermatologic adverse events of etanercept were mentioned. In 101 case reports/case series, 153 individual patients with approximately 65 different specific diagnoses (eg, not rash) were reported. CONCLUSIONS Etanercept is associated with a wide variety of dermatologic adverse events, many of which were described in study reports, but case reports also described numerous exceptional cases. Although the adverse events are usually mild, some reactions are serious and even potentially life threatening. Therefore, all drug-associated cutaneous abnormalities should be carefully evaluated. Diagnostic steps do not deviate from the norm in these patients, but management of the dermatologic adverse events may need special attention.

Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial: a critical appraisal

Arits et al. aimed to assess whether the effectiveness of imiquimod and fluorouracil is not inferior to methyl aminolaevulinic acid (MAL) photodynamic therapy (PDT) in patients with superficial basal cell carcinoma.