Abstract:Summary Evidence-based update meetings are held annually by the Centre of Evidence Based Dermatology, University of Nottingham. Topics are chosen by delegates at the previous year's conference and in the past have included blistering disorders, psoriasis, hair disorders and skin cancers. Once the topic is identified, a trials database search is undertaken with the aim of including speakers who are actively involved in trials that address the subject in question. This year, the eighth Evidence Based Update meet… Show more
“…Treatment is primarily aimed at symptomatic relief, and current first‐line options are nonsedating H 1 ‐antihistamines, which have a recognized efficacy and safety profile, although not all patients respond. H 1 ‐antihistamines are assumed to be safe at even up to four times the licensed dose, on the basis of off‐label use, and higher doses are commonly used for persistent symptoms, when potential benefits are considered to outweigh any risks. Currently, all second‐line treatments, including ciclosporin, H 2 ‐antihistamines, leukotriene‐receptor antagonists (LTRAs), systemic glucocorticoids and dapsone are off label …”
Section: Commentmentioning
confidence: 99%
“…The disease is not life threatening, but it is very disabling and has a significant effect on quality of life. 1 Approximately 50% of patients are unresponsive to H 1 -antihistamines, 2 and commonly used second-line agents such as ciclosporin or prednisolone have marked adverse effects. Thus there is a need for a safe and effective second-line therapy.…”
Summary
Aim
Maurer et al. (N Engl J Med 2013; 368: 924–35) aimed to evaluate the efficacy and safety of omalizumab (an IgE monoclonal antibody) in patients with moderate‐to‐severe chronic idiopathic urticaria who remain symptomatic despite H1‐antihistamine therapy at licensed doses.
Setting and design
Phase 3 international, multicentre, randomized, double‐blinded study (ratio 1:1:1:1).
Study exposure
Adults and adolescents aged over 12 years (or over 18 years in Germany) with chronic idiopathic urticaria, assigned to receive three subcutaneous injections of omalizumab 75, 150 or 300 mg, or placebo, over 12 weeks followed by a 16‐week observation period.
Outcomes
Outcome measures comprised scoring tools for itch and urticarial activity, including itch severity scores, 7‐day Urticaria Activity Score (UAS7), size of largest hives, Dermatology Life Quality Index (DLQI) and proportion of angio‐oedema‐free days. Additional outcomes included Chronic Urticaria Quality of Life Questionnaire scores, interference with sleep and daily activities, use of rescue medications and any contact with a healthcare professional.
Primary outcome measure
Change in the weekly itch severity scores (range 0–21) from baseline to week 12.
Results
Overall, 323 patients were included in the trial. At week 12, the mean ± SD changes from baseline in the weekly itch severity score were −5·1 ± 5·6 in the placebo group, −5·9 ± 6·5 in the 75‐mg group (P = 0·46), −8·1 ± 6·4 in the 150‐mg group (P = 0·001) and −9·8 ± 6·0 in the 300‐mg group (P < 0·001). During the follow‐up period, the mean weekly itch severity scores for all treatment groups reached similar values to those in the placebo group. With respect to the secondary end points, a statistically significant difference was demonstrated between the placebo group and the 150‐mg and 300‐mg groups in all aspects: changes from baseline in UAS7 and weekly score for number of hives, time until reduction from baseline of > 5 points in the weekly itch severity score (referred to as minimally important difference, MID), proportion of patients with UAS7 of ≤ 6, the proportion of patients with the MID response in weekly itch severity scores, the change from baseline in score for size of largest hive, change from baseline in overall DLQI and proportion of angio‐oedema‐free days from weeks 4–12. Statistical significance was reached for one secondary outcome in the 300‐mg group alone – difference in angio‐oedema‐free days from weeks 4–12. Most prespecified secondary outcomes at week 12 showed similar dose‐dependent effects. The frequency of adverse events was similar across groups. The frequency of serious adverse events was low, although the rate was higher in the 300‐mg group (6%) than in the placebo group (3%) or in either the 75‐mg or 150‐mg groups (1% for each).
Conclusions
Maurer et al. conclude that omalizumab administered as 150‐mg and 300‐mg doses at 4‐week intervals significantly reduced symptoms, compared with placebo, in patients with chronic idiopathic urticaria. The small sample size prevents def...
“…Peer review has a primary function of “improving the process and the coherence of scientific knowledge and its utility” [5]. In addition to the geographical imbalance in the authorship of papers focusing on the mental health of children and adolescents worldwide, the limited representation of reviewers from less resourced nations also imposes barriers that ultimately result in a reduced representation of the research output in a global perspective.…”
mentioning
confidence: 99%
“…Although such a model, in which authors are charged to get their work published, is potentially vulnerable to misuse, robust peer review once again becomes a key ingredient to ensure the quality of published research. A recent report by the UK Parliament concluded that experiences such as the PLoS ONE “will accelerate the pace of research communication and ensure that all work that is scientifically sound is published” [5]. …”
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