Birte Sporbeck

Efficacy and safety of systemic treatments for moderate‐to‐severe psoriasis: meta‐analysis of randomized controlled trials

Dermatologists may choose from various conventional and biological systemic agents to treat patients with moderate‐to‐severe psoriasis. We set out to analyse systematically the efficacy and tolerability of approved treatments for moderate‐to‐severe psoriasis. We undertook a systematic review and meta‐analysis of randomized controlled trials (RCTs) investigating the efficacy of systemic treatment approved for moderate‐to‐severe psoriasis. Efficacy was assessed as the proportion of participants with 75% improvement in Psoriasis Area and Severity Index at primary efficacy measurement (week 8–16). Safety was summarized as rates of adverse events and withdrawals. Direct and indirect comparative efficacy was assessed by random effects meta‐analysis of risk differences (RDs). In total, 48 eligible RCTs totalling 16 696 patients (11 178 randomized to biologics, 1888 to conventional treatments) were identified. In placebo‐controlled trials, infliximab was the most efficacious [RD 76%, 95% confidence interval (CI) 73–79%]. Adalimumab (RD 61%, 95% CI 56–67%), and ustekinumab 45 mg (RD 63%, 95% CI 59–66%) and 90 mg (RD 67%, 95% CI 60–74%) each had similar efficacy. These biologics are more effective than etanercept and all conventional treatments. Head‐to‐head trials indicate the superiority of adalimumab and infliximab over methotrexate (MTX), the superiority of ustekinumab over etanercept, the nonsignificant superiority of ciclosporin over MTX, and the dose‐dependent efficacy of etanercept and ustekinumab. Fumaric acid is as efficacious as MTX. Safety of treatments could not be pooled due to a lack of standardization in reporting across trials. In conclusion, the qualitative and quantitative evidence is much stronger for biological interventions than for conventional treatments.

Which Antipsoriatic Drug Has the Fastest Onset of Action?—Systematic Review on the Rapidity of the Onset of Action

The time necessary for a treatment to become effective is crucial for patients and physicians but has been largely neglected in the reporting and comparison of clinical trials in dermatology. The aim of this systematic review is to determine the time until the onset of action (TOA) of systemic agents approved for moderate-to-severe psoriasis. Primary outcome is the TOA defined as the weighted mean time until 25% of the patients achieved a psoriasis area and severity index (PASI) 75 response. Among the biologics, infliximab has the shortest TOA (3.5 weeks), followed by ustekinumab (high dose 4.6/low dose 5.1 weeks/not weight adapted), adalimumab (4.6 weeks), etanercept (high dose 6.6/low dose 9.5 weeks), and alefacept (high dose 15.4 weeks/low dose: no data). Among the conventional treatments, good data are available for cyclosporine A (CsA; TOA: 6.0 weeks) and limited data are found for methotrexate (MTX; TOA: high dose 3.2/low dose 9.9 weeks). No data are available for fumaric acid esters and retinoids. This systematic review provides clinically relevant information on the onset of action of antipsoriatic agents, although the data currently available allow only a limited assessment. Psoriasis trials should consider including TOA as an additional outcome measure.

German S2k guidelines for the therapy of pathological scars (hypertrophic scars and keloids).

© Deutsche Dermatologische Gesellschaft • Journal compilation

S2k guidelines for the treatment of pemphigus vulgaris/foliaceus and bullous pemphigoid.

(1) Department of Dermatology and Allergology, Philipps-Universität Marburg, Germany (2) Department of Dermatology, University Hospital Erlangen, Erlangen, Germany (3) Helios Hospital Wuppertal, Department of Dermatology, Allergology and Dermatosurgery, Wuppertal, Germany (4) Department of Dermatology and Venereology, University of Cologne (5) Department of Dermatology, Medical Center, University of Freiburg, Germany (6) Dermatologist in Private Practice, Fulda, Germany (7) Department of Dermatology and Allergology, University Hospital Ulm, Germany (8) Pediatric Immunology and Rheumatology, University Hospital and Outpatient Clinic for Pediatrics, Leipzig, Germany (9) Department of Dermatology, Allergology, and Venereology, Campus Luebeck, University Hospital Schleswig-Holstein (UKSH), Luebeck, Germany (10) Department of Dermatology, Venereology, and Allergology, University Hospital Wuerzburg, Wuerzburg, Germany (11) Division of Evidence-based Medicine (dEBM), Department of Dermatology, Charité University Hospital Berlin, Germany (12) Shire Deutschland GmbH, Berlin, Germany (13) Department of Dermatology and Venereology, University Hospital Munich (LMU), Munich, Germany (14) Allergy Center, Department of Dermatology, Charité University Hospital Berlin, Germany

S3-Leitlinie zum Umgang mit Antikoagulation bei Operationen an der Haut.

Hintergrund: Immer häufiger sind Patienten aufgrund verschiedener Erkrankungen auf die Einnahme von Antikoagulanzien und Thrombozytenaggregationshemmern angewiesen. Besteht bei diesen Patienten die Notwendigkeit einer Operation an der Haut, stellt sich die Frage des perioperativen Umgangs mit Antikoagulation.

Management of anticoagulation during dermatosurgical procedures in Germany – results from a cross‐sectional study

Background: Treatment with antiplatelet drugs (APD) and vitamin K antagonists (VKA) can be a challenge during the management of dermatosurgical interventions.

S3 guidelines for the management of anticoagulation in cutaneous surgery.

An increasing number of patients are being treated with anticoagulants and platelet inhibitors. Whenever surgical procedures of the skin are required, questions arise regarding the perioperative management of anticoagulation.

Risk of complications due to anticoagulation during dermatosurgical procedures: a systematic review and meta‐analysis

Background Management of anticoagulation and anti‐platelet drugs during cutaneous surgery is still a challenge for many dermatologists and standards of care with respect to stopping, continuing or bridging vary widely. Methods We performed a systematic review (Medline, Cochrane Library, until August 27th, 2013) of studies assessing the risk of complications due to anticoagulation during cutaneous surgery. Primary outcomes were mild‐moderate and severe postsurgical bleeding. The secondary outcomes were excessive and uncontrollable intraoperative bleeding and other postsurgical complications as wound dehiscence, erythema, wound infection. Results 1.287 publications were identified and 10 studies were included into the review. The frequencies of bleeding in the control groups in general were low (about 1%). In patients on aspirin, increased risks were seen neither with respect to mild‐moderate postoperative bleeding (RR 1.1, CI 0.5–2.3), nor with respect to severe bleeding (RR 0.9, CI 0.2–4.6). The studies with patients on warfarin showed a risk for mild‐moderate bleeding that was three times as high as in controls (RR 3.2, CI 1.4–7.1) and for severe bleeding that was 15 times higher (RR 14.8, CI 2.7–80.4). In general the study sizes were small and the methodological quality low. Conclusion The risk of bleeding due to a medication with aspirin seems to be negligible. With warfarin, the risk is increased; an exact estimate of the risk increase is difficult to give, because of the lack of sufficient high quality studies. A two‐fold increase appears likely, the 15‐fold increase is most likely due to statistical reasons arising from the rareness of the event in the small number of included patients. Stopping, bridging or continuing a medication should always be an individual decision. In accordance with guidelines from internal medicine for most patients it will be recommendable to continue with the medication.

S3-Leitlinie zur Therapie der Psoriasis vulgaris – Methodenreport

BACKGROUND This methods report summarizes the methodology used to update the German Psoriasis Guidelines. METHODS The guidelines were developed following the recommendations of the Association of the Scientific Medical Societies in Germany. Medline, Cochrane Library and Embase were searched to generate new evidence. In addition, the results from the literature search from the EU Psoriasis Guidelines were used. The recommendations were discussed during a consensus conference using nominal group technique and were voted on during the Delphi procedure. An extensive internal and external review (open) was performed. RESULTS Due to changes in drug licensing efalizumab was excluded from the guidelines and adalimumab and ustekinumab were added. 97 new studies were included to serve as a basis for the recommendations. The level of evidence improved for calcineurin inhibitors from level 4 to level 2/3 and for MTX and systemic retinoids from level 3 to level 2. A lack of evidence still exists for coal tar (level of evidence 4). All other described interventions have a level of evidence of 2 or 1. CONCLUSIONS The field of psoriasis therapy is in constant transition. A lack of head to head trials makes direct comparisons still a challenging task. Continuous updating will be necessary to respond to the further changes expected in the field of psoriasis.

Methods and Results Report – Evidence and consensus-based (S3) Guidelines for the Treatment of Actinic Keratosis –International League of Dermatological Societies in cooperation with the European Dermatology Forum

Methods and Results Report – Evidence and consensusbased (S3) Guidelines for the Treatment of Actinic Keratosis – International League of Dermatological Societies in cooperation with the European Dermatology Forum R.N. Werner, A. Jacobs, S. Rosumeck, R. Erdmann, B. Sporbeck, A. Nast Division of Evidence Based Medicine (dEBM), Department of Dermatology, Venerology and Allergology, Charit e – Universit€atsmedizin Berlin, Berlin, Germany Received: 3 March 2015; Accepted: 3 April 2015