[Current dermatology guidelines in Germany-selected recommendations from 2021 and 2022]. / Aktuelle dermatologische Leitlinien in Deutschland ­ Ausgewählte Empfehlungen aus den Jahren 2021 und 2022.

Guidelines are systematically developed decision-making aids to ensure appropriate clinical care for specific medical conditions. In Germany, dermatological guidelines are developed under the aegis of the German Dermatological Society (DDG) and the Professional Association of German Dermatologists (BVDD), while European and international guidelines are published by organisations such as the European Centre for Guidelines Development (EuroGuiDerm), founded by the European Dermatology Forum (EDF) in cooperation with the Division of Evidence-Based Medicine at Charité-Universitätsmedizin Berlin. In 2021 and 2022, the German guidelines were revised or developed on topics such as the management of anticoagulation during dermatological procedures, chronic pruritus, contact dermatitis, laser therapy of the skin, psoriasis vulgaris, rosacea, extracorporeal photopheresis, onychomycosis, mucous membrane pemphigoid and prevention of skin cancer. A selection of the most important recommendations and innovations in the guidelines is summarized here.

Impact of off-label use regulations on patient care in dermatology - a prospective study of cost-coverage applications filed by tertiary dermatology clinics throughout Germany.

BACKGROUND: In dermatology, a medical speciality with a relatively high number of rare diseases, physicians often have to resort to off-label treatment options. To avoid claims, physicians in Germany can file a cost-coverage request (off-label application, OL-A). OBJECTIVES: Our aim was to investigate the extent to which the current regulations affect patient care. MATERIAL AND METHODS: Prospective cohort study among tertiary dermatology clinics throughout Germany, consecutively including OL-As (05/2019-09/2020) and assessing the follow-up correspondence. We modelled regressions to assess factors associated with cost-coverage decisions and the time needed by health insurers to process the OL-As. RESULTS: Thirteen clinics provided data on 121 OL-As, two of which applied for on-label treatments. Of the remaining 119 OL-As, 70 (58.8%) were immediately approved and 44 (37.0%) rejected. Including cases with one or more appeals, 87 of 119 OL-As (73.1%) were finally approved and 26 (21.9%) rejected. There was an association of the final approval rate with (1) the class of medication/treatment, with approval rates being significantly lower for JAK inhibitors than for biologics (OR 0.16, 95%-CI: 0.03-0.82); (2) German state, with approval rates being lower in eastern than in western states (OR 0.30, 95%-CI 0.12-0.76); and (3) cost of the intervention (no linear trend). However, none of these predictors was significant in our multiple logistic regression models. The median health insurer's processing time (first response) was 29 days (IQR 22-38). Our analyses showed no evidence of an association with the predictors we assessed. In cases approved, the median time from the decision to file an OL-A to the actual initiation of the treatment was 65.5 days (IQR 51-92). CONCLUSIONS: Our study points to substantial delays and inequalities in the provision of timely health care for dermatological patients with rare diseases, often involving treatments for which there is no adequate approved therapy.

Efficacy and safety of systemic treatments in psoriatic arthritis: a systematic review, meta-analysis and GRADE evaluation.

Twenty per cent of patients with plaque psoriasis also have psoriatic arthritis - a disease affecting joints and entheses. Different treatment options exist but currently no succinct systematic overview exists. A systematic review of approved systemic treatments for psoriatic arthritis was conducted. We systematically searched in three databases (last update September 2017). Data were extracted for ACR20/50, HAQ-DI, SF-36 and adverse/serious adverse events after 16-24 weeks. We assessed the quality of evidence using GRADE. Twenty trials were included. Three trials compared two active substances. Results for ACR20 were infliximab + methotrexate vs. methotrexate: RR 1.40 (95% CI 1.07-1.84) very low quality evidence; ixekizumab Q2W vs. adalimumab Q2W: RR 1.08 (95% CI 0.86-1.36) very low quality, leflunomide vs. methotrexate: RR 1.01, (95% CI 0.84-1.21) low quality. Eighteen drug vs. placebo comparisons were included. For ACR20/50, HAQ-DI and SF-36, the active treatment was efficacious and the quality of the evidence was mostly moderate to low (15 of 18 comparisons). The quality of evidence for (serious) adverse events was mostly low; differences were rare. In three placebo-controlled comparisons, leflunomide, MTX and sulfasalazine failed to show statistical superiority for ACR. Besides the established treatment of anti-TNF antibodies and ustekinumab for psoriatic arthritis, the newer treatment options of IL17 antibodies and apremilast are also effective for the treatment of psoriatic arthritis. Based on just one comparative trial and one drug each, the new class of anti-IL 17 antibodies appears to be equally effective as the group of anti-TNF antibodies; for apremilast, this is yet unclear.

Prioritizing topics in guideline development: results of a two-phase online survey of dermatologist members of the EADV.

BACKGROUND: Most clinical guidelines in dermatology are encyclopaedic, covering a disease and its aetiology, diagnosis, treatment and prevention in their entirety. The usability and uptake of guideline recommendations might be improved by guidelines that are more concise and address specific questions ranked by users according to their perceived importance. OBJECTIVE: To survey the largest association of dermatologists in Europe, identify which questions in their everyday practice they felt would benefit from short, evidence-based guidance and rank these systematically. METHODS: A two-phase online survey using a structured ranking approach and the members directory of the European Academy of Dermatology and Venereology (EADV). RESULTS: The first survey yielded 265 suggestions, indicating a response rate of 3.7%. We grouped all responses according to themes and subsequently combined these into a list of 35 broader topics. These were presented to all members of the EADV in the second survey (response rate: 9.7%), which yielded a list of the top 10 topics participants felt were most in need of guidance. The first three were 'Systemic drug treatment in dermatology during pregnancy and for women wishing to have children in the near future', 'alopecia areata' and 'interpretation of laboratory results in connective tissue diseases'. CONCLUSION: Our two-phase survey of EADV members and a structured ranking process were practical to implement and yielded a list of the top 10 topics in dermatology and venereology for guideline development. Guideline dissemination needs to be improved, and practical, more concise guidelines may facilitate efforts to do so.