Purpose In contrast to Hodgkin lymphoma and systemic anaplastic large-cell lymphoma, CD30 expression of malignant lymphocytes in mycosis fungoides (MF) and Sézary syndrome (SS) is quite variable. Clinical activity and safety of brentuximab vedotin, a CD30 targeting antibody-drug conjugate, was evaluated in MF and SS. Tissue and blood biomarkers of clinical response were explored. Patients and Methods In this phase II study, patients with MF or SS with negligible to 100% CD30 expression levels were treated with brentuximab vedotin (1.8 mg/kg) every 3 weeks for a maximum of sixteen doses. The primary end point was overall global response rate. Secondary end points included correlation of tissue CD30 expression level with clinical response, time to response, duration of response, progression-free and event-free survivals, and safety. Results Of the 32 patients enrolled and treated, 30 patients had available efficacy evaluations. Objective global response was observed in 21 (70%) of 30 patients (90% CI, 53% to 83%). CD30 expression assessed by immunohistochemistry was highly variable, with a median CD30max of 13% (range, 0% to 100%). Those with <5% CD30 expression had a lower likelihood of global response than did those with 5% or greater CD30 expression (P < .005). CD163 positive tumor-associated macrophages, many of which coexpress CD30, were abundant in tissue. Peripheral neuropathy was the most common adverse event. Conclusion Brentuximab vedotin demonstrated significant clinical activity in treatment-refractory or advanced MF or SS with a wide range of CD30 expression levels. Additional biomarker studies may help optimize rational design of combination therapies with brentuximab vedotin.

The PARACELSUS score represents a novel, easily implementable, effective and sensitive diagnostic tool for PG.

Summary Pyoderma gangrenosum (PG) is a rare, treatable skin disorder that causes ulcers ‐ usually a single one but sometimes more. It is not contagious. Often it is diagnosed by ruling out other diseases with similar symptoms, and it can be misdiagnosed. The aim of this study, from Germany, was to establish a scoring system that includes symptoms and features that are specific to PG, that could easily be used in clinics to diagnose the disorder. The scoring system, called PARACELSUS, was tested on 60 participants with previously confirmed PG, and a control group of 50 patients with leg ulcers that are not caused by PG. The criteria included in the scoring system relate to how the ulcer looks, how it progresses and which drugs help clear it. The authors conclude that, based on their tests, the PARACELSUS score represents an easily implementable, effective and accurate diagnostic tool for PG.

No abstract