Safety and clinical outcomes of rituximab therapy in patients with different autoimmune diseases: experience from a national registry (GRAID)

Introduction: Evidence from a number of open-label, uncontrolled studies has suggested that rituximab may benefit patients with autoimmune diseases who are refractory to standard-of-care. The objective of this study was to evaluate the safety and clinical outcomes of rituximab in several standard-of-care-refractory autoimmune diseases (within rheumatology, nephrology, dermatology and neurology) other than rheumatoid arthritis or non-Hodgkin's lymphoma in a real-life clinical setting. Methods: Patients who received rituximab having shown an inadequate response to standard-of-care had their safety and clinical outcomes data retrospectively analysed as part of the German Registry of Autoimmune Diseases. The main outcome measures were safety and clinical response, as judged at the discretion of the investigators. Results: A total of 370 patients (299 patient-years) with various autoimmune diseases (23.0% with systemic lupus erythematosus, 15.7% antineutrophil cytoplasmic antibody-associated granulomatous vasculitides, 15.1% multiple sclerosis and 10.0% pemphigus) from 42 centres received a mean dose of 2,440 mg of rituximab over a median (range) of 194 (180 to 1,407) days. The overall rate of serious infections was 5.3 per 100 patient-years during rituximab therapy. Opportunistic infections were infrequent across the whole study population, and mostly occurred in patients with systemic lupus erythematosus. There were 11 deaths (3.0% of patients) after rituximab treatment (mean 11.6 months after first infusion, range 0.8 to 31.3 months), with most of the deaths caused by infections. Overall (n = 293), 13.3% of patients showed no response, 45.1% showed a partial response and 41.6% showed a complete response. Responses were also reflected by reduced use of glucocorticoids and various immunosuppressives during rituximab therapy and follow-up compared with before rituximab. Rituximab generally had a positive effect on patient well-being (physician's visual analogue scale; mean improvement from baseline of 12.1 mm). Conclusions: Data from this registry indicate that rituximab is a commonly employed, well-tolerated therapy with potential beneficial effects in standard of care-refractory autoimmune diseases, and support the results from other open-label, uncontrolled studies

Recent Developments in Topical Wound Therapy: Impact of Antimicrobiological Changes and Rebalancing the Wound Milieu

Wound therapy improves every year by developing new wound treatment options or by advancing already existing wound materials, for example, adding self-releasing analgesic drugs or growth factors to wound dressings, or by binding and inactivating excessive proteases. Also new dressing materials based on silk fibers and enhanced methods to reduce bacterial burden, for example, cold argon plasma, might help to fasten wound healing

Malignant Tumours Presenting as Chronic Leg or Foot Ulcers

Our purpose was to collect data on the incidence of malignant skin tumours presenting as chronic leg or foot ulcers in a tertiary centre, and to analyse the frequency and type of initial clinical misdiagnoses in these cases. A retrospective chart review of cases with melanoma or other malignant neoplasms of the skin of the lower extremity treated in a tertiary centre during January 2010 until February 2020 was conducted to identify cases that presented as chronic ulcers. Out of 673 cases, 26 (3.9%) were identified with a total of 27 malignant tumours presenting as chronic ulcers of the lower leg or foot. Therefrom, seven were diagnosed as melanoma, eight as squamous cell carcinoma, and twelve as basal cell carcinoma. The mean interval until diagnosis for all tumour types was 44.4 months (median 24 months). A delay in correct treatment occurred in 12 out of 26 cases (46%) as a result of misdiagnosis with subsequent treatment as chronic leg or foot ulcers of a different etiology. Misdiagnoses were venous ulcer, traumatic wound, mixed arterial and venous ulcer, arterial ulcer, and ulcer of an unknown origin. Malignant ulcers presenting as chronic ulcers are rare, but often lead to misdiagnosis

Beruflich erworbene MRSA-Besiedelung in der berufsdermatologischen Begutachtung (BK-Nr. 3101) : Auswertung der DGUV BK-Dokumentation und Gutachtenfall mit arbeitsbedingter MRSA-getriggerter atopischer Dermatitis

BACKGROUND: Person-to-person transmitted infectious diseases can cause occupational diseases (OD). These are subsumed as BK-No. 3101 in the German list of OD which applies for individuals with a considerably higher risk for infection as a consequence of their professional activity compared to the general population. OBJECTIVES: The special medical and insurance law aspects of a work-related MRSA colonization are presented using the example of an expert opinion case and an evaluation of the BK reports of suspected occupational disease (BK No. 3101) of the German Social Accident Insurance (DGUV). PATIENTS AND METHODS: The BK documentation of the DGUV from 2007–2012 and the patient cohort from the Department of Dermatology, University Hospital Erlangen, presenting for expert assessment from 2007–2012 were retrospectively analysed for human-to-human transmitted infectious diseases of the skin (BK-No. 3101). RESULTS: Person-to-person transmission of infectious diseases of the skin is rare in the field of occupational dermatology. In the DGUV cohort, suspected BK-No. 3101cases amounted to 2.6% of all notified cases; recognized BK-No. 3101 cases accounted for 4.2% of all recognized cases, amongst which 9 were caused by MRSA. In contrast to a symptomatic infection, an asymptomatic MRSA colonization is not being recognized as BK-No. 3101. Bacterial superantigens can trigger atopic dermatitis (AD). In particular cases, occupationally acquired MRSA can elicit AD and may justify classification as an OD (BK-No. 3101). CONCLUSIONS: Early detection of MRSA colonization and eradication are necessary for rehabilitation. Management of skin diseases due to infectious diseases within the framework of OD is presented.HINTERGRUND: Von Mensch zu Mensch übertragene Infektionskrankheiten können eine Berufskrankheit(BK)-Nr. 3101 bedingen, wenn sie bei Versicherten auftreten, die infolge der Ausübung ihrer Arbeitstätigkeit in bestimmten Bereichen einer gegenüber der allgemeinen Bevölkerung wesentlich erhöhten Infektionsgefahr ausgesetzt sind. ZIEL DER ARBEIT: Es erfolgt die Darstellung der besonderen medizinischen und versicherungsrechtlichen Aspekte einer beruflichen MRSA-Kolonisation am Beispiel eines Gutachtenfalles und Auswertung der BK-Verdachtsanzeigen (BK-Nr. 3101) der gewerblichen Berufsgenossenschaften und Unfallversicherungsträger. PATIENTEN UND METHODEN: Die Geschäftsergebnisse und BK-Dokumentation der gewerblichen Berufsgenossenschaften und Unfallversicherungsträger 2007 bis 2012 wurden zur BK-Nr. 3101 ausgewertet sowie das Patientenkollektiv berufsdermatologischer Begutachtungsfälle 2007 bis 2012 der Hautklinik Universitätsklinikum Erlangen zum Vorliegen von Mensch zu Mensch übertragener Infektionskrankheiten der Haut retrospektiv untersucht. ERGEBNISSE: Von Mensch zu Mensch übertragene Infektionskrankheiten der Haut sind in der berufsdermatologischen Begutachtung selten. Von den 2007 bis 2012 erfassten BK-Verdachtsanzeigen waren 2,6 % BK-Nr. 3101-Verdachtsfälle; 4,2 % aller anerkannten BKen entfielen auf BK-Nr. 3101-Fälle, darunter 9 Fälle von MRSA (Methicillin-resistenter Staphylococcus aureus). Eine symptomlose MRSA-Besiedlung wird im Gegensatz zur manifesten Infektionskrankheit nicht als BK-Nr. 3101 anerkannt. Bakterielle Superantigene können eine atopische Dermatitis (AD) triggern. Im Einzelfall kann eine AD infolge einer beruflich erworbenen MRSA-Ansteckung auftreten und eine BK-Nr. 3101 begründen. DISKUSSION: Ein frühzeitiger Nachweis einer MRSA-Kolonisation und Eradikation sind notwendig für eine Rehabilitation. Der Umgang mit Hauterkrankungen als Folge einer Infektionskrankheit im Berufskrankheitenverfahren wird dargelegt

Automatic Classification of Diabetic Foot Ulcer Images : A Transfer-Learning Approach to Detect Wound Maceration

Diabetic foot ulcer (DFU) is a chronic wound and a common diabetic complication as 2% – 6% of diabetic patients witness the onset thereof. The DFU can lead to severe health threats such as infection and lower leg amputations, Coordination of interdisciplinary wound care requires well-written but time-consuming wound documentation. Artificial intelligence (AI) systems lend themselves to be tested to extract information from wound images, e.g. maceration, to fill the wound documentation. A convolutional neural network was therefore trained on 326 augmented DFU images to distinguish macerated from unmacerated wounds. The system was validated on 108 unaugmented images. The classification system achieved a recall of 0.69 and a precision of 0.67. The overall accuracy was 0.69. The results show that AI systems can classify DFU images for macerations and that those systems could support clinicians with data entry. However, the validation statistics should be further improved for use in real clinical settings. In summary, this paper can contribute to the development of methods to automatic wound documentation

An Image Based Object Recognition System for Wound Detection and Classification of Diabetic Foot and Venous Leg Ulcers

Venous leg ulcers and diabetic foot ulcers are the most common chronic wounds. Their prevalence has been increasing significantly over the last years, consuming scarce care resources. This study aimed to explore the performance of detection and classification algorithms for these types of wounds in images. To this end, algorithms of the YoloV5 family of pre-trained models were applied to 885 images containing at least one of the two wound types. The YoloV5m6 model provided the highest precision (0.942) and a high recall value (0.837). Its mAP_0.5:0.95 was 0.642. While the latter value is comparable to the ones reported in the literature, precision and recall were considerably higher. In conclusion, our results on good wound detection and classification may reveal a path towards (semi-) automated entry of wound information in patient records. To strengthen the trust of clinicians, we are currently incorporating a dashboard where clinicians can check the validity of the predictions against their expertise