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4. Streptobacillus moniliformis and IgM and IgG Immune Response in Patient with Endocarditis

Author

Mathe, Philipp, Schmidt, Katja, Schindler, Viktoria, Fawzy, Ahmad, Schultze, Tilman, Voll, Reinhard E., Pauli, David, Popova, Milena, Schauer, Franziska, and Eisenberg, Tobias

Subjects
Immunoglobulin M -- Health aspects, Endocarditis -- Case studies -- Diagnosis, Immune response -- Health aspects, Streptobacillus -- Case studies, Gram-negative bacterial infections -- Case studies -- Diagnosis, Immunoglobulin G -- Health aspects, Health
Abstract

Rat-bite fever (RBF) is a rare disease that typically manifests with fever, rash, and arthritis (1). Possible complications are abscess formation, endocarditis, and death if left untreated (1,2). Streptobacillus moniliformis [...]

Published
2024
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9. Efficacy and safety of adjuvant immunoadsorption in pemphigus vulgaris and pemphigus foliaceus (IA-Pem Study): a multicentre randomized controlled trial.

Author

Beek, Nina van, Eming, Rüdiger, Reuss, Alexander, Zillikens, Detlef, Sárdy, Miklós, Günther, Claudia, Kiritsi, Dimitra, Benoit, Sandrine, Beissert, Stefan, Gläser, Regine, Gollnick, Harald, Horváth, Orsolya N, Pfeiffer, Christiane, Röcken, Martin, Schauer, Franziska, Schreml, Stephan, Steinbrink, Kerstin, Zink, Alexander, Schade-Brittinger, Carmen, and Hertl, Michael

Subjects
PEMPHIGUS vulgaris, IMMUNOADSORPTION, RANDOMIZED controlled trials, PEMPHIGUS, PATIENTS, AUTOIMMUNE diseases, DISEASE remission
Abstract

Background Pemphigus vulgaris (PV) and pemphigus foliaceus (PF) are potentially life-threatening autoimmune blistering diseases. Treatment is based on long-term immunosuppression with high doses of glucocorticosteroids in combination with potentially corticosteroid-sparing agents and/or rituximab. Immunoadsorption (IA) has emerged as a fast-acting adjuvant treatment option. Objectives To assess the clinical efficacy of IA in addition to best medical treatment (BMT). Methods We conducted a multicentre (26 centres from Germany and Austria) randomized controlled trial in 72 patients with newly diagnosed, relapsed or chronic active PV or PF (34 female patients and 38 male patients, aged 42–72   years) comparing BMT (prednisolone 1.0   mg kg−1 per day plus azathioprine or mycophenolate) with adjuvant IA (BMT + IA). Central 1 : 1 randomization was done at the coordinating centre for clinical trials (KKS Marburg). The primary endpoint was analysed using Kaplan–Meier and Cox regression methods. Results The study was ended prematurely owing to safety concerns after random allocation of 72 patients to BMT + IA (n = 34) or BMT (n = 38). The primary endpoint, time to complete remission on therapy, was not significantly different for the two groups [hazard ratio (HR) 1.35, 95% confidence interval (CI) 0.68–2.69; P = 0.39]. The cumulative dose of prednisolone was significantly lower in the BMT + IA group compared with BMT alone (difference −1214, 95% CI −2225 to −70; P = 0.03). In a post hoc analysis, patients with more extensive PV/PF showed a tendency towards a shorter time to remission in the BMT + IA group compared with the BMT group (HR 1.87, P = 0.17 in patients with baseline Pemphigus Disease Area Index ≥ 15). While more adverse events were observed in patients in the BMT group (29 vs. 25), severe adverse events were more frequent in patients in the BMT + IA group (17 events in 10 patients vs. 11 events in 8 patients). Conclusions In this study, adjuvant IA did not demonstrate a shorter time to clinical remission, but a corticosteroid-sparing effect was observed. In patients with extensive PV/PF, post hoc analysis suggests that adjuvant IA may lead to earlier remission, but potential adverse events must be carefully weighed against the expected benefits. [ABSTRACT FROM AUTHOR]

Published
2024
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10. Efficacy and safety of adjuvant immunoadsorption in pemphigus vulgaris and pemphigus foliaceus (IA-Pem Study): a multicentre randomised controlled trial

Author

van Beek, Nina, primary, Eming, Rüdiger, additional, Reuss, Alexander, additional, Zillikens, Detlef, additional, Sárdy, Miklós, additional, Günther, Claudia, additional, Kiritsi, Dimitra, additional, Benoit, Sandrine, additional, Beissert, Stefan, additional, Gläser, Regine, additional, Gollnick, Harald, additional, Horváth, Orsolya N, additional, Pfeiffer, Christiane, additional, Röcken, Martin, additional, Schauer, Franziska, additional, Schreml, Stephan, additional, Steinbrink, Kerstin, additional, Zink, Alexander, additional, Schade-Brittinger, Carmen, additional, Hertl, Michael, additional, and Schmidt, Enno, additional

Published
2023
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11. The gut microbiome in bullous pemphigoid: implications of the gut-skin axis for disease susceptibility

Author

Liu, Xiaolin, primary, van Beek, Nina, additional, Cepic, Aleksa, additional, Andreani, Nadia A., additional, Chung, Cecilia J., additional, Hermes, Britt M., additional, Yilmaz, Kaan, additional, Benoit, Sandrine, additional, Drenovska, Kossara, additional, Gerdes, Sascha, additional, Gläser, Regine, additional, Goebeler, Matthias, additional, Günther, Claudia, additional, von Georg, Anabelle, additional, Hammers, Christoph M., additional, Holtsche, Maike M., additional, Hübner, Franziska, additional, Kiritsi, Dimitra, additional, Schauer, Franziska, additional, Linnenmann, Beke, additional, Huilaja, Laura, additional, Tasanen-Määttä, Kaisa, additional, Vassileva, Snejina, additional, Zillikens, Detlef, additional, Sadik, Christian D., additional, Schmidt, Enno, additional, Ibrahim, Saleh, additional, and Baines, John F., additional

Published
2023
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16. The gut microbiome in bullous pemphigoid: implications of the gut-skin axis for disease susceptibility.

Author

Xiaolin Liu, van Beek, Nina, Cepic, Aleksa, Andreani, Nadia A., Chung, Cecilia J., Hermes, Britt M., Yilmaz, Kaan, Benoit, Sandrine, Drenovska, Kossara, Gerdes, Sascha, Gläser, Regine, Goebeler, Matthias, Günther, Claudia, von Georg, Anabelle, Hammers, Christoph M., Holtsche, Maike M., Hübner, Franziska, Kiritsi, Dimitra, Schauer, Franziska, and Linnenmann, Beke

Subjects
BULLOUS pemphigoid, GUT microbiome, DISEASE susceptibility, SHOTGUN sequencing, GABA, SKIN diseases
Abstract

Bullous pemphigoid (BP) is an autoimmune blistering disease that primarily affects the elderly. An altered skin microbiota in BP was recently revealed. Accumulating evidence points toward a link between the gut microbiota and skin diseases; however, the gut microbiota composition of BP patients remains largely underexplored, with only one pilot study to date, with a very limited sample size and no functional profiling of gut microbiota. To thoroughly investigate the composition and function of the gut microbiota in BP patients, and explore possible links between skin conditions and gut microbiota, we here investigated the gut microbiota of 66 patients (81.8% firstly diagnosed) suffering from BP and 66 age-, sex-, and study center-matched controls (CL) with non-inflammatory skin diseases (132 total participants), using 16S rRNA gene and shotgun sequencing data. Decreased alpha-diversity and an overall altered gut microbial community is observed in BP patients. Similar trends are observed in subclassifications of BP patients, including first diagnoses and relapsed cases. Furthermore, we observe a set of BP disease-associated gut microbial features, including reduced Faecalibacterium prausnitzii and greater abundance of pathways related to gamma-aminobutyric acid (GABA) metabolism in BP patients. Interestingly, F. prausnitzii is a well-known microbiomarker of inflammatory diseases, which has been reported to be reduced in the gut microbiome of atopic dermatitis and psoriasis patients. Moreover, GABA plays multiple roles in maintaining skin health, including the inhibition of itching by acting as a neurotransmitter, attenuating skin lesions by balancing Th1 and Th2 levels, and maintaining skin elasticity by increasing the expression of type I collagen. These findings thus suggest that gut microbiota alterations present in BP may play a role in the disease, and certain key microbes and functions may contribute to the link between gut dysbiosis and BP disease activity. Further studies to investigate the underlying mechanisms of the gut-skin interaction are thus clearly warranted, which could aid in the development of potential therapeutic interventions. [ABSTRACT FROM AUTHOR]

Published
2023
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28. Evaluation of Nomacopan for Treatment of Bullous Pemphigoid

Author

Sadik, Christian D., primary, Rashid, Hanan, additional, Hammers, Christoph M., additional, Diercks, Gilles F.H., additional, Weidinger, Anke, additional, Beissert, Stefan, additional, Schauer, Franziska, additional, Fettiplace, James, additional, Thaçi, Diamant, additional, Ngai, Yenting, additional, Nunn, Miles A., additional, Zillikens, Detlef, additional, and Horváth, Barbara, additional

Published
2022
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33. Clinical trial of ABCB5+ mesenchymal stem cells for recessive dystrophic epidermolysis bullosa

Author

Kiritsi, Dimitra, primary, Dieter, Kathrin, additional, Niebergall-Roth, Elke, additional, Fluhr, Silvia, additional, Daniele, Cristina, additional, Esterlechner, Jasmina, additional, Sadeghi, Samar, additional, Ballikaya, Seda, additional, Erdinger, Leoni, additional, Schauer, Franziska, additional, Gewert, Stella, additional, Laimer, Martin, additional, Bauer, Johann W., additional, Hovnanian, Alain, additional, Zambruno, Giovanna, additional, El Hachem, May, additional, Bourrat, Emmanuelle, additional, Papanikolaou, Maria, additional, Petrof, Gabriela, additional, Kitzmüller, Sophie, additional, Ebens, Christen L., additional, Frank, Markus H., additional, Frank, Natasha Y., additional, Ganss, Christoph, additional, Martinez, Anna E., additional, McGrath, John A., additional, Tolar, Jakub, additional, and Kluth, Mark A., additional

Published
2021
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34. Efficacy and safety of Oleogel-S10 (birch triterpenes) for epidermolysis bullosa: results from the phase III randomized double-blind phase of the EASE study.

Author

Kern, Johannes S, Sprecher, Eli, Fernandez, Maria Florencia, Schauer, Franziska, Bodemer, Christine, Cunningham, Tracy, Löwe, Sandra, Davis, Charles, Sumeray, Mark, Bruckner, Anna L, Murrell, Dédée F, and investigators, for the EASE

Subjects
EPIDERMOLYSIS bullosa, TRITERPENES, BIRCH, CHRONIC wounds & injuries, SQUAMOUS cell carcinoma, EARLY death
Abstract

Background Epidermolysis bullosa (EB) is a heterogeneous group of rare, difficult-to-treat, inherited multisystem diseases affecting epithelial integrity. Patients with EB are affected by mechanical fragility of epithelial surfaces including the skin and, as a result, extensive recurrent blistering is a characteristic of the condition. Chronic wounds predispose patients with EB to the development of squamous cell carcinoma, which is a major cause of premature death. Objectives EASE was a double-blind, randomized, vehicle-controlled, phase III study to determine the efficacy and safety of the topical gel Oleogel-S10 (birch triterpenes) in EB. EASE was funded by Amryt Research Limited. Methods Patients with dystrophic EB, junctional EB or Kindler EB and a target partial-thickness wound lasting ≥ 21 days and < 9 months that was 10–50 cm2, were enrolled and randomized via computer-generated allocation tables 1 : 1 to Oleogel-S10 or control gel – both with standard-of-care dressings. Study gel was applied to all wounds at least every 4 days. The primary endpoint was the proportion of patients with first complete closure of target wound within 45 days. Results A total of 223 patients were enrolled and treated (109 treated with Oleogel-S10, 114 with control gel). The primary endpoint was met; Oleogel-S10 resulted in 41·3% of patients with first complete target wound closure within 45 days, compared with 28·9% in the control gel arm (relative risk 1·44, 95% confidence interval (CI) 1·01–2·05; P = 0·013). Adverse events (AEs) occurred with similar frequency for Oleogel-S10 (81·7%) compared with control gel (80·7%). AEs were predominantly of mild-to-moderate intensity (4·6% were severe). Conclusions Oleogel-S10 is the first therapy to demonstrate accelerated wound healing in EB. Oleogel-S10 was well -tolerated. [ABSTRACT FROM AUTHOR]

Published
2023
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38. Clinical trial of ABCB5+ mesenchymal stem cells for recessive dystrophic epidermolysis bullosa

Author

Kiritsi, Dimitra, Dieter, Kathrin, Niebergall-Roth, Elke, Fluhr, Silvia, Daniele, Cristina, Esterlechner, Jasmina, Sadeghi, Samar, Ballikaya, Seda, Erdinger, Leoni, Schauer, Franziska, Gewert, Stella, Laimer, Martin, Bauer, Johann W., Hovnanian, Alain, Zambruno, Giovanna, El Hachem, May, Bourrat, Emmanuelle, Papanikolaou, Maria, Petrof, Gabriela, Kitzmüller, Sophie, Ebens, Christen L., Frank, Markus H., Frank, Natasha Y., Ganss, Christoph, Martinez, Anna E., McGrath, John A., Tolar, Jakub, Kluth, Mark A., Kiritsi, Dimitra, Dieter, Kathrin, Niebergall-Roth, Elke, Fluhr, Silvia, Daniele, Cristina, Esterlechner, Jasmina, Sadeghi, Samar, Ballikaya, Seda, Erdinger, Leoni, Schauer, Franziska, Gewert, Stella, Laimer, Martin, Bauer, Johann W., Hovnanian, Alain, Zambruno, Giovanna, El Hachem, May, Bourrat, Emmanuelle, Papanikolaou, Maria, Petrof, Gabriela, Kitzmüller, Sophie, Ebens, Christen L., Frank, Markus H., Frank, Natasha Y., Ganss, Christoph, Martinez, Anna E., McGrath, John A., Tolar, Jakub, and Kluth, Mark A.

Abstract

BACKGROUND. Recessive dystrophic epidermolysis bullosa (RDEB) is a rare, devastating, and lifethreatening inherited skin fragility disorder that comes about due to a lack of functional type VII collagen, for which no effective therapy exists. ABCB5+ dermal mesenchymal stem cells (ABCB5+ MSCs) possess immunomodulatory, inflammation-dampening, and tissue-healing capacities. In a Col7a1-/-mouse model of RDEB, treatment with ABCB5+ MSCs markedly extended the animals' lifespans. METHODS. In this international, multicentric, single-arm, phase I/IIa clinical trial, 16 patients (aged 4-36 years) enrolled into 4 age cohorts received 3 i.v. infusions of 2 × 106ABCB5+ MSCs/kg on days 0, 17, and 35. Patients were followed up for 12 weeks regarding efficacy and 12 months regarding safety. RESULTS. At 12 weeks, statistically significant median (IQR) reductions in the Epidermolysis Bullosa Disease Activity and Scarring Index activity (EBDASI activity) score of 13.0% (2.9%-30%; P = 0.049) and the Instrument for Scoring Clinical Outcome of Research for Epidermolysis Bullosa clinician (iscorEB-c) score of 18.2% (1.9%-39.8%; P = 0.037) were observed. Reductions in itch and pain numerical rating scale scores were greatest on day 35, amounting to 37.5% (0.0%-42.9%; P = 0.033) and 25.0% (-8.4% to 46.4%; P = 0.168), respectively. Three adverse events were considered related to the cell product: 1 mild lymphadenopathy and 2 hypersensitivity reactions. The latter 2 were serious but resolved without sequelae shortly after withdrawal of treatment. CONCLUSION. This trial demonstrates good tolerability, manageable safety, and potential efficacy of i.v. ABCB5+ MSCs as a readily available disease-modifying therapy for RDEB and provides a rationale for further clinical evaluation.

Published
2021

44. Polymorphisms in the Mitochondrial Genome Are Associated With Bullous Pemphigoid in Germans

Author

Russlies, Juliane, primary, Fähnrich, Anke, additional, Witte, Mareike, additional, Yin, Junping, additional, Benoit, Sandrine, additional, Gläser, Regine, additional, Günter, Claudia, additional, Eming, Rüdiger, additional, Erdmann, Jeanette, additional, Gola, Damian, additional, Gupta, Yask, additional, Holtsche, Maike Marleen, additional, Kern, Johannes S., additional, König, Inke R., additional, Kiritsi, Dimitra, additional, Lieb, Wolfgang, additional, Sadik, Christian D., additional, Sárdy, Miklós, additional, Schauer, Franziska, additional, van Beek, Nina, additional, Weidinger, Anke, additional, Worm, Margitta, additional, Zillikens, Detlef, additional, Schmidt, Enno, additional, Busch, Hauke, additional, Ibrahim, Saleh M., additional, and Hirose, Misa, additional

Published
2019
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45. Depressive symptoms are frequent, associated with disease severity, and affect quality of life in psoriasis and psoriatic arthritis: A questionnaire-based assessment of 300 patients

Author

Frede, Natalie, Hiestand, Sonja, Schauer, Franziska, Schempp, Christoph, Endres, Dominique, Tebartz van Elst, Ludger, Finzel, Stephanie, Voll, Reinhard, Thiel, Jens, and Venhoff, Nils

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Background: Psoriasis (PSO) and psoriatic arthritis (PsA) have both been associated with depression. It has been established that depression may lead to a reduced compliance as well as increased symptom load and disability in chronic conditions. Depression thus constitutes an important comorbidity in[for full text, please go to the a.m. URL], 47. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 33. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 29. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2019

46. Esophageal lichen planus: towards diagnosis of an underdiagnosed disease

Author

Schauer, Franziska, Monasterio, Carmen, Technau-Hafsi, Kristin, Kern, Johannes Steffen, Adhara Lazaro, Deibert, Peter, Hasselblatt, Peter, Schwacha, Henning, Heeg, Steffen, Brass, Volker, Küllmer, Armin, Schmidt, Arthur Robert, Schmitt-Graeff, Annette, and Kreisel, Wolfgang

Abstract

Background: Although lichen planus (LP) is a common skin disorder, the prevalence of esophageal involvement (ELP) and its clinical manifestations are poorly defined. We aimed to establish diagnostic criteria and characterize disease outcomes of ELP. Methods: Clinical, endoscopic, histological, and immunofluorescence data from consecutive patients with known LP between 2013 and 2018 were analyzed. We established endoscopic (denudation and tearing of the mucosa, hyperkeratosis and trachealization) and histological criteria (mucosal detachment, T-lymphocytic infiltrate, intraepithelial apoptosis, dyskeratosis, and fibrinogen deposits along the basement membrane) to grade disease severity. Endoscopic findings were correlated with clinical symptoms. Response to medical therapy was monitored. Results: Fifty-two consecutive patients (median age 59.5 years) were analyzed. According to our grading system, 16 patients were considered as severe and 18 as mild ELP. Dysphagia was the only symptom which differentiated patients with severe (14/16) or mild ELP (8/18) from patients without ELP (1/18). Concomitant oral and genital involvement of LP was associated with the presence of ELP, while oral involvement alone was not. Follow-up of 14/16 patients with severe EPL for at least one year revealed that most of these patients responded to topical corticosteroids (budesonide: n = 9/10 or fluticasone n = 2/2). Three budesonide patients experienced a resolution of symptomatic esophageal stenosis. Conclusions: Esophageal involvement of LP is frequent, but may be asymptomatic. ELP can be diagnosed using the diagnostic criteria proposed here. Dysphagia and combined oral and genital manifestation are associated with ELP. Therapy with topical corticosteroids appears to be a prudent therapeutic approach for ELP.

Published
2019
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47. Conceptualization and implementation of the central information portal on rare diseases : protocol for a qualitative study

Author

Litzkendorf, Svenja, Hartz, Tobias, Göbel, Jens, Storf, Holger, Pauer, Frédéric, Babac, Ana, Lührs, Verena, Bruckner-Tuderman, Leena, Schauer, Franziska, Schmidtke, Jörg, Biehl, Lisa, Wagner, TOF, Graf von der Schulenburg, J-Matthias, Frank, Martin, and Eysenbach, Gunther

Subjects
health information exchange, Health information exchange, Qualitative research, Protocol, Quality control, rare diseases, ddc:610, Dewey Decimal Classification::600 | Technik::610 | Medizin, Gesundheit, quality control, qualitative research, Rare diseases
Abstract

Background: Recently, public and political interest has focused on people living with rare diseases and their health concerns. Due to the large number of different types of rare diseases and the sizable number of patients, taking action to improve the life of those affected is gaining importance. In 2013, the federal government of Germany adopted a national action plan for rare diseases, including the call to establish a central information portal on rare diseases (Zentrales Informationsportal über seltene Erkrankungen, ZIPSE). Objective: The objective of this study, therefore, was to conduct scientific research on how such a portal must be designed to meet the needs of patients, their families, and medical professionals, and to provide high-quality information for information seekers. Methods: We chose a 3-step procedure to develop a needs-based prototype of a central information portal. In the first step, we determined the information needs of patients with rare diseases, their relatives, and health care professionals by means of qualitative interviews and their content-analytical evaluation. On the basis of this, we developed the basic structure of the portal. In the second step, we identified quality criteria for websites on rare diseases to ensure that the information linked with ZIPSE meets the quality demands. Therefore, we gathered existing criteria catalogs and discussed them in an expert workshop. In the third step, we implemented and tested the developed prototypical information portal. Results: A portal page was configured and made accessible on the Web. The structure of ZIPSE was based on the findings from 108 qualitative interviews with patients, their relatives, and health care professionals, through which numerous information needs were identified. We placed particularly important areas of information, such as symptoms, therapy, research, and advisory services, on the start page. Moreover, we defined 13 quality criteria, referring to factors such as author information, creation date, and privacy, enabling links with high-quality information. Moreover, 19 users tested all the developed routines based on usability and comprehensibility. Subsequently, we improved the visual presentation of search results and other important search functions. Conclusions: The implemented information portal, ZIPSE, provides high-quality information on rare diseases from a central point of access. By integrating the targeted groups as well as different experts on medical information during the construction, the website can assure an improved search for information for users. ZIPSE can also serve as a model for other Web-based information systems in the field of rare diseases. Registered Report Identifier: RR1-10.2196/7425.

Published
2018

48. Esophageal lichen planus: towards diagnosis of an underdiagnosed disease

Author

Schauer, Franziska, primary, Monasterio, Carmen, additional, Technau-Hafsi, Kristin, additional, Kern, Johannes Steffen, additional, Lazaro, Adhara, additional, Deibert, Peter, additional, Hasselblatt, Peter, additional, Schwacha, Henning, additional, Heeg, Steffen, additional, Brass, Volker, additional, Küllmer, Armin, additional, Schmidt, Arthur Robert, additional, Schmitt-Graeff, Annette, additional, and Kreisel, Wolfgang, additional

Published
2019
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50. THU0379 DEPRESSIVE SYMPTOMS AND FUNCTIONAL IMPAIRMENT ARE FREQUENT AND AFFECT QUALITY OF LIFE IN ANKYLOSING SPONDYLITIS AND PSORIATIC ARTHRITIS: A QUESTIONNAIRE-BASED ASSESSMENT OF 300 PATIENTS COMPARED WITH 150 PATIENTS WITH PSORIASIS AND 150 PATIENTS WITH MECHANICAL BACK PAIN

Author

Frede, Natalie, primary, Hiestand, Sonja, additional, Schauer, Franziska, additional, Schempp, Christoph, additional, Herget, Georg, additional, Endres, Dominique, additional, Elst, Ludger Tebartz van, additional, Voll, Reinhard, additional, Thiel, Jens, additional, and Venhoff, Nils, additional

Published
2019
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