Article Text
Abstract
Purpose The Treatment exit Options For non-infectious Uveitis (TOFU) registry documents disease courses for non-anterior non-infectious uveitis entities with and without treatment to generate more evidence for clinical management recommendations including treatment exit strategies. In this article, we present the participants’ baseline characteristics after the first 3 years.
Methods TOFU is an observational, prospective registry and recruits patients ≥18 years of age with non-anterior non-infectious uveitis with or without a history of previous disease-modifying antirheumatic drugs (DMARDs) treatment. The data are collected in the electronic data capture software REDCap and include ophthalmological and general medical history as well as clinical findings.
Results Between 24.10.2019 and 27.12.2022, 628 patients were enrolled at 25 clinical sites in Germany and Austria. Patients with intermediate uveitis were most frequently included (n=252; 40.1%) followed by posterior uveitis (181; 28.8%), panuveitis (n=154; 24.5%) and retinal vasculitis (n=41, 6.5%). At baseline, 39.6% were treated with systemic corticosteroids, 22.3% with conventional synthetic (cs) DMARDs, 20.5% with biological (b) DMARDs and 3.6% with other systemic treatments. Average best corrected visual acuity (BCVA) was 0.69 decimal. Patients with panuveitis had the worst BCVA with 0.63 decimal. Overall, only 8 patients (1.3%) suffered from severe visual impairment.
Conclusions Less than half of participants required DMARD treatment at baseline, with csDMARDs used more frequently than bDMARDs. The presence of severe visual impairment was low, mostly affecting patients with panuveitis. These findings are in line with comparable monocentric cross-sectional studies of tertiary uveitis centres in Germany and will allow us to generate generalisable evidence in TOFU.
- Inflammation
- Treatment Medical
- Immunology
Data availability statement
Data are available upon reasonable request. The raw data that support the findings of this study are available from the corresponding author (RPF) upon reasonable request and discussion with the authors. Data are located in controlled access data storage at the Department of Medical Biometry, Informatics and Epidemiology (IMBIE), Bonn, Germany.
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Data availability statement
Data are available upon reasonable request. The raw data that support the findings of this study are available from the corresponding author (RPF) upon reasonable request and discussion with the authors. Data are located in controlled access data storage at the Department of Medical Biometry, Informatics and Epidemiology (IMBIE), Bonn, Germany.
Footnotes
Collaborators Gerd U. Auffarth, Sebastian Bemme, Karl Boden, Benedikt Book, Christian K. Brinkmann, Dorothee Brockmann, Claudia Brockmann, Christoph M. E. Deuter, Katrin Engelmann, Nicole Eter, Robert R. Finger, David J. Fink, Julio J. González-López, Rafael Grajewski, Salvator Grisanti, Rainer Guthoff, Carsten Heinz, Markus Kohlhaas, Markus Ladewig, Tibor K. Lohmann, Katrin Lorenz, Thomas Ness, Uwe Pleyer, Herbert A. Reitsamer, Armin Mir Mohi Sefat, Berthold Seitz, Andreas Stahl, Nicole Stübiger, Stephan Thurau, Ricarda Wienrich, Antony William.
Contributors RPF, CH, DJF and MS were involved in the conception and design of the study. RPF, UP, TKL, CMED, HR, KTB, MWMW, CH, JD and DJF participated in data collection in the respective study centres. JD coordinated data collection across the study centres. MS, MB, TH, JD and DJF conducted data analysis. RPF, CH and DJF interpreted the data. DJF was responsible for drafting the article. MS, MB, TH, RPF, UP, TKL, CMED, HR, KTB, MWMW, CH and JD contributed to the critical revision of the article. RPF and CH supervised the study and acted as the guarantors of this study. All authors have given final approval of the manuscript.
Funding The TOFU registry is funded by the BMBF (Bundesministerium für Bildung und Forschung, German Federal Ministry of Education and Research; funding reference: 01GY1903) and the Stiftung Auge of the DOG (Deutsche Ophthalmologische Gesellschaft, German Ophthalmological Society). The imaging module pilot project was funded by Retina.net. The patient module pilot project was cofunded by the DOG. Biogen supported the study by providing additional funding.
Competing interests CH is a consultant for Alimera Sciences (Aldershot, Hampshire, UK) and received Honoria from AbbVie and Novartis. MWMW is a consultant for Heine Optotechnik GmbH and glaucare GmbH, has received honoraria from ASKIN & CO GmbH, Bayer AG, Berlin-Chemie AG, Heidelberg Engineering, Novartis Pharma GmbH, Pro Generika e.V., Eyepress Fachmedien GmbH, and Science Consulting in Diabetes GmbH, and research funding from CenterVue SpA, Carl Zeiss Meditec, and Novartis Pharma GmbH. RPF is a consultant for Alimera, Apellis, Biogen, Böhringer-Ingelheim, Bayer, Caterna, Novartis, ODOS, ProGenerika, Roche/Genentech, has received honoraria from Roche and research funding from Biogen. He is member of the advisory board of Stada Pharm, Roche and Opthea. CMED is a member of the advisory board of Alimera and he has received honoraria from AbbVie, Novartis, Santen and Thea. His institution received funding for clinical trials from Tarsier and Roche. UP received study support from Abbvie and honoraria from Abbvie, Alimera and Novartis. None of the following authors have any proprietary interests or conflicts of interest related to this submission: DJF, JD, TH, MB, MS, HR, KTB and TKL.
Provenance and peer review Not commissioned; externally peer reviewed.