Enteric-coated mycophenolate sodium in the treatment of non-infectious intermediate uveitis

• Verfasst von: Deuter, Christoph Martin Ekkehard [VerfasserIn]
• Verfasst von: Mackensen, Friederike [VerfasserIn]
• Titel: Enteric-coated mycophenolate sodium in the treatment of non-infectious intermediate uveitis
• Titelzusatz: results of a prospective, controlled, randomised, open-label, early terminated multicentre trial
• Verf.angabe: Christoph M E Deuter, Katrin Engelmann, Arnd Heiligenhaus, Ines Lanzl, Friederike Mackensen, Thomas Ness, Uwe Pleyer, Nicole Stuebiger, Barbara Wilhelm, Holger Luedtke, Manfred Zierhut, Deshka Doycheva
• Jahr: 2018
• Jahr des Originals: 2017
• Umfang: 7 S.
• Fussnoten: Published online first 13 September 2017 ; Gesehen am 22.10.2018
• Titel Quelle: Enthalten in: British journal of ophthalmology
• Ort Quelle: London : BMJ Publ. Group, 1917
• Jahr Quelle: 2018
• Band/Heft Quelle: 102(2018), 5, Seite 647-653
• ISSN Quelle: 1468-2079
• DOI: doi:10.1136/bjophthalmol-2017-310156
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1582168504

Abstract

Background/aims  To evaluate the efficacy, safety and tolerability of enteric-coated mycophenolate sodium (EC-MPS) in combination with low-dose corticosteroids compared with a monotherapy with low-dose corticosteroids in subjects with non-infectious intermediate uveitis (IU).Methods  Open-label, prospective, controlled, randomised multicentre trial. Patients were randomised in a 1:1 ratio to either the treatment group (prednisolone plus EC-MPS) or control group (prednisolone monotherapy). Patients in the control group who relapsed within 6 months changed to the crossover group (prednisolone plus EC-MPS). Maximum treatment duration was 15 months. The primary endpoint was the time to first relapse in the treatment group and control group.Results  Forty-one patients at eight sites were analysed. Twenty-two patients were allocated to the treatment group, with 19 patients in the control group. A first relapse occurred in 9 patients (40.9%) in the treatment group and 15 patients (78.9%) in the control group (p=0.03). The median time to the first relapse was >15 months for the treatment group and 2.8 months for the control group (p=0.07). The probability of relapse-free survival at month 15 was estimated to be 52.9% in the treatment group and 19.7% in the control group (p=0.01). 15 patients changed to the crossover group. Of these, only four patients developed a second relapse. No safety concerns arose during the trial. Only one patient had to discontinue EC-MPS due to increased liver enzymes.Conclusion  EC-MPS can be considered an effective and well-tolerated immunosuppressive drug to prevent relapses in patients with chronic IU. Trial registration number  EUDRACT number: 2009009998-10, Results.