Enteric-coated mycophenolate sodium in the treatment of non-infectious intermediate uveitis: results of a prospective, controlled, randomised, open-label, early terminated multicentre trial
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, pro...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2018
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| In: |
British journal of ophthalmology
Year: 2017, Volume: 102, Issue: 5, Pages: 647-653 |
| ISSN: | 1468-2079 |
| DOI: | 10.1136/bjophthalmol-2017-310156 |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1136/bjophthalmol-2017-310156 Verlag, Volltext: http://bjo.bmj.com/lookup/doi/10.1136/bjophthalmol-2017-310156 
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| Author Notes: | 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 |
| Summary: | 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. |
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| Item Description: | Published online first 13 September 2017 Gesehen am 22.10.2018 |
| Physical Description: | Online Resource |
| ISSN: | 1468-2079 |
| DOI: | 10.1136/bjophthalmol-2017-310156 |