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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: 2009-009998-10, Results.
- intermediate uveitis
- immunosuppressive treatment
- mycophenolic acid
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Footnotes
MZ and DD contributed equally.
Contributors CMED: study conception; protocol author; data collection; manuscript preparation. KE: data collection; manuscript review. AH: protocol review; data collection; manuscript review. IL: data collection; manuscript review. FM: protocol review; data collection. TN: protocol review; data collection; manuscript review. UP: protocol review; data collection; manuscript review. NS: data collection; manuscript review. BW: protocol review; data management; manuscript review. HL: protocol review; statistical planning and analysis; manuscript preparation. MZ: study conception; protocol review; data collection; manuscript review. DD: study conception; protocol review; data collection; manuscript review.
Funding This work was supported by a research grant from Novartis Pharma, Nuernberg. Novartis Pharma also supplied the investigational drug (Myfortic) free of charge. Novartis Pharma had no role in the design or conduct of this research.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Ethics Committee; BfArM.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators The following members of the MYCUV-IIT02 study group contributed to the clinical trial: Attenberger E (Department of Ophthalmology, St. Franziskus Hospital, Muenster, Germany); Auffarth G (Interdisciplinary Uveitis Center, University of Heidelberg, Heidelberg, Germany); Becker K (Eye Clinic, Klinikum Chemnitz gGmbH, Chemnitz, Germany); Brandauer K (Interdisciplinary Uveitis Center, University of Heidelberg, Heidelberg, Germany); Cürten C (University Eye Center, University of Freiburg, Freiburg, Germany); Diedenhofen N (Eye Clinic, Klinikum Chemnitz gGmbH, Chemnitz, Germany); Dobner B (Interdisciplinary Uveitis Center, University of Heidelberg, Heidelberg, Germany); Dreesbach J (Department of Ophthalmology, St. Franziskus Hospital, Muenster, Germany); Feil E (STZ eyetrial at the Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany); Felzmann S (University Eye Center, University of Freiburg, Freiburg, Germany); Gotzmann M (Department of Ophthalmology, St. Franziskus Hospital, Muenster, Germany); Hadeler J (Department of Ophthalmology, Technical University of Munich, Munich, Germany); Hecker J (Eye Clinic, Klinikum Chemnitz gGmbH, Chemnitz, Germany); Heinz C (Department of Ophthalmology, St. Franziskus Hospital, Muenster, Germany); Heinzelmann S (University Eye Center, University of Freiburg, Freiburg, Germany); Hobin L (Department of Ophthalmology, St. Franziskus Hospital, Muenster, Germany); Hoesel A (Eye Clinic, Klinikum Chemnitz gGmbH, Chemnitz, Germany); Jacubeck L (Department of Ophthalmology, St. Franziskus Hospital, Muenster, Germany); Jakob E (Interdisciplinary Uveitis Center, University of Heidelberg, Heidelberg, Germany); Knoll A (Interdisciplinary Uveitis Center, University of Heidelberg, Heidelberg, Germany); Maehrlein B (University Eye Center, University of Freiburg, Freiburg, Germany); Mann B (Interdisciplinary Uveitis Center, University of Heidelberg, Heidelberg, Germany); Max R (Interdisciplinary Uveitis Center, University of Heidelberg, Heidelberg, Germany); Mertz E (Interdisciplinary Uveitis Center, University of Heidelberg, Heidelberg, Germany); Metz J (University Eye Center, University of Freiburg, Freiburg, Germany); Metzner S (Department of Ophthalmology, Campus Virchow-Klinikum, Charite University Medicine, Berlin, Germany); Mueller C (University Eye Center, University of Freiburg, Freiburg, Germany); Peters T (STZ eyetrial at the Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany); Renner C (STZ eyetrial at the Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany); Roesel M (Department of Ophthalmology, St. Franziskus Hospital, Muenster, Germany); Ruokonen P (Department of Ophthalmology, Campus Virchow-Klinikum, Charite University Medicine, Berlin, Germany); Schlomberg J (Department of Ophthalmology, Campus Virchow-Klinikum, Charite University Medicine, Berlin, Germany); Strassburger P (Eye Clinic, Klinikum Chemnitz gGmbH, Chemnitz, Germany); Thees S (Department of Ophthalmology, Campus Virchow-Klinikum, Charite University Medicine, Berlin, Germany); Tierlich M (STZ eyetrial at the Centre for Ophthalmology, University of Tuebingen, Tuebingen, Germany); Uhlig A (Eye Clinic, Klinikum Chemnitz gGmbH, Chemnitz, Germany); Varani G (Eye Clinic, Klinikum Chemnitz gGmbH, Chemnitz, Germany); Wibben A (Department of Ophthalmology, St. Franziskus Hospital, Muenster, Germany); Winterhalter S (Department of Ophthalmology, Campus Virchow-Klinikum, Charite University Medicine, Berlin, Germany); Xuam-Mai T (Department of Ophthalmology, Technical University of Munich, Munich, Germany); Zeisberg A (Department of Ophthalmology, Campus Benjamin Franklin, Charite University Medicine, Berlin, Germany).
Presented at Dr Mackensen died in April 2016.
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