C Fiehn1, L Unger2, H Schulze-Koops3, F Proft3,4, J C Henes5, A Jacobi6, T Dörner4. 1. Praxis für Rheumatologie, Tätigkeitsschwerpunkt Klinische Immunologie, Beethovenstr. 2, 76530, Baden-Baden, Deutschland. c.fiehn@rheuma-badenbaden.de. 2. Städtisches Klinikum Dresden-Friedrichstadt, Dresden, Deutschland. 3. Sektion Rheumatologie und Klinische Immunologie, Medizinische Klinik IV, Klinikum der Universität München, München, Deutschland. 4. Charité Universitätsmedizin Berlin, Berlin, Deutschland. 5. Zentrum für Interdisziplinäre Klinische Immunologie, Rheumatologie und Autoimmunerkrankungen (INDIRA) und Innere Medizin II, Universitätsklinik Tübingen, Tübingen, Deutschland. 6. Sektion Rheumatologie und Klinische Immunologie, Medizinische Klinik D, Universität Münster, Münster, Deutschland.
Abstract
INTRODUCTION: In the treatment of poly- and dermatomyositis, only a limited number of treatment modalities are established. OBJECTIVE: The goal of the GRAID-2 registry was to study off-label use of biologic drugs for this indication in Germany. PATIENTS AND METHODS: Analysis of the data of the GRAID-2 registry for poly- and dermatomyositis. RESULTS: In 22 of the 23 patients in the GRAID-2 registry, rituximab (RIX) was administered, while 1 patient was given tocilizumab as off-label therapy. The 22 patients who received RIX treatment were analyzed. At the start of treatment, the following active manifestations were present: myositis (n = 18), lung involvement (mainly interstitial lung disease; n = 10), arthritis (n = 10), skin manifestation (n = 9), and Raynaud syndrome (n = 5). Nine of the patients were Jo-1-antibody positive. All patients had previous treatments with multiple conventional immunosuppressive drugs. Treatment with RIX was given as infusions of 1 g i. v., which were repeated after 2 weeks. Patients received a mean of 3.09 ± 2.27 infusions (equivalent to 1.5 cycles of 2 × 1 g, max. 5 cycles). Tolerability of RIX treatment was rated as very good in 16 of 22 patients (72%), good in 5 (23%), and moderate in 1 (5%). In all, 27 adverse events were documented, with the majority being infections, whereby 2 severe infections occurred (6.59 per 100 patient-years). Eighty six percent of the patients showed complete remission of their myositis and 79% of their arthritis. The mean value of creatinine kinase in plasma fell from 1505 ± 2534 U/l before the start of treatment to 39 ± 134 U/l at the last visit. Regarding lung involvement, 1 of 10 of the patients showed complete and 6 of 10 partial remissions. In 2 of 10 patients, lung disease was stable during treatment. CONCLUSION: RIX is the preferred off-label biologic drug for poly- and dermatomyositis in Germany. In spite of a strongly pretreated group of patients, the tolerability is acceptable, although the patient number in this investigation is small. Moreover, the results lead to the assumption that the majority of the patients had a good or even very good therapeutic response to RIX.
INTRODUCTION: In the treatment of poly- and dermatomyositis, only a limited number of treatment modalities are established. OBJECTIVE: The goal of the GRAID-2 registry was to study off-label use of biologic drugs for this indication in Germany. PATIENTS AND METHODS: Analysis of the data of the GRAID-2 registry for poly- and dermatomyositis. RESULTS: In 22 of the 23 patients in the GRAID-2 registry, rituximab (RIX) was administered, while 1 patient was given tocilizumab as off-label therapy. The 22 patients who received RIX treatment were analyzed. At the start of treatment, the following active manifestations were present: myositis (n = 18), lung involvement (mainly interstitial lung disease; n = 10), arthritis (n = 10), skin manifestation (n = 9), and Raynaud syndrome (n = 5). Nine of the patients were Jo-1-antibody positive. All patients had previous treatments with multiple conventional immunosuppressive drugs. Treatment with RIX was given as infusions of 1 g i. v., which were repeated after 2 weeks. Patients received a mean of 3.09 ± 2.27 infusions (equivalent to 1.5 cycles of 2 × 1 g, max. 5 cycles). Tolerability of RIX treatment was rated as very good in 16 of 22 patients (72%), good in 5 (23%), and moderate in 1 (5%). In all, 27 adverse events were documented, with the majority being infections, whereby 2 severe infections occurred (6.59 per 100 patient-years). Eighty six percent of the patients showed complete remission of their myositis and 79% of their arthritis. The mean value of creatinine kinase in plasma fell from 1505 ± 2534 U/l before the start of treatment to 39 ± 134 U/l at the last visit. Regarding lung involvement, 1 of 10 of the patients showed complete and 6 of 10 partial remissions. In 2 of 10 patients, lung disease was stable during treatment. CONCLUSION:RIX is the preferred off-label biologic drug for poly- and dermatomyositis in Germany. In spite of a strongly pretreated group of patients, the tolerability is acceptable, although the patient number in this investigation is small. Moreover, the results lead to the assumption that the majority of the patients had a good or even very good therapeutic response to RIX.
Authors: Rohit Aggarwal; Andriy Bandos; Ann M Reed; Dana P Ascherman; Richard J Barohn; Brian M Feldman; Frederick W Miller; Lisa G Rider; Michael O Harris-Love; Marc C Levesque; Chester V Oddis Journal: Arthritis Rheumatol Date: 2014-03 Impact factor: 10.995
Authors: Chester V Oddis; Ann M Reed; Rohit Aggarwal; Lisa G Rider; Dana P Ascherman; Marc C Levesque; Richard J Barohn; Brian M Feldman; Michael O Harris-Love; Diane C Koontz; Noreen Fertig; Stephanie S Kelley; Sherrie L Pryber; Frederick W Miller; Howard E Rockette Journal: Arthritis Rheum Date: 2013-02
Authors: Hans-Peter Tony; Gerd Burmester; Hendrik Schulze-Koops; Mathias Grunke; Joerg Henes; Ina Kötter; Judith Haas; Leonore Unger; Svjetlana Lovric; Marion Haubitz; Rebecca Fischer-Betz; Gamal Chehab; Andrea Rubbert-Roth; Christof Specker; Jutta Weinerth; Julia Holle; Ulf Müller-Ladner; Ramona König; Christoph Fiehn; Philip Burgwinkel; Klemens Budde; Helmut Sörensen; Michael Meurer; Martin Aringer; Bernd Kieseier; Cornelia Erfurt-Berge; Michael Sticherling; Roland Veelken; Ulf Ziemann; Frank Strutz; Praxis von Wussow; Florian M P Meier; Nico Hunzelmann; Enno Schmidt; Raoul Bergner; Andreas Schwarting; Rüdiger Eming; Michael Hertl; Rudolf Stadler; Michael Schwarz-Eywill; Siegfried Wassenberg; Martin Fleck; Claudia Metzler; Uwe Zettl; Jens Westphal; Stefan Heitmann; Anna L Herzog; Heinz Wiendl; Waltraud Jakob; Elvira Schmidt; Klaus Freivogel; Thomas Dörner Journal: Arthritis Res Ther Date: 2011-05-13 Impact factor: 5.156