Christof Specker1, Annette Alberding2, Martin Aringer3, Gerd-Rüdiger Burmester4, Jan-Paul Flacke5, Michael W Hofmann6, Peter Kästner7, Herbert Kellner8, Frank Moosig9, Maren Sieburg10, Hans-Peter Tony11, Gerhard Fliedner12. 1. Clinic of Rheumatology and Clinical Immunology, Evangelical Hospital, Clinic Essen-Mitte, Essen, Germany. specker@uni-duesseldorf.de. 2. Internal Rheumatology, St. Josef Hospital, Wuppertal, Germany. 3. Department of Medicine III, University Medical Center Carl Gustav Carus, TU Dresden, Germany. 4. Department of Rheumatology and Clinical Immunology Charité - Universitätsmedizin Berlin, Free University and Humboldt University Berlin, Germany. 5. Rheumatology, Roche Pharma AG, Grenzach-Wyhlen, Germany. 6. Rheumatology, Chugai Pharma Germany GmbH, Frankfurt am Main, Germany. 7. MVZ Ambulant Rheumatology Center Erfurt, Germany. 8. Rheumatology and Gastroenterology Specialty Practice, Munich, Germany. 9. Rheumatology Center Schleswig-Holstein Middle, Neumünster, Germany. 10. Allied Rheumatology Practice, Magdeburg, Germany. 11. Medical Clinic II, Department of Rheumatology and Clinical Immunology, University Clinic Würzburg, Germany. 12. Rheumatology Practice, Osnabrück, Germany.
Abstract
OBJECTIVES: We aimed to measure long-term effectiveness and safety of tocilizumab in patients with rheumatoid arthritis in daily German practice. METHODS: ICHIBAN was a prospective, multi-centre, non-interventional study (ML22928) that enrolled adult patients with active moderate to severe rheumatoid arthritis. Patients were to be treated according to tocilizumab label and observed for up to two years. Effectiveness outcomes included DAS28-ESR remission, EULAR response, CDAI and HAQ. RESULTS: Overall, 3164 patients received at least one dose of tocilizumab. Patient mean age was 55.5±13.1 years (74.8% female). At baseline, 72.1% of patients had at least one comorbidity. Approximately 50.9% of patients received concomitant csDMARDs, mostly methotrexate, and 80.7% received concomitant glucocorticoids (GCs). In patients receiving GCs at baseline, the mean dose decreased from 9.32±16.36 mg/d to 4.60±4.48 mg/d at week 104. In the effectiveness population with no prior TCZ (n=2902), 61.4% of patients achieved the primary outcome, DAS28-ESR remission. Improvements were seen as early as week 4. At week 104, 77.9% of patients had DAS28-ESR low disease activity, 89.6% achieved good or moderate EULAR response, and 29.5% achieved a CDAI-based remission. Effectiveness outcomes were similar in all previous therapy subgroups. The incidence of serious infections was similar to the rates in former studies involving tocilizumab. Patients receiving GC at baseline experienced slightly higher rates of treatment-related serious adverse events, mainly infections. No new safety signals were observed. CONCLUSIONS: Long-term effectiveness and safety in ICHIBAN were in line with previously reported tocilizumab efficacy and safety studies.
OBJECTIVES: We aimed to measure long-term effectiveness and safety of tocilizumab in patients with rheumatoid arthritis in daily German practice. METHODS: ICHIBAN was a prospective, multi-centre, non-interventional study (ML22928) that enrolled adult patients with active moderate to severe rheumatoid arthritis. Patients were to be treated according to tocilizumab label and observed for up to two years. Effectiveness outcomes included DAS28-ESR remission, EULAR response, CDAI and HAQ. RESULTS: Overall, 3164 patients received at least one dose of tocilizumab. Patient mean age was 55.5±13.1 years (74.8% female). At baseline, 72.1% of patients had at least one comorbidity. Approximately 50.9% of patients received concomitant csDMARDs, mostly methotrexate, and 80.7% received concomitant glucocorticoids (GCs). In patients receiving GCs at baseline, the mean dose decreased from 9.32±16.36 mg/d to 4.60±4.48 mg/d at week 104. In the effectiveness population with no prior TCZ (n=2902), 61.4% of patients achieved the primary outcome, DAS28-ESR remission. Improvements were seen as early as week 4. At week 104, 77.9% of patients had DAS28-ESR low disease activity, 89.6% achieved good or moderate EULAR response, and 29.5% achieved a CDAI-based remission. Effectiveness outcomes were similar in all previous therapy subgroups. The incidence of serious infections was similar to the rates in former studies involving tocilizumab. Patients receiving GC at baseline experienced slightly higher rates of treatment-related serious adverse events, mainly infections. No new safety signals were observed. CONCLUSIONS: Long-term effectiveness and safety in ICHIBAN were in line with previously reported tocilizumab efficacy and safety studies.