Background According to WHO definition approximately 15% of all patients with rheumatoid arthritis (RA) suffer from anemia (hemoglobin <13 g/dl for men and <12 g/dl for women). Interleukin 6 (IL-6) takes an active part in the pathogenesis of this inflammatory anemia.
Objectives The 6th interim analysis of the non-interventional ICHIBAN study (NCT01194401) evaluated the occurrence of inflammatory anemia, characterized the patient population with anemia, and observed the response during intravenous Tocilizumab therapy (TCZ i.v.). Patients were subgrouped according to their anemic/non-anemic status at baseline.
Methods Since 2010 the ICHIBAN study collects clinical data of the routine use of TCZ i.v. in RA patients. The observation period for each patient is up to two years. At the due date of the current interim analysis (Dec 10, 2015) 2999 patients were enrolled. 902 patients have completed the maximal 104 weeks observation period (Group W104).
Results At baseline, the proportion of patients with anemia (acc. to WHO definition) was 21.4% (men) and 22.0% (women) in the group W104.
On comparison, RA patients with anemia showed, amongst others, increased inflammation parameters, a higher disease activity and higher rates of comorbidities. Already after 4 weeks with TCZ i.v. the proportion of patients with anemia improved to 12.1% (men) and 12.7% (women). After 104 weeks therapy the proportion of patients with anemia reduced further to 7.4% (men) and 8.4% (women). The relevant response parameters and laboratory values are shown in Table 1.
Despite the higher disease activity at baseline for anemic patients, the benefit was comparable for patients with and without anemia. DAS28-ESR values decreased on average by 2.9 (women) and 3.1 (men) in RA patients with anemia and by 2.7 (women) and 2.8 (men) in RA patients without, resulting in similar disease scores at the end of the observational period.
The effectiveness of TCZ i.v. was also confirmed by patient reported outcomes (PROs) via visual analogue scales (VAS). In particular, a reduction of the intensity of pain (>50%) and a reduction of fatigue (>38%) was observed (Table 1).
Conclusions At start of therapy, approximately one out of five patients documented in ICHIBAN showed anemia according to the WHO definition. During TCZ i.v. therapy a noticeable decrease in the rate of anemia and improved hemoglobin values were observed. These effects can already be seen after four weeks of treatment and continue up to the end of this study (i.e. 2 years). Despite the higher burden of disease at baseline in RA patients with anemia, TCZ i.v. therapy resulted in good clinical response rates and PROs.
Acknowledgements We would like to thank all patients, their families, the investigators and the nurses who participated in this trial. This research was funded by Roche Pharma AG, Germany, and Chugai Pharma Europe Ltd., Germany. Support for third-party writing assistance for this abstract presentation was provided by Roche and Chugai and performed by Ecron Acunova GmbH, Germany.
Disclosure of Interest C. Specker Grant/research support from: Chugai, DRFZ, Consultant for: Abbvie, Janssen, Chugai, MSD, Novartis, UCB, Lilly, Boehringer, Speakers bureau: Abbvie, Celgene, Chugai, Euroimmun, MSD, Pfizer, UCB, H. Kellner: None declared, P. Kästner: None declared, C. Volberg: None declared, V. Braunewell: None declared, I. Schwarze: None declared, M. Aringer: None declared, M. Sieburg: None declared, M. Hofmann Employee of: Chugai Pharma Europe Ltd., Zweigniederlassung Deutschland, J. Flacke Employee of: Roche Pharma AG, Germany, H.-P. Tony Consultant for: Roche Pharma, Abbvie, BMS, Chugai, Janssen, Novartis, Pfizer, Sanofi, Lilly, MSD, Astra-Zeneca, G. Fliedner: None declared