POS0615 TOCILIZUMAB IS SAFE AND EFFECTIVE IN ELDERLY PATIENTS WITH RHEUMATOID ARTHRITIS
Authors: C. Specker, M. Aringer, G. R. Burmester, M. Peters, M. W. Hofmann, H. Kellner, F. Moosig, H. P. Tony, G. Fliedner
Journal: Annals of the Rheumatic Diseases (2021)

Background: Average life spans of patients with rheumatoid arthritis (RA) are approaching those of the general population. This results in a large proportion of RA patients being elderly at some point and underlines effective RA treatments needed for this population. Pivotal clinical trials have demonstrated the efficacy of tocilizumab (TCZ) for the treatment of RA. However, real-world studies that explore the effectiveness of TCZ especially in the elderly are lacking. ICHIBAN was a large, observational study that followed patients with RA treated with TCZ under real-world conditions in Germany for up to 2 years. Objectives: In this analysis of ICHIBAN, we examined the safety and effectiveness of long-term TCZ treatment according to patient baseline (BL) age (&lt;50, 50–65, &gt;65 years). Methods: ICHIBAN ( NCT01194401 ) was a prospective, non-interventional study that observed adult patients with active moderate to severe RA in German rheumatology clinics and practices. Patients were treated with TCZ according to the local label. The safety analyses set (SAF) included all patients who received at least one dose of TCZ. The effectiveness set (EFF) included all patients from the SAF who had no prior TCZ therapy. Patient-reported outcomes (PROs) were assessed using the visual analogue scale. Last observation carried forward was used to substitute for missing values. Results: At baseline (BL), 3,164 patients were included in the SAF: 29.2% &lt;50 years, 47.3% 50–65 years, and 23.5% &gt;65 years old (1.2% ≥80 years). Patients &gt;65 years old were not only the most likely to have comorbidities such as hypertension, anaemia, renal insufficiency, osteoporosis, diabetes, and coronary heart disease, but also had the highest BL disease activity according to Disease Activity Score-28 erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAI) (Table 1). Proportions of patients with adverse events (AEs) considered related to treatment were similar in patients &lt;50 (22.3%), 50–65 (21.9%) and &gt;65 years (22.2%). More patients &gt;65 years (20.2%) and 50–65 years (14.4%) experienced serious AEs (SAEs) than patients &lt;50 years (11.5%). Slightly more patients &gt;65 years old experienced infectious SAEs (4.8%) than younger patients (&lt;50 years, 3.2% and 50–65 years, 3.1%). Yet, similar proportions of patients across all age groups discontinued TCZ due to AE (7.0% &lt;50 years; 9.6% 50–65 years; 7.8% &gt;65 years). 2,902 patients were included in the EFF. Patients &lt;50 years experienced DAS28-ESR remission at least once during the treatment period (65.4%) more often than patients aged 50–65 years (59.8%) or &gt;65 years (59.5%). However, patients &gt;65 years had numerically greater improvements in DAS28-ESR (Table 1). Patients &lt;50 years had the best physical functioning at BL and the greatest reduction in Health Assessment Questionnaire Disease Index (HAQ-DI) score (Figure 1A). All age groups had similar improvements in PROs such as fatigue, strength of pain, and sleep disturbances (Figure 1B). Table 1. Model summary for prediction of DAS28CRP using time and etanercept originator (relative to biosimilar) &lt;50 years 50–65 years &gt;65 years DAS28-ESR, mean ± SD n* 777 1237 617 BL 4.9 ± 1.4 5.3 ± 1.3 5.4 ± 1.3 Last visit 2.8 ± 1.7 3.1 ± 1.7 3.2 ± 1.7 Change from BL -2.0 ± 1.7 -2.2 ± 1.7 -2.2 ± 1.8 CDAI, mean ± SD n* 768 1217 590 BL 25.7 ± 12.8 28.4 ± 13.3 28.8 ± 12.8 Last visit 13.3 ± 12.8 14.6 ± 13.2 14.5 ± 12.8 Change from BL -12.5 ± 13.6 -13.8 ± 14.0 -14.3 ± 13.8 *271 patients with missing data at BL **327 patients with missing data at BL Conclusion: Although elderly patients experienced a higher rate of infections, the proportion of patients withdrawing due to AE was not higher than in the other age groups. Starting with higher baseline disease activity, patients &gt;65 years had similar benefits to disease activity and PROs when compared with younger patients. Overall, these results indicate that long-term TCZ treatment of elderly patients is effective and has an acceptable safety profile. Disclosure of Interests: Christof Specker Speakers bureau: AbbVie, Celgene, Chugai, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, Boehringer Ingelheim, Chugai, Lilly, Novartis, Sobi, and UCB, Grant/research support from: Boehringer, Chugai, GSK, and Roche, Martin Aringer Speakers bureau: Roche and Chugai, Consultant of: Roche and Chugai, Grant/research support from: Roche, Gerd Rüdiger Burmester Consultant of: Lilly, Pfizer, Sanofi, and Roche, Grant/research support from: Roche, Marvin Peters Employee of: Roche Pharma AG, Michael W. Hofmann Employee of: Chugai Pharma Germany GmbH, Herbert Kellner Consultant of: Roche, Grant/research support from: Roche, Frank Moosig Grant/research support from: Roche, Hans-Peter Tony Speakers bureau: Roche, Abbvie, BMS, Chugai, Janssen, Novartis, Sanofi, and Lilly, Consultant of: Roche, Abbvie, BMS, Chugai, Janssen, Novartis, Sanofi, and Lilly, Grant/research support from: Roche, Gerhard Fliedner Grant/research support from: Roche, Chugai, Abbvie, and Lilly