1435: Effectiveness of Combination Therapy with Tocilizumab and Low-Dose Prednisolone as an Induction Therapy in Biologics-Naïve Patients with Rheumatoid Arthritis: A Prospective, Randomized, Controlled, Open-Label, Multicenter Study

Kazuhiro Yokota¹, Hayato Nagasawa², Yuji Akiyama³ and Toshihide Mimura⁴, ¹Department of Rheumatology and Applied Immunology, Faculty of Medicine, Saitama Medical University, Iruma Saitama, ²Nagasawa Clinic, Kawagoe, Japan, ³Department of Rheumatology and Applied Immunology, Faculty of Medicine, Saitama Medical University, Iruma Saitama, Japan, ⁴Department of Rheumatology and Applied Immunology, Faculty of Medicine, Saitama Medical University, Saitama, Japan

Background/Purpose: Efficacy and safety of tocilizumab (TCZ) in the treatment of rheumatoid arthritis (RA) has demonstrated in randomized controlled trials. However, the clinical response to TCZ in patients with RA is generally slower than those to tumor necrosis factor inhibitors and Janus kinase inhibitors. Glucocorticoids are commonly used to bridge the therapeutic effect of disease-modifying anti-rheumatic drugs, rapidly control inflammation, and mildly prevent the progression of joint destruction. Hence, we hypothesized that an early intensive combination strategy using TCZ with low-dose prednisolone (PSL) as an induction therapy might introduce rapid-control of the disease activity and long-term remission with better functional and radiographic outcomes. Therefore, the objective of this study was conducted to analyze the effectiveness and safety of combining TCZ with low-dose PSL compared to TCZ as induction therapy in biologics-naïve patients with active RA.

Methods: In this 24-week, prospective, randomized, controlled, open-label, multicenter study, 26 patients with biologics-naïve active RA (mean age 62.5±11.4 years old; mean disease duration 6.9±9.8 years; mean Clinical Disease Activity Index [CDAI] score 22.1±13.4) were enrolled. The patients were administered either TCZ plus low-dose PSL or TCZ (n=13, each) for 24 weeks. In TCZ plus low-dose PSL group, the patients were administered PSL 5 mg/day p.o. from the beginning of TCZ for 4 weeks and PSL was reduced by 1 mg/day every 4 weeks to 0 mg. The primary endpoints were achievement of a CDAI score of ≤2.8, and a Health Assessment Questionnaire disability index (HAQ DI) score of< 0.5 at week 24. The secondary endpoints were achievement of a change from baseline in the modified Total Sharp score (mTSS) ≤0.5 and safety at week 24.

Results: At week 24, the patients achieved both primary and secondary endpoints were more in the TCZ plus PSL group than in the TCZ group (p< 0.05 for all). A CDAI score of ≤2.8 was achieved by 90.9% of patients in the TCZ plus PSL group compared to 38.5% in the TCZ group (p< 0.05). A HAQ DI score of < 0.5 was observed in 75.0% of patients in the TCZ plus PSL group compared with 46.1% in the TCZ group (p< 0.05). A change from baseline in mTSS≤0.5 was achieved by 84.6% of patients in the TCZ plus PSL group compared to 46.2% in the TCZ group (p< 0.05). There were no significant differences in the incidence of treatment-related adverse events between the two groups.

Conclusion: Combination therapy with TCZ and low-dose PSL would suppress more rapidly disease activity as well as progression of joint destruction in active RA compared to TCZ alone. No short-term safety concern in the combination therapy was observed in this study.

Disclosures: K. Yokota, None; H. Nagasawa, None; Y. Akiyama, None; T. Mimura, None.