Simplified Disease Activity Index remission at month 6 is an independent predictor of functional and structural remissions at month 12 during abatacept treatment in patients with rheumatoid arthritis: A multi-center, prospective cohort study in Japan

Abstract

Objective: To evaluate association of clinical remission at month 6 with functional and structural remissions at month 12 during abatacept treatment in patients with rheumatoid arthritis (RA).

Methods: This 12-month prospective, multicenter cohort study enrolled 168 patients with RA who started abatacept. Outcomes were assessed using composite measures, quality of life indices, and the van der Heijde-modified total Sharp score (mTSS). The logistic regression analysis was applied to identify factors associated with outcomes and their odds ratios (OR) with 95% confidence interval (95% CI).

Results: At month 6 and 12, 21.4% and 26.2% of the patients achieved Simplified Disease Activity Index (SDAI) remission (SDAI <3.3), and 40.6% and 41.7% achieved Health Assessment Questionnaire-Disability Index (HAQ-DI <0.5) remission. Among 129 patients whose mTSS progression was evaluated at month 12, 83 (64.3%) achieved structural remission (ΔmTSS ≤0.5 for 12 months). SDAI remission at month 6 was identified as a significant predictor of both functional (OR, 3.732; 95% CI, 1.328–10.489) and structural remissions (OR, 4.301; 95% CI, 1.298–14.243) at month 12 after adjusting for covariates.

Conclusions: Aiming for SDAI remission at month 6 is an appropriate strategy to obtain good functional and structural outcomes at month 12.

Keywords:

• Abatacept
• Outcome assessment
• Remission
• Rheumatoid arthritis

Acknowledgments

The authors sincerely thank Ms. Marie Yajima (Tokyo Medical and Dental University) for helping us in maintaining the database of this study. The authors also thank the patients and their health care providers who participated in this study.

Conflict of interest

Tokyo Medical and Dental University (TMDU) has received unrestricted research grants for Department of Lifetime Clinical Immunology from Chugai Pharmaceutical Co., Ltd., Ono Pharmaceuticals, Mitsubishi Tanabe Pharma Co., UCB Japan, CSL Behring, Towa Pharmaceutical Co., Ltd., Abbvie Japan Co., Ltd., Japan Blood Products Organization, Ayumi Pharmaceutical Co., and Nippon Kayaku Co., Ltd. with which TMDU currently pays the salary of FH. FH also has received a speaking fees from Astellas Pharma Inc. TT has received grants, consulting fees and/or speaking fees from Abbvie Japan Co., Ltd., Asahi Kasei Medical K.K., Astra Zeneca K.K., Astellas Pharma Inc., AYUMI Pharmaceutical Corporation, Bristol Myers Squibb K.K., Celtrion, Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Merck Serono Co., Ltd., Mitsubishi Tanabe Pharma Co., Nipponkayaku Co. Ltd., Novartis Pharma K.K., Janssen Pharmaceutical K.K., Pfizer Japan Inc., Taisho Toyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd. AK has received grants and/or speaking fees from Abbvie Japan Co., Ltd., Astellas Pharma Inc., Bristol Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc. TS has received grants and/or speaking fees from Abbvie Japan Co., Ltd., Asahi Kasei Medical K.K., Astellas Pharma Inc., AYUMI Pharmaceutical Corporation, Bristol Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Janssen Pharmaceutical K.K., Pfizer Japan Inc., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd. RS has received a grant from Bristol Myers Squibb K.K. TN has received grants, consulting fees and/or speaking fees from Bristol Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., and Eli Lilly Japan K.K. MH received unrestricted research grants for Department of Pharmacovigilance at TMDU from Abbvie Japan Co., Ltd., Astellas Pharma Inc., Bristol Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Ono Pharmaceuticals, Pfizer Japan Inc., Sanofi-Aventis KK., Santen Pharmaceutical Co., Ltd., Sekisui Medical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., and UCB Japan with which TMDU paid salary for HY, RS, TN, and MH. HK received grants from AbbVie Japan Co., Ltd., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Japan Blood Products Organization, Mitsubishi Tanabe Pharma Co., Ono Pharmaceuticals, Pfizer Japan Inc., Takeda Pharmaceutical Co., Ltd., and Teijin Pharma Ltd. KA, JK, MK, WY, KN, HH, YN, MT, RK, and NM have nothing to declare.

Funding

This work was supported by Ministry of Health Labour and Welfare KAKENHI Grant Number H22-Menneki-Ippan-001 and unrestricted research grants for Department of Pharmacovigilance, Tokyo Medical and Dental University.