Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Although it is possible to achieve remission or low disease activity (LDA) with the combination of methotrexate (MTX) and biologics for many patients with early rheumatoid arthritis (RA), it is uncertain whether disease is controlled following withdrawal of biologics. The purpose of this observational study was to assess the effect of withdrawal of adalimumab (ADA) on disease activity following treatment with MTX plus ADA, and to identify predictors of biologic-free disease control in patients with early RA.
Methods: Patients with early RA received blinded ADA 40 mg every other week (EOW) plus MTX 6-8 mg every week (EW) or MTX 6-8 mg EW alone for 26 weeks. Thereafter, all patients received open-label ADA 40 mg EOW plus MTX 6-8 mg EW for 26 weeks in the HOPEFUL 1 study. At week 52, patients could be enrolled in the 52-week observational, follow-up, HOPEFUL 2 study, during which time they received ADA plus MTX treatment (ADA-continued group), or MTX alone (ADA-withdrawal group) at the investigator’s discretion. The primary outcomes of this study were disease activity score based on 28 joints count based on erythrocyte sedimentation rate (DAS28-ESR), Health Assessment Questionnaire-Disability Index (HAQ-DI), and modified total Sharp score (mTSS) at week 104. The factors correlated with the outcomes were also analyzed.
Results: Among 278 patients completing the 52-week HOPEFUL 1 study, 220 were enrolled in the HOPEFUL 2 study. At week 52, baseline characteristics including DAS28-ESR, HAQ-DI and mTSS were comparable between the ADA-continued (N=106) and ADA-withdrawal (N=114) groups. 70% and 50% from each group achieved low disease activity (LDA, DAS28-ESR<3.2) and clinical remission (DAS28-ESR<2.6), respectively. Table shows disease activity scores at week 104. Mean DAS28-ESR score at week 104 was significantly higher and the percentage of the patients who achieved LDA or clinical remission was significantly lower in the ADA-withdrawal group. There was no significant difference in HAQ-DI score and ΔmTSS in the two groups at week 104. In the ADA-withdrawal group, lower baseline CRP scores and lower DAS28-ESR scores at week 52 predicted LDA at week 104 in multivariate analysis. The cut-off point to sustain LDA through week 104 without using ADA was DAS28-ESR< 2.6 at week 52.
Conclusion: More patients who continued ADA therapy sustained LDA and clinical remission after 1 year. Nevertheless, half of ADA-withdrawal RA patients sustained LDA for 1 year. Achieving DAS28-ESR-remission after 52 weeks of treatment using ADA was the key determinant for biologic-free disease control in early RA patients.
Table. Disease activity scores at week 104 in ADA-continued group and ADA-withdrawal group
|
ADA-continued group |
ADA-withdrawal group |
P value |
|
|
DAS28-ESR, Mean±SD |
2.70±1.08 |
3.20±1.24 |
0.006 |
|
% of DAS28-ESR<3.2 |
72.5 |
55.8 |
0.021 |
|
% of DAS28-ESR<2.6 |
53.8 |
36.8 |
0.026 |
|
HAQ-DI, Mean±SD |
0.20±0.29 |
0.26±0.39 |
0.609 |
|
ΔmTSS from week 52, Mean±SD |
0.8±3.9 |
0.6±1.8 |
0.335 |
Disclosure:
Y. Tanaka,
BMS, MSD, Chugai, Mitsubishi-Tanabe, Astellas, Abbvie, Daiichi-Sankyo,
2,
Mitsubishi-Tanabe, Abbott, Abbvie, Eisai, Chugai, Janssen, Pfizer, Takeda, Astellas, Daiichi-Sankyo, GSK, AstraZeneca, Eli Lilly, Quintiles, MSD, Asahi Kasei,
8,
Mitsubishi-Tanabe, Abbott, Abbvie, Eisai, Chugai, Janssen, Pfizer, Takeda, Astellas, Daiichi-Sankyo, GSK, AstraZeneca, Eli Lilly, Quintiles, MSD, Asahi Kasei,
5;
H. Yamanaka,
AbbVie GK,
2,
Bristol-Myers Squibb,
2,
Chugai Pharmaceutical Co,
2,
Eisai Co,
2,
Janssen Pharmaceutical K.K.,
2,
Mitsubishi Tanabe Pharma Corporation,
2,
Otsuka Pharmaceutical Co,
2,
Pfizer Japan Inc,
2,
Takeda Industrial Pharmaceutical Co,
2,
UCB Japan Co,
2,
Abbvie GK,
8,
Bristol-Myers Squibb,
8,
Chugai Pharmaceutical Co,
8,
Eisai Co,
8,
Janssen Pharmaceutical K.K,
8,
Mitsubishi Tanabe Pharma Corporation,
8,
Otsuka Pharmaceutical Co,
8,
Pfizer Japan Inc,
8,
Takeda Pharmaceutical Co,
8,
UCB Japan Co,
8,
AbbVie GK,
5,
Bristol-Myers Squibb,
5,
Chugai Pharmaceutical Co,
5,
Eisai Co,
5,
Janssen Pharmaceutical K.K.,
5,
Mitsubishi Tanabe Pharma Corporation,
5,
Otsuka Pharmaceutical Co,
5,
Pfizer Japan Inc,
5,
Takeda Pharmaceutical Co,
5,
UCB Japan Co,
5;
N. Ishiguro,
Abbott Japan,
2,
Astellas Pharmaceutical,
2,
Bristol-Myers Squibb,
2,
Chugai Pharmaceutical Co,
2,
Eisai Co,
2,
Janssen Pharma,
2,
Mitsubishi Tanabe Pharmaceutical Co,
2,
Pfizer Japan,
2,
Takeda Pharma,
2;
N. Miyasaka,
AbbVie GK,
2,
Astellas Pharmaceutical,
2,
Banyu Pharmaceutical,
2,
Chugai Pharmaceutical Co,
2,
Daiichi Sankyo Pharmaceutical Co,
2,
Eisai Co,
2,
Janssen Pharmaceuticals,
2,
Mitsubishi Tanabe Pharma Corporation,
2,
Takeda Pharmaceutical Co,
2,
Teijin Limited,
2;
K. Kawana,
AbbVie GK,
3;
T. Kubo,
AbbVie GK,
3;
A. Kuroki,
AbbVie GK,
3;
T. Takeuchi,
Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., and Asahi Kasei Medical K.K,
5,
AbbVie GK., Bristol–Myers K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., and Takeda Pharmaceutical Co., Ltd.,
8,
AbbVie GK., Astellas Pharma, Bristol–Myers K.K., Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Nippon Shinyaku Co., Ltd., Pfizer Japan Inc., Sanofi–Aventis K.K.,
2,
Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., and Teijin Pharma Ltd.,
2.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/clinical-remission-after-52-weeks-of-treatment-is-a-predictor-of-adalimumab-free-disease-control-in-patients-with-early-rheumatoid-arthritis-hopeful-2-study/