Date: Sunday, October 21, 2018
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
HOPEFUL-1 trial showed efficacy of combination therapy with adalimumab (ADA) plus methotrexate (MTX) in MTX naïve patients with active early rheumatoid arthritis (eRA). In that trial, early introduction of ADA significantly reduced the joint destruction. However, although the biological disease-modifying antirheumatic drugs (bDMARDs) are the most effective treatment of RA, the costs are much higher than those of conventional synthetic DMARDs (csDMARDs). In recent years, HOPEFUL-2 trial and HIT-HARD trial showed the possibility of successful bio-free in patients with eRA. / To analyze efficacy of early introduction of ADA and bio-free condition in RA patients in real world.
Among 172 patients (M35, F137) who received ADA, 44 patients (M12, F32) started ADA as an early introduction. In this study, the definition of early introduction was within 3 months from the start of MTX. Four patients switched to tocilizumab due to inefficacy and 3 patients achieved clinical remission (CR). Four patients discontinued ADA due to side effects. We analyzed 30 patients who were followed up more than 52 weeks with the mean age of 54.0 ± 14.9 years old, the mean disease duration of 11.8 ± 22.7 months.
The mean DAS28-CRP decreased from 4.67 ± 1.38 to 1.73 ± 0.48 (p＜0.001) after initiation of ADA. Twenty six patients achieved CR (86.6%), and 16 patients (53.3%) achieved bio-free condition. One patient relapsed and re-started ADA. After achieving CR again, the patient wanted bio-free condition with the adjustment of csDMARDs. Therefore, tacrolimus was raised from 1.5mg/day to 3mg/day and ADA was discontinued again. The mean duration of bio-free condition was 20.9±14.7 months. MTX (mg/week) was significantly increased from 7.3 ± 1.9 to 8.8 ± 3.2 (p<0.001). The number of csDMARD other than MTX were changed from 0.9 ± 0.6 to 1.3 ± 0.9 (p=0.008). One patient discontinued bucillamine due to proteinuria. Prednisolone dose (mg/day) was decreased from 6.1 ± 3.5 to 2.9 ± 1.8 (p<0.001). Six patients with CR did not wanted bio-free condition. Six patients with sustained CR wanted bio-free condition and discontinuation of ADA was already scheduled.
Early introduction of ADA was effective and subsequent bio-free condition might be a good choice in terms of medical cost.
1. Yamanaka H, et al. Recovery of clinical but not radiographic outcomes by the delayed addition of adalimumab to methotrexate-treated Japanese patients with early rheumatoid arthritis: 52-week results of the HOPEFUL-1 trial. Rheumatology 2014;53:904-913
2. Tanaka Y, et al. Adalimumab discontinuation in patients with early rheumatoid arthritis who were initially treated with methotrexate alone or in combination with adalimumab: 1 year outcomes of the HOPEFUL-2 study. RMD Open 2016;2:e000189.
3. Detert J, et al. Induction therapy with adalimumab plus methotrexate for 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate therapy alone for DMARD-naïve patients with early rheumatoid arthritis: HIT HARD, an investigator-initiated study. Ann Rheum Dis 2013;72:844-850
To cite this abstract in AMA style:Ito S, Kurossawa Y, Hasegawa E, Kobayashi D, Taniguhi S, Abe A, Otani H, Nakazono K, Murasawa A, Narita I, Ishikawa H. An Analysis of Early Introduction of Adalimumab and Subsequent Bio-Free Condition in the Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/an-analysis-of-early-introduction-of-adalimumab-and-subsequent-bio-free-condition-in-the-patients-with-rheumatoid-arthritis/. Accessed December 9, 2019.
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