Sustainable Efficacy of Switching From Intravenous to Subcutaneous Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis

被引:27
|
作者
Ogata, Atsushi [1 ]
Atsumi, Tatsuya [2 ]
Fukuda, Takaaki [3 ]
Hirabayashi, Yasuhiko [4 ]
Inaba, Masaaki [5 ]
Ishiguro, Naoki [6 ]
Kai, Motokazu [7 ]
Kawabata, Daisuke [8 ]
Kida, Daihei [9 ]
Kohsaka, Hitoshi [10 ]
Matsumura, Ryutaro [11 ]
Minota, Seiji [12 ]
Mukai, Masaya [13 ]
Sumida, Takayuki [14 ]
Takasugi, Kiyoshi [15 ]
Tamaki, Shigenori [16 ]
Takeuchi, Tsutomu [17 ]
Ueda, Atsuhisa
Yamamoto, Kazuhiko [18 ]
Yamanaka, Hisashi [19 ]
Yoshifuji, Hajime [8 ]
Nomura, Akira [20 ]
机构
[1] Osaka Univ, Osaka, Japan
[2] Hokkaido Univ, Sapporo, Hokkaido 060, Japan
[3] Kurume Univ, Sch Med, Fukuoka, Japan
[4] Hikarigaoka Spellman Hosp, Sendai, Miyagi, Japan
[5] Osaka City Univ, Osaka 558, Japan
[6] Nagoya Univ, Nagoya, Aichi 4648601, Japan
[7] Natl Hosp Org, Mie Chuo Med Ctr, Tsu, Mie, Japan
[8] Kyoto Univ, Kyoto, Japan
[9] Nagoya Med Ctr, Nagoya, Aichi, Japan
[10] Tokyo Med & Dent Univ, Tokyo, Japan
[11] Chiba East Natl Hosp, Natl Hosp Org, Chiba, Japan
[12] Jichi Med Univ, Shimotsuke, Tochigi, Japan
[13] Sapporo City Gen Hosp, Sapporo, Hokkaido, Japan
[14] Univ Tsukuba, Tsukuba, Ibaraki 305, Japan
[15] Dogo Spa Hosp, Matsuyama, Ehime, Japan
[16] Nagoya Rheumatol Clin, Nagoya, Aichi, Japan
[17] Keio Univ, Tokyo, Japan
[18] Univ Tokyo, Tokyo, Japan
[19] Tokyo Womens Med Univ, Tokyo, Japan
[20] Chugai Pharmaceut, Tokyo, Japan
关键词
MODIFYING ANTIRHEUMATIC DRUGS; INTERLEUKIN-6 RECEPTOR INHIBITION; ANTI-ADALIMUMAB ANTIBODIES; DISEASE-ACTIVITY; IL-6; RECEPTOR; INADEQUATE RESPONSE; CONTROLLED-TRIAL; CLINICAL-TRIALS; DOUBLE-BLIND; SAFETY;
D O I
10.1002/acr.22598
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective. To evaluate the efficacy and safety of switching from intravenous (IV) tocilizumab (TCZ) to subcutaneous (SC) TCZ monotherapy in rheumatoid arthritis patients. Methods. Patients who had completed 24 weeks of TCZ-SC (162 mg/2 weeks) or TCZ-IV (8 mg/kg/4 weeks) monotherapy in the double-blind period of the MUSASHI study were enrolled in an 84-week open-label extension period. All received TCZ-SC (162 mg/2 weeks) monotherapy. Effects of the IV to SC switch were evaluated at week 36 (12 weeks after switching). Results. Overall, 319 patients received >= 1 dose of TCZ-SC during the open-label extension period; 160 switched from TCZ-IV to TCZ-SC (TCZ IV/SC) and 159 continued TCZ-SC (TCZ SC/SC). Disease Activity Score in 28 joints using the erythrocyte sedimentation rate clinical remission rates were 62.5% (100 of 160) for TCZ IV/SC and 50.0% (79 of 158) for TCZ SC/SC at week 24, and were maintained at 62.5% (100 of 160) and 57.0% (90 of 158), respectively, at week 36. In the TCZ IV/SC group, 9% of patients (9 of 100) who had achieved remission at week 24 could not maintain remission at week 36. In TCZ IV/SC patients weighing >= 70 kg, the percentage with a sufficient serum TCZ concentration (>= 1 mu g/ml) decreased from 90.9% (10 of 11) at week 24 to 45.5% (5 of 11) at week 36. Overall safety profiles were similar in TCZ IV/SC and TCZ SC/SC except for mild injection site reactions in TCZ IV/SC. Conclusion. Efficacy is adequately maintained in most patients switching from TCZ-IV (8 mg/kg/4 weeks) to TCZ-SC (162 mg/2 weeks) monotherapy. Patients receiving TCZ-IV can switch to TCZ-SC without serious safety concerns. Clinical efficacy may be reduced after switching in some patients with high body weight.
引用
收藏
页码:1354 / 1362
页数:9
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