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Randomized Controlled Trial
. 2021 Apr;26(4):370-377.
doi: 10.1111/resp.13978. Epub 2020 Nov 11.

Prednisolone and tacrolimus versus prednisolone and cyclosporin A to treat polymyositis/dermatomyositis-associated ILD: A randomized, open-label trial

Tomoyuki Fujisawa  1 , Hironao Hozumi  1 , Yosuke Kamiya  1 , Yusuke Kaida  2 , Taisuke Akamatsu  3 , Hideki Kusagaya  4 , Yasuomi Satake  5 , Kazutaka Mori  6 , Masashi Mikamo  7 , Hiroyuki Matsuda  8 , Koshi Yokomura  9 , Naoki Koshimizu  10 , Mikio Toyoshima  11 , Shiro Imokawa  12 , Hideki Yasui  1 , Yuzo Suzuki  1 , Masato Karayama  1 , Kazuki Furuhashi  1 , Noriyuki Enomoto  1 , Yutaro Nakamura  1 , Naoki Inui  1   13 , Takafumi Suda  1
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Free article
Randomized Controlled Trial

Prednisolone and tacrolimus versus prednisolone and cyclosporin A to treat polymyositis/dermatomyositis-associated ILD: A randomized, open-label trial

Tomoyuki Fujisawa et al. Respirology. 2021 Apr.
Free article

Abstract

Background and objective: The efficacy of combination therapy with corticosteroids and CNI, TAC and CsA, for PM/DM-ILD has been described retrospectively. However, it remains unknown which CNI treatment regimens, TAC or CsA regimens, are more effective as initial treatments for patients with PM/DM-ILD.

Methods: We conducted a prospective multicentre, open-label, randomized, 52-week phase 2 trial. Patients with PM/DM-ILD were randomly allocated to receive PSL plus TAC (TAC group) or PSL plus CsA (CsA group). The primary endpoint was PFS rate in the intention-to-treat population at 52 weeks. The secondary endpoints were OS rate at 52 weeks, changes in pulmonary function tests from baseline to 52 weeks and AE.

Results: Fifty-eight patients were randomly assigned to the TAC group (n = 30) and the CsA group (n = 28). The PFS rates at 52 weeks were 87% in the TAC group and 71% in the CsA group (P = 0.16). The OS rates at 52 weeks were 97% in the TAC group and 93% in the CsA group (P = 0.50). The %FVC at 52 weeks in the per-protocol populations significantly increased in both groups. None of the patients discontinued the treatment due to AE.

Conclusion: PSL plus TAC treatment may achieve a better short-term PFS rate compared with PSL plus CsA treatment. Further studies must be conducted to evaluate the long-term efficacy and safety of such treatment.

Keywords: clinical trial; combination therapy; cyclosporin A; dermatomyositis; interstitial lung disease; polymyositis; tacrolimus.

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