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Tripterygium wilfordii Hook F. in the treatment of synovitis, acne, pustulosis, hyperostosis, and osteitis syndrome: a clinical trial

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Abstract

Objective

This study aimed to investigate the efficacy and safety of Tripterygium wilfordii Hook F. (TwHF) in the treatment of osteoarticular lesions in synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome.

Methods

Eligible SAPHO patients were recruited to this single-center trial to receive 12-week TwHF treatment. Two dose groups (1.0-mg/kg/day group and 1.5-mg/kg/day group) were designed and patients were allocated (1:1) to these two groups. The primary endpoint was the change from baseline in Ankylosing Spondylitis Disease Activity Score on the basis of C-reactive protein level (ASDAS) at week 12.

Results

All the 30 included patients completed the trial. At week 12, both dose groups showed significant change from baseline in ASDAS (1.0-mg/kg/day group: − 1.34 (1.10), p = 0.000; 1.5-mg/kg/day group: − 1.53 (1.19), p = 0.000). Similar improvement was also found in the Visual Analogue Scale in global osteoarticular pain, Bath Ankylosing Spondylitis Disease Activity Index, and other efficacy measures. The results showed a fast-acting characteristic of TwHF that the maximum efficacy was achieved within the first 2–4 weeks and maintained at a stable level for the rest of the study. No significant differences were observed between the two dose groups under the current sample size. TwHF was well tolerated that no severe adverse events or irregular menstruation were recorded, except for one patient who developed severe alanine aminotransferase elevation at the last follow-up and has stopped the TwHF treatment after the 12-week follow-up.

Conclusions

TwHF should be considered for the treatment of osteoarticular lesions in SAPHO syndrome in clinical practice because of significant efficacy, reliable safety, and high socioeconomic value.

Trial registration

ChiCTR1900025912

Key points

• This is the first clinical trial to evaluate Tripterygium wilfordii Hook F. (TwHF) in the treatment of synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome.

• Twelve-week TwHF treatment in both dose groups designed (1.0-mg/kg/day group and 1.5-mg/kg/day group) was well tolerated and could lead to significant disease remission of SAPHO syndrome.

• No significant differences were observed between the two dose groups under the current sample size.

• TwHF should be considered for the treatment of osteoarticular lesions in SAPHO syndrome in clinical practice because of significant efficacy, reliable safety, and high socioeconomic value.

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Data availability

The datasets analyzed for this study regarding the efficacy and safety of treatment are available from Dr. Chen Li (casio1981@163.com) upon reasonable request.

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Acknowledgments

The authors thank all the patients who were enrolled in this study.

Funding

This work was supported by the CAMS Initiative for Innovation Fund for Medical Sciences (CIFMS) (2017-I2M-3-001), the Capital Medical Research and Development Fund (2016-4-40112), and the National Key Research and Development Program of China (2016YFC0901500).

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Author notes

  1. Lun Wang, Liang Gong and Xinlu Zhang contributed equally to this work.

Authors and Affiliations

  1. Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China

    Lun Wang, Liang Gong, Xinlu Zhang & Piaopiao Long

  2. Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China

    Yihan Cao

  3. Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China

    Wen Zhang & Xiaofeng Zeng

  4. Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, No.1 Shuaifuyuan, Beijing, 100730, China

    Chen Li

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  1. Lun Wang
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Correspondence to Chen Li.

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Wang, L., Gong, L., Zhang, X. et al. Tripterygium wilfordii Hook F. in the treatment of synovitis, acne, pustulosis, hyperostosis, and osteitis syndrome: a clinical trial. Clin Rheumatol 40, 2427–2438 (2021). https://doi.org/10.1007/s10067-020-05562-x

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