Dr. Peter E. Lipsky, MD
Formerly National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health, Bethesda, MD,
MedicalResearch.com: What are the main findings of the study?
Prof. Zhang & Lipsky--The results of this study indicate that TwHF is effective for the treatment of active rhematoid arthritis (RA). Importantly, these are the first data indicating that TwHF is effective in DMARD-naïve patients with active rheumatoid arthritis. At week 24, TwHF monotherapy resulted in significant improvement of disease activity, including pain assessment, the patient’s and physician’s global assessment, tender joint counts, swollen joint counts, ESR, CRP, and HAQ and SF-36 scores. MTX monotherapy and TwHF monotherapy had similar efficacy as shown by ACR20, ACR50 and ACR70 response criteria, EULAR and cDAI good response criteria, as well as DAS28 remission criteria and low disease activity(LDA) rate. The efficacy of TwHF was not inferior to that of MTX, and MTX +TwHF combination therapy was more effective than MTX monotherapy in treating active rhematoid arthritis. A safety evaluation of the study demonstrated that the frequency of total adverse events and severe adverse events of TwHF monotherapy was not significantly higher than that of MTX monotherapy, except for a slightly increased frequency of irregular menstruation.
MedicalResearch.com: Were any of the findings unexpected?
Prof. Zhang & Lipsky: In Peking Union Medical College Hospital (PUMCH), the tertiary referral centre in China, we treat over 30 000 patients with rhematoid arthritis each year and more than half of them are treated with TwHF, in most cases in combination with MTX, because of the low cost of TwHF. Importantly, in ‘real-world’ clinical practice, we have observed the considerable effectiveness of the MTX+TwHF combination, so we are not surprised at the findings of this RCT in which all patients were assessed by trained investigators who were unaware of the therapeutic regimen.
MedicalResearch.com: What should clinicians and patients take away from your report?
Prof. Zhang & Lipsky: TwHF could be a promising approach to the treatment of active rheumatoid arthritis, particularly as not all patients respond to DMARDs, and because these drugs are expensive.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Prof. Zhang & Lipsky: We will continue to follow-up this cohort of patients and compare the radiological progression when the patients have completed 2 years of treatment. We are looking forward to the results and will share our findings in the near future.
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