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At present, rheumatoid arthritis therapy mainly targets immune inflammation, which may have a ceiling effect.
Immune Seliciclib is an oral cyclin-dependent kinase inhibitor that can inhibit the proliferation of synovial fibroblasts.
The TRAFIC study is a non-randomized, open-label, dose-exploratory phase 1b/2a clinical trial.
diagnosis
Basic patient characteristics
Basic patient characteristicsFrom October 8, 2015 to August 15, 2017, 37 patients were screened , and 15 of them were divided into 5 cohorts to receive Seliciclib treatment (200 mg, 400 mg, 600 mg, 800 mg, or 1000 mg orally; 3 patients per dose level).
Screening
Dose-related toxicity
Dose-related toxicityThe maximum tolerated dose of Seliciclib is 400 mg , and the estimated dose-limiting toxicity probability at this dose level is approximately 0.
The maximum tolerated dose of Seliciclib is 400 mg The maximum tolerated dose of Seliciclib is 400 mg is consistent with the known safety issues of Seliciclib
Changes of DAS28-CRP score before and after treatment
Changes of DAS28-CRP score before and after treatmentIn addition, during the trial period, 65 non-severe adverse events occurred, of which 50 were considered to be related to treatment .
There were 65 non-severe adverse events, 50 of which were considered related to treatment
Treatment-related adverse reactions
Treatment-related adverse reactionsIn summary, the maximum tolerated dose of Seliciclib for TNF-blocked rheumatoid arthritis has been established (400 mg) .
The maximum tolerated dose of Seliciclib for refractory rheumatoid arthritis with TNF blockade has been determined (400 mg)
Original source:
Original source:Arthur G Pratt, et al.
org/10.
1016/S2665-9913(21)00061-8" target="_blank" rel="noopener">Targeting synovial fibroblast proliferation in rheumatoid arthritis ( TRAFIC): an open-label, dose-finding, phase 1b trial in this message