Defining the optimal disease duration of early diffuse systemic sclerosis for clinical trial design.
Robyn T DomsicShiyao GaoMaureen LaffoonSteven WisniewskiYuqing ZhangVirginia SteenRobert LafyatisThomas A MedsgerPublished in: Rheumatology (Oxford, England) (2021)
Regardless of whether the first SSc or first non-Raynaud manifestation is used to define disease onset, duration of <18 months at enrolment is preferable. A longer disease duration criterion more frequently results in regression to the mean of the mRSS score, and likely contributes to negative trial outcomes.