Evaluation of Rovadicitinib Compared to the Protocol Selected by Researchers in Third Line and Subsequent Studies of Moderate to Severe Chronic Graft-versus-host Disease

Best Objective Response Rate (BOR)

The best therapeutic effect among all therapeutic outcomes

Time frame: Week 24

Duration of Relief (DOR)

The duration of symptom relief for patients after receiving treatment

Time frame: Through study completion, an average of 2 year

Improvement in Lee cGVHD symptom score of subjects in week 24

The Lee cGVHD Symptom Score is a tool used to assess the severity of symptoms in chronic graft-versus-host disease (cGVHD), ranging from 0 to 4 points, with a maximum total score of 16 points. The higher the score, the more severe the cGVHD symptoms.

Time frame: Week 24

Failure free survival (FFS)

The time from the start of treatment to the occurrence of disease progression or death for any reason in the patient

Time frame: Weeks 2, 4, 8, 16, 36, 48, 60, 72, 84, 96

Primary disease recurrence rate (MR)

The probability of recurrence of the patient's disease within a certain period of time.

Time frame: Weeks 8, 16,24， 36, 48

Non-Relapse Mortality (NRM)

NRM was defined as death without recurrent or progressive disease

Time frame: Weeks 8, 16,24， 36, 48

Overall survival (OS)

From randomization to the time of death caused by any reason

Time frame: Through study completion, an average of 2 year

Percentage of subjects whose daily glucocorticoid dose decreased

Percentage of subjects whose daily glucocorticoid dose decreased by ≥ 50% in week 24, and percentage of subjects who discontinued all glucocorticoids

Time frame: Week 24

Changes in the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)

The FACT-BMT scale is a tool used to evaluate the quality of life (QOL) of patients after hematopoietic stem cell transplantation, the scale is filled out by the person closest to the patient, and each question has five possible answers on a scale of 0-4. Answer each question item based on the patient's actual situation in the past week, and mark the corresponding number with a "√"

Time frame: Through study completion, an average of 2 year

Changes in 5-level EQ-5D (EQ-5D-5L)

The scoring criteria of EQ-5D-5L scale include five dimensions: action ability, self-care ability, daily activity ability, pain or discomfort, anxiety or depression. After selecting a level for each dimension, a specific rating can be obtained. For example, if an individual chooses "slightly difficult" in terms of action ability, they will score 2 points on that dimension (from 0 to 5, where 0 indicates no difficulty and 5 indicates inability/very serious difficulty)

Time frame: Through study completion, an average of 2 year

Adverse events (AE)

The incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators.

Time frame: Through study completion, an average of 2 year

Cmax

The maximum concentration of medication that enters the bloodstream after administration

Time frame: Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle)

Ctrough

After multiple administrations, the blood drug concentration reaches a relatively stable state, which is called the steady-state concentration

Time frame: Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle)