Recent data indicate that Telitacicept is beneficial for lupus nephritis. Our goal is to determine whether Telitacicept is an effective and safe treatment, compared to standard-of-care Cyclophosphamide, for subclinical and clinical ILD in patients with early lupus.
Pulmonary abnormalities are present in up to 60% of patients with SLE, and up to 10% of the patients will develop clinical interstitial lung disease (ILD). Recent data indicate that Telitacicept is beneficial for lupus nephritis. Our goal is to determine whether Telitacicept is an effective and safe treatment, compared to standard-of-care Cyclophosphamide, for subclinical and clinical ILD in patients with early lupus. The study also explores disease mechanisms in lungs and serum immunological interaction, to identify potential biomarkers for diagnosis, prognosis, and response to treatment of lupus-ILD.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
In addition to conventional treatment (methyl-40mg or less /d), the treatment group also received hydroxychloroquine (100mg-200mg each time twice a day), and thalidomide (50mg-100mg each time once a day) could be added as appropriate.
The control group only received conventional treatment (methyl 40 mg/d or less), and other traditional immunosuppressants (including but not limited to cyclophosphamide, tacrolimus, sirolimus, cyclosporine, leflunomide, azathioprine, motecophenol ester, hydroxychloroquine, tripterine, methotrexate and sulazazopyridine, etc.). No more than 3 types of immunosuppressant should be added during the whole treatment period, and the dose should not exceed 30% from the baseline period)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGCorrelation between change from baseline at week 52 in forced vital capacity (FVC) [percentage (%) predicted]
Pulmonary function measurement (FEV1/FVC% % post-treatment difference during baseline)
Time frame: At baseline and at week 24, 52
Correlation between change from baseline at week 52 in diffusing capacity for carbon monoxide (DLco) [percentage (%) predicted]
Diffuse function DLco measurement (% post-treatment difference at baseline)
Time frame: At baseline and at week 24, 52
Anti-double-stranded DNA antibody conversion ratio
Anti-double-stranded DNA antibody conversion ratio
Time frame: At baseline and at week 12, 24, and 52
Complement C3 and C4 levels return to normal ratios
Complement C3 and C4 levels return to normal ratios
Time frame: At baseline and at week 12, 24, and 52
Six minutes walking distance
The 6-minute walk test (6MWT) is a simple, submaximal exercise test commonly used to assess functional capacity in individuals with interstitial lung disease (ILD). It measures the distance a person can walk in six minutes, and this distance (6MWD) can be correlated with disease severity and prognosis.
Time frame: At baseline and at week 12, 24, and 52
Changes from baseline in cumulative corticosteroid dose at week 52
Baseline dose was defined as the average corticosteroid dose (prednisone equivalent for all oral, IV, subcutaneous \[SC\], or intramuscular \[IM\] administrations) over the 7 days prior to, but not including, day 0; this was used to model the normalized cumulative baseline dose over 52 weeks. Actual cumulative corticosteroid dose (prednisone equivalent for all oral, IV, SC, or IM administrations) over 52 weeks was calculated
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Telitacicept is a TACI-Fc fusion protein, a type of drug used to treat autoimmune diseases. It works by targeting two key proteins, BLyS and APRIL, which are involved in the development and function of B cells, a type of white blood cell. By blocking these proteins, telitacicept can help to reduce B cell activity and suppress the immune system's overactivity in autoimmune diseases. Subcutaneous injection dose ranges from 80mg once a week to 160mg once a week.
Cyclophosphamide iv injection is used for severe complications of systemic lupus erythematosus 400mg twice a week
Time frame: At baseline and at week 52
Krebs von den Lungen-6
Krebs von den Lungen-6 (KL-6), is a biomarker primarily associated with interstitial lung disease (ILD). It's a high-molecular-weight mucin-like glycoprotein produced by type II alveolar pneumocytes. Elevated KL-6 levels in the blood can indicate the presence, severity, and progression of ILD.
Time frame: At baseline and at week 12, 24, and 52