This is a single-center, single-arm, open-label, prospective study on the efficacy and safety of Telitacicept in patients with refractory rheumatoid arthritis.
The treatment of rheumatoid arthritis (RA) has made significant progress over the past three decades. However, approximately 20-30% of patients remain resistant to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), and targeted synthetic DMARDs (tsDMARDs), presenting a major challenge in RA management. Telitacicept is a dual-target inhibitor of B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). By inhibiting B cell maturation, differentiation, and antibody secretion by plasma cells, it reduces autoantibody production and the release of pro-inflammatory cytokines such as Tumor necrosis factor-α (TNF-α) and Interleukin-6 (IL-6), thereby alleviating joint inflammation. Clinically, a Phase III study of telitacicept in RA patients with inadequate response to methotrexate demonstrated a rapid onset of action within 4 weeks. At week 24, the ACR20 response rate in the 160 mg telitacicept group reached 67.4%, and at week 48, the response rate increased to 72.2%. Nearly 90% of patients exhibited no radiographic progression. In terms of safety, the incidence of adverse events with telitacicept was comparable to that of conventional therapies. Currently, there are no clinical trials or registered studies investigating the use of telitacicept in the treatment of refractory RA. This study aims to evaluate the efficacy and safety of telitacicept in patients with refractory rheumatoid arthritis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Telitacicept 160mg qw subcutaneous injection
Peking Union Medical College Hospital
Beijing, China
ACR20 at week 12
ACR20 is a comprehensive index defined as an improvement of at least 20% in both the number of tender and swollen joints, and improvement in at least three of the following five parameters by at least 20%: 1) Visual Analogue Scale (VAS) for pain, 2) patient's global assessment, 3) physician's global assessment, 4) Health Assessment Questionnaire (HAQ), and 5) acute-phase reactants (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)).
Time frame: Week 12
ACR20 at week 24
ACR20 is a comprehensive index defined as an improvement of at least 20% in both the number of tender and swollen joints, and improvement in at least three of the following five parameters by at least 20%: 1) Visual Analogue Scale (VAS) for pain, 2) patient's global assessment, 3) physician's global assessment, 4) Health Assessment Questionnaire (HAQ), and 5) acute-phase reactants (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)).
Time frame: Week 24
The proportion of patients achieving DAS28 remission or low disease activity at week 12 and week 24
DAS28 evaluates RA severity by quantifying joint inflammation and systemic markers of disease activity.
Time frame: Week 12 and 24
The proportion of patients achieving SDAI remission or low disease activity at week 12 and week 24
Simplified Disease Activity Index (SDAI) is calculated by summing five parameters: Tender Joint Count (TJC28): Number of tender joints out of 28 assessed joints. Swollen Joint Count (SJC28): Number of swollen joints out of 28 assessed joints. Patient Global Assessment (PGA): Patient's self-rated health status on a 0-10 scale (0 = best, 10 = worst). Physician Global Assessment (MDGA): Physician's evaluation of disease activity on a 0-10 scale (0 = best, 10 = worst). C-reactive Protein (CRP): Laboratory value measured in mg/L.
Time frame: Week 12 and 24
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ACR50 at week 12 and 24
ACR50 is a comprehensive index defined as an improvement of at least 50% in both the number of tender and swollen joints, and improvement in at least three of the following five parameters by at least 50%: 1) Visual Analogue Scale (VAS) for pain, 2) patient's global assessment, 3) physician's global assessment, 4) Health Assessment Questionnaire (HAQ), and 5) acute-phase reactants (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)).
Time frame: Week 12 and 24
ACR70 at week 12 and 24
ACR70 is a comprehensive index defined as an improvement of at least 70% in both the number of tender and swollen joints, and improvement in at least three of the following five parameters by at least 70%: 1) Visual Analogue Scale (VAS) for pain, 2) patient's global assessment, 3) physician's global assessment, 4) Health Assessment Questionnaire (HAQ), and 5) acute-phase reactants (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)).
Time frame: Week 12 and 24
The proportion of patients achieving CDAI remission or low disease activity at week 12 and week 24
Clinical Disease Activity Index (CDAI) is a composite score used to assess disease activity in rheumatoid arthritis (RA). It calculates disease severity through the following parameters: Tender Joint Count (TJC28): Number of tender joints out of 28 assessed joints. Swollen Joint Count (SJC28): Number of swollen joints out of 28 assessed joints. Patient Global Assessment (PGA): Patient's self-rated health status on a 0-10 scale (0 = best, 10 = worst). Physician Global Assessment (MDGA): Physician's evaluation of disease activity on a 0-10 scale (0 = best, 10 = worst).
Time frame: Week 12 and 24
Change in glucocorticoid dosage
Change in glucocorticoid dosage at week 24 of treatment compared to baseline
Time frame: week 24
Adverse events
The incidence of all adverse events, serious adverse events, and the probability of drug discontinuation due to adverse events or serious adverse events
Time frame: during the study period and within 4 weeks after study completion