Systemic sclerosis & Raynaud's

BLyS/APRIL dual inhibition for systemic sclerosis: a single-centre, single-arm, open-label clinical trial of telitacicept

Clin Exp RheumatolPublished Single-arm clinical trial

Authors' conclusion

Telitacicept has the potential to be a safe and effective treatment for patients with SSc

Study context

Population
Systemic sclerosis (SSc) patients inadequately responding to traditional immunosuppressants
Participants
8 participants
Comparison
Telitacicept 160 mg weekly for 24 weeks added to stable background immunosuppression; week 24 vs baseline
  • Telitaciceptn = eight
Outcome
Changes in the median mRSS
Follow-up
Week 24
Methodological detailssingle-centre, open-label
  • Single-centre
  • Open-label

Main finding

As reported in the abstract

mRSS, change from baseline

Mean mRSS at baseline (±)

18.9±5.8

Mean mRSS at week 24 (±), vs baseline p=0.003

10.8±5.8

Further findings

mRSS at week 12

Mean mRSS at week 12 (±), vs baseline 18.9±5.8, p=0.008
12.5±5.0

SCTC-DI score, ScleroID questionnaire score and SF-36 physical score · week 24

Improved
P < 0.05

CRISS score

CRISS score, indicating clinical improvement (higher scores better)
0.75

CD19+ B cells

Decreased from 10.2% to 4.3%
P = 0.006

Transitional B cells

Decreased from 6.8% to 1.4 %
P = 0.005

Naive B cells

Decreased from 8.9% to 3.0%
P = 0.001

Immature B cells

Increased from 0.10 % to 0.24%
P = 0.03

Serum immunoglobulins (IgG, IgA, IgM) · week 24

Decreased
P < 0.05

Haemoglobin · week 12

Increased
P = 0.013

HRCT score for pulmonary fibrosis · week 24

Declined
P = 0.036

Titre of SSc-specific antibodies

Decrease observed in six out of eight patients
6/8

Deaths

No deaths occurred

Safety

Serious adverse events

No serious adverse events occurred

Adverse effects

Mainly hypogammaglobulinaemia, respiratory tract infection, urinary tract infections and rash

Original publication

BLyS/APRIL dual inhibition for systemic sclerosis: a single-centre, single-arm, open-label clinical trial of telitacicept. Clin Exp Rheumatol. Published 15 August 2025. doi:10.55563/clinexprheumatol/jckjcq

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