Sjögren's disease & overlap diseases
Efficacy and safety of telitacicept in primary Sjögren’s syndrome: a randomized, double-blind, placebo-controlled, phase 2 trial
Primary result · Change from baseline in ESSDAIResult — go to the resultPlacebo-adjusted least-squares mean change −4.3 95% CI −7.0 to −1.6Authors' conclusion
Telitacicept showed clinical benefits and good tolerance and safety in the treatment of pSS.
Study context
- Population
- Adults with pSS, positive anti-SSA antibody and ESSDAI ≥ 5
- Participants
- 42 adults
- Comparison
- Weekly subcutaneous telitacicept 240 mg or 160 mg vs placebo for 24 weeks
- Telitacicept 240 mgn = 14
- Telitacicept 160 mgn = 14
- Placebon = 14reference
- Primary endpoint
- Change from baseline in ESSDAI
- Follow-up
- Week 24
Methodological detailsphase II, double-blind, placebo-controlled
- Phase II
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Placebo-adjusted least-squares mean change
−4.3
95% CI −7.0 to −1.6
P = 0.002
Change by group
Telitacicept 240 mg
−2.7
mean · interval −5.6–0.1
Telitacicept 160 mgvs Placebo
placebo-adjusted least-squares mean change −4.3 (95% CI −7.0 to −1.6); P = 0.002
Further findings
MFI-20 and serum immunoglobulins · week 24
- Decreased significantly in both telitacicept groups vs placebo
- P < 0.05
Safety
- No serious adverse events observed in the telitacicept treating group
Original publication
Efficacy and safety of telitacicept in primary Sjögren’s syndrome: a randomized, double-blind, placebo-controlled, phase 2 trial. Rheumatology (Oxford). Published 3 July 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →