Abstract
OBJECTIVE: To evaluate the safety and durability of telitacicept treatment in patients with SLE by identifying the reasons for treatment discontinuation and potential risk factors for subsequent disease recurrence. METHODS: This retrospective study included 48 lupus patients who discontinued telitacicept and were under long-term follow-up at Peking Union Medical College Hospital. The underlying causes for treatment discontinuation and the subsequent disease outcomes were analysed. RESULTS: This study found that, among 48 patients who discontinued telitacicept, 18 (37.5%, 18/48) did so due to achieving a lupus low disease activity state (LLDAS), based on physician recommendations. Primary adverse discontinuation reasons included disease status changes necessitating treatment adjustment (16.7%, 8/48), decreased immunoglobulin G levels (6.2%, 3/48) and infection/fever (6.2%, 3/48). Among the 40 patients without changes to concomitant therapies post discontinuation, 30 (75%) maintained relatively stable Systemic Lupus Erythematosus Disease Activity Index scores, while 10 (25%) showed increased scores during the 12-month follow-up. Based on the characteristics at the time of telitacicept withdrawal, a high rate of central nervous system involvement was observed among patients who exhibited active disease after discontinuation. No significant fluctuations in serological markers were observed during the 12-month postdiscontinuation period (p>0.05 for all comparisons). CONCLUSIONS: The majority of patients (37.5%) discontinued telitacicept due to achieving LLDAS. During the 12-month follow-up after drug withdrawal, 75% (30/40) of patients remained stable, whereas 25% had disease progression. A higher proportion of neurological involvement was observed in patients with disease changes after drug withdrawal, suggesting that patients with major organ involvement should be carefully evaluated following treatment cessation.