Rongchang Biological Clinical Research appeared in international journals for the treatment of refractory pediatric systemic lupus erythematosus

On May 9, Rongchang Biopharmaceutical (Yantai) Co., Ltd. (stock code: 688331. SH；09995. HK) announced: Clinical data from a self-controlled trial of tetasil in the safety and efficacy of treatment of refractory pediatric systemic lupus erythematosus (cSLE), published in the journal Lupus. This is the first report at home and abroad on real-world clinical research data based on pediatric SLE.

Lupus is the only international journal specializing in lupus and related diseases. Includes the most promising new clinical and laboratory studies by leading experts in all lupus-related disciplines, including: rheumatism, skin diseases, immunology, obstetrics, psychiatry, cardiovascular research.

The article was published in Lupus, the only international journal specializing in lupus and related diseases

Childhood-onset systemic lupus erythematosus (cSLE) is a systemic autoimmune disease characterized by systemic multisystem or multi-organ damage and the presence of a large number of autoantibodies in the body, and the clinical manifestations are highly heterogeneous. CSLE has more acute onset, higher incidence of organ damage (especially kidneys), more prolonged course, and relatively worse prognosis, among which lupus nephritis (LN) is a common clinical manifestation of SLE and one of the important predictors of death. At present, there are no literature reports on the use of tatacept in the cSLE population at home and abroad. The clinical research published in Lupus was led by Professor Xu Hong (Children's Hospital Affiliated to Fudan University), Professor Sun Li (Department of Rheumatology, Children's Hospital Affiliated to Fudan University), Professor Shen Qian (Department of Nephrology, Children's Hospital Affiliated to Fudan University), Professor Zhao Fei (Children's Hospital Affiliated to Nanjing Medical University), Professor Yu Haiguo (Children's Hospital Affiliated to Nanjing Medical University), Professor Chen Yuqing (Anhui Children's Hospital), Professor Xu Zhiquan (Hainan Provincial Women's and Children's Medical Center), Multicenter retrospective study in which 5 participating centers participated. This is a self-controlled trial of tetasip applied to children with systemic lupus erythematosus (cSLE) to initially assess safety and efficacy and gain experience for future multicenter clinical studies of cSLE and/or pediatric LN.

The results showed that in 15 refractory cSLE cases [3 males (20%), 12 females (80%), median age and median weight of 13 years and 52 kg, and the median course was 30 months], after 5 to 26 weeks (80 or 160 mg per week) with tataxipril, the SRI-4 response rate was 66.7% (10 cases). In 12 patients, the dose of hormones was reduced from the median dose of 40 mg/day before medication to 17.5 mg/day. Eight patients with renal involvement with 24-hour urine protein quantification > 0.5 g at baseline before taking the drug, and the urine protein decreased at 24 hours after treatment. In 8 cases, 2 cases of urine protein turned negative, and 5 cases of plasma albumin rose to normal. In addition, in 3 of the 8 patients with renal impairment, renal function improved to varying degrees (eGFR ml/min·1.73 m2, from 17.4 to 26.6, 40.7 to 48.2 and 63.2 to 146.0, respectively. There were mild or moderate adverse events after treatment.

The conclusions showed that tetaczep combined with standard therapy could significantly improve the SRI-4 response rate in children with SLE, reduce the dose of glucocorticoids in refractory cSLE, and also show efficacy in lupus nephritis. No significant adverse events occurred during the study period, and the related adverse drug events were controllable. This study suggests that the efficacy of tetacil on children with systemic lupus erythematosus and lupus nephritis deserves further study.

As mentioned in this paper, this study found that in 15 patients with refractory pediatric SLE, disease activity after the use of tetacil can be improved or controlled in a short period of time, and hormones can be reduced quickly or avoided. The drug retention rate during observation was 100% in all 15 patients with SLE, and none of them spontaneously discontinued due to adverse drug reactions or difficulties in administration. Since glucocorticoid-induced damage increases the case fatality rate in patients with SLE, one of the main goals of current SLE treatment is to reduce the dose of glucocorticoids. There is still a lack of a unified strategy for hormone reduction in children, but the global pediatric rheumatology and nephrology specialties have begun to develop hormone dose reduction strategies, and targeted and low-side effect biologics are an important means of hormone reduction. Due to its convenient administration, less short-term side effects, and certain efficacy, tetaczept has shown certain advantages in children with refractory SLE, and the long-term side effects and efficacy have been continuously observed.

It is reported that in the past year, there have been relatively many studies on the use of biologics in adult patients with SLE, while the results of studies on the use of biologics in patients with cSLE are relatively rare. The team of Professor Xu Hong and Professor Sun Li took the lead in using tetacip for cSLE treatment and achieved positive results, which is expected to bring new hope and new choices for the treatment of cSLE in the future.

Tatacipu is an antibody fusion protein drug molecule invented and designed by Professor Fang Jianmin, CEO and Chief Scientific Officer of Rongchang Biology, which is the world's first dual-target biological drug for the treatment of systemic lupus erythematosus. It treats B-cell-mediated autoimmune diseases by simultaneously inhibiting both BLyS and APRIL cytokines, and in a registered clinical trial for the treatment of systemic lupus erythematosus, the high-dose group of tetazep has an effective rate of up to 79.2%. Based on its significant efficacy and safety, tetasil was approved for marketing by the State Food and Drug Administration of China on March 9, 2021, and was included in the new version of the National Medical Insurance Drug Catalogue in December of the same year. At present, its domestic phase II./III clinical treatment of rheumatoid arthritis, IgA nephritis, Sjogren's syndrome, optic nerve myelitis, myasthenia gravis and other autoimmune diseases has been fully launched. In terms of internationalization, the US phase III clinical trial for the treatment of systemic lupus erythematosus and the US phase II clinical trial for the treatment of IgA nephropathy have been initiated.