Belimumab has favorable safety and efficacy in patients with SLE

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The authors noted that SLE is more common, and generally more severe, in non-white populations than in white populations.

“In Japan, SLE is estimated to affect 4.3 to 37.7 people per 100,000, and in South Korea the estimated prevalence is 20.6 to 26.5 people per 100,000,” they wrote. .

There are gaps in the LED processing landscape. Although patients are usually prescribed immunosuppressants and corticosteroids, many patients still have a significant disease burden and may experience adverse reactions (ADRs) related to long-term use of these drugs.

Belimumab is a recombinant humanized immunoglobulin G1 lambda monoclonal antibody that binds to and antagonizes B-cell stimulator protein biology. Patients with SLE have high levels of this protein, the investigators wrote.

Intravenous belimumab is approved in the United States, Europe, Japan, and South Korea, but the authors said there was little evidence of long-term safety and effectiveness in Japanese populations. and South Koreans, despite a higher prevalence of the disease among these people. populations.

They built an open-label, phase 3 continuation study that built on 2 previous studies on belimumab. Patients who completed previous studies received 10 mg / kg belimumab once every 4 weeks for up to 7 years. The primary endpoint of the study was safety, and the secondary endpoints were response rate, SLE flares, and prednisone use.

A total of 142 patients were included, all with moderate SLE; 73.2% of patients completed the study. Study patients sought care at one of 27 study centers in Japan and South Korea.

In terms of safety, most patients (97.4%) experienced AEs, although only about a third (33.8%) were considered serious AEs. Cellulitis, bruising and shingles were the most frequently reported serious AEs. Only 4.9% of patients presented with an AE which led to withdrawal from the study.

“No clinical trends of concern have been observed over time with respect to the incidence of grade 3 or 4 values ​​in hematologic parameters, clinical chemistry and urine values,” the authors wrote. “No grade 3 or 4 serum IgG value was reported after the first dose of belimumab. “

Regarding secondary endpoints, the disease activity index scores suggest a significant reduction in disease activity in many patients over the duration of the study. For example, the number of patients reaching the threshold of SLE response index 4 (SRI4) has increased over time.

“Overall, the proportion of SRI4 responders during treatment with belimumab increased from 47.8% (65 of 136 patients) at year 1, week 24, to 68.2% (15 of 22 patients) at year 6, week 48, ”investigators said.

Severe flare-ups occurred in 14.8% of patients, on average 585 days after the first dose of belimumab. However, the data also showed that patients’ use of prednisone decreased over the long term, a positive sign of the effectiveness of belimumab.

“In conclusion, the safety results of this 7-year study of SLE patients from Japan and South Korea are consistent with those observed in the past 7 years. [to] 13-year open-label continuation studies of belimumab added to standard therapy, ”the authors wrote.

Reference

Tanaka Y, Bae SC, Bass D, et al. Long-term open-label continuation study of the safety and efficacy of belimumab for up to 7 years in patients with systemic lupus erythematosus from Japan and South Korea. RMD open. Published online July 7, 2021. doi: 10.1136 / rmdopen-2021-001629


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