{
  "abstract": "Objectives A few clinical trials have been performed studying Bruton’s tyrosine kinase (BTK) inhibitors in patients with systemic lupus erythematous (SLE). We evaluate the literature and evidence to assess whether BTK inhibitors have efficacy in the disease modulation of SLEMethods A systematic review of clinical trials studying BTK inhibitors in patients with SLE was conducted by searching MEDLINE and Embase during the period up to January 2025. We found three Phase II clinical trials each studying a different BTK inhibitor. These studies were assessed for risk of bias (RoB) using the Cochrane RoB tool. The primary efficacy outcome was SLE Responder Index 4 (SRI-4) at various timepoints. Meta-analysis was conducted through common and random effects models if at least two studies had comparable outcome measures.Results We examined 3 randomized controlled trials (RCTs) with overall low RoB with median follow up at 48 weeks. Primary endpoint of SLE Responder Index 4 (SRI-4) response was met in only 1 RCT but was confounded with the coadministration of a Janus kinase inhibitor. This study was excluded from the meta-analysis. Adverse event rates were largely comparable with that of placebo for each trial. There was no statistical difference with the common effect model (OR: 1.3; 95% CI 0.94 to 1.81; p = 0.1175) whereas there was a statistically significant difference with the random effects model (OR: 1.3; 95% CI 1.09 to 1.55; p = 0.0336).Abstract PO:11:293 Figure 1Conclusions The random effects model in the meta-analysis showed that SLE patients who received a BTK inhibitor had 30% higher odds of achieving SRI-4 response compared to those receiving standard of care. It is unclear if this is a clinically meaningful difference given the lack of strong positive results across the RCTs. The meta-analysis was limited by the small number of early phase clinical trials, each evaluating a different BTK inhibitor, which cannot definitively provide evidence for the efficacy of BTK inhibitor therapy for SLE.",
  "authors": [
    {
      "affiliations": [
        "The Ohio State University Medical Center, Columbus, USA"
      ],
      "name": "Joseph Kim"
    },
    {
      "affiliations": [
        "The Ohio State University Medical Center, Columbus, USA"
      ],
      "name": "Jianing Ma"
    },
    {
      "affiliations": [
        "The Ohio State University Medical Center, Columbus, USA"
      ],
      "name": "Judith Lin"
    }
  ],
  "title": "PO:11:293 Efficacy and safety of BTK inhibitors in systemic lupus erythematous: a systematic review and meta-analysis",
  "uid": "a799b39a-1182-557a-a76b-8b972ca8eae9"
}