Epratuzumab for Lupus Looks Promising

September 9, 2015

New data shows that epratuzumab safely produces sustained improvements in systemic lupus erythematosus.

New data shows that epratuzumab safely produces sustained improvements in disease activity and health-related quality of life for more than three years in patients with systemic lupus erythematosus - allowing patients to cut their steroid dose in half. Systemic lupus erythematosus is associated with widespread tissue damage affecting musculoskeletal, mucocutaneous and renal systems. Disease progression varies considerably among patients, which can make treating the condition challenging. Research developments over the past 50 years have shed new light on the pathogenesis of SLE, including the role of B cells as a new therapeutic target.  Corticosteroids are almost universally prescribed to patients to control inflammation, but they are associated with long-term complications. New treatments are designed to control inflammation and prevent organ damage in patients with active moderate-to-severe systemic lupus erythematosus. 

  • Epratuzumab plus standard care was well-tolerated for up to 3.2 years.
  • Patients maintained their initial improvements in disease activity.
  • Placebo patients exhibited similar improvements.
  • Median corticosteroid dose was halved from baseline for patients receiving epratuzumab therapy for 108 weeks.

 

Source: Arthritis Care & Research

[[{"type":"media","view_mode":"media_crop","fid":"41148","attributes":{"alt":"©KozakDmytro/Shutterstock.com","class":"media-image media-image-right","id":"media_crop_3351995761040","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"4298","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"font-size: 13.008px; line-height: 1.538em; float: right;","title":" ","typeof":"foaf:Image"}}]] In a new study published in the August 28 issue of

Arthritis Care & Research

, researchers report 55.7% of 203 patients experienced clinically meaningful improvements with epratuzumab and they were able to reduce their median steroid dose from 10.0 mg/day to 5.0 mg/day at 108 weeks. The findings are based on the results of an open-label extension study of patients who were enrolled in Emblem, a 12-week randomized, placebo-controlled study. Patients received 1200 mg of epratuzumab infusions at weeks 0 and 2 of repeating 12-week cycles, plus the standard of care. Of the 203 patients who entered the open-label trial, 113 continued on epratuzumab for a median of 3.2 years.  These results strongly support the continued study of epratuzumab for the treatment of patients with moderate-to-severe SLE,” wrote the researchers who were led by Daniel J. Wallace, MD, of the Cedars Sinai Medical Center in Los Angeles. ““Patients who had received placebo in EMBLEM also exhibited rapid improvements in disease activity following a switch to epratuzumab treatment.” Disease activity, measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, went from a median 10 points at the start of the extension study to 4 points by its end -- and clinically meaningful improvements were seen in the patients' global assessment (PtGA), Wallace and colleagues wrote. Adverse events, which were reported in 192 patients with the majority being mild or moderate, included, but was not limited to, infections, neoplasms and lupus nephritis. Urinary tract infections occurred in 50 patients (24.6%). Neoplasms (benign, malignant or unspecified) were reported in three patients. And, lupus nephritis developed in seven patients (3.4%), four of which were classified as serious. Earlier EMBLEM data reported in

Rheumatology Network

echoed the current findings that epratuzumab improved quality of life in lupus. Epratuzumab, a novel monoclonal antibody that binds to CD22, a co-receptor of the B cell receptor (BCR) and modulates B cells, is also being evaluated in Sjögren’s syndrome. Belimumab is currently licensed for use in moderate-to-severe systemic lupus erythematosus in the United States and Europe.  

Disclosures:

The study was funded by UCB Pharma, the Belgium-based developer of epratuzumab. Wallace and several co-investigators were consultants to the company. 

 

References:

Wallace DJ, Hobbs K, Clowse ME, et al.,

Long-term safety and efficacy of epratuzumab in the treatment of moderate-to-severe systemic lupus erythematosus: results from an open-label extension study.Arthritis Care & Research.

Aug. 28, 2015. DOI: 10.1002/acr.22694.