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FDA Approves First, Injectable Treatment for Lupus

July 26, 2017
GlaxoSmithKline received approval to market a once weekly, subcutaneous injectable version of belimumab for patients with SLE, which can be self-administered.

With William Stohl, MD, PhD

This new subcutaneous formulation of Benlysta (belimumab) was approved by the Food and Drug Administration for adults with active, autoantibody-positive systemic lupus erythematosus (SLE) who have been undergoing standard therapy.1  

In patients with moderate-to-severe SLE, weekly doses of belimumab SC (200 mg) added to standard SLE therapy produced a significant improvement in their SRI4 response—a primary endpoint—as well as decreased severe disease flares, while offering a safety profile similar to placebo.2

First ever self-injectable treatment for patients with lupus.

With Self-Treatment—More Flexibility, Less Time

Since 2011, belimumab intravenous (IV) has been prescribed to patients who needed more than standard therapy to manage their lupus symptoms. This required monthly administration by a health professional, which was given as a weight-based dose (10 mg/kg).3

“Belimumab IV must be administered at a clinic or infusion center, which is resource-intensive for the healthcare system and time-consuming for patients,” William Stohl MD, PhD, professor of medicine and chief of rheumatology at the University of Southern California Keck School of Medicine in Los Angeles, told Practical Pain Management.

“The ability to self-administer belimumab subcutaneous (SC) will reduce these costs and enhance treatment options for patients with SLE,” Dr. Stohl, a study co-author, continued, “Belimumab SC should provide greater convenience to patients than belimumab IV due to its less invasive and quicker administration time. These advantages of SC administration may be especially important for the chronic, long-term treatment of SLE.”

The new formulation gained approval following submission of data from the BLISS-SC phase 3 randomized, double-blind, placebo-controlled trial that supported a reduction in active disease after 1 year of treatment.2

Phase 3 Trial Data Met Endpoints

The BLISS-SC trial enrolled 839 patients (556 receiving belimumab and 280 taking a placebo) who were followed to assess safety and efficacy of the formulation in addition to standard therapy for 52 weeks.

The primary end point was the SLE Responder Index (SRI4) at week 52. Secondary end points were a reduction in the corticosteroid dosage and time to severe flare. Safety was assessed using adverse events (AEs) reports and laboratory test results.

A majority of patients who were administered belimumab were SRI4 responders vs. placebo (61.4% vs. 48.4%; [95% CI; 1.25–2.25]); P = 0.0006). Improvement in severe flares was noted in the treatment group both in time and risk (median 171 days versus 118 days; [95% CI; 0.35–0.74]; P = 0.0004).

In addition, a greater proportion of patients with SLE, receiving belimumab vs. placebo, were able to reduce their corticosteroid dosage by ‡25% (to £7.5 mg/day) during weeks 40 to 52 (18.2% vs. 11.9%; [95% CI; 0.95–2.84]; P = 0.0732.)2

Comparing the Formulations: IV vs. SC

“Since no head-to-head testing between belimumab IV and belimumab SC has been performed, there is no way to accurately assess any difference, if any, in efficacy between the two,” said Dr. Stohl, “That being said, I intuitively sense that if there is a difference in efficacy, then it is very small.”

The safety profile for belimumab SC was consistent with that of belimumab IV, with the addition of local injection site reactions, which occurred in 6.1% and 2.5% of patients, receiving belimumab and placebo, respectively.2

The incidence of adverse events (AEs) was similar between study groups, with 10.8% in patients who received belimumab and 15.7% in those receiving placebo.2 Worsening IgG hypoglobulinemia by ‡2 grades occurred in 0.9% vs. 1.4% of patients taking belimumab SC and placebo, respectively. 

Considering Formulations in Clinical Practice

With the new formulation, patients will have the option to self-administer belimumab as a once weekly 200 mg single dose injection either by prefilled syringe or autoinjection, after an initial loading regimen on days 1, 14 and 28.1  During this introductory treatment period, patients will gain training from their health care professional about the self-administration process.   

As to differences in the formulations and who may benefit, “any decision with regard to belimumab SC or IV must be a shared one between the patient and physician,” Dr. Stohl told Practical Pain Management, “There is ample experience among RA patients who receive TNF antagonists; some patients prefer self-administration, whereas others prefer infusions, so the same will undoubtedly hold for SLE patients who receive belimumab.”

Belimumab SC will be available from specialty pharmacies beginning in late August.

Financial disclosures are as follows: Drs. Stohl, Schwarting, Scheinberg, and Doria each received less than $10,000 in consulting, speaking and/or research grants from GlaxoSmithKline. Ms. Hammer and Kleoudis, Mr. Gordon, and Drs. Groark, Bass, Fox, and Roth own stock or stock options in GlaxoSmithKline.

 

 

Last updated on: July 28, 2017
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