Benlysta as an Add-On Treatment: German Cohort

New research examines belimumab, better known by the brand name, Benlysta, as an add-on therapy for people with lupus.

Researchers in Germany conducted an observational study of Benlysta use in the real world as an add-on treatment for lupus (SLE). After using Benlysta for 6 months, 78% of people experienced at least a 20% improvement in overall disease activity based on physician judgements. And, 42% experienced great benefit of the drug, defined as over a 50% improvement in physician analysis. Additionally, people were able to use fewer corticosteroids while using Benlysta and decreased unexpected use of health services like the ER.

Just published in the December 2016 issue of Rheumatology and Therapy, the results of the OBSErve Germany study mirror previous studies in the United States and Spain. OBSErve is a multinational study program funded by GlaxoSmithKline, the makers of Benlysta.

Benlysta: A quick overview

Belimumab (Benlysta) is a new type of medication called a biologic. Biologics are made up, or derived from, living organisms. Benlysta is a specific human monoclonal antibody that is able to inhibit B cells, which are linked to responses by the immune system.

Benlysta was approved by the FDA in 2011, but there were a number of reservations about the drug. The FDA had concerns that:

1. improvements measured using the SELENA-SLEDA scale were only marginal
2. the belimumab treatment groups had more deaths than controls (including three suicides);
3. participants of African or African-American descent did not significantly respond to the drug; and
4. there were high numbers of adverse events in the trials

Subsequent studies, including these OBSErve studies, aim to answer some of these concerns raised during the approval process.

Study Methodology

The OBSErve study was a retrospective, observational cohort study. That means that researchers analyzed health records to see how patients in the real world were responding to Benlysta based on common health indicators like SELENA/SLEDAI scores. Patient records were collected from 6 months prior to the start of Benlysta to 6 months after the start of Benlysta.

Results

78% of patients experienced a 20% or greater increase in overall clinical response as assessed by their physicians

Additionally, objective measures of patient disease status, such as the SELENA/SLEDAI were used to measure common clinical and serological symptoms of lupus.

In total, SELENA/SLEDAI scores decreased from 10.6 to 5.6 in the first 6 months of treatment. The reduction means that the disease was less symptomatic following the start of Benlysta.

Researchers also looked into 6 specific symptoms of lupus: arthritis, fatigue, rash, alopecia, low complement, and increased anti-dsDNA antibody levels. The great majority of patients experienced an improvement to some or all of these symptoms. There was notable improvement of arthritis and rashes. The full report of improvement or worse outcomes by symptom is available here.

Patients receiving belimumab therapy for six months were also able to switch to low dose corticosteroid doses. Low dose treatment is understood to be under 7.5 mg/day of corticosteroid. Typical patient corticosteroid use decreased from 13.7 mg to 7.6 mg; those on high doses of corticosteroids dropped from 17.5 to 8.6 mg after Benlysta treatment.

Other findings of note

6 patients of 102 in the study discontinued treatment of Benlysta during the six months. For 3 of them, the physician-documented discontinue reason was “disease progression” and “ineffective medication.” 1 patient had an allergic reaction – which is consistent with previous findings that approximately 1% of people are allergic to belimumab. Also, one patient passed away, but “no causal relationship to belimumab was suspected.”

There were interesting finding regarding the number of visits per patient to the clinic, hospital, and emergency room as well. While the number of scheduled visits increased per patient so that people could receive their infusions, the number of unscheduled visits decreased overall. That means that there were fewer hospitalizations and ER visits following the start of Benlysta therapy. The full chart if available here.

Participant Profiles

For a full view of baseline patient profiles, click here

102 patient records were collected from 21 sites in Germany in 2013

91% of the participants were female

101 of the participants were Caucasian

Average age of participants was 42.5 years old (with a standard deviation of plus/minus 13.83 years

Average body mass index (BMI) was 25.3 kg/m^2 (standard deviation 6.19 kg/m^2)

85% of participants had Moderate or Severe SLE as determined by disease indices like the SELENA/SLEDAI.

58% of participants had been diagnosed with SLE for over 10 years

Why start Benlysta?

88% of participants started Benlysta because the previous treatments were not effective. And, 61% of people had lupus that was getting worse.

In only 26% of people was Benlysta added because the prior treatment regimen was not tolerated well by participants.