Belimumab Scores High Against SLE in Real Clinical Practice

In arms of the same trial that reach across the Atlantic, the BAFF inhibitor belimumab (Benlysta) is showing substantial benefits against systemic lupus erythematosus (SLE) in use at non-academic rheumatology practices.

Latest results of the US and German arms of the trial called OBSErve were presented last week at the annual conference of the European Union League Against Rheumatism (EULAR) in Paris. The US results reflect 18 months of treatment, while the German data are based on only six months of treatment to date.

The trial focuses on rheumatologists not in academic medical centers and on SLE patients not previously involved in clinical trials of belimumab. In the US, 92 physicians from non-academic medical centers who treat at least 10 SLE patients per year were recruited at random, and then records were selected at random among those for patients who had received at least eight 10 mg/kg infusions of belimumab.

The doctors were asked to conduct chart reviews and to offer their judgment of disease severity at baseline and again every six months for up to two years, using a non-validated instrument.

Twelve-month changes in severity, as judged by the physicians, were as follows:[[{"type":"media","view_mode":"media_crop","fid":"25214","attributes":{"alt":"lupus","class":"media-image","height":"281","id":"media_crop_2454602982471","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2277","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","title":" ","typeof":"foaf:Image","width":"421"}}]] Further improvements followed the 12-month results. Within the subsequent six months, physicians judged that nearly two-thirds of patients (64.7%) had improved in severity by yet another 20%, and 40% were fully 50% better, compared to results after a year of treatment. Just above 2% of patients got worse during that period.

Since the start of treatment, all groups had reductions of mean SELENA-SLEDAI scores of at least 8.5 and mean reductions in steroid dosage of at least 14.9 mg/day.

In the German arm of the same trial, after six months of treatment, review of 102 charts has revealed clinical improvement of at least 50% in 42% of patients and at least 20% in more than three-quarters (78%), Physicians described more then 50% improvement in the following common symptoms of SLE:

•  arthritis, in 56% of patients,
•  rash in 51%
•  fatigue in 25%

In the US trial, 79 of 501 patients had discontinued belimumab by 18 months, 32 for unstated reasons of patient preference and 23 because the drug wasn't working. (Six of 102 have discontinued to date in the German arm.) Although the trial wasn't designed to address safety, adverse events were the reason for drug withdrawal in nine of the US cases, four of them involving sepsis.

These results may not be applicable to patients treated for less than six months or at dosages other than 10 mg/kg, the researchers note, reiterating that the measure used to judge severity has not been validated in other research. Authors of the US study include Christopher Collins MD of Georgetown University Medical Center, Maria dell'Era MD of University of California-San Francisco, and several others from Glaxo Smith-Kline.