Rx Helped Control Lupus Flares

Epratuzumab decreased corticosteroid use and increased quality of life in lupus patients

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) People living with lupus often report a worse quality of life than healthy people. Part of this is due to the fact that lupus treatments like corticosteroids can carry unpleasant side effects.

Because the cause of lupus is unknown, the symptoms are treated more often than the actual disease. Lupus patients are commonly prescribed corticosteroids to reduce inflammation and help control flare-ups. Some patients have reported that the treatments currently available to them impact their ability to perform everyday activities and generally make them feel bad.

Two recent research studies showed that treatment of lupus with epratuzumab increased patients' quality of life, decreased corticosteroid use and decreased disease flare-up. Patients themselves reported increased energy and better sense of well-being after taking epratuzumab.

"Discuss your lupus treatment options with a rheumatologist."

The main author of an article describing the two studies was Vibeke Strand from Stanford University in Palo Alto, CA.

Lupus is a autoimmune disease where the body attacks healthy tissue. It affects many body systems, including joints, kidneys, skin and brain. Patients have a range of symptoms, but most experience joint pain and swelling.

New types of medications, such as epratuzumab have been developed to target biologic processes involved in the overactivation of the immune system.

A total of 90 people took part in these two medication studies, called ALLEVIATE and SL0006, done at 44 different centers around the world. These studies were designed to see if epratuzumab would decrease lupus flares, cut down on corticosteroid need and improve general well-being.

Patients in these studies were 18 years old or older and had an anti-nuclear antibody test titer — which is an estimate of rheumatoid and lupus activity of 1:40 or greater.

In the ALLEVIATE study, 42 people were given 360 mgs/m2 (low dose) epratuzumab, 11 people were given 720mg/m(high dose), and 37 were given fake medicine, also called a placebo. Epratuzumab and the placebo were given intravenously (through a vein) in four cycles of 12 weeks each for a total of 48 weeks. The medication or placebo was given once a week for the first four weeks of cycle 1, then twice a week for cycles 2-4. Everyone in the study also received usual care for their disease.

All patients also received corticosteroids. Patients started the study on a dose not greater than 60 mg/day and that was slowly lowered after four weeks. The researchers' goal was to decrease corticosteroid doses to 5-10 mg/day by weeks 20 and 24 of the study.

After about 18 months from when the research first started, the study had to be stopped due to lack of availability of epratuzumab. Only data from patients who were in the study for more than six months were used.

A total of 29 patients who completed the ALLEVIATE study went on to be in the SL0006 study. Another shortage of epratuzumab delayed entering patients from the ALLEVIATE trial into the SL0006 trial for about 165 days.

The goal of the SL0006 study was to see how well low dose epratuzumab worked to control lupus and how safe it was. The patients in SL0006 were given epratuzumab in 12 week cycles, with intravenous infusions of the medication once a week for the first two weeks of each cycle. Most patients in the SL0006 study received 11 cycles of treatment and stayed in the study for 120 weeks. There was no placebo treatment given in this study.

In both studies, use of corticosteroids and tests for disease activity were evaluated every four weeks. Quality of life surveys were given to patients every four weeks so that these patients could report issues such as pain, general health, social functioning, vitality or energy and mental health. Patients and doctors also completed surveys that assessed disease activity every four weeks, called PGA for Physicians Global Assessment and PtGA for Patient Global Assessment.

Doctors assessed which patients showed a 20 percent or greater improvement by week 12 of the ALLEVIATE study using the PGA. They found this level of improvement in 77 percent of patients who had taken low dose epratuzumab, 80 percent of those who took high dose of the medication and only 60 percent of those given placebo.

When patients reported their own health assessment at 12 weeks on the PtGA, 68 percent of those who had taken low dose epratuzumab, 70 percent of those who were given high dose epratuzumab and 53 percent of those given placebo felt their disease was less active.

By 24 weeks in the ALLEVIATE study, 75 percent of the patients taking low dose epratuzumab, 100 percent of people who took high dose epratuzumab and 56.5 percent of patients given placebo had lowered their corticosteroid dose.

By week 48, the group who had been given low dose epratuzumab reported a score of 62 for vitality, while the placebo group scored their energy level at 43.8. The higher score reflected improved energy in the group taking low dose of the study medication.

The researchers reported that these results at 12, 24 and 48 weeks were not statisitically significant. The authors said, "However, the magnitude of some of these changes suggests clinical relevance."

During the SL0006 study, 21 of 29 patients reduced their corticosteroid dose and 11 discontinued it completely. Most study participants were taking 5 mg corticosteroid a day at 48 weeks and at 100 weeks.

At week 24, 75 percent of the patients taking 360 mg/m2 epratuzumab had decreased their corticosteroid dose, compared to 56.5 percent of those taking placebos. This was a significant decrease.

Decreases were seen in corticosteroid dose at 48 weeks and in patients taking high dose epratuzumab, but they were not statistically significant.

During the course of the ALLEVIATE study, three patients on placebo and two given high dose epratuzumab reported adverse events. The authors did not discuss whether these were directly caused by the study medications or the placebo, but did state that the incidences of all adverse events, serious adverse events and infusion-related adverse events, and rate of infection in the ALLEVIATE study were similar between the epratuzumab and placebo-treated groups.

There were three adverse events reported in the SL0006 study. All participants who experienced these adverse events dropped out of the studies.

The researchers noted that the results of the SL0009 trial should be interpreted cautiously as eight of the 29 patients had previously been given placebo in the ALLEVIATE study, so not all the effects seen could be attributed to the study medication.

The authors concluded that epratuzumab treatment improved patient-reported quality of life and decreased disease activity. It also resulted in large decreases in the amount of corticosteroids these patients took.

Dr. Strand's article was published November 22 in Rheumatology.

Partial funding for the ALLEVIATE studies came from Immunomedics and UCB Pharma. The SL0006 study was funded by UCB Pharma.

Dr. Strand disclosed that he is a consultant for and received honoraria from UCB Pharma, Abbott Immunology, Amgen, Anthera, AstraZeneca, BMS, Genentech/Roche, GSK, Human Genome Sciences, Idera, Janssen, Lilly, Medimmune, Novartis Pharmaceuticals, Novo Nordisk, Orbimed, Pfizer, Rigel, Sanofi and Takeda.

Review Date: 
December 4, 2013
Last Updated:
December 31, 2013