The American College of Rheumatology heralded 2011 as a year of focus on “treatment, treatment, treatment” for lupus. Presentations of data at this year’s scientific meeting in Chicago fulfilled that promise with studies evaluating investigational compounds in development as well as drugs already approved for lupus or for other conditions. Lupus Research Institute and its National Coalition of lupus patient groups were at the meeting and put together the following report of key industry achievements.
Epratuzumab, UCB and Immunomedics Inc.
Data from the EMBLEMTM study supported the BILAG-based Combined Lupus Assessment (BICLA) as a meaningful measure of systemic lupus erythematosus (SLE) disease activity. Using this assessment tool, researchers found a meaningful and statistically significant reduction in disease activity for patients treated with the investigational compound epratuzumab
“Evaluating disease activity in lupus clinical trials is challenging, because lupus has a complex pathophysiology, is highly variable between individuals, and has an unpredictable disease course,” commented Daniel J. Wallace, M.D., Lupus LA founder and Clinical Professor of Medicine, Cedars-Sinai/David Geffen School of Medicine at UCLA. “Following confirmation of the BICLA in the EMBLEM™ study we now have a sensitive, clinically meaningful composite measure of disease activity.” FULL ABSTRACT
IFNa-Kinoid, Neovacs SA
French biotech company Neovacs SA presented results of the IFNα-K double-blind, randomized and placebo-controlled clinical study in 28 patients with mild to moderate lupus. Study investigators noted that this is the first study to show positive results with active immunotherapy against Interferon-α in the treatment of Systemic Lupus Erythematosus. Further studies are planned in order to expand upon these observations. FULL ABSTRACT
Evista (raloxifene), Eli Lilly and Company
Data from a 12-month double-blinded randomized controlled trial showed that raloxifene significantly improved bone mineral density among postmenopausal lupus patients. To examine the effect of raloxifene on disease activity, flares, traditional risk factors and bone mineral density (BMD) in patients with SLE. Raloxifene is an oral selective estrogen receptor modulator (SERM) currently used in the prevention of osteoporosis in postmenopausal women.
Study investigators concluded that raloxifene is safe and well tolerated in stable SLE patients. No effect on blood clotting or increase in lupus activity or flares was found. FULL ABSTRACT
Orencia®(abatacept), Bristol-Myers Squibb
Abatacept, currently approved for treating rheumatoid arthritis, is being evaluated for possible use in lupus based on preclinical and clinical data in lupus.
- Presented by Dr. Richard Furie of North Shore-Long Island Jewish Health System, results of the Phase II/III of patients diagnosed with lupus nephritis (inflammation of the kidneys) showed that the addition of abatacept to standard treatment with mycophenolate mofetil did not improve effectiveness. However, an in-depth analysis showed a possible benefit for patients with nephrosis (noninflammatory kidney disease) that may warrant further study. FULL ABSTRACT
- Looking at the data from the same study, Dr. David Wofsky of VA Medical Center presented an analysis comparing two ways to evaluate efficacy. While the currently accepted measure of efficacy did not show statistically significant benefits, another measure — using a different definition of response to treatment — did show a benefit for patients treated with the addition of abatacept compared with those treated with standard therapy alone. FULL ABSTRACT
Benlysta®, (belimumab) Human Genome Sciences, GlaxoSmithKline
- Results of two small multi-center international Phase III trials suggest that belimumab may have beneficial effects on kidney disease among patients with lupus, supporting the value of initiating a randomized trial to evaluate belimumab treatment for lupus nephritis. FULL ABSTRACT
- Pooled analyses of Phase 3 clinical trial results showed that patients with SLE reported improvements in fatigue and health-related quality of life after one year of treatment with belimumab. FULL ABSTRACT
- Belimumab was shown generally well tolerated when used in combination with a wide range of standard SLE therapies according to results of an analysis of data from one phase 2 and two phase 3 multicenter, double-blind, clinical studies evaluating more than 2100 patients. FULL ABSTRACT
- Belimumab added to standard SLE therapy was well tolerated and maintained efficacy for patients remaining on treatment in an open-label continuation trial for over six years after participating in the original one-year Phase II trial. FULL ABSTRACT
- Analyses of two Phase III trial results revealed several measures to predict effective treatment with belimumab compared with standard of care alone. FULL ABSTRACT
Laquinimod, Teva Pharmaceuticals
- Results of a mouse study showed that treatment with laquinimod effectively inhibits disease progression. Teva reported, “These data suggest that the immunomodulator laquinimod is a promising new oral drug for treating SLE, and as such we have commenced clinical trials in both Lupus Nephritis and Lupus Arthritis.” FULL ABSTRACT