Big-Name Drugs Try New Roles In Rheumatism

Lilly’s Cymbalta performs well in major osteoarthritis trial.

Among others exploring new roles at the annual EULAR show, Bristol-Meyers Squibb's Orencia and Abbot's Humira were auditioning for parts in treating earlier-stage rheumatoid arthritis, while Lilly's Cymbalta , well-versed in depression, showed its worth in osteoarthritis.

Patients with undifferentiated inflammatory arthritis may stave off development of rheumatoid arthritis by taking Orencia (abatacept), according to a small Phase II study of 56 patients presented at the European League Against Rheumatism meeting, held from June 11 to June 14 in Paris.

Orencia has been used for adults with rheumatoid arthritis and recently won approval for treating moderately-to-severely active polyarticular juvenile iodiopathic arthritis in pediatric patients aged six years and up (¹ (Also see "FDA Clears BMS’ Orencia In Juvenile Arthritis" - Pink Sheet, 8 Apr, 2008.)).

In the new six-month randomized trial reported at EULAR, the drug was tried in patients who had undifferentiated disease and anti-cyclic citrullinated peptide antibodies, signifying higher risk of progression to RA.

Out of 50 patients available for analysis at the trial's end, 12 of 26 who took Orencia progressed to RA, versus 16 of 24 taking a placebo, researchers reported.

The drug was generally well-tolerated, with similar, side-effect, adverse event and discontinuation (one patient) rates in treatment and placebo study arms.

Early treatment of rheumatoid arthritis with Abbott's Humira (adalimumab) in combination with methotrexate yields economic benefits for society along with clinical gains for the patient, according to another new study presented at EULAR.

FDA approved Humira for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and up, earlier this year (² (Also see "Abbott’s Humira Approved For Juvenile Idiopathic Arthritis" - Pink Sheet, 22 Feb, 2008.)).

The new study concluded that the addition of Humira to the RA treatment regimen enhanced work performance and reduced absenteeism, benefits that contributed to indirect cost savings of $6,086 per patient per year, compared to treatment with methotrexate alone.

In early disease, the degree of joint damage affects patients' employment prospects, the study also found.

Researchers also presented a seven-year summary of trials studying Humira with methotrexate, covering a patient population of nearly 1,500 patients, with average length of exposure running 47 months. Among others, were three Phase III safety and efficacy trials: ARMADA, DE019 and STAR.

Separately, in another EULAR presentation, researchers said Humira provided long-term relief of symptoms in the majority of ankylosing spondylitis patients monitored over the course of the three-year ATLAS Phase III trial.

In this population of patients who had not gained relief through standard treatment with nonsteroidal anti-inflammatory and disease modifying antirheumatic drugs, nearly three fourths in the treatment arm responded to a 40 mg dose of Humira throughout the three-year trial period. Side effects included colds and upper respiratory tract infections.

Cymbalta performs in osteoarthritis

At the EULAR meeting, Eli Lilly said that serotonin-norepinephrine reuptake inhibitor Cymbalta (duloxetine) helped relieve osteoarthritis pain in the knee in a 13-week randomized study of 231 patients.

According to analyses of 24-hour average pain scores, 59 percent of those on Cymbalta had a 30 percent improvement, versus 45 percent for those on placebo. Furthermore, 47 percent on Cymbalta had a 50 percent improvement versus 29 percent on placebo.

Indianapolis-based Lilly said the data are important, marking the first time that Cymbalta has been "studied in a large, placebo-controlled trial in what's classified as an inflammatory disease state."

"Although the exact mechanism of action is unknown, this study may provide important insights into the treatment of pain in the central nervous system," the firm said in a statement

Cymbalta is approved for depression, anxiety and management of diabetic peripheral neuropathic pain. The firm submitted a supplemental new drug application for Cymbalta in the management of chronic pain last month (³ (Also see "Lilly Submits Cymbalta For Chronic Pain" - Pink Sheet, 29 May, 2008.)). Cymbalta is also under review for fibromyalgia.

- Emily Hayes ([email protected])