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Study Results of Oralgam in Juvenile Rheumatoid Arthritis Presented at Rheumatology Meeting

TUCSON, Ariz.--(BUSINESS WIRE)--Sept. 22, 2003--A Phase II clinical trial to evaluate the potential of Oralgam(TM) (oral human immunoglobulin) as an add-on therapy to treat juvenile rheumatoid arthritis (JRA) in children 3 to 16 years of age found that the longer patients remained on Oralgam, the more improvement was seen in multiple measures of disease activity. Study results will be presented by Ilona Szer, M.D., at the ACR Annual Meeting held Orlando, Fla., Oct. 24-28.

JRA, a severe and crippling condition, is the most common rheumatic disease in children, resulting in approximately 30,000 to 50,000 patients in the United States, according to the Arthritis Foundation. Drugs initially developed and approved for use in adults are currently being used in children with varying degrees of safety and efficacy. A significant number of children with JRA, however, fail to achieve adequate control of disease symptoms using standard therapies, including methotrexate, prednisone and anti-TNF or anti-IL1 biological response modifiers.

The 40 children with JRA in the Phase II clinical trial sponsored by Protein Therapeutics were selected based on having at least four active joints and inadequate response to standard treatment. Response to treatment was evaluated using the ACR Pediatric 30 criteria.

Findings of the study include:
-- Two-thirds of the children who remained on the drug for at least four months met the definition of improvement in disease activity by measures recognized by the American College of Rheumatology.

-- Regression analysis predicted a 57 percent improvement in daily disability scores (Childhood Health Assessment Questionnaire), an 88 percent improvement in active joint scores, a 69 percent improvement in Patient Global Assessment scores and a 76 percent improvement in Physician Global assessment scores over a 12-month period compared to baseline.

-- Steroid use was reduced by 71 percent of the patients receiving daily or weekly dosing with steroids.

-- Seven patients were able to eliminate steroids completely while participating in the trial.

-- Seventy-seven percent of the patients who reduced or eliminated steroid use during the trial met the ACR definition of response while steroid use was being tapered or eliminated.

The study concluded that the safety of the treatment and the response of patients who previously had been inadequately controlled with multiple conventional drugs are encouraging and suggest that Oralgam should be evaluated further in longer-term, dose-ranging clinical trials.

The complete abstract of the study results, "Oral Human Immunoglobulin in Juvenile Rheumatoid Arthritis (JRA)," is available at www.rheumatology.org/annual/abstracts.

Protein Therapeutics has an approved Investigational New Drug (IND) application with the U.S. Food and Drug Administration for the use of Oralgam in the treatment of juvenile rheumatoid arthritis. The FDA also has granted orphan drug designation to Oralgam to help facilitate its development for the treatment of JRA. Currently, Oralgam is the only drug being developed specifically to treat JRA. The established safety of human immunoglobulin allows the drug to be tested in children without first having to be tested in adults.

Oral administration of human immunoglobulin, as Oralgam, is being studied as a new and unique approach to treating JRA and other autoimmune diseases. Instead of suppressing the body's immune system as current therapies do, oral immunoglobulin, prepared from pooled normal human donor plasma, supplements the body's immune system.

Source: Protein Therapeutics

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