November 13, 2008

• Study to focus on premier therapies for autoimmune disorders

• Biologics' full risks and benefits unknown for rheumatologists

BIRMINGHAM, Ala. - The University of Alabama at Birmingham (UAB) Center for Education and Research on Therapeutics (CERTs) has won a $2.2 million grant to study the risks and benefits of a newer class of medicines called biologics. These are genetically engineered therapies that target the immune system of patients who have rheumatoid arthritis, Crohn's disease, psoriasis and other autoimmune disorders.

The award will allow the UAB CERTs to pinpoint which biologics have potential safety concerns. Additionally, researchers will examine which biologics work best for specific groups of patients, including women, children, minorities and the disabled. All of the biologics being studied are U.S. Food and Drug Administration (FDA) approved.

Funding for new safety assessments comes at a crucial moment in the distribution and acceptance of newer autoimmune drugs, said Kenneth Saag, M.D., M.Sc., director of the UAB CERTs and a professor in the Division of Clinical Immunology and Rheumatology. Biologics have become a premier treatment for serious inflammatory conditions diagnosed by rheumatologists and other specialties.

CLARIFYING SAFETY

"These medicines have revolutionized the way chronic inflammatory disease is treated, and they have benefited millions of patients," said Saag, the principal investigator of the biologics grant. "We need the full picture, which is why side effects and patient risks and vulnerable patient groups must be examined."

The CERTs study will boost understanding of the risks and benefits of these drugs and better guide medical professionals, drug manufacturers, the FDA and the Agency for Healthcare and Quality (AHRQ), an agency within the Department Health and Human Services. AHRQ awarded the $2.2 million to UAB.

The UAB CERTs is one of only 14 such centers in the nation, and the only center devoted to the study of bone and joint diseases.

Researchers will focus on the use of eight biologics used for a range of autoimmune disorders. Among the studied drugs is what's called anti-TNF agents, or anti-tumor necrosis factor alpha agents. This category includes adalimumab (Humira), etanercept (Enbrel) and infliximab (Remicade). Five additional biologics will be studied.

The analysis will include patients who live in rural areas, and those who've been diagnosed with more than one autoimmune illness. Data will come from more than 100,000 biologics patients in the period 1998 to 2007.

The biologics study will include researchers from Brigham and Women's Hospital in Boston, Kaiser Permanente's Division of Research in California, Oregon Health and Science University in Portland, the University of Massachusetts Medical Center in Worcester, the University of Pennsylvania in Philadelphia and Vanderbilt University in Nashville.

*Note: Saag maintains a consulting relationship with Enbrel-maker Amgen, Inc. and with other biologics manufacturers.