Drugs in the Pipeline
Meet the next generation of biologics
Since 1998, six new biologics have been FDA approved for treating autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, psoriasis and ankylosing spondylitis. As of December 2007, two more of these drugs are in phase III trials and one has been submitted to the FDA for new drug approval. (Find out more about the approval process.) Several others are in phase II trials.
Baminercept (BG 9924)
Phase II
Being studied for: Crohn’s disease, lupus, multiple sclerosis and RA
How it’s taken: Weekly injection
Target: Lymphotoxin-beta, a component on the surface of cells that signals the inflammatory process to begin
Highlights: Patients taking baminercept showed 60 percent improvement in swollen joints 35 days after starting treatment, compared with only 4.6 percent improvement in those on placebo.
Lowlights: Headache, moderate flu-like symptoms after first dose
Certolizumab pegol (Cimzia)
Approved for: Crohn's disease
Phase III for: psoriasis and RA
How it’s taken: Monthly injection
Target: The inflammatory protein tumor necrosis factor alpha (TNF-a)
Highlights: Cimzia may reduce tender and swollen joints in four months, as opposed to six or eight – the norm for existing TNF inhibitors. Approximately 57 percent of patients experienced a 20 percent improvement in symptoms such as pain, swelling and stiffness within the first month of treatment, compared with 8.5 percent of those on placebo. Positive effects were greatest in people who had C-reactive protein levels higher than 10 mg/L at the start of the study. Cimzia also appears to be a safe option for women of childbearing age because it doesn’t cross the placenta during pregnancy and is not evident in breast milk.
Lowlights: Increased risk of infection, simliar to the risk encountered with current TNF blockers
Denosumab (AMG 162)
Phase II for RA
Phase III for osteoporosis and bone cancer
Being studied for: RA, bone cancer and osteoporosis
How it’s taken: Twice-yearly injections
Target: RANK ligand, a protein involved in the development of bony erosions, which are a hallmark of RA damage
Highlights: Reduces the rate at which bone erodes in people with RA by blocking RANK ligand and slowing the process of bone resorption. Those who received the highest dose (180 milligrams) showed the greatest decreases in erosions.
Lowlights: This drug isn’t designed to improve joint pain, inflammation or other RA symptoms.
| For information on other types of arthritis drugs in the pipeline, go to the Arthritis Foundation's Research Highlights section. |
Golimumab (CNTO 148)
Phase III
Being studied for: Ankylosing spondylitis, psoriatic arthritis
and RA
How it’s taken: Monthly injection
Target: The inflammatory protein tumor necrosis factor alpha (TNF-α)
Highlights: Improves musculoskeletal and skin symptoms. After 14 weeks of treatment, approximately 56 percent of patients (with psoriatic arthritis) had a 20 percent improvement in symptoms – such as pain; inflammation of tendons, ligaments or joints; and swelling in the hands or feet – compared with only 12 percent of those on placebo. Skin and nail problems associated with psoriasis also improved, by 75 percent. Tuberculosis or other infections did not occur, as they do in a small percentage of people taking other TNF-α inhibitors.
Lowlights: One or two cases of prostate cancer and basal cell carcinoma occurred among the 405 people in one clinical trial.
Ofatumumab (HuMax-CD20)
Phase III
Being studied for: RA (particularly in those who have failed methotrexate or anti-TNF therapy), non-Hodgkin’s lymphoma and chronic lymphocytic leukemia and potentially for Crohn’s disease and Wegener’s granulomatosis
How it’s taken: Intravenous infusion
Target: B cells (a type of white blood cell)
Highlights: Reduces the number of B cells, which may decrease disease activity. In a phase II study, 46 percent of people with RA showed at least a 20 percent improvement in joint swelling and tenderness, compared with only 15 percent of those given placebo. Those also taking methotrexate responded better than those taking ofatumumab alone. No serious infections were reported.
Lowlights: Mild or moderate infusion reactions occurred, with symptoms including shortness of breath, rash and sore throat.
Tocilizumab (Actemra)
New Drug Application submitted to FDA
Being studied for: RA, Castleman’s disease and systemic-onset juvenile idiopathic arthritis
How it’s taken: Intravenous infusion
Target: The inflammatory protein interleukin-6 (IL-6)
Highlights: Reduces pain and stiffness when given with methotrexate Twice as many people (53 percent) taking tocilizumab and methotrexate showed a 20 percent reduction in the signs and symptoms of RA at 24 weeks compared with those (26 percent) taking only methotrexate. Also, 28 percent of those taking both tocilizumab and methotrexate achieved remission compared with only one percent of people taking methotrexate alone. At high doses, it normalizes levels of C-reactive protein – an indicator of inflammation in the body.
Lowlights: Infections and an increase in blood cholesterol and liver enzymes occurred in some cases.
Check here periodically to follow how certain new drugs for arthritis are moving through the pipeline and to see what new ones are added.
