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New vaccines look promising
At the recent 63rd Annual Meeting of the American College of Rheumatology in Boston, researchers shared the latest findings on how to reduce the pain and disability associated with rheumatoid arthritis and osteoarthritis. These studies may help you offer your patients new treatment options for these crippling diseases.
A pooled analysis of clinical studies of celecoxib capsules, a drug designed to target only the COX-2 (cyclooxygenase-2) enzyme, indicates that the drug helps elderly osteoarthritis patients more easily perform a variety of activities of daily living, including getting out of bed, putting on socks, and rising from a chair.
Researchers studied 956 patients with osteo-arthritis of the hip or knee who were at least 70 years old. The study used a subset analysis of three pooled 12-week studies involving 3,255 patients. Researchers assessed pain, stiffness and physical functioning using the Western Ontario and McMaster Universities Osteoarthritis Index and the Short-Form 36 Health Survey.
The 956 patients were randomized to receive celecoxib capsules (50 mg, 100 mg, or 200 mg), naproxen, or placebo. Overall, celecoxib was as effective as naproxen and better than placebo at improving patients’ functioning.
Roll up your sleeve
Researchers from Johns Hopkins University in Baltimore told colleagues at the meeting that data from a Phase IIb clinical trial of a therapeutic vaccine indicate that it appears safe and effective for the treatment of rheumatoid arthritis.
The Immune Response Corp. in Carlsbad, CA, manufactures the vaccine IR501 which in an earlier Phase II trial of 99 rheumatoid arthritis patients appeared safe and well-tolerated with apparent clinically meaningful improvement, or marked reduction of tenderness and swelling of joints, after 24 weeks of treatment.
In the current double-blind trial, 340 patients received either 30 mcg or 90 mcg of IR501 therapeutic vaccine; 30 mcg or 90 mcg of IR 703 therapeutic vaccine; or placebo. Treatments were administered as a single intramuscular injection at weeks zero, four, eight, and 20. Patients were followed for 24 weeks.
• Patients receiving either doses of IR501 (30 mcg or 90 mcg) and the higher dose (90 mcg) of IR703 appeared to have clinically meaningful improvement in their disease condition after three injections.
• An increased positive clinical response was observed after each of the three primary monthly injections. After week 16, this clinical response appeared to decrease until a fourth injection was administered at week 20. Following the last injection, the clinical response increased back to the levels observed at week 16 for both the 30 mcg IR501 group and the 90 mcg IR703 group.
For best results . . .
Researchers noted that those results suggest that continued monthly injections appear to maintain a clinical response and should be evaluated in any future trials to confirm or extend the therapeutic benefit. In addition, they reported that the therapeutic vaccine may be most effective in patients in early-stage disease. In a subset of patients who had the disease for less than three years, a statistically significant treatment effect was observed in both the 30 mcg IR501 and the 90 mcg IR703 groups at the end of the trial. After the final injection, 50% of patients from both of those treatment groups appeared to improve, compared to less than 10% of the control group.
Researchers told their colleagues that the oral disease-modifying rheumatoid arthritis medication, Arava (leflunomide), which is manufactured by Kansas City, MO-based Hoeschst Marion Roussel, is still safe and effective after two years. In fact, patients on leflunomide therapy showed statistically significant improvement at two years in tenderness and swelling of the joints compared to patients on the active control drug, methotrexate.
In a one-year, Phase III placebo-controlled trial presented at last year’s meeting, 482 patients were given one of three treatments:
• leflunomide 20 mg/day after a loading dose of 100 mg/day for three days;
• methotrexate 7.5 mg/week with an increase to 15 mg/week for continued active disease.
Researchers followed 235 patients in the second-year continuation of the trial. "The data showed that clinical and radiographic improvement observed with leflunomide and methotrexate at one year was maintained at two years, providing evidence of the durability and consistency of leflunomide’s efficacy and safety," said Vibeke Strand, MD, clinical associate professor at Stanford University in Palo Alto, CA. "Addition ally, at two years, leflunomide demonstrated significantly significant improvements in clinical response rates compared to the active control, methotrexate."
In the same study, improvement in physical function with leflunomide remained consistent over two years and was statistically significant compared to methotrexate. A separate scientific analysis of leflunomide presented at the meeting compared and analyzed results of three large, multinational, controlled trials. Leflunomide consistently retarded the structural damage associated with rheumatoid arthritis across all three clinical trials regardless of patient disease duration.
More than 70% of children with severe, long-standing juvenile rheumatoid arthritis respond — often dramatically — to etanercept therapy, according to an ongoing three-year study at the Children’s Hospital Medical Center of Cincinnati.
In this clinical trial, 74% (51 of 69) of children age 4 to 17 demonstrated clinically significant improvement when treated with etanercept for three months. In the second segment of the study, the 51 children who showed improvement were randomized to receive either etanercept or placebo. In this segment, 72% of patients treated with etanercept continued to improve on treatment without any arthritis flares, compared to only 28% of patients treated with placebo.
"These findings show a significant, often profound, improvement for most children with juvenile rheumatoid arthritis when treated with etanercept over placebo," said Daniel J. Lovell, MD, MPH, a pediatric rheumatologist at Children’s Hospital and Medical Center, principal investigator of the study. "Before etanercept treatment, many children with severe juvenile rheumatoid arthritis had poor response to existing treatment options. Often they had to stop attending school. They’d be stiff for hours in the morning and experience pain every time they walked. Now there’s hope for these children."
The third segment of the study is an open-label extension study of etanercept to treat juvenile rheumatoid arthritis. Results to date show that with continued treatment with etanercept, 80% of children who demonstrated initial clinical response to the drug continued to respond for more than one year.
Patients in the study had an average of 29 active inflamed joints when starting this trial. Of those patients, 31% no longer have joints with active arthritis after one year of treatment with etanercept. In addition, 32% of patients have been relieved of all joint pain, and 76% no longer experience morning stiffness.
Fosamax (alendronate sodium), manufactured by Philadelphia-based Merck & Co., prevents the early loss of bone mass that often occurs in patients following hip replacement surgery.
The two-year study brings good news to the nearly 300,000 patients who undergo hip replacements each year in the United States. The surgery causes a redistribution of load to the bone around the implant, which can lead to rapid bone loss following surgery and ultimately to loosening of the hip implant.
Researchers presented data from a two-year, double-blind, single-center, placebo-controlled, randomized trial. In the first year of the study, 49 patients between 46 and 81 years of age who underwent hip replacement were divided into the following three patient groups:
• 16 "acute" patients with a recent hip replacement within 30 days of entering the study;
• 17 "chronic" patients with hip replacement more than five years prior to the study with no evidence of loosening of the implant due to bone loss;
• 16 "revision" patients with hip replacement surgery performed more than five years ago and loosening of their implant due to bone loss. Those patients were enrolled in the study while waiting revision surgery to replace the loose implant.
Patients were randomized to receive either Fosamax (10 mg once daily) or placebo. All patients were supplemented with 500 mg elemental calcium daily. Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
• Acute patients treated with Fosamax had a 0.8 + 1.06% gain in bone mineral density from baseline compared to a loss of 4.78 + 0.47% from baseline in patients treated with placebo.
• Chronic patients treated with Fosamax showed no significant difference compared to those treated with placebo.
"These results show that it may be more beneficial to begin treatment with Fosamax soon after hip replacement surgery in order to prevent loss of bone mass," said Albert Leung, MD, PhD, associate director of endocrine and metabolism clinical research for Merck Research Laboratories.