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Study Suggests Infliximab May Reduce Sciatica Symptoms
This trial marks the first study of anti-TNF-alpha therapy for patients suffering from sciatica, a condition characterised by a protruding disc in the lower spinal column pressing on the lower spinal nerve roots.
"These results are very promising for patients suffering from severe sciatica, for whom surgery is the only treatment option," said Jaro Karppinen, M.D., of Oulu University Hospital, Oulu, Finland, one of the two sites where the study was conducted. "While more research is needed, these findings indicate that infliximab may provide a potential new alternative to help fulfil this unmet medical need."
According to the American Academy of Orthopaedic Surgeons, sciatica occurs predominantly in people between the ages of 30 and 50 years old. Sciatica may be caused by the effects of normal wear and tear to the body, plus any sudden pressure on a disc that supports the vertebrae of the lower spine, resulting in a herniated disc. Approximately one in every 50 people experiences a herniated disc. Of these, 10 to 25 per cent have symptoms lasting more than six weeks, such as weakness, numbness, or a burning or tingling sensation travelling down the leg.
"This study is very encouraging in a number of ways," said Heikki Hurri, M.D., Ph.D., director of the Orton Rehabilitation Centre. "Not only do the findings provide new hope for sciatica patients, but the data lend further evidence to the emerging role of TNF-alpha in sciatica, as has been shown in earlier studies in a large variety of immune-mediated inflammatory disorders such as ankylosing spondylitis, psoriasis, and psoriatic arthritis in addition to its proven role in rheumatoid arthritis and Crohn's disease."
The purpose of this open-label study was to evaluate the efficacy and safety of a single intravenous infusion of infliximab for patients with severe sciatica indicated for surgical treatment. Ten patients with disc herniation-induced severe sciatica received infliximab intravenously over two hours, and the outcome was measured at one hour, one week, two weeks, one month and three months after the infusion. Patients who received the infliximab therapy were compared with a historical control group. The primary outcome measurement was leg pain, with more than a 75 per cent decrease from the baseline score constituting a painless state. Other outcomes measured included disability, sick leave and clinical status.
Results demonstrated that infliximab produced a rapid improvement in leg pain among patients with severe sciatica. Specifically, one hour after the infusion, leg and back pain decreased by approximately 50 per cent. At two weeks, 60 per cent of patients in the infliximab group were painless versus only 16 per cent of historical control patients. This benefit was sustained at three months.
At one month, results also indicated that every patient being treated with infliximab had returned to work versus only the 38 per cent as expected based on the historical control group. Additionally, none of the infliximab patients underwent surgery during the three-month follow-up period, compared with 15% of the patients in the historical control group. Neither immediate nor delayed adverse drug reactions nor any adverse effects due to infliximab medication were observed.
"When these findings are confirmed in randomised clinical trials, infliximab may have the potential to dramatically impact patients' ability to resume their daily activities, eliminating the need for surgery in many cases, thus reducing the overall costs associated with the need for hospitalisation and time lost from work," said Dr. David Borenstein, clinical professor of medicine and former director of the Spine Center, George Washington University Medical Center, Washington, DC.
Dr. Karppinen is scheduled to present longer-term, follow-up sciatica data at the International Society for the Study of the Lumbar Spine (ISSLS) annual meeting, 13 May - 17 May in Vancouver, Canada. The findings will look at the ability of infliximab to demonstrate an extended treatment benefit for sciatica. A large multi-national, randomised, controlled study is currently being conducted to verify these initial findings.