If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Tanezumab Appears Safe for Relieving Pain Associated With Osteoarthritis of the Knee: Presented at OARSI By Louise Gagnon MONTREAL -- September 14, 2009 -- Tanezumab relieves pain associated with osteoarthritis (OA) of the knee and is safe, according to research presented here September 12 at the 2009 World Congress of the Osteoarthritis Research Society International (OARSI). Leslie Tive, PhD, Pfizer Inc., New York, New York, said the agent could be administered in a physician’s office since it is administered by slow infusion only every 8 weeks. “Patients don’t have to take a medication everyday, so it is liberating over time,” said Dr. Tive on September 12, noting patients with advanced knee osteoarthritis face challenges with daily activities like walking. “They worry about when they will get flares,” she said. “It helps if they have a stable level of analgesia over time.” Participants had been in a previous study to evaluate the appropriate dosage of the medication, explained Dr. Tive. A total of 281 patients participated in the open-label, extension period of the phase 2 study. Patients had to receive at least 2 doses in the initial study before entering the extension phase. Patients received between 1 and 8 infusions of tanezumab 50 mcg/kg over a mean period of 224 days. The mean age of patients was 59.3, and the majority were female. “This is a humanised, monoclonal antibody that is anti-NGF [nerve growth factor],” explained Dr. Tive. “We are studying its efficacy for several types of pain including osteoarthritis.” Elevated levels of NGF have been linked to increased pain in several pain conditions, such as OA, while declines in NGF have been linked to decreases in pain response, according to Dr. Tive. Patients rated their overall knee pain, using a visual analogue scale of 0 to 100, with a mean score of 60.6 at baseline. A score of zero indicated no pain and 100 indicated extreme pain. A total of 6 patients (2.1%) received 8 infusions, up to week 56. Investigators concluded patients experienced pain relief throughout their treatment. A total of 168 patients (59.8%) experienced adverse events, with 21 (7.5%) experiencing adverse events related to treatment. The most common side effects reported by patients included arthralgia, back pain, and headache. Some patients also experienced abnormal peripheral sensations such as hypoaesthesia, paraesthesia, hyperaesthesia, and peripheral neuropathy. “It was safe and well tolerated up to a year,” she said in an interview. “The abnormal peripheral sensations are usually transient, lasting less than 2 weeks, and resolving on their own. Patients rarely experience the (abnormal peripheral) sensation after the second dose. It appears to be an adaptation of the peripheral nervous system.” Funding for this study was provided by Pfizer Inc. [Presentation title: Safety of Tanezumab in Treating Moderate to Severe Pain Due to Osteoarthritis of the Knee: An Open-Label Extension Study. Abstract 322]
|
