EXTON, Pa.--()--BioTrends Research Group, one of the world’s leading research and advisory firms for specialized biopharmaceutical issues, finds that the recent availability of Novartis’s Gilenya in the EU5 has impacted second- and third-line disease-modifying agent (DMA) use for multiple sclerosis (MS) patients without influencing first-line DMA choice. In the recently published ChartTrends®: Multiple Sclerosis, patient-level data indicate that the introduction of Gilenya, the only oral DMA currently on the market, has pulled later-line patient share from Biogen Idec’s Avonex, Bayer Schering’s Betaferon, Novartis’s Extavia and Merck’s Rebif compared to 2011 audit data captured prior to the Gilenya launch. According to current Gilenya prescribers in the EU5, Gilenya’s perceived ability to reduce relapse rates is the main driver behind its initiation.
Nine months after commercial availability, 19 percent of audit patients have been tested with the anti-JC virus antibody assay, which is used to help mitigate the progressive multifocal leukoencephalopathy (PML) risk associated with treatment with Biogen Idec/Elan’s Tysabri. Audit data shows that assay candidates are clearly those patients who are either on Tysabri or who are being considered for a switch to Tysabri at the time of testing. In fact, 51 percent of patients were prescribed Tysabri at the time of testing, with only 5 percent of patients being DMA-naïve. Of the 67 percent of patients who test seronegative, the majority either remain on Tysabri (if already prescribed when tested) or are subsequently switched to Tysabri, suggesting that the assay is having a direct impact on Tysabri prescribing decisions.
When asked to hypothetically switch audit patients to one of the DMAs in late stage clinical development, EU5 neurologists identify the greatest potential for Biogen Idec’s BG-12 (26 percent of audit patients), followed by Biogen Idec’s PEG-Avonex (21 percent) and Teva’s laquinimod (17 percent). Analysis of patient and disease characteristics among identified BG-12 candidates suggests that BG-12 may see early adoption among mild RRMS patients, many of which are currently prescribed Teva’s Copaxone, upon launch.
ChartTrends®: Multiple Sclerosis is a syndicated annual patient audit designed to compare what physicians self-report about disease management to what actually occurs at the patient level. The 2012 audit captures information from 1030 patient charts provided by 242 neurologists from France, Germany, Spain, Italy, and the UK in March and April 2012. All patients are on one of the commercially-available DMA brands (Avonex, Betaferon, Copaxone, Extavia, Gilenya, Rebif, Tysabri) at the time of the audit. Through an in-depth review of specific patient charts, details such as product initiation, switching, exacerbation management, and a host of laboratory tests and patient demographic variables help define patient types and identify therapy triggers. Patient profiles for the seven DMAs in late clinical development (teriflunomide, BG-12, alemtuzumab, PEG-Avonex, daclizumab, laquinimod, ocrelizumab) are also characterized.
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