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agate
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 Posted: Sat Jun 01, 2013 6:21 pm Post subject: MRI findings drive treatment changes in MS |
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From MedPage Today, June 1, 2013:
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MRI Findings Drive Tx Changes in MS
By John Gever, Deputy Managing Editor, MedPage Today
Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner
ORLANDO -- Decisions to change multiple sclerosis treatments soon after starting them appear to be driven more by MRI findings of increasing disease activity than worsened clinical symptoms, a researcher said here.
In a retrospective analysis of 606 patients showing suboptimal responses to an initial disease-modifying therapy, the factor showing the strongest association with a change in treatment was increased disease activity seen in MRI scans (odds ratio 6.3 compared with a single relapse alone, 95% CI 3.1-12.9), reported Barbara Teter, PhD, MPH, of the State University of New York at Buffalo.
Oddly, though, the patients least likely to change treatments were those showing relapses plus either worsened disability or increased MRI lesions, according to Teter. She and her colleagues had no firm explanation for this finding, but their hypothesis is that such patients are psychologically resistant to seeking other treatments, she told MedPage Today.
Other factors associated with increased or decreased likelihood of changing treatments after a suboptimal initial response included multiple relapses, disability progression, patient age, and time elapsed from diagnosis to initiation of disease-modifying treatment.
Teter and colleagues reviewed data from 1,448 patients in a New York state registry of MS patients from 1996 to 2009, comprising 14 MS clinics and neurology practices. Records were complete for 606 patients who had started treatment with either interferon-beta (Rebif, Avonex, Betaseron) or glatiramer acetate (Copaxone) and subsequently suffered an MS "event."
An event was defined as a clinical relapse, disability worsening as measured on the Expanded Disability Status Score (EDSS) system, increases in MRI lesion volumes or counts, or any combination of these noted at a single clinic visit. Patients who changed treatments after a second MS event separated in time from the first were not included in the analysis.
Patient demographics and clinical characteristics were reflective of the general MS population starting on disease-modifying drugs during the study period. About 75% were women, they were in their early 30s on average at symptom onset, and they started their first disease-modifying treatment a mean of about 8 years later. Mean EDSS score at initiation of disease-modifying therapy was 2.3 (SD 1.6).
Of the 606 patients in the analysis, 214 changed to another disease-modifying treatment within 6 months of an event, whereas the other 392 remained on their initial therapy. Switchers changed treatments a mean of 3.4 years (SD 2.7) after starting the first therapy.
The most common event in the overall sample was EDSS worsening alone, seen in 25% of patients, followed by relapse alone (22%), MRI worsening alone (16%), and relapse combined with EDSS worsening (16%). Other combinations were seen in less than 10% of patients.
Among those switching treatments, 32% did so after experiencing MRI worsening alone, compared with 8% of those not switching. Another 32% of switches occurred after EDSS worsening alone, whereas that was the index event in 21% of non-switchers.
In a logistic regression adjusted for clinical and demographic characteristics and clinic location, Teter and colleagues calculated the following odds ratios for switching after a given type of event, with a single relapse alone as the reference:
~MRI worsening alone: OR 6.3 (95% CI 3.1-12.9)
~EDSS worsening alone: OR 2.2 (95% CI 1.2-4.1)
~MRI and EDSS worsening combined: OR 2.5 (95% CI 1.1-5.9)
~Relapse plus MRI and/or EDSS worsening: OR 0.25 (95% CI 0.12-0.52)
~Multiple relapses plus MRI and/or EDSS worsening: OR 0.62 (95% CI 0.24-1.60)
Such factors as time from EDSS worsening to initiating the first disease-modifying treatment or the time from starting treatment to the first event were not related to the likelihood of switching, the researchers found.
But older age was negatively associated with likelihood of switching (OR 0.46, 95% CI 0.30-0.71). Clinic location was also a significant factor, suggesting that switching may be discouraged or encouraged in specific practices.
In explaining the strong apparent effect of MRI results on treatment decisions, Teter told MedPage Today that these findings may weigh especially heavily on clinicians' judgment. When MRI scans show increased disease activity, that may drive many clinicians to recommend a different therapy, she said -- more so than findings of relapse alone.
But she pointed out that the study period of 1996 to 2009 was a significant limitation to the analysis. At that time, the interferons, glatiramer acetate, and natalizumab (Tysabri) were the only disease-modifying therapies available. Moreover, Teter said, the study spanned the interval in 2005 and 2006 when natalizumab was taken off the U.S. market, leaving even fewer options.
Since then, a series of oral disease-modifying treatments have been approved including fingolimod (Gilenya), teriflunomide (Aubagio), and dimethyl fumarate (Tecfidera, BG-12), availability of which may alter patients' and clinicians' decision-making when responses to first-line drugs are suboptimal. Teter said her group plans to update the analysis with more current data.
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The study was supported by Novartis. Two co-authors were Novartis employees.
Teter reported relationships with Novartis, Biogen Idec, Teva, Avanir, and EMD-Serono.
Primary source: CMSC-ACTRIMS Joint Meeting
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Source reference:
Teter B, et al., "Predictors of switching first-line disease-modifying therapy for MS patient[s]," CMSC-ACTRIMS 2013; Abstract DX56. |
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