MS disease activity in RESTORE

Fox, Robert J.; Cree, Bruce A. C.; Sèze, Jérôme De; Gold, Ralf; Hartung, Hans Peter; Jeffery, Douglas; Kappos, Ludwig; Kaufman, Michael D.; Montalbán, Xavier; Weinstock‐Guttman, Bianca; Anderson, Brad; Natarajan, Amy; Ticho, Barry; Duda, Petra W.

doi:10.1212/wnl.0000000000000355

Cited by 174 publications

(213 citation statements)

References 25 publications

Supporting

Mentioning

195

Contrasting

Unclassified

Order By: Relevance

“…2 However, these data provided no information on whether the return of disease activity and disability progression could be mitigated by switching to alternative therapies. In the phase 4, randomized RESTORE trial, 21 which enrolled patients who were stable while taking natalizumab treatanother treatment. However, these differences were not statistically significant (Figure 4C and D).…”

Section: Sf-12 Pcs Changementioning

confidence: 99%

Disability Progression After Switching from Natalizumab to Fingolimod or Interferon Beta/Glatiramer Acetate Therapies

Cofield

Fox²,

Tyry

et al. 2016

International Journal of MS Care

View full text Add to dashboard Cite

show abstract

Section: Sf-12 Pcs Changementioning

confidence: 99%

Disability Progression After Switching from Natalizumab to Fingolimod or Interferon Beta/Glatiramer Acetate Therapies

Cofield

Fox²,

Tyry

et al. 2016

International Journal of MS Care

View full text Add to dashboard Cite

show abstract

“…Several articles have demonstrated acute disease recurrence on stopping DMTs. 5,6 Patients in these studies were younger (mean ages in the fifth decade), with only 1 year of treatment in the article by Wu et al 6 and only 1 year of no relapses in the article by Fox et al 5 Again, no data were presented as to when one could safely discontinue DMTs in individuals with nonrelapsing disease. To address this issue, we initiated this prospective study.…”

mentioning

confidence: 99%

Stopping Disease-Modifying Therapy in Nonrelapsing Multiple Sclerosis

Birnbaum¹

2017

International Journal of MS Care

View full text Add to dashboard Cite

Background: Current disease-modifying therapies (DMTs) are of benefit only in people with relapsing forms of multiple sclerosis (RMS). Thus, safely stopping DMTs in people with secondary progressive MS may be possible. Methods: Two groups of patients with MS were studied. Group A consisted of 77 patients with secondary progressive MS and no evidence of acute central nervous system inflammation for 2 to 20 years. These patients were advised to stop DMTs. Group B consisted of 17 individuals with RMS who stopped DMTs on their own. Both groups were evaluated at treatment cessation and for a minimum of 1 year thereafter. Multiple variables were assessed to determine those that predicted recurrent acute disease. Results: Nine patients in group A (11.7%) and ten patients in group B (58.8%) had recurrent acute disease, almost always within 1 to 2 years of stopping treatment. The only variable of significance in group A distinguishing stable and relapsing patients was age (P = .0003), with relapsing patients being younger. Group B patients were younger and had significantly lower Expanded Disability Status Scale scores than group A, with no significant differences in age between relapsed and stable patients. Conclusions: The DMTs can be stopped safely in older patients with MS (≥7 decades) with no evidence of acute disease for 2 years or longer, with an almost 90% probability of remaining free of acute recurrence. The high proportion of untreated patients with RMS experiencing recurrent acute disease is consistent with published data.

show abstract

“…lesion of [0.8 cm 3 in volume, (2) two or more Gd? lesions of any size, as reported by the Central MRI Reading Center, or (3) a relapse meeting specific criteria, including changes in Expanded Disability Status Scale (EDSS) score, as previously described [25].…”

Section: Methodsmentioning

confidence: 99%

“…Full RESTORE study details are described in a separate report [25]. Each site's institutional review board reviewed and approved the study protocol and amendments, and all participants provided written informed consent.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Radiologic MS disease activity during natalizumab treatment interruption: findings from RESTORE

et al. 2014

View full text Add to dashboard Cite

The objective of this study is to characterize the timing and extent of radiologic MS disease recurrence during the 24-week natalizumab treatment interruption period in RESTORE. RESTORE was a randomized, partially placebo-controlled exploratory study. Natalizumabtreated patients with no gadolinium-enhancing (Gd?) lesions at screening (n = 175) were randomized 1:1:2 to continue natalizumab (n = 45), switch to placebo (n = 42), or switch to other therapies (n = 88) for 24 weeks. MRI assessments were performed every 4 weeks. Predictors of increased numbers of Gd? lesions during natalizumab treatment interruption were evaluated. The numbers of Gd? lesions were compared with retrospectively collected pre-natalizumab MRI reports and data from placebo-treated patients from two historical randomized clinical trials. Gd? lesions were detected in 0 % (0/45) of natalizumab patients, 61 % (25/41) of placebo patients, and 48 % (39/81) of other-therapies patients during the randomized treatment period. Gd? lesions were detected starting at week 12; most were observed at week 16 or later. Thirteen percent (14/107) of patients had [5 Gd? lesions on C1 (of 6) scans during the randomized treatment period versus 7 % (7/107) of patients pre-natalizumab (based on medical record of a single scan). Younger patients and those with more Gd? lesions prenatalizumab were more likely to have increased MRI activity. Distribution of total and persistent Gd? lesions in RESTORE patients was similar to placebo-treated historical control patients. In most patients, recurring radiological Drs. Ticho and Duda are former employees of Biogen Idec Inc. and were at the company during study conduct.

show abstract

MS disease activity in RESTORE

Cited by 174 publications

References 25 publications

Disability Progression After Switching from Natalizumab to Fingolimod or Interferon Beta/Glatiramer Acetate Therapies

Disability Progression After Switching from Natalizumab to Fingolimod or Interferon Beta/Glatiramer Acetate Therapies

Stopping Disease-Modifying Therapy in Nonrelapsing Multiple Sclerosis

Radiologic MS disease activity during natalizumab treatment interruption: findings from RESTORE

Contact Info

Product

Resources

About