Immune Reconstitution Inflammatory Syndrome in Patients With Multiple Sclerosis Following Cessation of Natalizumab Therapy

Miravalle, Augusto; Jensen, Rikke Beck; Kinkel, R. Philip

doi:10.1001/archneurol.2010.257

Cited by 164 publications

(166 citation statements)

References 13 publications

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“…The follow-up visit occurred at week 52. MRI scans were performed at the screening visit (week -4) and at weeks 0, 4,8,12,16,20,24,28, and 52 and were read by the Central MRI Reading Center (NeuroRx Research, Montreal, Canada).…”

Section: Methodsmentioning

confidence: 99%

“…In one trial, patients with MS naive to natalizumab were randomized to receive placebo or natalizumab infusions for 24 weeks; MRI scans (manual reads) were performed at weeks -4 (screening), 0, 4,8,12,16,20,24, and 36 and 52 (follow-up) [26]. In the other trial, patients with relapsing-remitting MS were randomized to receive placebo or dimethyl fumarate for 24 weeks.…”

Section: Placebo-treated Historical Cohortsmentioning

confidence: 99%

“…Discontinuation of natalizumab is associated with return of MS disease activity [7][8][9][10][11][12][13][14][15][16][17][18][19][20]. Some reports suggest disease activity after natalizumab cessation exceeds baseline levels [11,13,16,18,19,[21][22][23], while other studies do not [12,14,17,24].…”

Section: Introductionmentioning

confidence: 99%

“…Some reports suggest disease activity after natalizumab cessation exceeds baseline levels [11,13,16,18,19,[21][22][23], while other studies do not [12,14,17,24].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2014

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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.

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Section: Methodsmentioning

confidence: 99%

Section: Placebo-treated Historical Cohortsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…Some reports suggest disease activity after natalizumab cessation exceeds baseline levels [11,13,16,18,19,[21][22][23], while other studies do not [12,14,17,24].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2014

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“…IRIS is not unique to HIV. For example, neurologists involved in the care of patients with multiple sclerosis recognize the potential for serious neurological deterioration with immune recovery after disease modifying therapies are withdrawn [38]. Similar but more profound immune recovery occurs when powerful combination ART is given to very immune-deficient HIV-positive hosts.…”

Section: Introduction To Immune Reconstitution Inflammatory Syndromementioning

confidence: 99%

Update and New Directions in Therapeutics for Neurological Complications of HIV Infections

Ellis

Letendre

2016

Neurotherapeutics

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Rebound of Disease Activity After Withdrawal of Fingolimod (FTY720) Treatment

Havla

Pellkofer²,

Meinl³

et al. 2012

Arch Neurol

102

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Background: The oral sphingosine-1-phosphate receptor modulator fingolimod (FTY720) was recently approved for the treatment of relapsing-remitting multiple sclerosis. To date, data about a possible recurrence of disease activity after discontinuation of fingolimod treatment are scarce. Objective: To describe a patient who discontinued fingolimod treatment after a local malignant melanoma was diagnosed. Three months after cessation, he had a striking rebound of multiple sclerosis activity. Design: Case report and review of literature.

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Immune Reconstitution Inflammatory Syndrome in Patients With Multiple Sclerosis Following Cessation of Natalizumab Therapy

Abstract: To assess clinical consequences of temporary natalizumab dosage suspension.

Cited by 164 publications

References 13 publications

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

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

Update and New Directions in Therapeutics for Neurological Complications of HIV Infections

Rebound of Disease Activity After Withdrawal of Fingolimod (FTY720) Treatment

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