Multiple Sclerosis Symptom Recrudescence at the End of the Natalizumab Dosing Cycle

Ratchford, John N.; Brock-Simmons, Regina; Augsburger, Amanda; Steele, Sonya; Mohn, Kristie; Rhone, Mandi; Bo, Jinyan; Costello, Kathleen

doi:10.7224/1537-2073.2013-017

Cited by 22 publications

(23 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Studies that do address this phenomenon report an incidence of the wearing-off effect of 61%-67%. [3][4][5] The incidence in our cohort is slightly lower (54%) and we show that the majority of these patients do not experience the wearing-off effect during every cycle. In earlier work, we have shown that intraindividual trough natalizumab concentrations are stable in a set infusion interval.…”

Section: Discussionmentioning

confidence: 70%

“…By far the most reported wearing-off symptom was fatigue, which is in agreement with other reports. [3][4][5] Natalizumab led to significant improvement of fatigue symptoms after 1 year of treatment in a one-arm, open-label trial. 18 However, in one of the pivotal trials, fatigue was reported significantly more frequently as an adverse event in the natalizumab group than in the placebo group.…”

Section: Discussionmentioning

confidence: 99%

“…2 However, many neurologists prescribing natalizumab are aware of a notable part of patients reporting an increase of symptoms at the end of the natalizumab cycle. [3][4][5] Patients might mention the natalizumab is wearing off and they are in need of their next infusion. Although this wearing-off effect during natalizumab treatment is widely recognized, research regarding this phenomenon is limited.…”

mentioning

confidence: 99%

See 2 more Smart Citations

The natalizumab wearing-off effect

et al. 2019

View full text Add to dashboard Cite

Objective Natalizumab is effective in treating relapsing-remitting multiple sclerosis (RRMS). However, many patients report an increase of multiple sclerosis symptoms at the end of the natalizumab cycle: a wearing-off effect. The objective of this study was to evaluate the prevalence of the wearing-off effect in patients with standard and extended intervals and to study possible associations with pharmacokinetic/dynamic measurements and patient characteristics in a prospective, monocenter, cross-sectional cohort study. Methods Patients with RRMS, with a minimum of 6 natalizumab infusions, were asked to complete 3 questionnaires: the Multiple Sclerosis Impact Scale, the 36-Item Short Form Health Survey, and a general questionnaire regarding the wearing-off effect. Natalizumab concentration and α4-integrin receptor saturation were measured before redosing. Results Ninety-three patients were included. A total of 54% experienced a wearing-off effect during natalizumab treatment and 32% experienced a current wearing-off effect at time of measurement. The self-reported wearing-off effect was not associated with natalizumab concentration nor with α4-integrin receptor saturation. The wearing-off effect was more frequently reported in the standard interval group (39%) than in the extended interval group (19%); the duration of symptoms was comparable between both groups. The wearing-off effect was not associated with number of infusions, disease duration, age, or sex. Conclusion The wearing-off effect is a frequently reported phenomenon but is unlikely to reflect a nonoptimal pharmacokinetic/dynamic state. We did not find risk factors predicting the wearing-off effect.

show abstract

Section: Discussionmentioning

confidence: 70%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

See 1 more Smart Citation

The natalizumab wearing-off effect

et al. 2019

View full text Add to dashboard Cite

show abstract

“…Observational studies. Depression was reported most often (n = 4, IPs 0.1-12%) (Butzkueven et al, 2014;Horga et al, 2011;Penner et al, 2015;Ratchford et al, 2014), followed by anxiety/panic attack (3 Fig. 2.…”

Section: Study Characteristicsmentioning

confidence: 98%

“…Ten studies (8 observational studies, 2 RCTs) examined changes in depression symptoms following Natalizumab treatment (Iaffaldano et al, 2012;Kunkel et al, 2015;Lang et al, 2012;Nagesh et al, 2015;Penner et al, 2015;Ratchford et al, 2014;Rorsman et al, 2017;Rudick et al, 2006;Sater et al, 2016;Svenningsson et al, 2013); only 5 provided the information needed for meta-analysis. The meta-analysis of these studies (Kunkel et al, 2015;Lang et al, 2012;Ratchford et al, 2014;Rorsman et al, 2017;Sater et al, 2016), found that depression symptoms improved (Fig. 4C, SMD: 0.31 [−0.06; 0.68]), although this was not statistically significant.…”

Section: Natalizumabmentioning

confidence: 99%

Adverse psychiatric effects of disease-modifying therapies in multiple Sclerosis: A systematic review

Gasim

Bernstein

Graff

et al. 2018

Multiple Sclerosis and Related Disorders

View full text Add to dashboard Cite

show abstract

Natalizumab wearing-off symptoms: effect of extend interval dosing during Sars-CoV-2 pandemic

et al. 2022

View full text Add to dashboard Cite

Background Many patients treated with Natalizumab experience wearing-off symptoms (WoS) towards the end of the administration cycle. During the pandemic we advised and asked patients undergoing treatment with Natalizumab if they wanted to be shifted from a standard interval dosing (StID of 4 weeks) to an extended interval dosing (ExID of 5-6 weeks), regardless of their JCV index. Our main objective was to study prevalence and incidence of WoS when ExID was adopted. Methods We enrolled 86 patients, from May 2020 to January 2021, evaluated at baseline and during a 6 months follow-up with a survey focused on WoS, Fatigue Severity Scale (FSS), Expanded Disability Status Scale (EDSS) and MRI. Results Among the 86 patients, 32 (37.2%) reported WoS. Most common one was fatigue (93.7%). Mean EDSS was higher in the group reporting WoS (3.8 WoS vs 3.1 non-WoS, p < 0.05). Sphincterial function was the EDSS item that significantly differed between the WoS group and the non-WoS group (1.4 WoS vs 0.6 non-WoS, p < 0.001). WoS correlate with the FSS scale (p < 0.001). Conclusion Adopting an extended interval dosing does not result in significantly different occurrence of WoS between the ExID and the StID populations, in our cohort of patients. Interestingly, there is a strong correlation between WoS and a higher EDSS and FSS. Safety and efficacy of Natalizumab with ExID are relatively preserved in our study. KeywordsFatigue • Multiple sclerosis • Natalizumab wearing-off symptoms (WoS) • End of dosing interval symptoms (EDIs) • Extended interval dosing (ExID)

show abstract

Multiple Sclerosis Symptom Recrudescence at the End of the Natalizumab Dosing Cycle

Abstract: Background: This study was undertaken to determine how frequently patients receiving natalizumab for multiple sclerosis (MS) experience recrudescence of their MS symptoms at the end of the dosing cycle.

Cited by 22 publications

References 14 publications

The natalizumab wearing-off effect

The natalizumab wearing-off effect

Adverse psychiatric effects of disease-modifying therapies in multiple Sclerosis: A systematic review

Natalizumab wearing-off symptoms: effect of extend interval dosing during Sars-CoV-2 pandemic

Contact Info

Product

Resources

About