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Drug Holiday of Interferon Beta 1b in Multiple Sclerosis: A Pilot, Randomized, Single Blind Study of Non-inferiority

Identifieur interne : 000874 ( Main/Exploration ); précédent : 000873; suivant : 000875

Drug Holiday of Interferon Beta 1b in Multiple Sclerosis: A Pilot, Randomized, Single Blind Study of Non-inferiority

Auteurs : Silvia Romano [Italie] ; Michela Ferraldeschi [Italie] ; Francesca Bagnato [États-Unis] ; Rosella Mechelli [Italie] ; Emanuele Morena [Italie] ; Marzia Caldano [Italie] ; Maria Chiara Buscarinu [Italie] ; Arianna Fornasiero [Italie] ; Marco Frontoni [Italie] ; Viviana Nociti [Italie] ; Massimiliano Mirabella [Italie] ; Flavia Mayer [Italie] ; Antonio Bertolotto [Italie] ; Carlo Pozzilli [Italie] ; Nicola Vanacore [Italie] ; Marco Salvetti [Italie] ; Giovanni Ristori [Italie]

Source :

RBID : PMC:6646514

Abstract

Introduction: To compare a schedule with cyclic withdrawal (CW) of interferon beta (IFN-b) 1b, respect to the full regimen (FR), in relapsing-remitting MS (RR-MS).

Methods: Participants were randomly assigned to CW or FR schedule and monthly monitored with brain MRI scans for 12 months (three of run-in and 9 of treatment). CW schedule included drug withdrawal for 1 month after two of treatment for a total of three quarters over the 9-month treatment period. The assessing neurologist and the expert neuroradiologists were blind. After the blind phase of the study all participants took their indicated disease modifying therapies in a prospectively planned, open-label extension phase (up to 120 months).

Results: Of 60 randomized subjects 56 (29 in FR and 27 in CW group) completed the single-blind phase: the two groups were comparable, except for a non-significant difference in the number of contrast-enhanced lesions (CEL) at the end of run-in. The two-sided 90% CI for the ratio between median number of cumulative CEL was 0.29–1.07, allowing to significantly reject the null hypothesis of a ratio ≥1.2 and to meet the primary end-point of non-inferiority (the threshold and the ratio between median were chosen according to the non-normal distribution of the data). The differences (CW vs. FR) were also non-significant for secondary end points: mean cumulative number of T2-weighted new and enlarging lesions (3.48 ± 5.34 vs. 3.86 ± 6.76); mean number and volume (cm3) of black holes (1.24 ± 1.61 vs. 2.71 ± 4.56; 489.11 ± 1488.12 vs. 204.48 ± 396.98); number of patients with at least an active scan (21 vs. 22); mean relapse rate (0.52 ± 0.89 vs. 0.34 ± 0.66), relapse risk ratio adjusted for baseline variables (2.15 [0.64–7.18]), EDSS score (1.0 [1–1.56] vs. 1.5 [1–1.78]), proportion of patients with antibodies anti-IFN (5 [21%] vs. 8 [36%]). Fifty-four patients (27 for each study arm) completed the open-label phase. The annualized RR, EDSS, proportion of patients shifting to progressive disease and hazard ratio of shifting, adjusting for baseline covariates, were comparable between the two study groups.

Conclusions: A calendar with CW was non-inferior than FR at the beginning of IFN-b therapy, and may not affect the long-term outcome.

Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT00270816


Url:
DOI: 10.3389/fneur.2019.00695
PubMed: 31379701
PubMed Central: 6646514


Affiliations:

Links toward previous steps (curation, corpus...)

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<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Bertolotto, Antonio" sort="Bertolotto, Antonio" uniqKey="Bertolotto A" first="Antonio" last="Bertolotto">Antonio Bertolotto</name>
<affiliation wicri:level="1">
<nlm:aff id="aff4">
<institution>Neurologia – Centro Riferimento Regionale Sclerosi Multipla and Neuroscience Institute Cavalieri Ottolenghi, San Luigi Hospital</institution>
,
<addr-line>Turin</addr-line>
,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Pozzilli, Carlo" sort="Pozzilli, Carlo" uniqKey="Pozzilli C" first="Carlo" last="Pozzilli">Carlo Pozzilli</name>
<affiliation wicri:level="1">
<nlm:aff id="aff2">
<institution>Department of Neurology and Psychiatry, “Sapienza” University of Rome</institution>
,
<addr-line>Rome</addr-line>
,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Vanacore, Nicola" sort="Vanacore, Nicola" uniqKey="Vanacore N" first="Nicola" last="Vanacore">Nicola Vanacore</name>
<affiliation wicri:level="1">
<nlm:aff id="aff8">
<institution>National Centre of Epidemiology, National Institute of Health</institution>
,
<addr-line>Rome</addr-line>
,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Salvetti, Marco" sort="Salvetti, Marco" uniqKey="Salvetti M" first="Marco" last="Salvetti">Marco Salvetti</name>
<affiliation wicri:level="1">
<nlm:aff id="aff1">
<institution>Neurosciences, Mental Health, and Sensory Organs (NESMOS) Department, Center for Experimental Neurological Therapies, S. Andrea Hospital-site, “Sapienza” University of Rome</institution>
,
<addr-line>Rome</addr-line>
,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1">
<nlm:aff id="aff9">
<institution>IRCCS Istituto Neurologico Mediterraneo (INM) Neuromed</institution>
,
<addr-line>Pozzilli</addr-line>
,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Ristori, Giovanni" sort="Ristori, Giovanni" uniqKey="Ristori G" first="Giovanni" last="Ristori">Giovanni Ristori</name>
<affiliation wicri:level="1">
<nlm:aff id="aff1">
<institution>Neurosciences, Mental Health, and Sensory Organs (NESMOS) Department, Center for Experimental Neurological Therapies, S. Andrea Hospital-site, “Sapienza” University of Rome</institution>
,
<addr-line>Rome</addr-line>
,
<country>Italy</country>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Frontiers in Neurology</title>
<idno type="eISSN">1664-2295</idno>
<imprint>
<date when="2019">2019</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc>
<textClass></textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">
<p>
<bold>Introduction:</bold>
To compare a schedule with cyclic withdrawal (CW) of interferon beta (IFN-b) 1b, respect to the full regimen (FR), in relapsing-remitting MS (RR-MS).</p>
<p>
<bold>Methods:</bold>
Participants were randomly assigned to CW or FR schedule and monthly monitored with brain MRI scans for 12 months (three of run-in and 9 of treatment). CW schedule included drug withdrawal for 1 month after two of treatment for a total of three quarters over the 9-month treatment period. The assessing neurologist and the expert neuroradiologists were blind. After the blind phase of the study all participants took their indicated disease modifying therapies in a prospectively planned, open-label extension phase (up to 120 months).</p>
<p>
<bold>Results:</bold>
Of 60 randomized subjects 56 (29 in FR and 27 in CW group) completed the single-blind phase: the two groups were comparable, except for a non-significant difference in the number of contrast-enhanced lesions (CEL) at the end of run-in. The two-sided 90% CI for the ratio between median number of cumulative CEL was 0.29–1.07, allowing to significantly reject the null hypothesis of a ratio ≥1.2 and to meet the primary end-point of non-inferiority (the threshold and the ratio between median were chosen according to the non-normal distribution of the data). The differences (CW vs. FR) were also non-significant for secondary end points: mean cumulative number of T2-weighted new and enlarging lesions (3.48 ± 5.34 vs. 3.86 ± 6.76); mean number and volume (cm
<sup>3</sup>
) of black holes (1.24 ± 1.61 vs. 2.71 ± 4.56; 489.11 ± 1488.12 vs. 204.48 ± 396.98); number of patients with at least an active scan (21 vs. 22); mean relapse rate (0.52 ± 0.89 vs. 0.34 ± 0.66), relapse risk ratio adjusted for baseline variables (2.15 [0.64–7.18]), EDSS score (1.0 [1–1.56] vs. 1.5 [1–1.78]), proportion of patients with antibodies anti-IFN (5 [21%] vs. 8 [36%]). Fifty-four patients (27 for each study arm) completed the open-label phase. The annualized RR, EDSS, proportion of patients shifting to progressive disease and hazard ratio of shifting, adjusting for baseline covariates, were comparable between the two study groups.</p>
<p>
<bold>Conclusions:</bold>
A calendar with CW was non-inferior than FR at the beginning of IFN-b therapy, and may not affect the long-term outcome.</p>
<p>
<bold>Clinical Trial Registration:</bold>
<ext-link ext-link-type="uri" xlink:href="http://www.ClinicalTrials.gov">www.ClinicalTrials.gov</ext-link>
, identifier: NCT00270816</p>
</div>
</front>
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</TEI>
<affiliations>
<list>
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<li>États-Unis</li>
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<tree>
<country name="Italie">
<noRegion>
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</noRegion>
<name sortKey="Bertolotto, Antonio" sort="Bertolotto, Antonio" uniqKey="Bertolotto A" first="Antonio" last="Bertolotto">Antonio Bertolotto</name>
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<name sortKey="Caldano, Marzia" sort="Caldano, Marzia" uniqKey="Caldano M" first="Marzia" last="Caldano">Marzia Caldano</name>
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<name sortKey="Frontoni, Marco" sort="Frontoni, Marco" uniqKey="Frontoni M" first="Marco" last="Frontoni">Marco Frontoni</name>
<name sortKey="Mayer, Flavia" sort="Mayer, Flavia" uniqKey="Mayer F" first="Flavia" last="Mayer">Flavia Mayer</name>
<name sortKey="Mechelli, Rosella" sort="Mechelli, Rosella" uniqKey="Mechelli R" first="Rosella" last="Mechelli">Rosella Mechelli</name>
<name sortKey="Mirabella, Massimiliano" sort="Mirabella, Massimiliano" uniqKey="Mirabella M" first="Massimiliano" last="Mirabella">Massimiliano Mirabella</name>
<name sortKey="Morena, Emanuele" sort="Morena, Emanuele" uniqKey="Morena E" first="Emanuele" last="Morena">Emanuele Morena</name>
<name sortKey="Nociti, Viviana" sort="Nociti, Viviana" uniqKey="Nociti V" first="Viviana" last="Nociti">Viviana Nociti</name>
<name sortKey="Nociti, Viviana" sort="Nociti, Viviana" uniqKey="Nociti V" first="Viviana" last="Nociti">Viviana Nociti</name>
<name sortKey="Pozzilli, Carlo" sort="Pozzilli, Carlo" uniqKey="Pozzilli C" first="Carlo" last="Pozzilli">Carlo Pozzilli</name>
<name sortKey="Ristori, Giovanni" sort="Ristori, Giovanni" uniqKey="Ristori G" first="Giovanni" last="Ristori">Giovanni Ristori</name>
<name sortKey="Salvetti, Marco" sort="Salvetti, Marco" uniqKey="Salvetti M" first="Marco" last="Salvetti">Marco Salvetti</name>
<name sortKey="Salvetti, Marco" sort="Salvetti, Marco" uniqKey="Salvetti M" first="Marco" last="Salvetti">Marco Salvetti</name>
<name sortKey="Vanacore, Nicola" sort="Vanacore, Nicola" uniqKey="Vanacore N" first="Nicola" last="Vanacore">Nicola Vanacore</name>
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<name sortKey="Bagnato, Francesca" sort="Bagnato, Francesca" uniqKey="Bagnato F" first="Francesca" last="Bagnato">Francesca Bagnato</name>
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</tree>
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