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Original research
Clinical effectiveness of different natalizumab interval dosing schedules in a large Italian population of patients with multiple sclerosis
  1. Clara Grazia Chisari1,
  2. Luigi Maria Grimaldi2,
  3. Giuseppe Salemi3,
  4. Paolo Ragonese3,
  5. Pietro Iaffaldano4,
  6. Simona Bonavita5,
  7. Maddalena Sparaco5,
  8. Marco Rovaris6,
  9. Alessia D'Arma6,
  10. Alessandra Lugaresi7,8,
  11. Maria Teresa Ferrò9,
  12. Paola Grossi9,
  13. Alessia Di Sapio10,
  14. Eleonora Cocco11,
  15. Franco Granella12,
  16. Erica Curti12,
  17. Vito Lepore13,14,
  18. Maria Trojano4,
  19. Francesco Patti1
  20. on behalf of the Italian MS Register Study Group
  1. 1 Department of Surgical and Medical Sciences Advanced Technologies GF Ingrassia, University of Catania, Catania, Italy
  2. 2 Neurology Unit, Fondazione Istituto San Raffaele G. Giglio di Cefalù, Cefalu, Sicily, Italy
  3. 3 Department of Biomedicine, Neurosciences and Advanced Diagnostics, Università degli Studi di Palermo, Palermo, Sicilia, Italy
  4. 4 Department of Basic Medical Sciences, Neurosciences and Sense Organs, Università degli Studi di Bari Aldo Moro, Bari, Puglia, Italy
  5. 5 Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Napoli, Campania, Italy
  6. 6 Multiple Sclerosis Center and Rehabilitation Unit, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy
  7. 7 Dipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Emilia-Romagna, Italy
  8. 8 Istituto delle Scienze Neurologiche di Bologna, Unità Operative Semplici d'Istituto (UOSI) Riabilitazione Sclerosi Multipla, Bologna, Italy
  9. 9 Neurology Unit, Presidio Ospedale Maggiore di Crema, Crema, Lombardia, Italy
  10. 10 Department of Neurology, Ospedale Regina Montis Regalis-ASLCN1, Presidio di Mondovì Ceva, Mondovi, Piedmont, Italy
  11. 11 Multiple Sclerosis Centre Binaghi Hospital, ATS Sardegna, University of Cagliari, Cagliari, Sardegna, Italy
  12. 12 Neurosciences Unit, Department of Medicine and Surgery, Università degli Studi di Parma, Parma, Emilia-Romagna, Italy
  13. 13 Istituto di Ricerche Farmacologiche Mario Negri Sede di Milano, Milano, Lombardia, Italy
  14. 14 Coreserach Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy
  1. Correspondence to Dr Francesco Patti, Department of Surgical and Medical Sciences Advanced Technologies GF Ingrassia, University of Catania, Catania 95126, Italy; patti{at}unict.it

Abstract

Introduction Natalizumab (NTZ) is one of the most effective treatment options for multiple sclerosis (MS) treatment. Our study aimed to evaluate the effectiveness of NTZ when administered according to the extended dosing strategy compared with standard 4-weekly administration in a large Italian MS population.

Materials and methods This retrospective multicentre study included patients with relapsing-remitting MS (RR-MS) who received NTZ administrations between the 1 June 2012 and the 15 May 2018 and were followed by the ‘Italian MS Register’. All patients with MS were stratified into two groups based on NTZ administration schedule: standard interval dosing (SID) patients who received infusions on average from 28 to 32 days (median 30) and extended interval dosing (EID) including patients who have been infused with interval between 33 and 49 days (median 43). Clinical data were assessed at baseline (before starting NTZ), after 12 (T1) and 24 months (T2) of treatment.

Results Out of 5231 patients with RR-MS screened, 2092 (mean age 43.2±12.0, 60.6% women) were enrolled. A total of 1254 (59.9%) received NTZ according to SID, and 838 (40.1%) according to EID. At 12 and 24 months, no differences in terms of annualised relapse rate and disability status were found between the two groups. Progression index and confirmed disability worsening were similar between the two groups.

Discussion The use of NTZ with an extended interval schedule showed similar effectiveness compared with SID. Unchanged clinical efficacy of EID schedule may raise the question of a possible advantage in terms of tolerability and safety.

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Footnotes

  • Contributors CGC: contributed to the data collection, performed the statistical analysis and interpreted data, drafted the work and revised it critically for important intellectual content and approved the final version of the paper. LMG: contributed to the design of the work and to the data collection, drafted the work and revised it critically for important intellectual content and approved the final version of the paper. GS and PR: contributed to the design of the work and to the data collection and approved the final version of the paper. PI, MS, AD, MTF, PG, ADS, ElC, FG and ErC: contributed to the data collection, approved the final version of the paper. SB: contributed to the data collection, revised and approved the final version of the paper. MR: contributed to the data collection, revised and approved the final version of the paper. AL: contributed to the data collection, revised and approved the final version of the paper. VL: contributed to the study design and approved the final version of the paper. MT: contributed to the design of the work and to the data collection, revised the paper critically for important intellectual content and approved the final version of the paper. FP contributed to the data collection, performed the statistical analysis and interpreted data, drafted the work and revised it critically for important intellectual content and approved the final version of the paper.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests CGC has received grants for congress participation from Almirall, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme and Teva. GS received speaker’s honoraria, consulting fees, honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. PR has received grants for speaking activities from Biogen, Merck Serono, Novartis, TEVA and grants for congress participation from Almirall, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme and TEVA. LMG received speaker’s honoraria, consulting fees, honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. SB received speaker’s honoraria, consulting fees, honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. AL received speaker’s honoraria, consulting fees, honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. MTF received speaker’s honoraria, consulting fees, honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. ElC received speaker’s honoraria, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. FG received honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. MT received speaker’s honoraria, consulting fees, honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. FP has received honoraria for speaking activities by Almirall, Bayer Schering, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi Genzyme and TEVA; he also served as advisory board member the following companies: Bayer Schering, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi Genzyme and TEVA; he was also funded by Pfizer and FISM for epidemiological studies; he received grants for congress participation from Almirall, Bayer Shering, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi Genzyme and TEVA.

  • Patient consent for publication Obtained.

  • Ethics approval This study protocol was approved by the local Ethical Committee of the University of Catania (Catania 1) and by the ethical committee of the participating centres.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on reasonable request. the data that support the findings of this study are available from the corresponding author on reasonable request.

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