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MRI activity and neutralizing antibody as predictors of response to IFN-β treatment in MS
  1. L Durelli (luca.durelli{at}unito.it)
  1. Dipartimento Scienze Cliniche e Biologiche, Università di Torino, Italy
    1. P Barbero (p.barbero{at}isiline.it)
    1. Dipartimento Scienze Cliniche e Biologiche, Università di Torino, Italy
      1. M Bergui (mauro.bergui{at}gmail.it)
      1. Dipartimento di Neuroscienze, Università di Torino, Italy
        1. E Versino (elisabetta.versino{at}unito.it)
        1. Dipartimento di Salute Pubblica, Università di Torino, Italy
          1. M A Bassano (m.bassano{at}dimensione-ricerca.com)
          1. Dimensione Ricerca, Contract Research Organization, Roma, Italy
            1. E Verdun (elisabettaverdun{at}libero.it)
            1. Dipartimento Scienze Cliniche e Biologiche, Università di Torino, Italy
              1. C Rivoiro (chiarariv{at}libero.it)
              1. Dipartimento Scienze Cliniche e Biologiche, Università di Torino, Italy
                1. C Ferrero (ferrero.cinzia{at}katamail.it)
                1. Dipartimento Scienze Cliniche e Biologiche, Università di Torino, Italy
                  1. E Picco (elisabettapicco{at}alice.it)
                  1. Dipartimento Scienze Cliniche e Biologiche, Università di Torino, Italy
                    1. P Ripellino (pao.ripe{at}hotmail.it)
                    1. Dipartimento Scienze Cliniche e Biologiche, Università di Torino, Italy
                      1. G Giuliani (ggiuliani{at}asl9.marche.it)
                      1. Dipartimento di Medicina, Unità di Neurologia, Macerata, Italy
                        1. E Montanari (emontanari{at}ausl.pr.it)
                        1. Divisione di Neurologia, Ospedale Civile, Fidenza, Italy
                          1. M Clerico (marinellaclerico{at}libero.it)
                          1. Dipartimento Scienze Cliniche e Biologiche, Università di Torino, Italy

                            Abstract

                            Background: Not all patients with multiple sclerosis (MS) experience a satisfactory treatment response and may require treatment adjustment. Indicators for assessing treatment effectiveness need to be sought and validated.

                            Objective: To prospectively validate MRI activity and neutralizing anti-interferon antibody (NAb) status during the first 6 months of interferon-beta (IFN-β) treatment as response indicators in MS.

                            Methods: Patients with relapsing-remitting MS were prospectively followed during the first 2 years of treatment. Neurological assessments were performed every 3 months or when a relapse was suspected. MRI scans performed at baseline and Months 3, 4, 5, and 6 after start of treatment were centrally assessed for disease activity: new T2 or gadolinium-enhancing T1 lesions. NAb were assessed using the MxA protein assay; positivity was defined as two consecutive titers ≥20 NU/mL. We evaluated the sensitivity and specificity of an active scan, NAb positivity, or both during the first 6 months of treatment to predict clinical disease activity (relapses or confirmed disability progression) in the following 18 months.

                            Results: 147 patients were assessed at 16 centers. Predictivity parameters (with confidence intervals) were: active scan, sensitivity 52% (34% to 69%), specificity 80% (65% to 91%), p = 0.002; NAb positivity, sensitivity 71% (45% to 88%), specificity 66% (55% to 76%), p = 0.01; active scan and NAb positivity, sensitivity 71% (38% to 91%), specificity 86% (73% to 94%), p = 0.0003.

                            Conclusions: MRI activity and NAb occurrence during the first 6 months of IFN-β treatment are reliable predictors of long-term clinical response, particularly when combined.

                            • MRI activity
                            • NAb
                            • interferon beta
                            • multiple sclerosis
                            • treatment response indicators

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