Multiple Sclerosis
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`http://msj.sagepub.com/
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`Oral Presentations
`Mult Scler
` 2006 12: S1
`DOI: 10.1177/135248506071178
`
`The online version of this article can be found at:
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`European Committee for Treatment and Research in Multiple Sclerosis
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`Americas Committee for Treatment and Research in Multiple Sclerosis
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`Pan-Asian Committee for Treatment and Research in Multiple Sclerosis
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`
`Latin American Committee on Treatment and Research of Multiple Sclerosis
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`
` EXHIBIT NO. 1037 Page 1
`
` AMNEAL
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` EXHIBIT NO. 1037 Page 2
`
` AMNEAL
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`(cid:160)
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`
`S82
`
`Abstracts
`
`P314
`
`Neurological consequences of delay treatment in early relap-
`sing-remitting multiple sclerosis. A five-year follow-up
`study
`B. Casanova, I. Bosca, A. Pascual Lozano, C. Valero, F. Coret; Hospital
`Universitari La Fe (Vale`ncia, E); Hospital Arnau de Vilanova (Vale`ncia, E);
`Hospital Clı´nic Universitari (Vale`ncia, E)
`
`Objective: To study if there are differences in the disability at five-year
`of multiple sclerosis patients when interferon treatment is iniciated
`earlier. Method: Patients with a first event suggestive of multple
`sclerosis were recruited. In patients visited between January 1996 to
`December 1998 (group A) a minimun of one year after a stablished
`diagnosis according the Poser criteria (CDMS) must be accomplished to
`begin treatment with interferon. And in patients visited from January
`1999 to April 2001 (Group B) this year of delay as CDMS was
`eliminated. We have analysed the impact over the disability at year
`five of the application of these criteria. Results: 65 patients accom-
`plished the criteria to begin treatment; 28 in the group A, and 37 in the
`group B. Mean time to CDMS was similar in both groups (11.0
`months). Mean time to begin treatment was 16.0 and 7.3 months
`(group A and B). Total time under IFNB was 33.0 and 40.7 (group A and
`B). The final median EDSS for patients treated in the group A was 3.0 vs.
`2.0 in patients treated in the group B (pB0.000). The time to reach an
`EDSS of 3.0, was lower for patients of the group B (Hazard ratio 7.4, p
`0.0003). Conclusions: Earlier treatment had a favorable impact over
`the disability in the first five years of evolution of RRMS.
`
`P315
`
`Betainterferons in the treatment of multiple sclerosis: a
`naturalistic survey
`H.M. Kuusisto, R. Soikkeli, T. Luukkaala, I. Elovaara; Tampere University
`Hospital (Tampere, FIN); Tampere University (Tampere, FIN)
`
`Background: Controlled clinical trials have shown that beta-inter-
`ferons are effective and moderately well tolerated in the treatment of
`multiple sclerosis (MS). The annual costs of the treatment are,
`however, substantial. To date, reports of the efficacy and tolerability
`of beta-interferons in unselected MS patient populations are scarce.
`Objectives: To evaluate retrospectively the efficacy and tolerability
`of beta-interferons in an unselected MS-cohort. Subjects and
`Methods: The data was collected of 96 consecutive patients with
`relapsing- remitting MS (RRMS) treated at the Tampere University
`Hospital, Finland between 1996 2003. Results: During beta-inter-
`feron treatment, the annual relapse rate declined in 66% of the
`patients. The total number of relapses was reduced by 58% compared
`to the time prior to the treatment. Adverse effects were experienced by
`80% of the patients. Altogether 28% of the patients switched to
`another beta-interferon product during the follow up. The main
`reason for change of a product was lack of efficacy. Conclusions:
`Beta-interferons are efficacious and well tolerated by most of the
`RRMS-patients. However, one third of the patients seem to obtain no
`benefit from the treatment and adverse effects can be common. Thus,
`the effects of beta-interferon treatment should be carefully monitored
`and the value of the therapy should be always individually assessed.
`
`P316
`
`The Global Adherence Project A multicentre observational
`
`study on adherence to disease-modifying therapies in pa-
`tients suffering from relapsing-remitting multiple sclerosis
`V. Devonshire, Y. Lapierre, R. MacDonell, C. Ramo Tello, F. Patti, P.
`Fontoura, L. Suchet, R. Hyde, I. Balla, B. Kieseier, E. Frohman on behalf of
`the GAP Study Group
`
`Background and Objectives: Adherence is a key component in the
`therapy of chronic diseases. The Global Adherence Project (GAP) is
`
`the largest global, observational study that has evaluated real-world
`adherence rates to approved disease-modifying therapies (DMTs) for
`relapsing-remitting multiple sclerosis (RRMS),
`factors influencing
`adherence, quality of life and level of cognition and depression.
`Design/Methods: Eligible RRMS patients were 18 years old and
`on their current DMT for at least six months. 179 sites across 22
`countries recruited patients in this retrospective paper-based survey.
`Neurologists completed a practice-related survey and patients com-
`pleted a patient survey plus the Multiple Sclerosis International
`Quality of Life Questionnaire (MusiQoL) and the Multiple Sclerosis
`Neuropsychological Screening Questionnaire (MSNQ,
`in English-
`speaking countries). Non-adherence was defined as missing at least
`one DMT injection or changing dose within 4 weeks prior to the
`survey. Results: 2646 patients treated with Avonex, Rebif, Betafer-
`on/Betaseron or Copaxone had a mean age of 40 years, 73% were
`female, median disease duration was 6 years, and median time on
`treatment was 32 months. Overall, 25.3% of patients reported non-
`adherence. The non-adherence rate was significantly lower
`for
`Avonex (15.0%) than for Rebif 22 mcg (22.0%, p0.012), Rebif 44
`mcg (27.3%,) Betaferon/Betaseron (30.9%), and Copaxone (34.2%),
`all pB0.0001. The most common reason for non-adherence was
`forgetting to administer the injection (50.6%). Other univariate
`factors that affected adherence included duration of current DMT
`(p0.017) and duration of disease (p0.0004). Adherent patients
`had higher MusiQoL scores in 7 of 9 dimensions (indicating better
`QOL; pB0.05), fewer cognitive problems (MSNQ, p0.0002) and
`fewer problems with injection-site reactions (pB0.01) than non-
`adherent patients. Full multivariate analyses will be conducted on all
`primary factors that impact adherence. Conclusions: Several uni-
`variate factors including current DMT used, duration of current DMT
`and disease duration affected adherence to therapy. Adherent
`patients reported better quality of life, less cognitive impairment
`and fewer problems with injection site reactions than non-adherent
`patients.
`
`P317
`
`Incidence and impact of neutralising antibodies in a
`clinical setting
`F.
`Jacques;
`I. Gaboury on behalf of
`l’Outaouais
`
`the Clinique de SEP/NM de
`
`Background: In pivotal trials the frequency of neutralizing anti-
`bodies (Nabs) against different interferon Beta products have varied
`from 7% to 41%. Most Nabs appear between 12 and 24 months of
`treatment. Previous studies have suggested that Nabs reduce the
`therapeutic benefit of interferon Beta in multiple sclerosis (MS)
`patients. From this
`it has been suggested that poor clinical
`evolution should mandate Nab testing. Objective: To evaluate
`prospectively in a clinical setting the relative incidence of Nabs to
`the four interferon Beta products and their impact on clinical
`evolution. Methods: From July, 2004 all MS patients at our clinic,
`independent of clinical status, who have received interferon Beta
`treatment for more than one year were tested for Nabs using an
`antiviral cytopathic effect (CPE) assay. A titer of ]20 LU/ml was
`considered the threshold for positivity. Results: Over a 22 months
`period 111 patients were tested at our clinic. 14% (n16) overall
`tested positive. These patients had as a group a median duration of
`treatment of 3 years (0.8), a median EDSS of 1.0 (0.3) and a median
`annual relapse rate of 1 (0.4). Using a Wilcoxon Mann-Whitney
`test, we were not able to demonstrate a significant evolution in
`EDSS between baseline and the year testing positive for Nabs
`(median difference:1, 95% CI: 1.1; p0.281). Similarly, no sig-
`nificant evolution could be demonstrated in the number of relapses
`(median difference: 0, 95% CI: 1.1; p0.660). The relative
`incidence per product was: Avonex 5.0%, Rebif 26.0% and Betaser-
`on 9.0%. Conclusions: The incidence of Nabs at our clinic is less
`than previously reported in the pivotal
`trials. We could not
`demonstrate any impact on clinical evolution and thus could not
`have predicted Nab positivity from it.
`
`Multiple Sclerosis 2006; 12: S1 S228
`
`www.sagepub.co.uk
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` at UNIV CALIFORNIA SAN DIEGO on November 18, 2014
`
` EXHIBIT NO. 1037 Page 3
`
` AMNEAL