QualiCOP: AN OPEN-LABEL, PROSPECTIVE, OBSERVATIONAL STUDY OF
`GLATIRAMER ACETATE IN PATIENTSWITH RELAPSING-REMITTING MULTIPLE
`SCLEROSIS
`T. Ziemssen1, P. Calabrese2, I.-K. Penner2, A. Rainer3
`1Neurology, University of Dresden, Germany
`2Cognitive Psychology, University of Basel, Switzerland
`3Medical Affairs, Teva Pharma Germany, Germany
`Rainer.Apfel@teva.de
`
`Introduction: Multiple sclerosis (MS) has a profound impact on patients' quality of life (QoL),
`and improvement of cognitive function, depressive symptoms and levels of fatigue remains a
`goal of disease-modifying therapy. Such improvements would in turn potentially support
`adherence to therapy, consequently further enhancing treatment outcomes.
`Methods: QualiCOP was a prospective, observational, non-interventional, open-label study
`similar to the Coptimize trial and conducted at 170 sites in Germany. Patients (N=754),
`primarily (95.6%) with relapsing-remitting MS, with or without previous treatment, were
`observed for 24 months following conversion to treatment with once-daily glatiramer acetate
`20mg/1mL s.c. (GA), a first line disease modifying therapy with more than 2 Million
`patient/years on treatment. A series of 11examinations was conducted, including assessment
`of relapse rate, disease progression, overall functioning, QoL, cognition, fatigue, and
`depression.
`Results: Treatment with GA over 24 months was associated with a reduction of annual
`relapse rate from 0.87 to 0.49 (P .0001), while the proportion of relapse-free patients rose
`from 11.3% to 69.5%. Total remission was achieved in 56.4% of patients. MSFC scores
`showed slight improvement in overall functioning (P .0001), while PASAT and MUSIC showed
`robust improvement in cognition (both P .0001). The CES-D also showed significant
`improvement of depressive symptoms (P=.0006). Scores on the EDSS, MUSIC-Fatigue and
`FAMS (all NS) showed that disease severity, fatigue, and QoL were stable over the
`observation period.
`Conclusions: These findings suggest that patients experiencing inadequate symptom control
`will benefit from conversion to GA therapy, with improvements going beyond the standard
`measures of relapse and disease severity.
`
`
`
`
`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 1