‘AVGSEINOEM
`
`>V EF Nw
`
`P06.141
`Randomized, Prospective, Rater-Blinded, Four
`Year Pilot Study To Compare the Effect of Daily
`Versus Every Other Day Glatiramer Acetate 20
`mg Subcutaneous Injections in RRMS Christina Caon,
`Detroit, MI, Alexandros Tselis, Rochester Hills, MI, Wendy Ching,
`Moeein Din, [mad Zak, Zahid Latifi Fen Boo, Samia Ragheb,
`Alan Hudson, Omar Khan, Detroit, MI
`OBJECTIVE: We conducted a pilot trial to compare the effect of GA 20 mg
`SC daily to every other day (QOD) on clinical, MRI, and immunologic
`outcomes in RRMS. BACKGROUND: The recommended dose of glati-
`rauier acetate (GA) for the treatment of RRMS is 20 mg SC daily though
`the optimal dose remains unknown. Recent studies failed to show improved
`efficacy with higher than the recommended dose. DESIGN/METHODS:
`Treatment naive RRMS patients were randomized to GA 20 mg SC QD or
`QOD and followed prospectively for 2 years. After 2 years, patients in each
`group were given the option to continue or switch to the other group, and
`followed for an additional 2 years. EDSS was recorded every 6 months by a
`masked-rater. Brain MRI scans were obtained at baseline, years 2 and 4.
`Blood for immunologic testing was obtained at baseline and multiple time
`points alter randomization. RESULTS: 30 patients were randomized to GA
`20 mg SC given QD or QOD. Both groups were matched for age, disease
`duration, EDSS, relapse rate, and T2W lesions. After 2 years, there were no
`difference in the relapse rate, disease progression, or any MRI outcome. In
`vitro GA-proliferative responses and Thl/Th2 cytokine expression did not
`differ between the two groups at any time point after randomization. After
`2 years, all patients in the QD group opted to switch to QOD. After a total
`of 4 years of prospective follow-up, there was no difference in the clinical
`efiicacy between the “QD-QOD cross over” and the “always QOD” groups.
`Injection related lipoatrophy was significantly less in the QOD group,
`CONCLUSIONS/RELEVANCE: This pilot study suggests that GA 20 mg
`SC administered QD or QOD may be equally effective in RRMS. Larger,
`multi-center studies are warranted to confirm our findings and identifying
`the optimal dose of GA in RRMS.
`Supported by: Wayne State University Neuroscience Program.
`Disdosure: Ms. Caon has nothing to disclose. Dr. Tselis has nothing to disclose. Dr.
`Ching has nothing to disclose. Dr. Din has nothing to disclose. Dr. Zak has nothing to
`disclose. Dr. Latif has nothing to disclose. Dr. Bao has nothing to disclose. Dr. Ragheb
`has received research support from ’l‘eva Neuroscience. Dr. Hudson has nothing to
`disclose. Dr. Khan has received personal compensation for activities with Teva Neuro-
`science, Serono, Biogen Idec, and Bayer Health Care. Dr. Khan has received research
`support from Teva Neuroscience, Serono, Biogen Idec, and Bayer Health Care.
`
`A317 NEUROLOGY 72 March 17, 2009 (Suppl 3)
`
`MYLAN INC. EXHIBIT NO. 1011 Page 1
`
`MYLAN INC. EXHIBIT NO. 1011 Page 1
`
`

`

`FOG-1 41
`
`Randomized, Prospective, Rater-Blinded, Four
`Year Pilot Study To Compare the Effect of Daily
`Versus Every Other Day Glatiramer Acetate 20
`mg Subcutaneous Injections in BRMS Christina Coon,
`Detroit, MI, Alexandros Tselis, Rochester Hills, MI, Wendy Ching,
`Moeein Din, Imad Zak, Zohid Lotifi Fen Boo, Somia Ragheb,
`Alan Hudson, Omar Khan, Detroit, MI
`
`OBJECTIVE: We conducted a pilot trial to compare the effect of GA 20 mg
`SC daily to every other day (QOD) on clinical, MRI, and immunologic
`outcomes in RRMS. BACKGROUND: The recommended dose of glati-
`ramer acetate (GA) for the treatment of RRMS is 20 mg SC daily though
`the optimal dose remains unknown. Recent studies failed to show improved
`efficacy with higher than the recommended dose. DESIGN/METHODS:
`Treatment naive RRMS patients were randomized to GA 20 mg SC QD or
`QOD and followed prospectively for 2 years. After 2 years, patients in each
`group were given the option to continue or switch to the other group, and
`followed for an additional 2 years. EDSS was recorded every 6 months by a
`masked-rater. Brain MRI scans were obtained at baseline, years 2 and 4.
`Blood for immunologic testing was obtained at baseline and multiple time
`points after randomization. RESULTS: 30 patients were randomized to GA
`20 mg SC given QD or QOD. Both groups were matched for age, disease
`duration, EDSS, relapse rate, and T2W lesions. After 2 years, there were no
`difference in the relapse rate, disease progression, or any MRI outcome. In
`vitro GA-proliferative responses and Th1fl‘h2 cytokine expression did not
`differ between the two grOups at any time point after randomization. After
`2 years, all patients in the QD group opted to switch to QOD. After a total
`of 4 years of prospective follow-up, there was no difference in the clinical
`efficacy between the “QD-QOD cross over” and the “always QOD” groups.
`Injection related lipoatrophy was significantly less in the QOD group.
`CONCLUSIONSIRELEVANCE: This pilot study suggests that GA 20 mg
`SC administered QD or QOD may be equally effective in RRMS. Larger,
`multi-center studies are warranted to confirm our findings and identifying
`the optimal dose of GA in RRMS.
`Supported by: Wayne State University Neuroscience Program.
`Disclosure: Ms- Caon has nothing to disclose. Dr. Tselis has nothing to disc10se. Dr.
`Ching has nothing to disclose. Dr. Din has nothing to disclose. Dr. Zak has nothing to
`disclose. Dr. Latif has nothing to disclose. Dr. Ben has nothing to disclose. Dr. Ragheb
`has received research support from ’I‘eva Neuroscience. Dr. Hudson has nothing to
`disclose. Dr. Khan has received personal compensation for activities with Teva Neuro-
`science, Serono, Biogen Idec, and Bayer Health Care. Dr. Khan has received research
`support from Teva Neuroscience, Serono, Biogen Idec, and Bayer Health Care.
`
`MYLAN INC. EXHIBIT NO. 1011 Page 2
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`MYLAN INC. EXHIBIT NO. 1011 Page 2
`
`

`

`Neurology.
`v. 72. no. 11,3uppl. 3 (Mar. 17 2009)
`General Collection
`W1 NE337
`2009-03—23 06:45:51
`
`as:
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`
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`
`
`
`
`Convention and
`fade Center ,
`.C09Héadqua vars Hotels:
`, Sheraton Seattle Hots!
`Grand Hyatt Seattte L
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` Wérshingtjon Staté
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`VBeitterr Prac (#38,, B'e'ttefbutcomes
`VAAN 61STANNUAL MEETING
`APRIL 25 ———-.MAY:'2, 2009
`
`MYLAN INC. EXHIBIT NO. 1011 Page 3
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`