up‘Avcisauaam-.
`
`Dn EI
`
`-
`to
`
`POGJ41
`Randomized, Prospective, I-later-Blinded. Four
`Year Pllot Study To compare the Eflect of Daily
`Venue Every other Day Olatlramer Acetate 20
`mg Sllscutanoous lnjectlons In anus Christina Caan,
`Detroit, MI, Alexandros Tselis. Rochester Hills, MI, Wendy Ching,
`Moeein Din, [mad Zak, Zahid Latifl Fen Baa, Samia Ragheb,
`Alan Hudson, Omar Khan, Detroit, MI
`OBJECTIVE: We conducted a pilot trial to compare the efiect of GA 20 mg
`SC daily to every other day (QOD) on clinical, MR1, and immunologic
`outcomes in RRMS. BACKGROUND: The recommended dose of gluti-
`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
`eflicacy 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. Afler 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 afiaer 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 T2“! lesions. After 2 years, there were no
`diflerence in the relapse rate, disease progression, or any MR1 outcome. In
`vitro GA-proliferativs responses and ’l‘h1fl‘h2 cytokine expression did not
`difl'er between the two groups at any time point am: 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
`eficacy between the “QD-QOD cross over’ and the ‘always QOD” groups.
`Injection related lipostrophy was significantly less in the QOD group.
`CONCLUSIONSIRELEVANCE: This pilot study suggests that GA 20 mg
`SC administered QD or QOD may be equally efiective in RRMS. Larger.
`multi-center studies are warranted to confirm our findings and identifying
`the optimal dose ofGA in RRMS.
`Supported by: Wayne State University Neuroscience Program.
`Dlaclolurex Ms. Caon has nothing to disclose. Dr. Teelis has nothing to disclose. Dr.
`Chlm has nothing to disclose. Dr. Din has nothing to disclose. Dr. Zak has nothing to
`disclose Dr. Latlf has nothing to disclose. Dr. Bao has nothing to disclose. Dr. Ragheb
`has received research support from 'l'evs Neuroscience. Dr. Hudson has nothing to
`disclose. Dr. Khan has received personal compensation for activities with ‘Deva Neuro-
`science, Setono. Biogsn idea, and Bayer Health Cue Dr. Khan has received research
`support from ‘Dave Neuroscience. Serena, Biogsn idea. and Bayer Health Care.
`
`A317 NEUROLOGY '72 March 11, HID (filsppl 3)
`
`AMNEAL
`
`EXHIBIT NO. 1011 Page 1
`
` AMNEAL
`
`

`
`P06.1 41
`
`Randomized, Prospective, Rater-Blinded, Four
`Year Pilot Study To Compare the Effect of Daily
`Versus Every other Day Glatirarner Acetate 20
`mg Subcutaneous Injections in BRMS Christina Caon,
`Detroit, MI, Alexandros Tselis, Rochester Hills, MI, Wendy Ching,
`Moeein Din, Imad Zak, Zahid Latif, 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-
`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. DESIGNIMETHODS:
`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 Th]/Th2 cybokjne expression did not
`differ between the two groups at any time point after randomization. Afier
`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 diflerence 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 efi'ective 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 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 ’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.
`
`AMNEAL
`
`EXHIBIT NO. 1011 Page 2
`
` AMNEAL
`
`

`
`
`
`Neurology.
`v.72. no. 11,supp|. 3 (Mar. 17 2009)
`General Collection
`W1 NE337
`2009-03-23 06:45:51
`
`
`
`.5. Better Onficrwr. Etx,
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`A/\N BWANNUAL MEETWG
`APRIL 25 *— MAY 2. 2009
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`AMNEAL
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`n
`o .
`
`2009
`
`ANNUAL
`
`MEETING
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`PROGRAM
`
`Washir‘».gt:;n State
`Corn/ention and
`Tr
`, Ce-mer
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`C0-Hear_iqLJarters Hotels
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