5134
`
`Abstracts
`
`with the desired number of transactions for most subscales with the
`lowest satisfaction for social companionship. Discussion: The pur-
`suit of studying prognostic risk factors is driven by the prospect that
`appropriate intervention, early in the course of the problem directed
`at the risk factor may delay chronic disability. By the end of the sum-
`mer, our research team can present results from three different mea-
`surements from the influence of an exercise program on instrumental
`and functional social support.
`
`P453
`
`The impact of regularly scheduled neutralising antibody
`testing on treatment patterns versus usual care in MS pa-
`tients taking high -dose interferon
`C. Markowitz, E. Fox, A. Goodman, B. Green, R. Murray
`University of Pennsylvanian (Philadelphia, USA); Multiple Sclerosis Clinic
`of Central Texas (Round Rock, USA); Rochester Multiple Sclerosis Center
`(Rochester, USA); West County Multiple Sclerosis Center (St. Louis, USA);
`Murray Multiple Sclerosis Clinic of Colorado (Denver, USA)
`
`Objective: To determine the impact of regularly scheduled neutral-
`izing antibody (Nab) testing on treatment patterns compared to the
`usual care of MS subjects receiving high dose (HD IFN) therapy. Back-
`ground: Recent publications support the use of routine NAbs testing
`in the management of patients receiving HD IFN. However, barriers
`to NAbs testing exist, including cost, accessibility, result interpretation
`and reimbursement. Removal of these barriers may lead to increased
`use of routine NAb testing, changes in prescribing behavior, and im-
`proved patient care. Design/Methods: 230 sites are participating with
`an enrollment target of 2440 subjects diagnosed with MS and taking
`HD IFN > 12 months and < 4 years that have not had previous NAbs
`testing. In a randomized controlled open -label parallel group design,
`subjects are being enrolled in either a Regular NAbs Testing or a Usual
`Care Arm. In the NAb Testing Arm, subjects may receive up to 4 binding
`(BAb) and /or NAb evaluations over the 12 months. In the Usual Care
`Arm, subjects experience usual care conditions which could include ad
`hoc NAb testing. Primary outcome is the proportion of subjects whose
`HD IFN therapy changes in the NAbs Testing Arm versus the Usual
`Care Arm. Changes in therapy are defined as stopping current IFN, IFN
`dose /frequency changes, or starting new immunotherapy. Additional
`outcome measures include the nature and reasons of any management
`change, the temporal relationship of adverse events to the appearance
`of NAbs, and whether the BAb level is predictive of a positive NAb
`test. Results /Conclusions: Evaluation of regularly scheduled NAbs
`testing on the management of HD IFN patients will provide greater
`understanding of the effects of NAB results on therapy decisions and
`may add further support to the use of routine testing as a part of MS
`patient care. This study is sponsored by Teva Neuroscience.
`
`P454
`
`Exploring interventions for management of injection site
`reactions with glatiramer acetate
`H. Zwibel, H. Jolly, M. Oleen -Burkey, J. Conner, D. Denney on behalf of the
`Alcohol Wipes, Warm Compress, and Oral Antihistamine Study Groups
`
`Background: A common reason for discontinuing therapy early in
`the course of treatment for multiple sclerosis (MS) is the develop-
`ment of local injection site reactions (LISRs). Research directed toward
`reduction of LISRs can aid nurses who provide training and advice
`to patients regarding regular self -injection. Objective: Three studies
`were implemented to explore interventions for reducing LISRs prior
`to daily injections of glatiramer acetate (GA): 1) the elimination of
`alcohol wipes, 2) the use of warm compresses, and 3) the use of oral
`antihistamines. Design/Methods: Single cross -over designs with 50
`patients were used to investigate the impact of 1) removing alcohol
`wipes from the injection site preparation and 2) using warm com-
`presses on the injection sites for 5 minutes prior to self- injections of
`GA. A randomized placebo -controlled group design with 80 patients
`
`was used to investigate the impact of using an oral antihistamine
`30 minutes prior to self- injections of GA. Patients used standardized
`daily diaries to record LISRs and were required to pass concordance
`testing before participating in the studies. The primary endpoint was
`total number of LISRs recorded at 5 minutes post- injection. Results:
`There was no statistically significant difference in LISRs when alco-
`hol wipes were or were not used in the injection preparation for 30
`days. However, patients recorded a significantly lower number of
`LISRs when warm compresses were applied to GA injection sites over
`14 days compared to usual site preparation (p = 0.002). Compared
`to using placebo, patients who took an oral antihistamine prior to
`each self- injection of GA for 14 days did not record a statistically
`significant difference on the primary endpoints but some post -hoc
`exploratory analyses did reveal some statistically significant differ-
`ences between the treatment groups. Conclusions: At this time only
`warm compresses can be recommended for the management of LISRs
`associated with self- injections of GA. The injection site intervention
`studies were sponsored by Teva Neuroscience.
`
`P455
`
`Impact of an oral antihistamine on local injection site reac-
`tions with glatiramer acetate
`G. Pardo, C. Boutwell, J. Conner, D. Denney
`MS Center of Oklahoma (Oklahoma City, USA); Neurological Consultants
`of KC, Inc. (Kansas City, USA); Teva Neuroscience (Kansas City, USA);
`University of Kansas (Lawrence, USA)
`
`Background: While generally not serious in nature, local injec-
`tion site reactions (LISRs) can be troublesome to patients beginning
`therapy with injectable MS therapies and can lead to treatment dis-
`continuation. This was one of several studies designed to explore the
`effect of a short -term intervention on the frequency and type of LISRs
`encountered by patients using glatiramer acetate (GA). Objective: To
`compare LISRs between patients receiving an oral antihistamine or a
`placebo 30 minutes prior to daily injections of GA. Design/Methods:
`This double -blind, randomized, placebo controlled study enrolled.
`patients who had started GA therapy within the past three months.
`Patient diaries were used to determine the number of LISRs occur-
`ring across a 14 -day Baseline period followed by a 14 -day Treatment
`period, expressed as LISR scores. The outcome measures were the LISR
`scores reported immediately, 2 minutes and 5 minutes post- injection
`for two weeks during both Baseline and Treatment periods. Mean LISR
`scores during the Baseline period were compared to that during the
`Treatment period using paired samples t tests. Results: Eighty -five
`patients were randomized; eighty -three completed a 14 -day Baseline
`period followed by a 14 -day Treatment period. A decline in the LISR
`scores at each post -injection time interval in the antihistamine arm,
`but not in the placebo arm, were observed. However, the comparison
`between arms was not statistically significant (primary endpoint).
`Post -hoc exploratory analyses did reveal some statistically significant
`differences between the treatment and placebo arms. Conclusions:
`Although modest effects were seen in the active treatment group
`when LISRs were compared prior to starting the antihistamine and
`during antihistamine therapy, there were no statistically significant
`differences between the treatment group and the placebo group on
`the primary endpoint. Antihistamine use as a strategy to reduce LISRs
`in patients on GA therapy, cannot be recommended at this time. The
`Oral Antihistamine Study was sponsored by Teva Neuroscience.
`
`P456
`
`Reduction of injection -site reactions with hydrocortisone,
`witch hazel, or moisturising lotion after subcutaneous in-
`terferon beta la treatment for multiple sclerosis
`A. Perrin Ross, B. Singer, K. Kresa -Reahl, D. Mikol, A. AL- Sabbagh, R.
`Bennett, V. Divan
`Loyola University Medical Center (Maywood, USA); Barnes- Jewish Hospital
`Plaza (St, Louis, USA); Capital Neurology (Charleston, USA); University
`
`Multiple Sclerosis 2007; 13: S7 -S273
`
`http : / /msj.sagepub.com
`
`MYLAN PHARMS. INC. EXHIBIT 1069 PAGE 1