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16. P.057 Achievement of minimal symptom expression in acetylcholine receptor antibody-positive participants treated with efgartigimod in ADAPT/ADAPT+

Author

Bril, V, Muppidi, S, Howard, JF, Murai, H, Phillips, G, Qi, C, Gelinas, D, Brauer, E, Zhao, S, and Vissing, J

Abstract

Background: A key efficacy indicator in generalized myasthenia gravis (gMG) treatment is improvement in MG-ADL score. Minimal symptom expression (MSE, MG-ADL total score of 0 or 1) is explored as a novel proposed treatment target in gMG in the phase 3 study of intravenous efgartigimod, ADAPT, and its open-label extension, ADAPT+. Methods: Post hoc analyses of acetylcholine receptor antibody positive participants in ADAPT (n=129) and ADAPT+ (n=111) were performed. Results: In ADAPT, 44.6% receiving efgartigimod achieved MSE vs 10.9% of participants given placebo. Despite less frequent assessment during ADAPT+, 40.5% of participants achieved MSE. Eighty-one percent of participants treated with efgartigimod who achieved MSE in ADAPT also achieved MSE during ADAPT+; 23% who had not achieved MSE in ADAPT did in ADAPT+. Achieving MSE was associated with substantial improvements in QMG, MGC, MG-QoL15r, and EQ-5D-5L mean scores of 11.4, 16.0, 12.4, and 0.3 points, respectively, from baseline to best score (across all visits). These drastic improvements resulted in quality of life (QoL) comparable to that of healthy populations. MSE achievement also resulted in sustained improvements in these disease-specific and QoL measures. Conclusions: Participants who achieved MSE showed substantial and consistent improvements across multiple disease measures and experienced QoL comparable to that of healthy populations.

Published
2024
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19. The Challenges of an Operationalized National Guard and a Militia Alternative

Author

NATIONAL DEFENSE UNIV NORFOLK VA JOINT ADVANCED WARFIGHTING SCHOOL, Gelinas, D. E., NATIONAL DEFENSE UNIV NORFOLK VA JOINT ADVANCED WARFIGHTING SCHOOL, and Gelinas, D. E.

Abstract

The National Guard contributes nearly half of the total combat forces currently employed in both Operations Enduring Freedom and Iraqi Freedom and a majority of Operation Noble Eagle. The Department of Defense must acknowledge this increasingly unsustainable pace and toll of domestic and overseas tasking for the National Guard as the Guard attempts to fulfill its statutory requirements under Titles 10 and 32 of United States Code. The thesis of this paper is that the National Guard can not adequately support the dual status requirements of the states and the nation as an operationalized reserve engaged in the War on Terror and that reconstituting a traditional militia construct would provide the nation an affordable, legal, adequately trained and equipped citizenry which is relevant to the state governors and USNORTHCOM for employment in domestic and defensive crises. A dedicated and properly resourced traditional militia would permit the continued employment of the Air and Army National Guard as vital operational reserve forces to the active duty forces supporting the Geographic Combatant Commands overseas military combat and contingency operations. Such an institution would give members of the All Volunteer Force several new enlistment options in their decision to serve the nation., The original document contains color images.

Published
2008

34. Placebo-controlled trial of gabapentin in patients with amyotrophic lateral sclerosis

Author

Miller, R. G., primary, Moore, D., additional, Young, L. A., additional, Armon, C., additional, Barohn, R. J., additional, Bromberg, M. B., additional, Bryan, W. W., additional, Gelinas, D. F., additional, Mendoza, M. C., additional, Neville, H. E., additional, Parry, G. J., additional, Petajan, J. H., additional, Ravits, J. M., additional, Ringel, S. P., additional, and Ross, M. A., additional

Published
1996
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36. Clinical trials of riluzole in patients with ALS

Author

Miller, R. G., primary, Bouchard, J. P., additional, Duquette, P., additional, Eisen, A., additional, Gelinas, D., additional, Harati, Y., additional, Munsat, T. L., additional, Powe, L., additional, Rothstein, J., additional, Salzman, P., additional, and Sufit, R. L., additional

Published
1996
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41. Practice parameter: the care of the patient with amyotrophic lateral sclerosis (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology: ALS Practice Parameters Task Force.

Author

Miller RG, Rosenberg JA, Gelinas DF, Mitsumoto H, Newman D, Sufit R, Borasio GD, Bradley WG, Bromberg MB, Brooks BR, Kasarskis EJ, Munsat TL, Oppenheimer EA, ALS Practice Parameters Task Force, Miller, R G, Rosenberg, J A, Gelinas, D F, Mitsumoto, H, Newman, D, and Sufit, R

Published
1999
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45. Effect of recombinant human insulin-like growth factor-I on progression of ALS

Author

Lai, E. C., Felice, K. J., Festoff, B. W., Gawel, M. J., Gelinas, D. F., Kratz, R., Murphy, M. F., Natter, H. M., Norris, F. H., and Rudnicki, S. A.

Abstract

The objective of this study was to investigate the safety and efficacy of recombinant human insulinlike growth factor-I (rhIGF-I) in the treatment of sporadic ALS. A double-blind, placebo-controlled, randomized study of 266 patients was conducted at eight centers in North America. Placebo or rhIGF-I(0.05 mg/kg/day or 0.10 mg/kg/day) was administered for 9 months. The primary outcome measure was disease symptom progression, assessed by the rate of change (per patient slope) in the Appel ALS rating scale total score. The Sickness Impact Profile (SIP), a patient-perceived, health-related quality of life assessment, was a secondary outcome variable. Progression of functional impairment in patients receiving high-dose (0.10 mg/kg/day) rhIGF-I was 26% slower than in patients receiving placebo (p= 0.01). The high-dose treatment group was less likely to terminate the study due to protocol-defined markers of disease symptom progression, and members in this group exhibited a slower decline in quality of life, as assessed by the SIP. Patients receiving 0.05 mg/kg/day of rhIGF-I exhibited trends similar to those associated with high-dose treatment, suggesting a dose-dependent response. The incidence of clinically significant adverse experiences was comparable among the three treatment groups. Recombinant human insulin-like growth factor-I slowed the progression of functional impairment and the decline in health-related quality of life in patients with ALS with no medically important adverse effects.

Published
1997

46. Proposed Model for the Peroxidase-Catalyzed Oxidation of Indole-3-acetic Acid in the Presence of the Inhibitor Ferulic Acid 1

Author

Gelinas, D. A.

Subjects
Articles
Abstract

Linear increments in ferulic acid concentration produce logarithmic increases in the ferulic acid-induced lag periods prior to the peroxidase-catalyzed oxidation of indole-3-acetic acid in a system containing 2,4-dichlorophenol and MnCl(2) in acetate buffer at pH 5.6. Maintaining the ratio of indole-3-acetic acid to ferulic acid constant at 100 while linearly raising the ferulic acid concentration results in linear increases in the lag period. Both indole-3-acetic acid and ferulic acid are substrates of horseradish peroxidase in the presence of H(2)O(2), and indole-3-acetic acid competitively inhibits the oxidation of ferulic acid. A model for the enzymatic oxidation of indole-3-acetic acid catalyzed by peroxidase is proposed.

Published
1973

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