Self-reported smoking status associated with clinical disease worsening in CombiRx
ECTRIMS Online Library. Cofield S. 10/26/17; 200065; P410
Assoc. Prof. Stacey S. Cofield
Assoc. Prof. Stacey S. Cofield
Contributions
Abstract

Abstract: P410

Type: Poster

Abstract Category: Clinical aspects of MS - 11 Comorbidity

Background: Smoking history may increase risk of MS development and there is increasing evidence that smoking can increase risk of disease worsening.
Objective: We explored if self-report smoking status was associated with relapse, measures of disease progression, and MSFC in relapsing remitting MS participants in the CombiRx clinical trial.
Methods: This analysis was carried out using the clinical data from 1008 RRMS subjects enrolled in the CombiRx trial, a multi-center, phase-III investigation of combination therapy of interferon and glatiramer acetate, followed for up to 7 years. Of the 1008 randomized participants, 840 completed the self-report smoking questions: Never, Past, or Current; analyzes as Non Current (NC, Past and Never) and Current Smokers (CS). Relapse required a confirmed change in EDSS, progression was a 6 month confirmed 1-point worsening of EDSS, MSFC was measured quarterly. Models were adjusted for baseline EDSS, race, gender, age, treatment, and time on study.
Results: Randomized between 2005-2009, the majority of participants reported never having smoked (49.2%), with 24.6% past and 26.2% current smokers. Age at baseline 37.9 (SD 9.6), 70.1% Female. CS were more likely to experience a relapse compared to NC (OR 1.39, p=0.037). CS had worse MSFC scores overtime compared to NC (0.59 lower, p=0.040). There was no statistical difference in the proportion experiencing 6-month progression (31.3% CS vs 28.4% NC, p=0.41). However NC were more likely to remain clinically disease free (no progression and no relapse) compared to CS
(OR 1.6, p=0.004).
Conclusion: Self-report smoking is associated with clinical worsening in terms of MSFC While there was no difference in those with confirmed progression, current smokers experienced worse accumulation of clinical disease.
Disclosure: The study was funded by the NINDS of the NIH, with medications and matched placebos provided by Biogen Idec and Teva Pharmaceuticals to a central distribution site at the Veterans Administration Distribution Center at Perry Point, Maryland. Design, analysis, and decision to publish results were the responsibility of the study investigators with the oversight of the DSMB and NINDS. The trial is listed on www.clincaltrials.gov as NCT00211887.
Stacey S Cofield: grant support from Pfizer, consulting fees from Department of Defense, American Shoulder and Elbow Society, Oxford University Press, MedImmune, Inc.
Tarah Gustafson: nothing to disclose
Gary Cutter: fees from Data and Safety Monitoring Boards: AMO Pharmaceuticals, Apotek, Gilead Pharmaceuticals, Horizon Pharmaceuticals, Modigenetech/Prolor, Merck, Merck/Pfizer, Opko Biologics, Neuren, Sanofi-Aventis, Reata Pharmaceuticals, Receptos/Celgene, Teva pharmaceuticals, NHLBI (Protocol Review Committee), NICHD (OPRU oversight committee). Consulting or Advisory Boards: Atara Biotherapeutics, Bioeq GmBH, Cerespir Inc, Consortium of MS Centers (grant), Genzyme, Genentech, Innate Therapeutics, Jannsen Pharmaceuticals, Klein-Buendel Incorporated, Medimmune, Medday, Nivalis, Novartis, Opexa Therapeutics, Roche, Savara Inc., Somahlution, Teva pharmaceuticals, Transparency Life Sciences, TG Therapeutics. Dr. Cutter is employed by the University of Alabama at Birmingham and President of Pythagoras, Inc. a private consulting company located in Birmingham AL.
Fred Lublin: Funding for Research: Acorda Therapeutics, Inc.; Biogen Idec; Novartis Pharmaceuticals Corp; Teva Neuroscience, Inc.; Genzyme; Sanofi; Celgene; NIH; NMSS; Consulting Agreements/Advisory Boards/DSMB: Bayer HealthCare Pharmaceuticals; Biogen Idec; EMD Serono, Inc.; Novartis; Teva Neuroscience; Actelion; Sanofi-Aventis; Acorda; Questcor; Roche, Genentech; Celgene; Johnson & Johnson; Revalesio; Coronado Bioscience, Genzyme, MedImmune; Bristol-Myers Squibb, Xenoport, Receptos; Forward Pharma; Co-Chief Editor: Multiple Sclerosis and Related Diseases; Stock Ownership: Cognition Pharmaceuticals, Inc.
Stephen Krieger: Consultant for Acorda Therapeutics, Bayer, Biogen, EMD Serono, Genentech, Genzyme Corporation, Novartis, and Teva Pharmaceutical Industries. He has participated in Industry-Sponsored Non-Promotional, Non-Marketing Lectures for Genzyme Corporation, Genentech, and Biogen Idec.
Jerry Wolinsky: consulting/speakers agreements with AbbVie, Alkermes, Athersys, Inc., Bayer HealthCare, Celgene, EMD Serono, Forward Pharma, Genentech, Genzyme, Jansen R&D, Novartis, Roche, Sanofi, Teva, Teva Neurosciences, to-BBB, and XenoPort; royalties from Chemicon International; research/contractual support from Genzyme, Sanofi, the National Institutes of Health, and National MS Society.

Abstract: P410

Type: Poster

Abstract Category: Clinical aspects of MS - 11 Comorbidity

Background: Smoking history may increase risk of MS development and there is increasing evidence that smoking can increase risk of disease worsening.
Objective: We explored if self-report smoking status was associated with relapse, measures of disease progression, and MSFC in relapsing remitting MS participants in the CombiRx clinical trial.
Methods: This analysis was carried out using the clinical data from 1008 RRMS subjects enrolled in the CombiRx trial, a multi-center, phase-III investigation of combination therapy of interferon and glatiramer acetate, followed for up to 7 years. Of the 1008 randomized participants, 840 completed the self-report smoking questions: Never, Past, or Current; analyzes as Non Current (NC, Past and Never) and Current Smokers (CS). Relapse required a confirmed change in EDSS, progression was a 6 month confirmed 1-point worsening of EDSS, MSFC was measured quarterly. Models were adjusted for baseline EDSS, race, gender, age, treatment, and time on study.
Results: Randomized between 2005-2009, the majority of participants reported never having smoked (49.2%), with 24.6% past and 26.2% current smokers. Age at baseline 37.9 (SD 9.6), 70.1% Female. CS were more likely to experience a relapse compared to NC (OR 1.39, p=0.037). CS had worse MSFC scores overtime compared to NC (0.59 lower, p=0.040). There was no statistical difference in the proportion experiencing 6-month progression (31.3% CS vs 28.4% NC, p=0.41). However NC were more likely to remain clinically disease free (no progression and no relapse) compared to CS
(OR 1.6, p=0.004).
Conclusion: Self-report smoking is associated with clinical worsening in terms of MSFC While there was no difference in those with confirmed progression, current smokers experienced worse accumulation of clinical disease.
Disclosure: The study was funded by the NINDS of the NIH, with medications and matched placebos provided by Biogen Idec and Teva Pharmaceuticals to a central distribution site at the Veterans Administration Distribution Center at Perry Point, Maryland. Design, analysis, and decision to publish results were the responsibility of the study investigators with the oversight of the DSMB and NINDS. The trial is listed on www.clincaltrials.gov as NCT00211887.
Stacey S Cofield: grant support from Pfizer, consulting fees from Department of Defense, American Shoulder and Elbow Society, Oxford University Press, MedImmune, Inc.
Tarah Gustafson: nothing to disclose
Gary Cutter: fees from Data and Safety Monitoring Boards: AMO Pharmaceuticals, Apotek, Gilead Pharmaceuticals, Horizon Pharmaceuticals, Modigenetech/Prolor, Merck, Merck/Pfizer, Opko Biologics, Neuren, Sanofi-Aventis, Reata Pharmaceuticals, Receptos/Celgene, Teva pharmaceuticals, NHLBI (Protocol Review Committee), NICHD (OPRU oversight committee). Consulting or Advisory Boards: Atara Biotherapeutics, Bioeq GmBH, Cerespir Inc, Consortium of MS Centers (grant), Genzyme, Genentech, Innate Therapeutics, Jannsen Pharmaceuticals, Klein-Buendel Incorporated, Medimmune, Medday, Nivalis, Novartis, Opexa Therapeutics, Roche, Savara Inc., Somahlution, Teva pharmaceuticals, Transparency Life Sciences, TG Therapeutics. Dr. Cutter is employed by the University of Alabama at Birmingham and President of Pythagoras, Inc. a private consulting company located in Birmingham AL.
Fred Lublin: Funding for Research: Acorda Therapeutics, Inc.; Biogen Idec; Novartis Pharmaceuticals Corp; Teva Neuroscience, Inc.; Genzyme; Sanofi; Celgene; NIH; NMSS; Consulting Agreements/Advisory Boards/DSMB: Bayer HealthCare Pharmaceuticals; Biogen Idec; EMD Serono, Inc.; Novartis; Teva Neuroscience; Actelion; Sanofi-Aventis; Acorda; Questcor; Roche, Genentech; Celgene; Johnson & Johnson; Revalesio; Coronado Bioscience, Genzyme, MedImmune; Bristol-Myers Squibb, Xenoport, Receptos; Forward Pharma; Co-Chief Editor: Multiple Sclerosis and Related Diseases; Stock Ownership: Cognition Pharmaceuticals, Inc.
Stephen Krieger: Consultant for Acorda Therapeutics, Bayer, Biogen, EMD Serono, Genentech, Genzyme Corporation, Novartis, and Teva Pharmaceutical Industries. He has participated in Industry-Sponsored Non-Promotional, Non-Marketing Lectures for Genzyme Corporation, Genentech, and Biogen Idec.
Jerry Wolinsky: consulting/speakers agreements with AbbVie, Alkermes, Athersys, Inc., Bayer HealthCare, Celgene, EMD Serono, Forward Pharma, Genentech, Genzyme, Jansen R&D, Novartis, Roche, Sanofi, Teva, Teva Neurosciences, to-BBB, and XenoPort; royalties from Chemicon International; research/contractual support from Genzyme, Sanofi, the National Institutes of Health, and National MS Society.

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