Contributions
Abstract: P407
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Comorbidity
Objective: To compare disease outcomes in tobacco versus non-tobacco users treated with oral disease modifying therapies (DMT) in clinical practice at 24-month follow-up.
Background: Numerous studies demonstrated that tobacco exposure is a risk factor for early disability. However, studies evaluating the relationship between tobacco and multiple sclerosis (MS) disease activity and DMT persistence have yielded conflicting results. We sought to address this issue from routine clinical practice.
Methods: 659 MS patients using either dimethyl fumarate (DMF) or fingolimod (FTY) were followed for 24 months in a large academic MS center and were stratified by tobacco use. DMT discontinuation and measures of disease activity were assessed using propensity score (PS) weighting. Covariates used in the PS model included demographics and baseline clinical and MRI characteristics within 12 months of DMT initiation. Outcome measures included annualized relapse rate (ARR), and the proportions with discontinuation, new brain MRI lesions, absence of disease activity (defined as freedom from clinical relapses and MRI activity), and depression (PHQ-9 score ≥10) by 24 months on-treatment. After PS adjustment, odds ratio estimates were calculated as tobacco vs non-tobacco use. Based on clinical experience, we hypothesized DMF tobacco users would be more at risk of breakthrough disease.
Results: 164 tobacco users (DMF n=101; FTY n=63) and 495 non-tobacco users (DMF n=294; FTY n=201) were identified. PS weighting showed excellent covariate balance. By 24 months, tobacco (39.4%) and non-tobacco (34.4%) users were equally likely to discontinue their respective DMT [OR=1.17, 95% CI (0.79, 1.75)]. Tobacco users had decreased odds of absence of disease activity [OR=0.61, 95% CI (0.44, 0.83)]. Similarly, tobacco users trended towards a higher ARR [OR=1.38, 95% CI (0.97, 1.96)] and proportion with new gadolinium-enhancing lesions [OR=1.39, 95% CI (0.80, 2.60)], new T2 lesions [OR=1.62, 95% CI (0.94, 2.79)], and depression [OR=1.38, 95% CI (0.84, 2.27)], but did not reach statistical significance. Disease activity endpoints were not driven by either DMT alone.
Conclusions: In our study, tobacco users were less likely to achieve absence of disease activity compared to non-tobacco users in a population of patients treated with oral DMTs. This finding suggests that tobacco is a negative risk factor for inflammatory disease activity and warrants further exploration with larger studies.
Disclosure: Dr. Carrie Hersh has received speaking and consulting fees from Genzyme, Teva, Biogen, and Novartis; she has served on advisory committees for Biogen, Teva, and Genentech; Grants- Biogen and Genentech.
Miss Haleigh Harris has nothing to disclose.
Ms. Malissa Ayers has received speaking fees from Genzyme.
Dr. Robert Bermel has received speaking and consulting fees from Biogen, Novartis, Genzyme, and Genentech; Grants- Biogen and Genentech.
Dr. Robert Fox has received consulting fees from Actelion, Biogen, Genentech, Novartis and Teva; he has served on advisory committees for Biogen and Novartis; Grants- Biogen and Novartis.
Dr. Jeffrey Cohen has received consulting fees from Adamas and Celgene; Co-editor of MSJ-ETC.
Dr. Ontaneda has received consulting fees from Acorda, Alkermes, Biogen Idec, Genentech, Genzyme, Mallinckrodt, Novartis, and Synthon; Grants-Genzyme, Novartis, Genentech, NMSS, and NIH.
Dr. Devon Conway has received research support paid to his institution from Novartis Pharmaceuticals. He has received personal compensation for consulting for Novartis Pharmaceuticals, Arena Pharmaceuticals, and Tanabe Pharmaceuticals.
Abstract: P407
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Comorbidity
Objective: To compare disease outcomes in tobacco versus non-tobacco users treated with oral disease modifying therapies (DMT) in clinical practice at 24-month follow-up.
Background: Numerous studies demonstrated that tobacco exposure is a risk factor for early disability. However, studies evaluating the relationship between tobacco and multiple sclerosis (MS) disease activity and DMT persistence have yielded conflicting results. We sought to address this issue from routine clinical practice.
Methods: 659 MS patients using either dimethyl fumarate (DMF) or fingolimod (FTY) were followed for 24 months in a large academic MS center and were stratified by tobacco use. DMT discontinuation and measures of disease activity were assessed using propensity score (PS) weighting. Covariates used in the PS model included demographics and baseline clinical and MRI characteristics within 12 months of DMT initiation. Outcome measures included annualized relapse rate (ARR), and the proportions with discontinuation, new brain MRI lesions, absence of disease activity (defined as freedom from clinical relapses and MRI activity), and depression (PHQ-9 score ≥10) by 24 months on-treatment. After PS adjustment, odds ratio estimates were calculated as tobacco vs non-tobacco use. Based on clinical experience, we hypothesized DMF tobacco users would be more at risk of breakthrough disease.
Results: 164 tobacco users (DMF n=101; FTY n=63) and 495 non-tobacco users (DMF n=294; FTY n=201) were identified. PS weighting showed excellent covariate balance. By 24 months, tobacco (39.4%) and non-tobacco (34.4%) users were equally likely to discontinue their respective DMT [OR=1.17, 95% CI (0.79, 1.75)]. Tobacco users had decreased odds of absence of disease activity [OR=0.61, 95% CI (0.44, 0.83)]. Similarly, tobacco users trended towards a higher ARR [OR=1.38, 95% CI (0.97, 1.96)] and proportion with new gadolinium-enhancing lesions [OR=1.39, 95% CI (0.80, 2.60)], new T2 lesions [OR=1.62, 95% CI (0.94, 2.79)], and depression [OR=1.38, 95% CI (0.84, 2.27)], but did not reach statistical significance. Disease activity endpoints were not driven by either DMT alone.
Conclusions: In our study, tobacco users were less likely to achieve absence of disease activity compared to non-tobacco users in a population of patients treated with oral DMTs. This finding suggests that tobacco is a negative risk factor for inflammatory disease activity and warrants further exploration with larger studies.
Disclosure: Dr. Carrie Hersh has received speaking and consulting fees from Genzyme, Teva, Biogen, and Novartis; she has served on advisory committees for Biogen, Teva, and Genentech; Grants- Biogen and Genentech.
Miss Haleigh Harris has nothing to disclose.
Ms. Malissa Ayers has received speaking fees from Genzyme.
Dr. Robert Bermel has received speaking and consulting fees from Biogen, Novartis, Genzyme, and Genentech; Grants- Biogen and Genentech.
Dr. Robert Fox has received consulting fees from Actelion, Biogen, Genentech, Novartis and Teva; he has served on advisory committees for Biogen and Novartis; Grants- Biogen and Novartis.
Dr. Jeffrey Cohen has received consulting fees from Adamas and Celgene; Co-editor of MSJ-ETC.
Dr. Ontaneda has received consulting fees from Acorda, Alkermes, Biogen Idec, Genentech, Genzyme, Mallinckrodt, Novartis, and Synthon; Grants-Genzyme, Novartis, Genentech, NMSS, and NIH.
Dr. Devon Conway has received research support paid to his institution from Novartis Pharmaceuticals. He has received personal compensation for consulting for Novartis Pharmaceuticals, Arena Pharmaceuticals, and Tanabe Pharmaceuticals.