Association of clinical epidemiological factors to polypharmacy among patients with multiple sclerosis: real-life data

Introduction: Treatment for multiple sclerosis should focus on relapse prevention and treatment, as well as symptom and disease progression control, which require the use of multiple medications. Objective: To evaluate the association of polypharmacy and related clinical, epidemiological factors in multiple sclerosis patient cohorts. Methods: It was conducted a prospective study of multiple sclerosis patients that held a prescription of disease-modifying drugs between January and December 2017. The medications were analyzed and classified as either long-term or as-needed medications for therapeutic objective and prescription status purposes. Results: During 2017, 124 patients were attended, 106 were eligible for the study, and 81 agreed to participate. The average age was 40.95±11.69 years. The disease duration varied between 6 months and 30 years, with a median of 7 years. More than half of the multiple sclerosis patients suffered from comorbidities (54.32%), and 76.54% were categorized as polypharmacy. The comparison of polypharmacy between the groups yielded significant differences for comorbidities and employment status and regarding age between patients with polypharmacy and patients without polypharmacy of long-term medications. Conclusion: The age of the patient and the presence of comorbidities are important factors related to polypharmacy.

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Long-term outcome and predictors of long-term disease activity in natalizumab-treated patients with multiple sclerosis: real life data from the Austrian MS Treatment Registry

Journal of Neurology ◽

10.1007/s00415-021-10559-w ◽

2021 ◽

Author(s):

Michael Guger ◽

◽

Christian Enzinger ◽

Fritz Leutmezer ◽

Franziska Di Pauli ◽

...

Keyword(s):

Multiple Sclerosis ◽

Disease Activity ◽

Rate Ratio ◽

Disease Duration ◽

Treatment Initiation ◽

Incidence Rate Ratio ◽

Real Life ◽

Life Data ◽

Real Life Data

Abstract Objectives To evaluate long-term effectiveness of natalizumab (NTZ) and to determine demographic, clinical, and radiological predictors regarding long-term disease activity (≥ 7 years) in a nationwide observational cohort, using data collected prospectively in a real-life setting. Materials and methods We analysed data from 230 patients from the Austrian Multiple Sclerosis Treatment Registry (AMSTR), who had started treatment with NTZ at any time since 2006 and stayed on NTZ for at least 7 years without treatment gap of more than three months. Results Estimated mean annualised relapse rates (ARR) over a mean treatment period of 9.3 years were 0.07 for NTZ. Sustained EDSS progression for 12 weeks was observed in 36 (19%) patients and for 24 weeks in 31 (16.3%) cases. Sustained EDSS regression for 12 and 24 weeks was seen in 45 (23.7%) and 42 (22.1%) cases. The baseline parameters ≥ 1 Gadolinium-enhancing MRI lesion(s) [incidence rate ratio (IRR) of 0.409 (95% CI 0.283–0.593), p = 0.001], ARR ≤ 1 in the prior 12 month before treatment initiation with NTZ [IRR of 0.353 (95% CI 0.200–0.623), p = 0.001] and EDSS ≤ 1 [incidence rate ratio (IRR) of 0.081 (95% CI 0.011–0.581), p = 0.012] were significantly associated with a reduced relapse risk, whereas a disease duration ≤ 5 years increased significantly the ARR [IRR of 1.851 (95% CI 1.249–2.743), p = 0.002]. The only predictive baseline parameter for experiencing EDSS progression (sustained for 12 and 24 weeks) was age > 35 years [HR of 2.482 (95% CI 1.110–5.549), p = 0.027, and HR of 2.492 (95% CI 1.039–5.978), p = 0.041, respectively]. Conclusions These real-life data show a stable disease course regarding relapse activity and disease progression under NTZ treatment for more than 7 years. The main predictors for disease activity were higher relapse rate before treatment initiation, higher disability, shorter disease duration and absence of Gadolinium-enhancing MRI lesions at baseline. Older age at NTZ start was the only significant risk factor for disease progression over long-term.

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Long-Term Data of Efficacy, Safety, and Tolerability in a Real-Life Setting of THC/CBD Oromucosal Spray-Treated Multiple Sclerosis Patients

The Journal of Clinical Pharmacology ◽

10.1002/jcph.670 ◽

2015 ◽

Vol 56 (7) ◽

pp. 845-851 ◽

Cited By ~ 8

Author(s):

Damiano Paolicelli ◽

Vita Direnzo ◽

Alessia Manni ◽

Mariangela D'Onghia ◽

Carla Tortorella ◽

...

Keyword(s):

Multiple Sclerosis ◽

Real Life ◽

Real Life Setting ◽

Multiple Sclerosis Patients ◽

Term Data

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Nabiximols discontinuation rate in a large population of patients with multiple sclerosis: a 18-month multicentre study

Journal of Neurology Neurosurgery & Psychiatry ◽

10.1136/jnnp-2019-322480 ◽

2020 ◽

Vol 91 (9) ◽

pp. 914-920

Author(s):

Clara Grazia Chisari ◽

Claudio Solaro ◽

Pasquale Annunziata ◽

Roberto Bergamaschi ◽

Assunta Bianco ◽

...

Keyword(s):

Multiple Sclerosis ◽

Rating Scale ◽

Numerical Rating Scale ◽

Large Population ◽

Real Life ◽

Discontinuation Rate ◽

Real Life Data ◽

Numerical Rating ◽

Therapy Option

IntroductionDelta-δ-tetrahydrocannabinol and cannabidiol (THC:CBD) oromucosal spray is used as an add-on therapy option for moderate to severe multiple sclerosis (MS) spasticity resistant to other medications. Aims of this study were to provide real-life data on long-term clinical outcomes in a large population of Italian patients treated with THC:CBD and to evaluate predictors of THC:CBD therapy continuation.Materials and methodsThis prospective observational multicentre Italian study screened all patients with MS consecutively included in the Agenzia Italiana del Farmaco e-registry at the start of THC:CBD treatment (baseline), after 4 weeks (T1), 12±3 weeks (T2), 24±3 weeks (T3), 48±3 weeks (T4) and 72±3 weeks (T5) from baseline.ResultsA total of 1845 patients were recruited from 32 MS Italian centres. At T1, 1502 (81.4%) of patients reached a Numerical Rating Scale (NRS) improvement of ≥20%, with an NRS reduction of 26.9% at T1 and of 34.4% at T5. At T5, 725 patients (48.3% of 1502) discontinued treatment with highest discontinuation rate at T2 and T3. Daily number of puffs was generally stable through the observation period. The multivariate analysis showed that higher NRS scores at baseline (OR 2.28, 95% CI 1.15 to 6.36, p<0.01) and higher differences of NRS between T0 and T1 (OR 2.11, 95% CI 1.08 to 8.26, p<0.05) were associated with an increased probability to continue therapy after 18 months.DiscussionTHC:CBD effects were sustained for 18 months with a relatively stable number of puffs per day. About 50% of patients abandoned THC:CBD therapy for loss of efficacy or adverse events.

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Alemtuzumab in a Large Real-Life Cohort: Interim Baseline Data of the TREAT-MS Study

Frontiers in Neurology ◽

10.3389/fneur.2021.620758 ◽

2021 ◽

Vol 12 ◽

Author(s):

Tjalf Ziemssen ◽

Frank Hoffmann ◽

Stephan Richter ◽

Ulrich Engelmann ◽

Robin White

Keyword(s):

Multiple Sclerosis ◽

Real World ◽

Disease Duration ◽

Real Life ◽

Surface Glycoprotein ◽

Cell Surface Glycoprotein ◽

Long Term Study ◽

Relapsing Remitting ◽

Treatment Sequences

The non-interventional long-Term study foR obsErvAtion of Treatment with alemtuzumab in active relapsing–remitting MS (TREAT-MS) study collects the so far largest real-life cohort regarding utilization, long-term effectiveness, and safety of alemtuzumab, a humanized monoclonal antibody directed against the cell surface glycoprotein CD52, in adult patients with active relapsing–remitting multiple sclerosis (RRMS). An interim analysis of baseline parameters at inclusion of a non-interventional real-world study about alemtuzumab in Germany including previous multiple sclerosis (MS) medication utilization, MS activity, severity, and duration, as well as comorbidities was performed. Of the 883 patients, 71.6% were women. Mean age was 35.7 ± 9.2 years, time since first MS symptoms (=disease duration) is 8.0 ± 6.8 years, and Expanded Disability Status Scale (EDSS) is 2.7 ± 1.8 points (range, 0.0–7.5 points). The number of relapses in the 12 and 24 months prior to inclusion were 1.6 ± 1.2 and 2.2 ± 1.8, respectively. Of the patients, 14.4% were treatment naive, while for the majority, a wide spectrum of MS disease-modifying treatments (DMTs) and treatment sequences were documented. Overall, interferon beta (IFN-beta) was reported most frequently (52.4%), followed by fingolimod (35.2%), natalizumab (34.9%), and glatiramer acetate (28.9%). Patients with longer disease duration and higher EDSS had a higher number of previous DMTs. Compared to the pivotal phase 2/3 studies, RRMS patients starting alemtuzumab treatment had a longer disease duration in real-world conditions. There was variety of different treatment sequences before the final switch to alemtuzumab. In the future, linking these treatment sequences or other baseline characteristics with effectiveness and safety outcomes might be useful to support treatment decisions. Registered at Paul-Ehrlich-Institut under NIS 281.

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Radiological and Laboratory Features of Multiple Sclerosis Patients With Immunosuppressive Therapy: A Multicenter Retrospective Study in Japan

Frontiers in Neurology ◽

10.3389/fneur.2021.749406 ◽

2021 ◽

Vol 12 ◽

Author(s):

Shinji Ashida ◽

Hirofumi Ochi ◽

Mio Hamatani ◽

Chihiro Fujii ◽

Ryusei Nishigori ◽

...

Keyword(s):

Multiple Sclerosis ◽

Relapse Prevention ◽

Demyelinating Disease ◽

Multiple Logistic Regression Analysis ◽

Oligoclonal Bands ◽

Laboratory Findings ◽

Disease Modifying Drugs ◽

Laboratory Features ◽

Multiple Sclerosis Patients ◽

Clinical Records

Background: Multiple sclerosis (MS) is a relapsing, inflammatory, and demyelinating disease of central nervous system showing marked clinical heterogeneity. Many factors might influence the choice of relapse prevention drug, and treatment response varies among patients. Despite the enlargement of disease-modifying drugs for MS (MS-DMDs), some patients have been treated with corticosteroid and/or immunosuppressant (CS/IS).Objective: To clarify the radiological and laboratory features of MS treated with CS/IS for relapse prevention.Methods: Clinical records including radiological and laboratory findings, and drugs used for relapse prevention were reviewed retrospectively.Results: Out of 92 consecutive MS patients, 25 (27%) were treated with CS/IS. The followings were observed less frequently in patients treated with CS/IS than in those with MS-DMDs: three or more periventricular lesions, ovoid lesions, subcortical lesions, typical contrast-enhancing lesions, negative for serum autoantibodies, and positive for oligoclonal bands in the cerebrospinal fluid. Multiple logistic regression analysis revealed that the absence of typical contrast-enhancing lesions and positivity for serum autoantibodies were independent factors associated with CS/IS prescription (odds ratio 25.027 and 14.537, respectively).Conclusion: In this cohort of Japanese patients clinically diagnosed with MS, radiological and serological findings atypical of MS were observed more frequently in patients treated with CS/IS than in those with MS-DMDs as a part of MS therapy. The absence of contrast-enhancing lesions typical of MS and positivity for serum autoantibodies were independent factors strongly associated with CS/IS use.

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