Disease-modifying Therapies Adherence Research Articles

Health Related Quality of Life Outcomes Among Patients with Sickle Cell Disease during the Transition Period from Pediatric to Adult Care in Newark, NJ

Background: Sickle Cell Disease (SCD) is a genetic condition associated with painful vaso-occlusion episodes (VOE), chronic pain, and organ damage. Painful VOE and chronic pain can hinder daily activities and thus affect Quality of Life (QoL). The transition period of SCD patients from pediatric to adult care is often marked by frequent hospitalizations, complications and higher mortality. Our study evaluated patient reported health related QoL outcomes in SCD patients who transitioned from pediatric to adult care. Methods: This is a descriptive study of SCD patients receiving medical care at Newark Beth Israel Medical Center. The informed consent and assent were obtained from patients and/or legal guardians. Enrolled patients filled out a questionnaire using seven domains from the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me): pain episodes, medical history, pain impact, sleep impact, social functioning, stiffness, and emotional impacts. Eligible patients were aged 16-25 years, presenting to the pediatric or adult hematology clinic for their well visit. Recruitment took place from December 2021 to April 2023. Results: Seventy-six individuals were enrolled and questionnaire was administered. Most were aged 16-21 years with homozygous sickle cell disease. Pain episodes: 10-18% of 16-20 year-olds reported pain attacks in the previous year, while 43-100% of 21-25 year-olds reported pain attacks. Among 22-25 year-olds, 25-50% could not do most things that they usually did or relied on family or friends compared to 40-83% of 16-21 year-olds. Pain impact: 50-100% of 22-24 year-olds struggled all day due to pain, while most younger patients were unaffected. About 25-60% of 20-25 year-olds were occasionally, rarely, or never pain-free. In the sleep impact domain, 29-60% of 20-25 year-olds did not get enough sleep, and 20-60% of all ages stayed up most of the night due to difficulty falling asleep. Medical history: 17-36% of 16-20 year-olds and 40-100% of 21-25 year-olds used daily pain medicine. Sickle cell complications affected 8-40% of patients in all age groups. Social functioning domain: 25-60% of 20-25 year-olds often or always had their health that kept them away from doing something fun. Also, 16-17 year-olds (21%) and 20-22 year-olds (25-60%) reported that their family felt that they were a burden. No significant findings were noted in stiffness impact across all age ranges. Emotional impact: 25-83% of all patients were often or always sad about their health (70% of 16 year-olds and 83% of 21 year-olds). Nine % (19 year olds) to 83% (21 year olds) were depressed about their health problems and 21 year olds seemed most affected by emotional impact of their disease. Conclusion: Our cross-sectional study revealed a significant impact of SCD on HRQoL during the transition years from childhood to adulthood. Therefore, screening for mental health in patients aged 16-25 years is crucial, offering support to those at risk. Disease-modifying therapy adherence should be emphasized. Limitations of our study include a small sample size, especially in the older age group. Further studies may be needed to assess age and genotype stratified HRQoL outcomes for 16-25-year-old SCD patients and potential improvement measures.

Factors Associated With Disease-Modifying Therapy Adherence and Persistence in Multiple Sclerosis: A Scoping Literature Review.

Patients with multiple sclerosis (MS) receiving disease-modifying therapies (DMT) show published adherence rates of 27.0% to 93.8% and published persistence rates of 49.7% to 96.5%. Improvements in DMT adherence and persistence are key to optimizing MS care, and enhanced understanding could improve MS disease management and identify research gaps. This scoping literature review aims to examine the nature and findings of the literature evaluating factors associated with DMT adherence and persistence in patients with MS. Eligible articles included in the literature review were quantitative clinical studies written in English, included adherence or persistence as primary outcomes, and accounted for covariates/confounders. The articles were assessed to identify factors associated with adherence/persistence and analyzed according to DMT type (self-injectable, oral, infusion). Fifty-eight studies (103,450 patients) were included. Study distribution by DMT type was self-injectable only (n = 41), oral only (n = 2), infusion only (n = 1), and more than 1 type (n = 14). Older age and previous DMT use were associated with increased adherence and/or persistence. Increased alcohol consumption, DMT adverse events, higher education, and higher body mass index were negatively associated with adherence and/or persistence. Greater number and severity of relapses was associated with increased adherence but decreased persistence. Most studies examined factors associated with adherence and persistence to self-injectable DMTs. These factors should be evaluated further for oral and infusion DMTs. Insights into the modifiable factors associated with adherence and persistence could guide treatment decisions and help improve adherence and clinical outcomes.

Objective medication adherence and persistence in people with multiple sclerosis: a systematic review, meta-analysis, and meta-regression.

BACKGROUND: Medication adherence is critical for the realization of pharmacotherapy benefits and reduced healthcare expenditure. Studies have shown up to 60% of people with Multiple sclerosis (MS) experience suboptimal medication adherence, which is associated with poorer health outcomes and subsequent discontinuation. The current systematic review reported on objectively measured adherence and discontinuation rates for self-administered oral and injectable disease-modifying therapies (DMTs). OBJECTIVES: To identify whether, in people with MS, the introduction of oral DMTs has improved medication adherence when compared with injectable DMTs. The secondary aim was to report synthesized objectively measured medication adherence and persistence rates for both oral and injectable DMTs in MS across varying study durations. METHODS: Literature searches were conducted through PubMed, Web of Science, Scopus, and PsycINFO. Inclusion criteria were limited to English, peer-reviewed, objective, self-administered DMT articles, published between July 1993 to December 2019. Publications reporting combined intravenous and self-administered DMT data, or that did not account for DMT switching in discontinuation rates, were excluded. Data were synthesized into observation lengths ranging from less than 8 months to greater than 36 months. Meta-analysis and meta-regression were undertaken on both oral and injectable 12-month adherence and discontinuation data. RESULTS: In total, 61 articles were included; 46 articles examined adherence and 26 examined discontinuation. Twelve-month adherence ranged between 53.0% to 89.2% for oral (N = 7) and 47.0% to 77.4% for injectable DMTs (N = 7). Results from the meta-analysis and meta-regression show significantly higher pooled mean medication possession ratio (MPR) adherence for oral DMTs (91.0%) when compared to injectable DMTs (77.0%) over 12 months (β = -0.146; 95% CI: -0.263 to -0.029). Results indicate major asymmetry across studies (LFK index: -5.18), proposing the presence of significant publication bias. Mean discontinuation over 12 months was between 10.5% to 33.3% for oral (N = 7) and 15.2% to 50.8% for injectable DMTs (N = 10), with meta-analysis results indicating the presence of significant heterogeneity (I2 Injectable: 99.5%; I2 Oral: 93.1%) between studies included in each subgroup. However, no appreciable difference in mean discontinuation rates across groups (Injectable: 27%; 95% Cl: 19.0%-34.0%; Oral: 24%; 95% CI: 17.0%-31.0%) was found. CONCLUSIONS: Medication adherence for oral DMTs suggests a significant improvement compared to adherence for injectable DMTs. No significant difference in discontinuation rates between oral and injectable DMTs was found. Oral DMT adherence and persistence studies are limited, given their relatively recent introduction. Suboptimal medication adherence and discontinuation issues remain present for both oral and injectable DMTs. Future studies would benefit from improved consistency in methodology, such as comparable adherence and persistence definitions. DISCLOSURES: The authors did not receive any funding for this study. Mardan and Hussain have nothing to disclose. Grech reports grants from Merck Pharmaceutical, outside the submitted work. Allan reports grants received from Merck Pharmaceutical outside the submitted work. Allan holds advisory board and consulting positions with Merck and advisory board positions for Bristol Myers Squibb and Novartis, for which Monash Institute of Neurological Diseases receives consulting fees.

Electronic pill bottles to monitor and promote medication adherence for people with multiple sclerosis: A randomized, virtual clinical trial

ObjectiveWe perform a randomized trial to test the impact of electronic pill bottles with audiovisual reminders on oral disease modifying therapy (DMT) adherence in people with MS (PwMS). MethodsAdults with multiple sclerosis (MS) taking an oral DMT were randomized 1:1 for 90 days to remote smartphone app- and pill bottle-based (a) adherence monitoring, or (b) adherence monitoring with audiovisual medication reminders. Optimal adherence was defined as the proportion of doses taken ±3 h of the scheduled time. Numbers of missed pills and pills taken early, on time, late, and extra were recorded. A multivariable regression model tested possible associations between optimal adherence and age, MS duration, cognitive functioning, and number of daily prescription pills. Results85 participants (66 female; mean age 44.9 years) took dimethyl/diroximel fumarate (n = 49), fingolimod (n = 26), or teriflunomide (n = 10). Optimal adherence was on average higher in the monitoring with reminders arm (71.4%) than the monitoring only arm (61.6%; p = 0.033). In a multivariable model, optimal adherence was less likely in younger participants (p < 0.001) and those taking more daily prescription pills (p < 0.001). In the monitoring only arm, 4.0% of doses were taken early, 61.6% on time, 5.6% late, 4.4% in excess, and 24.4% were missed. In the reminders arm, these proportions were 3.4%, 71.4%, 3.7%, 8.7%, and 12.8%, respectively. ConclusionWe map real-world oral DMT adherence patterns using mHealth technology. PwMS who received medication reminders had higher optimal adherence. Nonadherence was more nuanced than simply missing pills. Developing strategies to improve adherence remains important in longitudinal MS care.

Association Between Pharmacy Benefit Restrictions and Disease-Modifying Therapy Use in the Medicare Part D Program.

To determine the association between Medicare Part D plan disease-modifying therapy (DMT) restrictiveness and adherence and outcomes among people with multiple sclerosis (MS). We used Medicare claims data from 2010 to 2014 to identify individuals with a full year enrollment (Parts A, B, and D), an MS diagnosis, and 1 or more self-administered DMT prescription. Plans were considered restrictive if all available DMTs required a prior authorization or step therapy restriction; otherwise they were considered permissive. We compared DMT adherence, defined as a medication possession ratio ≥80%, MS-related emergency department or inpatient admissions, and outpatient visits by Part D plan restrictiveness. We used multivariate regression models to control for patient demographics and comorbidities. There were 37,713 Medicare beneficiaries with MS who were enrolled in either restrictive (n = 29,901) or permissive (n = 7812) Part D plans during the study period. Patients enrolled in restrictive plans were older (60 vs 58 years; p < 0.001), more likely to live in the south (38% vs 23%; p < 0.001), eligible through disability (67% vs 60%; p < 0.001), and more likely to have several chronic comorbid conditions. Patients enrolled in restrictive plans were less likely to be adherent to their DMT (54% vs 57%; p < 0.001; adjusted odds ratio [aOR] 0.92, 95% confidence interval [CI] 0.88-0.98) and had a higher rate of MS-related outpatient visits (1.7 vs 1.4 per year; p < 0.001; aRR 1.27, 95% CI 1.23-1.31). Medicare beneficiaries with MS enrolled in restrictive Part D plans were less adherent to their DMT and had higher rates of MS-related outpatient visits.

Association between multiple sclerosis disease severity and adherence to disease-modifying therapies.

BACKGROUND: For multiple sclerosis (MS) patients taking disease-modifying therapies (DMTs), adherence to treatment is a key component of achieving beneficial outcomes, such as delayed disease progression and the reduction and prevention of symptoms and relapses. OBJECTIVES: The aim of this study was to assess the impact of a claims-based measure of MS disease severity on DMT adherence in a one-year study period. METHODS: Patients were identified from Humana Medicare Advantage claims data from January 1, 2013 to December 31, 2015. Patients over the age of 18 with at least 12 months of continuous enrollment and > 1 outpatient MS visit with DMT use prior to the index date were included. Patients who switched DMT type (oral, platform, IV) during the study period were excluded. Medication possession ratios (MPR) for DMTs were calculated from pharmacy and medical claims over 12 months of claims data, and a previously developed claims algorithm was used to determine MS disease severity. Patients with MPRs of 0.8 or higher were considered adherent to DMT treatment. Multivariable logistic regression was used to evaluate the association of MS disease severity, gender, DMT type, and age category with DMT adherence. RESULTS: The study population of 3,347 patients had an average MPR of 84.7 (75% were classified as adherent). Multivariable logistic analysis demonstrated that compared to the 18-45 age group, the 46-64 and 65+ age groups were 1.33 (OR: 1.33 [95% CI 1.08-1.64]) and 1.55 (OR: 1.55, [95% CI 1.18-2.05]) times more likely to be adherent. Patients with a high level of MS disease severity were 53% (OR: 0.47, [95% CI 0.36-0.62]) less likely to be adherent compared to those with low MS disease severity. No significant difference was identified for gender or DMT type (oral, platform, or IV). CONCLUSIONS: Increased age and lower MS disease severity were associated with better DMT adherence. MS disease severity should be considered when assessing risk for low DMT adherence. DISCLOSURES: No funding supported this project. The authors have nothing to disclose. Preliminary results were previously presented virtually at AMCP Annual 2020 in April 2020.

Impact of the COVID-19 pandemic on access to healthcare services amongst patients with multiple sclerosis in the Lazio region, Italy.

Background and purposeMultiple sclerosis (MS) is a complex chronic, autoimmune inflammatory disease involving multidisciplinary assessments and interventions. Access to outpatient specialist and home healthcare services was explored during the pandemic outbreak and the lockdown amongst MS patients in the Lazio region. Adherence to disease‐modifying therapies (DMTs) is also described.MethodsA population‐based study was conducted using regional healthcare administrative databases. A validated algorithm was used to identify MS cases over the period 2011–2018. The numbers of specialist and home‐based services were compared between 2019 and 2020. The medication possession ratio was used to measure adherence to DMTs.ResultsA total of 9380 MS patients were identified (68% women). A decline in the number of outpatient care services between March and June 2020 compared to the previous year was observed, in particular for rehabilitation (−82%), magnetic resonance imaging (−56%) and neurological specialist services (−91%). Important year‐to‐year variations were observed in May and June 2020 in home‐based nursing and medical care (−91%) and motor re‐education services (−74%). Adherence to DMTs was higher in the first 4 months of 2019 compared to the same period of 2020 (67.1% vs. 57.0%).ConclusionsA notable disruption of rehabilitative therapy and home‐based services as well as in DMT adherence was observed. Since the pandemic is still ongoing and interruption of healthcare services could have a major impact on MS patients, it is necessary to monitor access of MS patients to healthcare resources in order to ensure adequate treatments, including rehabilitative therapies.

The Impact of Patient Support Programs on Adherence to Disease-Modifying Therapies of Patients with Relapsing-Remitting Multiple Sclerosis in Germany: A Non-Interventional, Prospective Study.

IntroductionDisease-modifying therapies (DMTs) in multiple sclerosis (MS) are chronic therapies, and patients are likely to face challenges in adhering to DMT dosing regimens over time. DMT manufacturers offer patient support programs (PSPs) to increase adherence. PSPs are managed offerings typically encompassing nurse services, phone services, online resources, or mobile offerings. This study evaluated whether PSPs have a positive impact on adherence to DMTs among patients with mild-to-moderate relapsing-remitting multiple sclerosis (RRMS) in Germany, independent of the treatment duration on DMT.MethodsThis was a non-interventional, prospective, cross-sectional, multi-center study with patient-reported outcomes. Patients reported their DMT adherence using patient adherence questionnaires at four visits during an observation period of 24 weeks; PSP participation for this period was reported at the last visit. The primary objective was to evaluate the impact of PSPs on adherence across different DMTs by comparing patients with PSP participation versus no participation; adherence was defined as not missing a single dose of DMT.ResultsOne hundred eighty-four patients were analyzed (mean age: 44.6 years; 73.4% female; mean time on DMT: 7.2 years). Adherence across DMTs was significantly higher for PSP participants (92.9%) compared with non-participants (61.8%) (P = 0.0197). The observed rate of PSP participation (7.6%) was significantly lower than reported in earlier studies (P < 0.0001); PSP awareness among patients analyzed was low (22.3%).ConclusionWe consider this study to have shown that PSPs have a positive impact on adherence to DMTs in MS, independent of the treatment duration on DMT. The majority of PSP participants also believe in this positive effect. PSP participation and patient awareness were low, and real-world adherence levels were found to be higher with self-injectable DMTs than with oral DMTs. In summary, physicians should actively advise patients with MS to participate in PSPs and, together with their patients, consider achievable real-world adherence under different DMTs when deciding MS treatment strategies.

Disease-Modifying Therapy Adherence and Associated Factors in a National Sample of Medicare Patients With Multiple Sclerosis

ObjectivesDisease-modifying therapies (DMTs) reduce relapse rates and disability progression for relapsing multiple sclerosis (MS). Although 25% to 30% of all US patients with MS are Medicare beneficiaries, limited information exists on this population. This is the first study using national Medicare data to (1) describe characteristics of patients with MS using DMTs, (2) estimate adherence to DMTs over a 1-year and 3-year follow-up, and (3) examine factors associated with DMT adherence. MethodsThis retrospective claims analysis used 2011-2014 100% Medicare files. Monthly adherence to MS DMTs was defined as the proportion of days covered ≥0.80 with any DMT in each month for 1-year (n = 36 593) and 3-year (n = 17 599) follow-up samples of MS DMT users. Generalized estimating equation logistic regressions were used to estimate factors associated with adherence to DMTs. ResultsOver 90% of patients were eligible for Medicare owing to disability, and about three-quarters qualified for low-income subsidies. A downward trend in DMT adherence was observed over time in both samples. Monthly adherence dropped significantly between December of the prior year to January of the following year (from 76% to 65% in the 1-year follow-up sample and similar drops seen across all years in the 3-year follow-up sample). Multivariable regressions indicated characteristics such as being low-income, having a disability, and having high patient out-of-pocket DMT costs associated with poor adherence to DMTs. ConclusionOur study provides important insights into the characteristics and DMT adherence of Medicare patients with MS and highlights the need for interventions and policies mitigating barriers to adherence in this population.

Risk Factors for Suboptimal Medication Adherence in Persons With Multiple Sclerosis: Development of an Electronic Health Record-Based Explanatory Model for Disease-Modifying Therapy Use

ObjectiveTo determine which factors are associated with suboptimal disease-modifying therapy (DMT) adherence and to develop an explanatory model that could be used to identify individuals at risk and potentially inform interventions. DesignCross-sectional cohort study using electronic health records. SettingVeterans Health Administration (VA). ParticipantsVeterans with multiple sclerosis (MS) (N=2939; 79.69% men) who received care through the VA and were included in the VA MS Center of Excellence Data Repository. InterventionsNot applicable. Main Outcome MeasuresSuboptimal DMT adherence (<80%), demographics, co-occurring conditions, and health care use. ResultsNearly 31% of participants had suboptimal adherence. Flags for suboptimal adherence included >20% missed appointments (odds ratio [OR], 3.78; 95% CI, 2.45-2.82), traumatic brain injuries (OR, 1.55; 95% CI, 1.12-2.14), age younger than 59 years (OR, 1.47; 95% CI, 1.23-1.74), ≥1 emergency department visits (OR, 1.40; 95% CI, 1.18-1.67), mood disorders (ie, depressive and bipolar disorders) (OR, 1.40; 95% CI, 1.18-1.66), and service connection (OR, 1.22; 95% CI, 1.01-1.47). Hyperlipidemia (OR, 0.77; 95% CI, 0.65-0.92) and being issued a wheelchair (OR, 0.83; 95% CI, 0.70-1.00) were associated with lower risk. ConclusionsSuboptimal adherence to DMTs continues to be an issue. Interventions that focus on person-level barriers should be urgently explored to increase adherence and improve self-management abilities.

The Impact of Disease-Modifying Therapy Access Barriers on People With Multiple Sclerosis: Mixed-Methods Study.

BackgroundIn the United States, people with relapsing-remitting multiple sclerosis (RRMS) can face difficulty accessing disease-modifying therapies (DMTs) because of insurance, pharmacy, or provider policies. These barriers have been associated with poor adherence and negative health outcomes.ObjectiveThe goals of this study were to describe the overall occurrence of difficulties and delays associated with gaining access to DMTs among people with RRMS, to assess DMT adherence during periods of reduced access, and to contextualize the patients’ journey from receipt of a prescription for DMT to obtaining and taking their medication when faced with access barriers.MethodsWe recruited US-based adults self-reporting RRMS from a Web-based health data-sharing social network, PatientsLikeMe. Individuals were invited to complete a Web-based survey if they reported a diagnosis of RRMS and were prescribed a DMT for MS. Follow-up phone interviews were conducted with 10 respondents who reported experiencing an MS-related relapse during the time they had experienced challenges accessing DMTs.ResultsAmong 507 survey completers, nearly half were either currently experiencing an issue related to DMT assess or had difficulty accessing a DMT in the past (233/507, 46.0%). The most frequently reported reasons for access difficulty were authorization requirements by insurance companies (past issues: 78/182, 42.9%; current issues: 9/42, 21%) and high out-of-pocket costs (past issues: 54/182, 29.7%; current issues: 13/42, 31%). About half (20/39, 51%) of participants with current access issues and over a third (68/165, 41.2%) of those with past issues went without their medication until they could access their prescribed DMT. Relapses were reported during periods of reduced DMT access for almost half (56/118, 47.5%) of those with past issues and nearly half (22/45, 49%) of those with current issues. Resolving access issues involved multiple stakeholder agents often coordinated in a patient-led effort. Among those who had resolved issues, about half (57/119, 47.9%) reported that doctors or office staff were involved, under half (48/119, 40.3%) were involved themselves, and about a third (39/119, 32.8%) reported the drug manufacturer was involved in resolving the issue. Follow-up interviews revealed that the financial burden associated with obtaining a prescribed DMT led to nonadherence. Additionally, participants felt that DMT treatment delays and stress associated with obtaining the DMT triggered relapses or worsened their MS.ConclusionsThis study expands current research by using a patient-centered, mixed-methods approach to describe barriers to MS treatment, the process to resolve barriers, and the perceived impact of treatment barriers on outcomes. Issues related to DMT access occur frequently, with individuals often serving as their own agents when navigating access difficulties to obtain their medication(s). Support for resolution of DMT access is needed to prevent undue stress and nonadherence.

Patient-Reported Disease-Modifying Therapy Adherence in the Clinic: A Reliable Metric?

BackgroundAdherence to multiple sclerosis (MS) disease-modifying therapy (DMT) is commonly assessed through patient reporting, but patient-reported adherence is rarely studied.ObjectiveTo determine rates of DMT adherence reported from patient to clinician, reasons for nonadherence, and relationships between adherence and outcomes.MethodsWe identified relapsing–remitting MS patients on DMT for ≥3 months. DMT adherence was defined as taking ≥80% of doses. Linear and logistic regression models were created used to determine the association of baseline adherence with several patient reported outcomes and the timed 25-foot walk at 6 months, 1 year, 2 years, and 3 years after the index visit.ResultsThe analysis included 1148 patients, of whom 501 had data at 6 months, 544 at 1 year, 331 at 2 years, and 247 at 3 years. Baseline adherence was 94.9% and overall adherence was 93.1%. Forgetting was the most common reason for missed doses. In the adjusted models, adherence was not associated with the outcomes.ConclusionsHigher than expected adherence and a lack of association between adherence and outcomes suggests patient reported adherence may not be reliable. Further research is needed to clarify the relationship between patient-reported adherence and relapses or new lesion formation.

Baseline predictors of DMT reinitiation among patients with multiple sclerosis following an MI-CBT intervention.

Patients with multiple sclerosis (MS) are often nonadherent to their disease modifying therapy (DMT). While recent studies demonstrate enhanced DMT adherence following intervention grounded in motivational interviewing (MI), little is known about how to address DMT reinitiation among MS patients who have prematurely discontinued DMT against medical advice and do not intend to reinitiate. We examined baseline predictors of DMT reinitiation among patients with MS who discontinued medications against medical advice following a telephone-based MI and Cognitive Behavioral Therapy (MI-CBT) intervention. Following MI-CBT intervention, 66 patients reported whether or not they opted to reinitiate DMT. Rate of disease progression (β=0.295) and perceived personal control (β=-0.131) emerged as unique significant predictors of DMT reinitiation following intervention. Clinical characteristics and health-related beliefs may be used to prospectively identify patients most likely to reinitiate DMT following MI-CBT intervention, furthering the goal of preserving brain health and preventing neurologic decline in MS via appropriate DMT utilization. Further study is warranted to delineate potential mediators and moderators of DMT reinitiation outcomes.

Associations Between Treatment Satisfaction, Medication Beliefs, and Adherence to Disease-Modifying Therapies in Patients with Multiple Sclerosis.

Adherence to disease-modifying therapy (DMT) remains problematic for many patients with multiple sclerosis (MS). An improved understanding of factors affecting DMT adherence may inform effective interventions. This study examined associations between treatment satisfaction, medication beliefs, and DMT adherence. A survey was mailed in 2016 to 600 adult patients with relapsing-remitting MS taking an injectable or oral DMT. Patients were sampled from the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry. The survey measured self-reported DMT adherence (doses taken divided by doses prescribed during previous 2-week period-adherence ≥0.80), DMT satisfaction using the Treatment Satisfaction Questionnaire for Medication version II, medication beliefs using the Beliefs About Medicines Questionnaire, and demographic and clinical covariates. Relationships between variables were examined using multivariate logistic regression. Final analyses included 489 usable surveys. Mean ± SD participant age was 60.5 ± 8.3 years. Most respondents were white (93.8%), female (86.6%), taking an injectable DMT (66.9%), and adherent to DMT (92.8%). Significant predictors of DMT adherence were age (odds ratio [OR], 1.086; 95% CI, 1.020-1.158; P = .011), type of DMT (oral vs. injectable; OR, 23.350; 95% CI, 2.254-241.892; P = .008), and DMT experience (naive vs. experienced; OR, 2.831; 95% CI, 1.018-7.878; P = .046). In patients with MS sampled from a patient registry, treatment satisfaction and medication beliefs were not significantly associated with DMT adherence. Based on significant predictors, younger patients, patients taking injectable DMTs, and patients with previous experience with another DMT(s) are at higher risk for nonadherence. Future research is warranted to assess relationships between variables in more diverse MS populations.

Disease-Modifying Therapies and Adherence in Multiple Sclerosis: Comparing Patient Self-Report with Pharmacy Records

Background: Self-report and pharmacy records are often used to measure adherence rates to disease-modifying therapies (DMTs) in multiple sclerosis (MS), but little is known about how the sources compare. Objective: Compare self-report and pharmacy records for assessing DMT use and adherence rates. Methods: Demographic information, self-reported DMT use, and missed DMT doses in the previous 30 days were obtained from consecutive MS patients attending an MS clinic and linked to pharmacy records. A medication possession ratio (MPR) was calculated using pharmacy records for the year before and after the visit; MPR <80% defined nonadherence. Agreement between self-report and pharmacy records was assessed using Cohen's kappa (κ). Results: Of 326 participants, 135 reported using an injectable DMT. There was near-perfect and perfect agreement between self-report and pharmacy records for DMT use (κ = 0.95; 95% CI 0.91-0.98) and DMT agent (κ = 1.00). Nonadherence was estimated at 13% (17/128) from the 30-days self-report compared to 30% (34/113) and 43% (53/123) in the year pre- and post-clinic visit from pharmacy records, indicating moderate to fair agreement (year prior: κ = 0.41; 95% CI 0.22-0.59; year post: κ = 0.22; 95% CI 0.09-0.36). Conclusions: Patients self-reports closely reflected pharmacy records when assessing DMT use and product. Moderate to fair agreement was found when comparing adherence rates between sources.

Adherence to disease-modifying therapies for multiple sclerosis and subsequent hospitalizations.

The aim of this study was to examine the association between optimal adherence to first-line disease-modifying therapies (DMT) for multiple sclerosis (MS) and hospitalizations. We used population-based administrative data from three Canadian provinces. All individuals receiving DMT (interferon-B-1b, interferon-B-1a, or glatiramer acetate) between January 1, 1996, and December 31, 2011 (British Columbia); March 31, 2012 (Manitoba); or March 31, 2014, (Saskatchewan) were included. Adherence was estimated for the first year of DMT (year 0), using the medication possession ratio (MPR). The association between optimal adherence (MPR≥80%) and all-cause and MS-specific hospitalizations in the subsequent 1, 2, and 5years was assessed using Hurdle Poisson and logistic regression. Rate and odds ratios were adjusted (aRR and aOR) for sociodemographic factors and prior health-care utilization. Overall, 4746 subjects were followed for a mean 7.8 (SD 4.0) years; 3598 (76%) were women. Optimal DMT adherence was achieved in 3564/4746 (75.1%) subjects. Subsequent all-cause and MS-specific hospitalizations were lower for subjects with optimal versus suboptimal adherence, but none reached statistical significance (1-year period, aRR=0.77, 95%CI: 0.47-1.26; aOR=0.80, 95%CI: 0.52-1.25). Similar findings were observed in the 2-year and 5-year periods. Prior health-care utilization (hospitalizations and medications) was associated with future hospitalizations; for every additional medication class, the 5-year all-cause hospitalization rate and likelihood of an MS-specific hospitalization increased by 5% and 11%, respectively (aRR=1.05, 95%CI: 1.02-1.07; and aOR=1.11, 95%CI: 1.07-1.14). Hospitalization rates were lower in subjects with optimal DMT adherence, but findings were not statistically significant. Prior hospitalization and polypharmacy were associated with increased risk for future hospitalizations in MS. Copyright © 2017 John Wiley & Sons, Ltd.

Psychological interventions for enhancing adherence to disease-modifying therapies (DMTs) in multiple sclerosis

© 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of psychological interventions designed to improve adherence to disease-modifying therapies (DMTs) in adults with multiple sclerosis (MS) in terms of adherence. This will be considered in relation to levels of adherence in a comparison group. Secondary objectives are to assess the impact of interventions on potential predictors of adherence such as motivation, self-efficacy beliefs and healthcare engagement to DMTs adherence.

The impact of persistence with therapy on inpatient admissions and emergency room visits in the US among patients with multiple sclerosis

Objective:Disease-modifying therapy (DMT) for multiple sclerosis (MS) can reduce relapses and delay progression; however, poor adherence and persistence with DMT can result in sub-optimal outcomes. The associations between DMT adherence and persistence and inpatient admissions and emergency room (ER) visits were investigated.Methods:Patients with MS who initiated a DMT in a US administrative claims database were followed for 1 year. Persistence to initiated DMT was measured as the time from DMT initiation to discontinuation (a gap of >60 days without drug ‘on hand’) or end of 1-year follow-up. Adherence to initiated DMT was measured during the persistent period and was operationalized as the medication possession ratio (MPR). Patients with an MPR <0.80 were considered non-adherent. Claims during the 1-year follow-up period were evaluated for the presence of an all-cause inpatient admission or an ER visit. Adjusted odds ratios (AORs) for inpatient admission or ER visit comparing persistent vs non-persistent and adherent vs non-adherent patients were estimated using logistic regression models adjusted for patient characteristics.Results:The final sample included 16,218 patients. During the 1-year follow-up period, 35.3% of patients discontinued their initiated DMT and 13.9% were not adherent while on therapy. During that same period, 10.0% of patients had an inpatient admission and 24.9% had an ER visit. The likelihoods of inpatient admission and ER visit were significantly decreased in persistent patients (AOR [95% CI] = 0.50 [0.45, 0.56] and 0.65 [0.60, 0.69], respectively) and in adherent patients (AOR [95% CI] = 0.83 [0.71, 0.97] and 0.86 [0.77, 0.95], respectively).Conclusions:Persistence and adherence with initiated DMT are associated with decreased likelihoods of inpatient admission or ER visit, which may translate to improved clinical outcomes.

Impact of increasing adherence to disease-modifying therapies on healthcare resource utilization and direct medical and indirect work loss costs for patients with multiple sclerosis

Objectives:To estimate the effect of adherence to disease-modifying therapies (DMTs) among patients with multiple sclerosis (MS) on healthcare resource utilization (HRU) and costs, and model the impact of a 10 percentage point increase in adherence on these outcomes.Methods:Employed patients, 18–64 years old, with ≥2 MS diagnoses and ≥1 DMT claim during January 1, 2002 to September 30, 2012 were identified from a large commercially-insured US claims database. Adherence was measured as proportion of days covered (PDC) during follow-up. Multivariate regression analyses were conducted to estimate the effect of adherence on HRU related to urgent care (i.e., inpatient or emergency room visit), days of work loss, direct medical cost, and indirect work loss costs. Model coefficients were used to evaluate the impact of a 10 percentage point increase in adherence on the outcomes.Results:A total of 1510 patients were included (mean age = 43.4 years, 64% female). Patients with higher adherence had lower HRU, fewer days of work loss, and lower direct and indirect costs. A 10 percentage point increase in adherence significantly decreased the likelihood of an inpatient or emergency room visit by 9–19%, days of work loss by 3–8%, and direct and indirect costs by 3–5%, depending on the follow-up period (all p < 0.01).Conclusions:Increasing DMT adherence was found to significantly decrease urgent-care HRU, days of work loss, and direct and indirect costs among patients with MS.

Adherence and persistence among multiple sclerosis patients after one immunomodulatory therapy failure: Retrospective claims analysis

There are no published data on patient adherence to, and persistence with, disease-modifying therapies (DMT) for multiple sclerosis (MS) after one immunomodulatory failure. The present study compares secondline DMT adherence and persistence among patients with MS. Patients with MS initiating a second-line treatment with natalizumab, intramuscular interferon beta-1a (i.m.-IFNβ-1a), subcutaneous (s.c.) IFNβ-1a, interferon beta-1b (IFNβ-1b), and glatiramer acetate (GA) from January 1, 2006 to October 4, 2008 were identified from a retrospective claims database associated with a large US health plan. Adherence was measured with medication possession ratio (MPR); adherence indicated MPR ≥ 0.80. Persistence was measured as time until a minimum 60-day gap in second-line therapy. Adherence and persistence were modeled with logistic and Cox proportional hazard regressions, respectively. The study population comprised 1381 patients. Multivariate analysis showed that the odds of adherence were significantly higher in the natalizumab cohort compared with all other second-line cohorts. The natalizumab cohort was more likely to be persistent compared with the i.m.-IFNβ-1a and IFNβ-1b cohorts. The natalizumab cohort was more adherent compared with the other second-line DMT cohorts, likely due in large part to active physician involvement and monitoring. Adherence to DMT, even after first-line failure, is critical to achieving optimal therapeutic benefit.