Background: The Gilenya ® Go Program TM offers education and support services, including coordination of first dose observation (FDO) and follow-up contact to reinforce monitoring recommendations and compliance in fingolimod-treated relapsing-remitting multiple sclerosis (RRMS) patients. Methods: Data were analyzed for patients enrolled in the Canadian Gilenya ® Go Program TM from March 2011 to January 2016. The retention to fingolimod therapy, reasons for treatment discontinuation and incidence of adverse events (AEs) during treatment are reported. Results: At data cut-off, 3956 patients had completed FDO; 3201 patients were being actively treated. Mean age at enrolment was 41.0 years; 74.9% patients were female. The overall fingolimod exposure was 7869 patient-years. Most recent previous therapies (n=3746) included interferons (43.3%) and glatiramer acetate (29.6%). Most common reasons for switching to fingolimod (n=3674) was lack of efficacy (31.8%). Retention to therapy at data cut-off was 81.3%. AEs (45.2%) were the most common reason (n=334) for treatment discontinuation and included low lymphocyte count/abnormal hematology values (13.8%), gastrointestinal disturbances (6.9%), and elevated liver enzyme levels (7.8%). Adherence to recommended ophthalmic examination was 92.4%. Conclusions: In real-world clinical practice in Canada, adherence to both fingolimod treatment and monitoring was high. The Gilenya ® Go Program™ helps to meet the safety monitoring recommendations for fingolimod-treated RRMS patients.
OBJECTIVE:
To explore the patient continuation rate as an indicator of treatment satisfaction for all registrants in the GILENYA® Go ProgramTM who were previously on an injectable disease-modifying therapy (DMT).
BACKGROUND:
The Canadian GILENYA® Go ProgramTM provides patient support services, reinforces patient adherence to recommended monitoring and coordinates first-dose observation (FDO) at specialized FDO centers.
DESIGN/METHODS:
Clinical reports were collected and analyzed for all patients with RRMS enrolled in the GILENYA® Go ProgramTM who received a prior injectable DMT, from the time of first patient enrollment in March 2011 to March 2013.
RESULTS:
During the two-year observation period, 1,224 patients (78% female), previously treated with an injectable DMT, entered FDO. Prior therapies were glatiramer acetate SC (33.6%), interferon-beta-1a SC (29.2%), interferon-beta-1a IM (16.6%), interferon-beta-1b SC (12.9%) and others (7.7%). 99.6% patients completed FDO. The two-year continuation rate was 85.8%. 174 patients discontinued due to: AEs (62%), physician request (17%), patient request (9%), lack of efficacy (6%), switched medications (0.5%), moved (0.5%), and no reason given (3%). A total of 34 patients (2.8%) discontinued 30 days. AEs associated with late discontinuation included: low WBC count/abnormal blood work (1.1%), infections (0.9%), liver function/elevated liver enzymes (0.8%) and headache (0.6%). Two cases of macular edema (0.2%) on days 146 and 289 were attributed to treatment. There was one death reported without causality and three cancers (0.2%) diagnosed on days 14-483.
CONCLUSIONS:
Fingolimod is well tolerated with >99% successfully completing first-dose. The overall continuation rate at two years was 85.8%, suggesting that patient acceptance of treatment is high with fingolimod.
GILENYA® is a registered trademark
Study Supported by:
Novartis Pharmaceuticals Canada Inc. Disclosure: Dr. Lapierre has received personal compensation for activities with Serono, Inc. and Novartis as a scientific advisory board member and speaker, and with Biogen Idec as a speaker. Dr. Lapierre has received personal compensation in an editorial capacity for Teva Neuroscience. Dr. Selchen has received personal compensation for activities with Teva Neuroscience, Merck Serono, Genzyme Corp., Novartis, Biogen Idec, Bristol-Myers Squibb Co. and Boerhinger Ingelheim Pharmaceuticals Inc. Dr. Devonshire has received personal compensation for activities with Biogen Idec, EMD Serono, Novartis, and Genzyme Corp. Dr. Schecter has received personal compensation for activities with Novartis as an employee.
Background: We recently reported that sleep disorders are significantly associated with fatigue in multiple sclerosis (MS). Objective: The objective of this paper is to assess the effects of sleep disorder treatment on fatigue and related clinical outcomes in MS. Methods: This was a controlled, non-randomized clinical treatment study. Sixty-two MS patients completed standardized questionnaires including the Fatigue Severity Scale (FSS), Multidimensional Fatigue Inventory (MFI), Epworth Sleepiness scale (ESS) and Pittsburgh Sleep Quality Index (PSQI), and underwent polysomnography (PSG). Patients with sleep disorders were offered standard treatment. Fifty-six subjects repeated the questionnaires after ≥ three months, and were assigned to one of three groups: sleep disorders that were treated (SD-Tx, n=21), sleep disorders remaining untreated (SD-NonTx, n=18) and no sleep disorder (NoSD, n=17). Results: FSS and MFI general and mental fatigue scores improved significantly from baseline to follow-up in SD-Tx ( p <0.03), but not SD-NonTx or NoSD subjects. ESS and PSQI scores also improved significantly in SD-Tx subjects ( p <0.001). Adjusted multivariate analyses confirmed significant effects of sleep disorder treatment on FSS (-0.87, p = 0.005), MFI general fatigue score ( p = 0.034), ESS (p = 0.042) and PSQI (p = 0.023). Conclusion: Treatment of sleep disorders can improve fatigue and other clinical outcomes in MS.
most disease-modifying therapies (DMTs) for multiple sclerosis (MS) are self-injectable medications that must be taken on an ongoing basis to reduce disease activity. Thus, adherence to therapy becomes an important challenge that must be addressed to maximize benefits of therapy. This study evaluated rates of adherence to prescribed treatment and explored factors affecting adherence amongst patients with relapsing-remitting MS.this was an observational, multicenter, multinational, phase 4 study. Patients and physicians received paper questionnaires regarding adherence to DMTs approved at the time of the study, including intramuscular interferon beta-1a (IFNβ-1a), subcutaneous IFNβ-1a, IFNβ-1b, and glatiramer acetate. Quality of life and cognition data also were collected. Multivariate analysis was conducted to identify factors associated with adherence to long-term DMTs.two thousand six hundred and forty-eight patients were studied, revealing an average treatment duration of 31 months. Seventy-five percent of patients (n = 1923) were adherent to therapy. The most common reasons for non-adherence were forgetting to administer the injection (50.2%) and other injection-related reasons (32.0%). Adherent patients reported better quality of life (P < 0.05) and fewer neuropsychological issues (P < 0.001) than non-adherent patients. Adherent patients had significantly shorter duration of disease (P < 0.001) and shorter duration of therapy (P = 0.005) than non-adherent patients. Women were more likely than men to adhere to treatment.identifying factors that affect adherence to prescribed treatments is the first step in improving adherence of patients with MS to therapy, thereby helping maximize the benefits of long-term DMTs.
FTY720 (fingolimod) treatment of multiple sclerosis (MS) results in lymphopenia due to increased recruitment into and decreased egress from secondary lymphoid organs of CCR7(+) lymphocytes. Although absolute numbers of NK lymphocytes were reported as being unaltered in FTY720-treated MS patients (MS-FTY), such analyses did not detect a change in a minor subset. Because expression of CCR7 has been described on CD56(bright) NK cells, a minority population of NK cells, we investigated the effect of FTY720 treatment on the phenotype and function of human NK cells in the peripheral circulation of MS patients. MS-FTY patients displayed a decreased proportion of peripheral CD56(bright)CD62L(+)CCR7(+) NK cells compared with untreated MS and healthy donors. In vitro treatment with FTY720-P increased migration of untreated donor NK cells to CXCL12 while reducing the response to CX3CL1 with similar migration responses seen in NK cells from MS-FTY patients. FTY720-P inhibited sphingosine 1-phosphate-directed migration of CD56(bright) and CD56(dim) NK cells subsets from untreated healthy donors. IL-12- and IL-15-stimulated NK cells from MS-FTY patients displayed similar capacity to produce IFN-γ, TNF, IL-10, and MIP-1α cytokines/chemokines compared with NK cells from untreated healthy donors and displayed comparable levels of degranulation in response to K562 tumor cells compared with untreated donors. Subset alterations and function of NK cell populations will need to be considered as part of assessing overall immunosurveillance capacity of patients with MS who will receive sustained FTY720 therapy.