Drulovic Jelena, Cukic Mirjana, Grgic Sanja, Dincic Evica, Raicevic Ranko, Nadj Congor, Toncev Gordana, Vojinovic Slobodan, Mesaros Sarlota, Kisic Tepavcevic Darija, Dujmovic Irena, Tadic Daliborka, Miletic-Drakulic Svetlana, Dackovic Jelena, Kostic Smiljana, Erakovic Jevto, Sakalas Lorand, Savic Dejan, Suknjaja Vesna, Martinovic Vanja, Maric Gorica, Pekmezovic Tatjana
Clinic of Neurology, Clinical Center of Serbia, Faculty of Medicine, University of Belgrade, Dr Subotica 6, Belgrade 11000, Serbia.
Clinic of Neurology, Clinical Center of Montenegro, Ljubljanska bb, Podgorica 81000, Montenegro.
Mult Scler Relat Disord. 2017 Jan;11:56-61. doi: 10.1016/j.msard.2016.12.002. Epub 2016 Dec 8.
Long-term treatment adherence to disease-modifying drugs (DMDs) may have significant impact on clinical outcomes in multiple sclerosis (MS). It has been recently emphasized that low treatment satisfaction (TS) may be an important factor for achieving high rates of treatment adherence. Interferon (IFN) beta-1b was the first DMD approved for the treatment of MS. The aims of our study were to assess TS in subjects with relapsing-remitting (RR) MS treated with IFN beta-1b in Serbia, Montenegro and the Republika Srpska, Bosnia and Herzegovina (B&H), and additionally, to evaluate the impact of patient support program on TS and adherence.
This is a cross-sectional survey performed in order to examine TS and adherence with IFN beta-1b in seven MS centers across three countries (Serbia, Montenegro and B&H). Included in the study were 296 adult patients with RRMS treated with IFN beta-1b for at least 6 months. They were invited to complete the Treatment Satisfaction Questionnaire for Medication (TSQM). Additional two treatment adherence questions were also asked. Patient support program (Betaplus®) was available exclusively for patients in Serbia and not for those in Montenegro and the Republika Srpska, B&H. In order to assess the potential impact of this program on TSQM, we combined two groups of patients from Montenegro and B&H and compared their results with those from patients in Serbia. Statistical analysis includes multivariable linear regression analysis in order to assess the differences between three MS patients groups in terms of the TSQM scores, adjusted for potential confounders. For the evaluation of the effects of Betaplus® program, multivariable logistic regression was used, controlling for the same confounding factors.
Each of the TSQM summary scores in all three countries implicated high level of patients' satisfaction. There was statistically significant group difference on the Effectiveness summary score (p=0.001) and the Side effects summary score (p=0.006) between the group of subjects from Serbia and the combined group of subjects from Montenegro and B&H, in favor of the former cohort. There was statistically significant group difference neither on the Convenience summary score nor on the Overall satisfaction summary score. Results of adjusted logistic regression analysis based on the availability of patient support program (dependent variable) implicate that it had the most significant impact on the Effectiveness summary score (p=0.008). According to the correlation coefficients in the total patient cohort, all TSMQ summary scores except Effectiveness significantly correlated with the decreased adherence (Side effects: p=0.037; Convenience: p=0.016; Overall satisfaction: p=0.046).
TS with IFN beta-1b was high in our MS patients. Additionally, these results have demonstrated that patient support program have significant impact on TS with IFN beta-1b in the Balkan cohort of RRMS patients.
长期坚持使用疾病修饰药物(DMDs)可能对多发性硬化症(MS)的临床结局产生重大影响。最近有人强调,低治疗满意度(TS)可能是实现高治疗依从率的一个重要因素。干扰素(IFN)β-1b是首个被批准用于治疗MS的DMD。我们研究的目的是评估在塞尔维亚、黑山以及波斯尼亚和黑塞哥维那(波黑)斯普斯卡共和国接受IFNβ-1b治疗的复发缓解型(RR)MS患者的TS,此外,评估患者支持项目对TS和依从性的影响。
这是一项横断面调查,旨在调查三个国家(塞尔维亚、黑山和波黑)七个MS中心患者对IFNβ-1b的TS和依从性。纳入研究的是296例接受IFNβ-1b治疗至少6个月的RRMS成年患者。他们被邀请完成药物治疗满意度问卷(TSQM)。还询问了另外两个治疗依从性问题。患者支持项目(Betaplus®)仅在塞尔维亚提供给患者,而不在黑山和波黑斯普斯卡共和国提供。为了评估该项目对TSQM的潜在影响,我们将来自黑山和波黑的两组患者合并,并将他们的结果与塞尔维亚患者的结果进行比较。统计分析包括多变量线性回归分析,以评估三组MS患者在TSQM评分方面的差异,并对潜在混杂因素进行校正。为了评估Betaplus®项目的效果,使用了多变量逻辑回归,并控制相同的混杂因素。
所有三个国家的TSQM总分均表明患者满意度较高。塞尔维亚组与黑山和波黑合并组在有效性总分(p = 0.001)和副作用总分(p = 0.006)上存在统计学显著的组间差异,前者更具优势。在便利性总分和总体满意度总分上均无统计学显著的组间差异。基于患者支持项目可用性(因变量)的校正逻辑回归分析结果表明,它对有效性总分影响最为显著(p = 0.008)。根据整个患者队列中的相关系数,除有效性外,所有TSMQ总分均与依从性降低显著相关(副作用:p = 0.037;便利性:p = 0.016;总体满意度:p = 0.046)。
我们的MS患者对IFNβ-1b的TS较高。此外,这些结果表明,患者支持项目对巴尔干地区RRMS患者队列中IFNβ-1b的TS有显著影响。