Percentage Of Relapse-free Patients Research Articles

Comparison of Therapies in MS Patients After the First Demyelinating Event in Real Clinical Practice in the Czech Republic: Data From the National Registry ReMuS

Background: Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system. Well-established drugs used for MS patients after the first demyelinating event in the Czech Republic include glatiramer acetate (GA), interferon beta-1a (IFNβ-1a), IFN beta-1b (IFNβ-1b), peginterferon beta-1a (peg-IFNβ-1a), and teriflunomide.Objective: The objective of this observational study was to compare the effectiveness of the abovementioned drugs in patients with MS who initiated their therapy after the first demyelinating event. Patients were followed for up to 2 years in real clinical practice in the Czech Republic.Methods: A total of 1,654 MS patients treated after the first demyelinating event and followed up for 2 years were enrolled. Evaluation parameters (endpoints) included the annualized relapse rate (ARR), time to next relapse, change in the Expanded Disability Status Scale (EDSS) score, and time of confirmed disease progression (CDP). When patients ended the therapy before the observational period, the reason for ending the therapy among different treatments was compared.Results: No significant difference was found among the groups of patients treated with IFNβ-1a/1b, GA, or teriflunomide for the following parameters: time to the first relapse, change in the EDSS score, and the proportion of patients with CDP. Compared to IFNβ-1a (44 mcg), a significant increase in the percentage of relapse-free patients was found for GA, but this treatment effect was not confirmed by the validation analysis. Compared to the other drugs, there was a significant difference in the reasons for terminating GA therapy.Conclusion: Small differences were found among GA, IFNβ and teriflunomide therapies, with no significant impact on the final outcome after 2 years. Therefore, in clinical practice, we recommend choosing the drug based on individual potential risk from long-term therapy and on patient preferences and clinical characteristics.

Tolerability and Safety Profile of a New Brand-Generic Product of Glatiramer Acetate in Iranian Patients with Relapsing-Remitting Multiple Sclerosis: An Observational Cohort Study

BackgroundThe aim of this study was to evaluate the safety, tolerability, and efficacy of a brand-generic glatiramer acetate product in patients with relapsing-remitting multiple sclerosis over a 12-month period. A noninterventional cohort study was conducted on 185 patients. The patients had a confirmed and documented diagnosis of relapsing-remitting multiple sclerosis as defined by the Revised McDonald Criteria (2010), were ambulatory with a Kurtzke Expanded Disability Status Scale score of 0 to 5.5, and their treatment by glatiramer acetate 40 mg/mL was just started. MethodsAdverse drug reactions, relapse rate, magnetic resonance imaging parameters, and Expanded Disability Status Scale score were evaluated over 1 year. ResultsOf 185 enrolled patients from 21 different cities, 170 completed the study. The mean (SD) Expanded Disability Status Scale score was 1.97 (0.75) at the time of screening. The mean age was 33 years with an average of 4-year multiple sclerosis history, and 83% were women. Hepatic disorder and depression were the most frequent medical history. The most common adverse drug reactions were local pain (45.4%) and erythema (38.9%). The immediate postinjection reactions included dyspnea (10.3%), anxiety (9.7%), palpitation (8.1%), urticaria (5.4%), flushing (3.24%), chest pain (2.16%), and throat constriction (0.54%). The percentage of relapse-free patients at Month 12 was 87%, and the annual relapse rate was 0.134. An increase in the Expanded Disability Status Scale score was observed in 20% of patients, and new T2 and gadolinium-enhancing lesions were found in 34.7% and 9.4%, respectively. The rate of treatment failure was 1.6% and 4.3% according to the Modified Rio and Rio scores, respectively. ConclusionsThe 40 mg brand-generic glatiramer acetate product was well tolerated in this selected group of Iranian patients with relapsing-remitting multiple sclerosis, and patient adherence was favorable over 1 year.

Observational Study of Switching from Natalizumab to Immunomodulatory Drugs

Objective: To determine the effect of disease-modifying drugs (DMDs) on disease activity rebound in patients discontinuing natalizumab (NTZ). Methods: Twenty-one patients with relapsing-remitting multiple sclerosis (RRMS) treated with NTZ for ≥1 year and who switched to DMDs (glatiramer acetate [GA] or interferon) were followed up for 12 months in clinical practice. Clinical outcomes after NTZ cessation were assessed every 3 months for 1 year and MRI was performed at 12 months. Results: Twelve months after switching from NTZ to DMDs, there were no significant differences in the annualized relapse rate (ARR) compared to the days that NTZ was used (0.3 vs. 0.1; p = 0.083); and the ARR never reached similar values to those prior to NTZ use (1.61; p < 0.001). The percentage of relapse-free patients after switching from NTZ was 71.4%. These patients did not have lower disease activity before NTZ compared with those with clinical relapses (1.3 vs. 1.7; p = 0.302), but they had lower Expanded Disability Status Scale scores (3.4 vs. 5.7; p = 0.001). DMDs had beneficial effects on MRI parameters, as 10 of 16 patients (62.5%) presented no evidence of radiological activity 12 months after NTZ discontinuation. Conclusions: Patients with RRMS and moderate disability who discontinued NTZ for safety reasons may benefit from the DMDs GA and interferon with no known risk for progressive multifocal leukoencephalopathy.

Factors associated with relapse after a response to electroconvulsive therapy in unipolar versus bipolar depression

BackgroundWhile electroconvulsive therapy (ECT) treatment for depression is highly effective, the high rate of relapse is a critical problem. The current study investigated factors associated with the risk of relapse in mood disorders in patients in which ECT was initially effective. MethodThe records of 100 patients with mood disorders (61 unipolar depression, 39 bipolar depression) who received and responded to an acute ECT course were retrospectively reviewed. Associations between clinical variables and relapse after responding to acute ECT were analyzed. The Ethics Committee of NHO Kure Medical Center approved the study protocol. ResultsAfter one year, the percentage of relapse-free patients was 48.7%. There was no significant difference between patients with either unipolar or bipolar depression who were relapse-free (unipolar: 51.1%, bipolar: 45.5%, P=0.603). Valproate maintenance pharmacotherapy in unipolar depression patients was associated with a lower risk of relapse compared to patients without valproate treatment (multivariate analysis, hazard ratio: 0.091; P=0.022). Lithium treatment, reportedly effective for unipolar depression following a course of ECT, tended to lower the risk of relapse (hazard ratio: 0.378; P=0.060). For bipolar depression, no treatment significantly reduced the risk of relapse. LimitationsThe current findings were retrospective and based on a limited sample size. ConclusionsThe relapse-free rate was similar between unipolar and bipolar depression. Valproate could have potential for unipolar depression patients as a maintenance therapeutic in preventing relapse after ECT.

Effects of diazoxide in multiple sclerosis

Objective:The aim of this study was to test the safety of diazoxide and to search for signs of efficacy in patients with relapsing-remitting multiple sclerosis (RRMS).Methods:In this multicenter, randomized, placebo-controlled, double-blind trial (treatment allocation was concealed), 102 patients with RRMS were randomized to receive a daily oral dose of diazoxide (0.3 and 4 mg/d) or placebo for 24 weeks (NCT01428726). The primary endpoint was the cumulative number of new T1 gadolinium-enhancing lesions per patient, recorded every 4 weeks from week 4 to week 24. Secondary endpoints included brain MRI variables such as the number of new/enlarging T2 lesions and the percentage brain volume change (PBVC); clinical variables such as the percentage of relapse-free patients, relapse rate, and change in the Expanded Disability Status Scale score; and safety and tolerability.Results:Diazoxide was well-tolerated and it produced no serious adverse events other than 1 case of Hashimoto disease. At the 2 doses tested, diazoxide did not improve the primary endpoint or the MRI and clinical variables related to the presence of new lesions or relapses. Patients treated with diazoxide showed reduced PBVC compared with the placebo group, although such changes could be confounded by the higher disease activity of the treated group and the vascular effects of diazoxide.Conclusion:At the doses tested, oral diazoxide did not decrease the appearance of new lesions evident by MRI. The effects in slowing the progression of brain atrophy require further validation.Classification of evidence:This study provides Class I evidence that for patients with RRMS, diazoxide (0.3 and 4 mg/d) does not significantly change the number of new MRI T1 gadolinium-enhancing lesions.

Clinical trial: once‐daily mesalamine granules for maintenance of remission of ulcerative colitis – a 6‐month placebo‐controlled trial

Ulcerative colitis (UC) is a chronic relapsing and remitting idiopathic inflammatory bowel disorder. To evaluate once-daily mesalamine (mesalazine) granules (MG) for maintenance of remission of UC. Randomized, double-blind, placebo-controlled trial of patients (n=209 MG, n=96 placebo) with UC in remission [revised Sutherland Disease Activity Index (SDAI) rectal bleeding=0, mucosal appearance <2] who took MG 1.5 g or placebo once-daily for up to 6 months. Primary efficacy endpoint: the percentage of patients who remained relapse-free at month 6/end of treatment. Relapse was defined as SDAI rectal bleeding score ≥1 and a mucosal appearance score ≥2, a UC flare, or initiation of medication to treat a UC flare. The percentage of relapse-free patients at month 6/end of treatment was higher with MG than placebo (78.9% vs. 58.3%, P < 0.001) in the intent-to-treat analysis. Significant differences (P ≤ 0.025) favouring MG were observed for most secondary endpoints including improvement in rectal bleeding, physician's disease activity rating, stool frequency, the SDAI at month 6/end of treatment, patients classified as a treatment success and relapse-free duration. The incidence of adverse events was similar between groups. Once-daily mesalamine (mesalazine) was effective in maintaining remission of UC for 6 months.

P.1.a.020 Oxytocin receptor polymorphisms and adult attachment style in patients with depression

While electroconvulsive therapy (ECT) treatment for depression is highly effective, the high rate of relapse is a critical problem. The current study investigated factors associated with the risk of relapse in mood disorders in patients in which ECT was initially effective.The records of 100 patients with mood disorders (61 unipolar depression, 39 bipolar depression) who received and responded to an acute ECT course were retrospectively reviewed. Associations between clinical variables and relapse after responding to acute ECT were analyzed. The Ethics Committee of NHO Kure Medical Center approved the study protocol.After one year, the percentage of relapse-free patients was 48.7%. There was no significant difference between patients with either unipolar or bipolar depression who were relapse-free (unipolar: 51.1%, bipolar: 45.5%, P=0.603). Valproate maintenance pharmacotherapy in unipolar depression patients was associated with a lower risk of relapse compared to patients without valproate treatment (multivariate analysis, hazard ratio: 0.091; P=0.022). Lithium treatment, reportedly effective for unipolar depression following a course of ECT, tended to lower the risk of relapse (hazard ratio: 0.378; P=0.060). For bipolar depression, no treatment significantly reduced the risk of relapse.The current findings were retrospective and based on a limited sample size.The relapse-free rate was similar between unipolar and bipolar depression. Valproate could have potential for unipolar depression patients as a maintenance therapeutic in preventing relapse after ECT.

Factors causing early relapse after lung metastasis surgery

Haematogenous lung metastases are usually considered a sign of widespread metastatic disease. However, in most primary cancers, the first filter for distant tumours are the lungs. In some patients, the metastatic process may stop at the lungs. In these selected patients, there are studies that have shown the benefits of metastasectomy. The objective of this paper is to analyse the morbidity and mortality of lung metastasectomy and determine the factors that predispose to early relapse. Forty-two patients operated on for lung metastases, and four were excluded as they were assessed intraoperatively to be unresectable, leaving 38 patients to be analysed. The variables analysed were: age, sex, primary tumour, disease-free interval, number of metastases, bilaterality, morbidity and mortality, relapse, reinterventions, relapse-free interval after metastasectomy and survival. The surgical technique was a posterolateral thoracotomy, and there were no perioperative deaths. Morbidity was 11% (n = 4), and surgical reintervention of the haemothorax was necessary. Survival after 1, 2 or 3 years was 87%, 61% and 25% respectively, and the percentage of relapse-free patients was 71%, 56% and 17% respectively. The main factors associated with early relapse were histological type of tumour (more relapse in sarcoma, and less in adenocarcinoma), the disease-free interval between the primary tumour and lung metastases, and the number of metastases. Surgery was required a second time in five patients who had relapsed lung metastases, but extirpation could be performed in only four patients, of whom three were relapse free after 6, 12 and 24 months respectively, and the fourth had relapsed lung metastases after 18 months. Resection of lung metastases can be performed with low morbidity and mortality. The main prognostic factors for survival are complete surgery, histological type, disease-free interval between the primary tumour and metastases, and the number of lung metastases.

Neutralizing antibodies reduce the efficacy of βIFN during treatment of multiple sclerosis

To analyze the impact of neutralizing antibodies (NAbs) on the clinical efficacy of IFNbeta. This was an open-label study involving 78 patients with multiple sclerosis treated with Betaferon 8 million IU (MIU) subcutaneously (SC) every other day (n = 20), Rebif 22 micro g SC 3 times weekly (n = 25), or Avonex 30 micro g IM once weekly (n = 33). Every 3 months, blood samples were collected and sera were analyzed for NAbs using an antiviral cytopathic effect assay. Patients were categorized according to their NAb status: NAb negative (NAb-); isolated NAb positive (NAb+), patients with > or =1 positive sample (titer > or = 20); and persistent NAb+, patients with > or =2 consecutive positive samples (titer > or = 20). Patients who were NAb- and persistent NAb+ were compared for relapse rate, time between first and second relapse, percentage of relapse-free patients, and percentage of patients who had a sustained progression of > or =1 point on the Expanded Disability Status Scale (EDSS). The incidence of persistent NAb+ patients was 35% for Betaferon, 20% for Rebif, and 3% for Avonex. During IFNbeta treatment, both NAb+ and NAb- patients showed a reduction in relapse rate; this reduction (25%) was not significant in NAb+ patients but was significant (67%; p < 0.0001) in NAb- patients. In addition, the mean relapse rate was higher (p = 0.039), mean time between first and second relapse was shorter (13 vs 21 months; p = 0.0064), and there was a trend suggesting that NAbs affected the probability of remaining relapse free (p = 0.08). A higher percentage of NAb+ patients versus NAb- patients had worsening of EDSS scores during follow-up (p = 0.013). Persistent NAbs significantly reduce the clinical efficacy of IFNbeta.

Colloidal bismuth subcitrate in peptic ulcer--a review.

De-Nol (colloidal bismuth subcitrate, CBS) precipitates in an acid environment and adheres to the exudate layer covering an ulcer crater; moreover, CBS blocks pepsin activity, retards hydrogen-ion back-diffusion and stimulates prostaglandin synthesis. The average healing rate in duodenal ulcer (DU) after 4 weeks' treatment with CBS is 78% versus 63% with cimetidine. In a direct comparison, CBS gives 84% healing as opposed to 78% with ranitidine. The average healing rate after 4 weeks' treatment with CBS in gastric ulcer (GU) is 68% compared to 54% with cimetidine. The percentage of relapse-free patients, 1 year after DU or GU healing, with CBS is substantially higher than is the case with H2-receptor blockers.