Treatment Continuation Rate Research Articles

Comparative Effectiveness of Second Generation Long-acting Injectable Antipsychotics Based on Nationwide Database Research in Hungary: An Update.

Greater 1-year and 2-year treatment continuation rates and longer median time to discontinuation for second-generation antipsychotic (SGA) long-acting injectables (LAIs) vs oral antipsychotics (OAPs) in Hungary were previously reported. This study reports an updated comparison between new LAIs vs OAPs in Hungary. De-identified claims data from Hungarian National Health Insurance Fund database of schizophrenia patients who were newly initiated on SGAs (November 01, 2016 to June 30, 2017) were retrospectively analyzed. Primary outcomes were likelihood of all-cause 1-year and 1.5-year discontinuation of newly initiated SGA and median time till discontinuation. Among 5400 patients, 3977 (73.6%) were OAP users and 1423 (26.4%) were LAI users. The 1-year continuation rate were 12.7% (risperidone)-34.1% (olanzapine) for OAPs and 26.4% (risperidone LAI)-78.6% (paliperidone 3-monthly [PP3M]) for LAIs. The 1.5-year continuation rates were 9.3%-29.5% for OAPs and 24.9%-76.4% for LAIs. Median (95% CI) time to discontinuation was 52 (33-67) days (clozapine)-152 (134-168) days (aripiprazole) for OAPs and 125 (64-196) days (risperidone LAI)-491 (250-not reached) days (aripiprazole LAI) for LAIs. All-cause discontinuation risk was significantly higher in all OAPs vs PP3M and aripiprazole LAI (P < .01) as well as in each LAI vs PP3M (P < .05). Patients switching on new LAIs from another LAI remained longer than those who switched from OAPs/no previous treatment. Results showed the advantage of LAIs over OAPs in terms of time to treatment discontinuation. Moreover, new SGA LAIs (PP3M) seem to be better than previous LAIs in terms of time to treatment discontinuation.

Examination of osteoporosis treatment continuation rate in outpatient clinic 3rd report: With for the Corona era

Examination of osteoporosis treatment continuation rate in outpatient clinic 3rd report: With for the Corona era

Treatment Continuation of Asenapine or Olanzapine in Japanese Schizophrenia Patients: A Propensity Score Matched Study.

ObjectiveAsenapine is a second-generation antipsychotic agent that is classified as a multi-acting receptor-targeted antipsychotic and is similar to olanzapine. Our study aimed to compare the treatment continuation rate and reason for discontinuation of asenapine or olanzapine in schizophrenia using real-world data.MethodsThis design was a retrospective study. The primary endpoint was Kaplan–Meier estimates of the continuation rate at six months, with the propensity score method applied to adjust for potential confounders.ResultsA total of 95 patients were analyzed in this study (asenapine, n = 46; olanzapine, n = 49). Matched data were adjusted to consider six covariates (age, sex, chlorpromazine equivalent, diazepam equivalent, history of clozapine use, and history of modified electro convulsive therapy). The continuation rate at six months was 27.3% (95% CI, 15.6–47.6) in the asenapine group and 50.8% (95% CI, 34.3–75.3) in the olanzapine group (hazard ratio, 0.41; 95% CI, 0.21–0.82; P = 0.0088 by the Log rank test) in matched data. Cases of discontinuation because of the lack of efficacy were almost as frequent for asenapine (13.0%) as for olanzapine (10.2%). Discontinuation due to bitter taste (6.5%) and burden of the dosing method (6.5%) were observed only with asenapine, whereas anticholinergic side effects such as dry mouth (4.1%) and constipation (2.0%) were observed only with olanzapine.ConclusionThe low continuation rate of asenapine in real-world data may be related to specific factors such as bitter taste and burden of the dosing method.

Therapy outcome related to adalimumab trough levels in pediatric patients with inflammatory bowel disease

Objectives We evaluated the relationship between serum concentration and efficacy of adalimumab (ADA), an anti-tumor necrosis factor-alpha agent, in pediatric patients with inflammatory bowel disease (PIBD). Materials and methods This retrospective cross-sectional study traced 75 patients with PIBD (Crohn’s disease, n = 57) treated with ADA at two tertiary centers in Finland in 2012–2018. Drug levels and drug antibody titers were chart-reviewed, and the treatment continuation rate of ADA therapy was evaluated. We also assessed the impact of trough levels in the first 3 months on the continuation of ADA within one year of therapy. Results ADA was introduced at a median age of 13.4 years, and the median disease duration was 2.7 years. During the first year, 22 patients (29%) discontinued ADA due to either loss of response (20%, n = 15) or anti-drug antibody formation (5.3%, n = 4). Regarding trough levels in the first 3 months, 9/16 patients (56%) with trough levels <5 mg/L and 12/20 (60%) with trough levels <7.5 mg/L at 3 months discontinued the therapy by the end of the first year. In comparison, only 8/32 patients (25%) with trough levels >7.5 mg/L at 3 months discontinued treatment during the first year (p = .005). At the last follow-up (median 1.5 years), 52% of the 75 patients were on maintenance therapy and had a median trough level of 8.8 mg/L. Conclusion Higher trough levels in the first 3 months of adalimumab treatment are associated with lower rates of discontinuation due to loss of response during the first year.

Tolerance and Efficacy of Polyethylene Glycol 4000 in Elderly Patients with Chronic Constipation: A Retrospective, Single-center, Observational Study.

Objectives: This retrospective, observational study aimed to evaluate the tolerance and efficacy of polyethylene glycol 4000 plus electrolytes (PEG 4000) in elderly patients with chronic constipation. Methods: PEG 4000 powder was orally administered once daily at a dose of one or two 6.9 g sachets as the initial dose. The outcome measures were changes in the Cleveland Clinic Constipation Score (CCCS) and the Bristol Stool Form Scale (BSFS) value before and 2 weeks after drug administration. Results: This study included 324 patients aged ≥65 years (mean age: 78.6 ± 7.6 years, range: 65-100 years) with chronic constipation. The total CCCS was noted to significantly improve from 11.5 ± 4.6 at baseline to 7.4 ± 5.2 after drug administration. All CCCS sub-scores also improved significantly. The average BSFS value at baseline (2.5 ± 1.6) significantly improved to 4.3 ± 1.1 after treatment. Side effects (16 events) were observed in 13 patients (4.0%), with the most common being diarrhea (6 patients, 1.9%). All events were mild in severity, with none of the symptoms being serious. The cumulative treatment continuation rate at 1 year was 83.1%. Conclusions: PEG 4000 treatment was safe, effective, and well tolerated in elderly patients with chronic constipation. Thus, it appears to be a promising drug that can be continued for a long time.

Long-Term Maintenance of Golimumab Effectiveness for Injection Spacing in Rheumatoid Arthritis Patients with Low Disease Activity Who Previously Received Other TNF Inhibitors: Minimum 2-year Data From an Observational Study.

BackgroundGolimumab (GLM) has been reported to have lower immunogenicity than do other TNF inhibitors used for treating rheumatoid arthritis (RA). We previously found a prolonged effect of and improvement similar to that associated with infliximab (IFX) after switching to subcutaneous GLM (GLM-SC) for control of RA activity or adverse events. Thus, this study aimed to evaluate the continued maintenance of treatment efficacy and safety for > 2 years by switching to GLM-SC in RA patients with low disease activity or in remission after previous treatment with another tumor necrosis factor (TNF) inhibitor.MethodsThirty-two patients treated with etanercept or infliximab were switched to GLM-SC and maintained low disease activity. The patients were divided into two groups (GLMq4w and GLMq8w) through discussion with each patient, considering their general condition and convenience. The groups included patients with low disease activity or in remission who switched to 50-mg GLM therapy at 4-week and 8-week intervals, respectively.ResultsThe mean DAS28-ESR and DAS-CRP values in the GLMq4w group (17 patients) and GLMq8w group (15 patients) were maintained from baseline throughout the 104-week treatment period. Two patients from the GLMq4w group showed disease flaring to moderate disease activity. No serious adverse events occurred, and the treatment continuation rate at 104 weeks was 100% in both groups. After > 2 years of treatment, three patients in the GLMq8w group and one patient in the GLMq4w group discontinued GLM treatment due to relapse or complications. The 5-year survival rates were 88.2% and 75.5% in the GLMq4w and GLMq8w groups, respectively. The average treatment duration was 5.0 (2.0–7.5) years.ConclusionAdministration of GLM-SC at 4-week and 8-week intervals after switching from TNF inhibitors showed sustained long-term efficacy and acceptable safety in RA patients with low disease activity.

Is social support related to better mental health, treatment continuation and success rates among individuals undergoing in-vitro fertilization? Systematic review and meta-analysis protocol.

Infertility and its treatment via in-vitro fertilization (IVF) represent a global health area of increasing importance. However, the physical and psychological burden of IVF can negatively impact psychological wellbeing, as well as treatment retention and success. Social support has been found to have positive health effects among populations facing health-related stressors worldwide, and its potential protective role for IVF patients merits further attention. We present a protocol for a systematic review of peer-reviewed published studies quantitatively investigating associations between social support and i) mental health; ii) the decision to (dis)continue with IVF treatment cycles and; iii) IVF success (pregnancy and birth rates); among individuals who are undertaking or have undertaken IVF cycles. Studies will be included if they work with human subjects, provide correlation coefficients between measures of social support and at least one of the outcomes of interest, and are in the English language. Social support may derive from both naturally occurring networks and more formalized sources or interventions. The protocol for this systematic review was developed according to the PRISMA-P guidelines. Ten health-, psychology- and sociology-related databases will be searched using composite search terms that include keywords for ‘IVF’ and ‘social support’. To assess methodological quality, the authors will use a modified version of the Newcastle-Ottawa Scale. Should three or more moderate or good quality studies be identified for any one outcome of interest, correlation meta-analyses, using the Hedges-Olkin method, will be conducted to pool effect sizes and heterogeneity will be assessed. Should the number, quality and characteristics of eligible studies not allow for reliable quantitative synthesis, the authors will limit the analysis to qualitative synthesis, with a focus on implications of findings for future research and programming.

A multicenter observational study of lenvatinib for unresectable hepatocellular carcinoma in Japan.

e16118 Background: Lenvatinib is an oral tyrosine kinase inhibitor that has been available for treatment of unresectable hepatocellular carcinoma (uHCC) in Japan since March 2018. We conducted a multicenter prospective observational study to evaluate the safety and efficacy of lenvatinib in clinical practice. Methods: This study conducted as a prospective study, and enrolled patients with uHCC initially receiving lenvatinib as systemic therapy who gave informed consent from July 2018 through January 2019. The observation period per patient was 12 months and e-CRF was used. Results: 713 patients were registered at 133 clinical sites. The safety analysis set and efficacy analysis set were 703 patients. Patient baseline characteristics included median age:73.0 years (25 to 94), male/ female: 564/139, bodyweight: &lt; 60kg/≥60kg: 323/380, HBV/HCV/alcohol/NAFLD or NASH: 137/287/167/88, Child-Pugh classification A/B or higher: 624/75, BCLC stage A/B/C/D: 57/291/332/11, Vp 0/1/2/3/4: 520/31/52/60/22, with/without extrahepatic metastasis: 236/461. Previous treatment (local and systemic therapy) for hepatocellular carcinoma is with/without TACE: 513/190, median number of TACE treatment: 3.0 times (1 to 26), with/without HAIC: 74/629, with/without TKI pretreatment: 131/572. The initial dose was 8 mg (80.5%) and 12 mg (68.2%) in patients with &lt; 60 kg and ≥60 kg, respectively. Median relative dose intensity was 64.2% and the treatment continuation rate at 3 and 12 months after administration of lenvatinib were 67.3% and 24.8%. Regarding safety, the incidence of treatment-related adverse events (TRAEs) was 84.9% (grade 3 or higher: 42.5%). Common TRAEs (incidence rate ≥10%) were decreased appetite (23.9%), malaise (21.8%), hypertension (21.3%), proteinuria (18.3%), palmar-plantar erythrodysesthesia syndrome (16.5%), hypothyroidism (15.8%), and diarrhea (13.9%). TRAEs of grade 3 or higher （incidence rate ≥2.5%） were proteinuria (6.7%), hypertension (6.4%), malaise (3.8%), decreased appetite (3.6%), platelet count decreased (3.3%), palmar-plantar erythrodysesthesia syndrome (2.7%), diarrhea (2.7%) and hepatic encephalopathy (2.6%). The incidence of TRAEs leading to discontinuation of lenvatinib was 32.9％, and main TRAEs leading to discontinuation of lenvatinib were (incidence rate ≥2%) decreased appetite (6.3%), malaise (4.7%), proteinuria (3.3%) and hepatic encephalopathy (2.4%). Regarding efficacy, the ORR and DCR was 39.5% (95% CI: 35.1, 43.9) and 78.9% (75.1, 82.5) in 494 patients who were evaluated for the best response by mRECIST. The median OS was 498.0 days (95% CI: 439.0, -) in 703 patients. Conclusions: The incidence of TRAEs leading to discontinuation of lenvatinib tended to be higher than in phase 3 REFLECT trials (19.7%), but the safety profile and effectiveness findings for lenvatinib in this study were consistent with previous reports.

Continuation rate for asenapine and brexpiprazole treatment in patients with schizophrenia.

IntroductionThe current study sought to compare the treatment continuation rates of asenapine and brexpiprazole while specifically investigating the factors influencing this index and the clinical efficacy of brexpiprazole.MethodsRetrospective study on patients with schizophrenia who were prescribed either asenapine (n = 73) or brexpiprazole (n = 136), as part of their routine medical care.ResultsThe treatment continuation rates for asenapine and brexpiprazole were 19.0% and 38.6% at 52 weeks, with that of brexpiprazole found to be significantly higher than that of asenapine (p = .002). Moreover, age was found to be a significant factor affecting the treatment continuation rate for brexpiprazole (p = .03). Additionally, patients with a longer continuation duration had significantly lower Clinical Global Impression‐Severity of Illness (CGI‐S) scale scores compared to those who discontinued early (p = .04). The continuation rate was also significantly higher for those who began using the drug as outpatients compared to those first administered the drug as inpatients (p = .04). Furthermore, disease duration, CGI‐S scale, and continuation duration significantly affected the clinical efficacy of brexipiprazole (p < .05 for all).ConclusionsThe continuation rate for brexpiprazole increases as the age of the patient increases, as disease severity decreases, and if the patient first uses the drug as an outpatient. Shorter disease duration and longer drug administration may lead to improved clinical efficacy. These results suggest that brexpiprazole is an effective treatment option for maintenance therapy of schizophrenia.

A descriptive study of 10-year clozapine use from the nationwide database in Japan

This survey was conducted to identify the actual usage of clozapine and changes required to increase the number of patients with schizophrenia who would benefit from clozapine. We obtained Clozaril® Patient Monitoring Service (CPMS) data for 8,263 patients that received clozapine between July 2009 and January 2020. Patients were divided into the early (n=3,696 cases, which have been analyzed previously) and late groups (n=4,567 cases) according to the date of the treatment initiation. In total, 417 facilities offered the drug, with a surge in cases in the late group (40.0 hospitals/year, 568.6 cases/year vs. 39.3 hospitals/year, 1,141.8 cases/year). We found a significant between-group difference in the mean dosage during treatment (early group: 309.1 mg/day; late group: 247.9 mg/day). The treatment continuation rates at 1 and 4 years in all study participants were 77.2% and 65.1%, respectively. The incidences of granulocytopenia and agranulocytosis were 5.5% and 1.0%, respectively. The discontinuation rate because of granulocytopenia was significantly lower in the late group. There were no differences in the discontinuation rate because of glucose intolerance between the groups. An assessment of the current CPMS regulations may be required to further examine the clozapine use effectiveness.

Compliance with Testosterone Replacement Therapy in Patients with Testosterone Deficiency Syndrome: A 10-Year Observational Study in Korea.

PurposeTo determine the compliance rate with testosterone replacement therapy (TRT) in patients with testosterone deficiency syndrome (TDS), we evaluated the treatment continuation rate and the reasons for discontinuation of initial treatment according to each formulations and patient characteristics.Materials and MethodsAmong men over 40 years of age who were diagnosed with TDS and then underwent TRT, their medical records were retrospectively analyzed for those who were followed up for more than 10 years.ResultsA total of 640 patients were included in the analysis. It was found that 75.9% of patients continued treatment for 1 year after starting. Patients treated with 1,000 mg of testosterone undecanoate injection had the highest treatment rate. Inconvenience of medication was the most common reason for discontinuing treatment, followed by cost, concern about side effects, lack of efficacy, and symptom recovery. The reasons for discontinuing treatment differed according to the xlink:type of formulations, and the longest continuous treatment period in all patients was 15.4±7.6 months on average. The treatment continuation rate tended to be high in patients with low serum total testosterone before starting treatment, in patients with severe erectile dysfunction, and in patients using phosphodiesterase-5 (PDE5) inhibitors.ConclusionsAmong the various formulations of TDS, testosterone undecanoate injection (1,000 mg) had the highest compliance rate. In addition, it was found that the reasons for discontinuation of treatment varied according to the characteristics of each formulation.

Prevalence of Osteoporosis Treatment and Its Effect on Post-Operative Complications, Revision Surgery and Costs After Multi-Level Spinal Fusion

Study Design:Retrospective cohort study.Objective:To study the prevalence of pre-operative osteoporosis treatment, and its effect on risk of ORC, revision surgery and costs in osteoporotic patients undergoing ≥3-level spinal fusion for degenerative pathology.Methods:Patients and procedures of interest were included using International Classification of Diseases (ICD) and Current Procedural Terminology (CPT) coding. Our outcome measures were ORC at 1-year post-operatively and included instrumentation complications, pathological fracture, and revision surgery. Kaplan-Meier survival curves and Cox proportional hazards analysis was done to study the effect of osteoporosis treatment on risk of ORC.Results:We included a total of 849 patients with documented osteoporosis undergoing ≥3-level spinal fusion. White (85.6%), female (82.7%), and 60-79 years of age (79.9%) was the most common demographic. Of entire cohort, 121(14.3%) were on osteoporosis treatment prior to spinal fusion. Of treated patients, 52/121 (43.0%) had continued prescriptions at 1 year post-operatively. Treated patients and not-treated patients had 1-year ORC incidence of 9.1% and 15.0%, respectively. The average 1-year reimbursement/patient for managing ORC was $3,053 (treated) and $21,147 (not-treated). On adjusted cox analysis, pre-operative osteoporosis treatment was associated with a lower risk of ORC (HR: 0.53, 95% CI: 0.28-0.99, p = 0.04).Conclusions:Pre-operative osteoporosis treatment is associated with lower risk of ORC and revision surgery at 1-year after ≥3-level spinal fusion. There is a low incidence of osteoporosis treatment prior to spinal fusion, and subsequently a low rate of treatment continuation after surgery. These findings highlight the need for heightened awareness, patient education and management of osteoporosis before elective multi-level spinal fusion.

Long-term Use of Golimumab in Daily Practice for Patients with Rheumatoid Arthritis.

Objective To evaluate the effectiveness and drug retention rate of golimumab (GLM) for long-term use in daily practice for patients with rheumatoid arthritis (RA). Methods Patients with RA who started GLM therapy with a minimum follow-up period of 52 weeks were included. The patients were divided into a biologic-naïve group and switch group. The disease activity score (DAS) 28-erythrocyte sedimentation rate (ESR) (DAS28-ESR), grip power, and Japanese version of the health assessment questionnaire (J-HAQ) score were assessed. In addition, the treatment continuation rate was evaluated at the final follow-up. Patients Sixty-five patients [58 women and 7 men; median (range) age, 69 (61-74) years; median (range) disease duration, 9 (5-16) years] were included. Twenty-eight patients were biologic-naïve (naïve group), and 37 were switched to biologics (switch group). Results The median (range) follow-up period was 134 (58-162) weeks. The DAS28-ESR improved from a median (range) of 4.31 (3.52-5.25) to 2.65 (2.28-3.77) in the naïve group and from 4.27 (3.19-4.89) to 2.89 (2.49-3.88) in the switch group. The grip power improved in both groups (p<0.01); however, the J-HAQ score showed no marked improvement in either group. The continuation rates were 22/28 (78.6%) in the naïve group, and 26/37 (70.3%) in the switch group at the final follow-up. Conclusion We herein report for the first time that the long-term use of GLM improves the grip power. Improving the grip power may help prevent sarcopenia and frailty in the future. Given the efficacy and high continuation rate, we suggest that GLM would be a well-tolerated treatment option for RA.

Open-label study to evaluate the treatment continuation rate after a dose reduction of lubiprostone due to onset of adverse events

ABSTRACT Objective To investigate the continuation rate with a reduced lubiprostone dose (12 mcg twice daily, BD) after the onset of adverse events (AEs) in patients with chronic constipation (CC). Methods In this exploratory, open-label, multicenter study, patients with CC received lubiprostone 24 mcg BD and the dose was reduced to 12 mcg BD in subjects experiencing AEs. The primary objective was the continuation rate after dose reduction due to nausea/vomiting. Secondary objectives included the continuation rate after dose reduction due to diarrhea/any AE and efficacy, including changes in number of weekly bowel movements and Bristol Stool Form Scale. Results Of the 146 patients included in the study, 42 (28.8%) received lubiprostone 12 mcg BD (dose-reduced group) due to any AE. Thirty-six (85.7%) subjects in the dose-reduced group continued treatment and completed the study. 22/27 (81.5%) and 17/19 (89.5%) patients in whom the dose was reduced due to nausea/vomiting or diarrhea, respectively, continued treatment. There was no clinically relevant difference in efficacy after dose reduction. Conclusion These results suggest that treatment withdrawal due to AEs associated with lubiprostone 24 mcg BD could be minimized in patients with CC after dose reduction to 12 mcg BD, thus resulting in improved long-term outcomes. Clinical trial registration Japan Registry of Clinical Trials (https://jrct.niph.go.jp/latest-detail/jRCTs031180069)

Re-challenge of Platinum-based Chemotherapy for Platinum-refractory Patients with Recurrent or Metastatic Head and Neck Cancer: Claims Data Analysis in Japan.

BackgroundThe role of platinum rechallenge in head and neck cancer (HNC) has not yet been fully evaluated.ObjectivesIt is our goal to assess the real-world treatment patterns and usefulness of platinum rechallenge in patients with platinum-refractory recurrent or metastatic HNC receiving platinum rechallenge.MethodsThis is a retrospective study using data from a Japanese hospital claims database stored in electronic hospital information systems. Patients with HNC or undefined histology with an HNC diagnosis using the disease code, between January 1, 2013 and September 30, 2016, were included. Patients diagnosed with other malignancies on or before the initial diagnosis of HNC and those without cancer stage information in the database were excluded from the study.ResultsA total of 43 994 patients were identified from the database as HNC patients. Of those, in patients who had cancer progression within 6 months after platinum-based chemotherapy administered for primary or recurrent disease (N=842), the median treatment duration of platinum rechallenge for platinum refractory patients was only 1 cycle. The second-line treatment continuation rate at 6 months was 20.1% for patients who received platinum rechallenges and 32.8% for those who received non–platinum-based regimens.ConclusionsThe findings from this study of data from routine clinical practice suggest that the benefit of platinum rechallenge in a platinum-refractory setting would be limited.

Weekly docetaxel monotherapy for metastatic extramammary Paget's disease: Retrospective single-institute analysis.

Monthly docetaxel (DTX) monotherapy is the first-line regimen that is preferably used for metastatic extramammary Paget's disease (EMPD). However, the high-dose DTX regimen frequently causes severe hematological adverse events (AE). To overcome such safety concerns, a weekly low-dose DTX monotherapy has been proposed for use in the treatment of various cancer types. In this study, we aimed to evaluate the feasibility and efficacy of weekly DTX (25mg/m2 ) monotherapy for metastatic EMPD by retrospectively analyzing the clinical courses of 14 patients treated with this regimen. Weekly DTX monotherapy was well tolerated and all patients completed the treatment schedule without treatment withdrawal, dose reduction or treatment-related death. While five cases (35.7%) experienced hematological AE, their severity was mild. The response rate was 35.7% (5/14 cases), which included five partial responses. The mean progression-free survival (PFS) and overall survival were 7.1 (95% confidence interval [CI], 5.1-9.1) and 26.4months (95% CI, 16.7-36.1), respectively. Furthermore, the median PFS was 7.3months (95% CI, 4.5-10.0) in patients aged 65years and younger and 7.1months (95% CI, 4.4-9.9) in patients older than 65years. These results suggest that weekly DTX monotherapy may be a useful regimen that has a high treatment continuation rate with low levels of hematological toxicity, regardless of the patient's age for metastatic EMPD.

Comparison of oral naltrexone and naltrexone implant treatment in alcohol use disorders

Objective: The aim of this study is to retrospectively compare the efficacy of long acting naltrexone (XR-NTX) and oral naltrexone (O-NTX) treatment in alcohol use disorder patients. Methods: In the study, retrospective data including sociodemographic characteristics, treatment continuation rates, mean treatment duration (duration of abstinence) and liver function test results were scanned from the medical records and then analyzed in a group of 16 patients and a group of 27 patients who were put on XR-NTX and O-NTX treatments, respectively. Results: 87.5% (14 patients) of the XR-NTX treatment group and 88.9% (24 patients) of the O-NTX treatment group com-prised of male patients. The mean age in the XR-NTX group was 41.31±10.26 years; whereas it was 42.14±9.07 in the O-NTX group. Fourteen patients in the XR-NTX (87.5%) and 15 patients (55.6%) in the O-NTX group returned for control after the first admission. Thus, treatment compliance was significantly higher in the XR-NTX group than in the O-NTX group. Conclusion: An increase in treatment compliance with XR-NTX treatment was observed in the study. This study may suggest that XR-NTX is more efficient than O-NXR in the treatment of alcohol use disorder. Thus XR-NTX treatment may be a good alternative for patients with alcohol use disorder to stay on treat-ment for a longer time.

Infliximab biosimilar CT-P13 is interchangeable with its originator for patients with inflammatory bowel disease in real world practice.

Background/AimsAn interim analysis of post-marketing surveillance of CT-P13, an infliximab biosimilar, was performed to evaluate its safety and efficacy in Japanese patients with inflammatory bowel disease.MethodsPatients were prospectively enrolled between November 2014 and March 2017, after the launch of CT-P13 in Japan, and case report forms of patients followed for at least 4 months were analyzed as of July 2018.ResultsOf 523 patients in the analysis set, 372 remained on CT-P13 therapy, while 54 (20.2%) of 267 patients with Crohn’s disease, and 97 (37.9%) of 256 patients with ulcerative colitis were withdrawn during follow-up. A total of 144 adverse drug reactions (ADRs) were reported in 106 patients (20.3%). Infusion reaction was the most frequent ADR observed in 49 patients (9.4%). Efficacy parameters decreased immediately after the start of treatment in naïve patients to anti-tumor necrosis factor-α antibody. In the patients switched from originator infliximab for nonmedical reasons, the decreased parameters due to proceeded treatment with the originator were maintained in low ranges, and the treatment continuation rate was high with low ADR incidence. In contrast, in patients switched for medical reasons such as adverse event or loss of response, the incidence of ADRs was high. However, the efficacy parameters were improved, and the treatment continuation rate was not significantly different from that of the naïve patient group.ConclusionsIn this interim analysis, CT-P13 was comparable to the originator infliximab with respect to ADRs and efficacy, and is therefore considered to be a cost-efficient interchangeable biosimilar for Japanese patients with inflammatory bowel disease.

Study of twice-weekly injections of Teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study

SummaryA 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial (the TWICE study) conducted in Japanese primary osteoporosis patients with a high risk of fractures demonstrated that a 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen of teriparatide, while also improving safety.IntroductionWhile a 56.5-μg once-weekly regimen of teriparatide has high efficacy for osteoporosis, treatment continuation rates are low, with one of the major causes being adverse drug reactions such as nausea or vomiting. The TWICE study was therefore conducted to investigate whether a twice-weekly regimen with 28.2-μg teriparatide can provide comparable efficacy to the 56.5-μg once-weekly regimen while improving safety.MethodsA 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan. Patients with primary osteoporosis aged ≥ 65 years at high risk of fractures (n = 553) were randomly allocated to the 28.2-μg twice-weekly group (n = 277) or the 56.5-μg once-weekly group (n = 276). The primary endpoint was the percentage change in lumbar spine (L2–L4) bone mineral density (BMD) at final follow-up.ResultsThe percentage changes in lumbar spine (L2–L4) BMD at final follow-up in the 28.2-μg twice-weekly and 56.5-μg once-weekly groups were 7.3% and 5.9%, respectively; the difference (95% confidence interval [CI]) in percentage change was 1.3% (0.400–2.283%). Since the lower limit of the 95% CI was above the pre-specified non-inferiority margin (− 1.6%), non-inferiority of the 28.2-μg twice-weekly group was demonstrated. Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group.ConclusionsA 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen while improving safety.Clinical trial registrationJapicCTI-163477.

Continuation of schizophrenia treatment with three long-acting injectable antipsychotics in South Korea: A nationwide population-based study

Long-acting injectable (LAI) antipsychotics have been developed to prevent symptom relapse in patients with schizophrenia; relapse has a detrimental clinical impact and high social burden. However, data on treatment continuation rates of LAI antipsychotics are inconsistent, primarily because of study design; limited data exist for patients taking oral psychotropic medications taken along with LAI antipsychotics, and factors related to LAI antipsychotics treatment discontinuation. Patients with schizophrenia in the South Korea Health Insurance Review Agency database from 2007 to 2016 who had received LAI haloperidol, LAI paliperidone, or LAI risperidone were included. Treatment continuation rates and proportions of patients using concurrent oral psychotropic medications were calculated. Cox proportional hazard ratios were used for analysis related to discontinuation. There was a significant difference in treatment continuation rates at 6 months after initiation (36.8% LAI haloperidol, 57.5% LAI paliperidone, and 34.5% LAI risperidone). A substantial proportion of patients in all three groups were prescribed oral antipsychotics during LAI antipsychotics treatment. In the LAI paliperidone group, type of hospital was significantly associated with a higher risk of treatment discontinuation, with a hazard ratio of 1.195–1.598. Early discontinuation of LAI antipsychotic treatment occurs in a large number of patients with schizophrenia. Intervention strategies for improving the LAI antipsychotics treatment adherence are needed.