Treatment Continuation Rate Research Articles

Real-world effectiveness of long acting aripiprazole: Treatment persistence and its correlates in the Italian clinical practice

ObjectivesTo identify the variables that are associated with persistence to Aripiprazole-Long Acting (A-LAI), in adult patients with schizophrenia. MethodsObservational, retrospective, non-interventional study involving 261 patients with schizophrenia. ResultsEighty-six percent of study subjects were persistent for at least 6 months. All subjects with baseline CGI-S of 1 or 2, 95% of subjects with CGI-S of 3, 86% with CGI-S of 4, 82% of subjects with CGI-S of 5, 73% of subjects with CGI of 6 and 90% of subjects with CGI of 7 were persistent. A-LAI treatment continuation rate was higher in patients with: 1) baseline CGI score ≤ 4; 2) schizophrenia dimension (LDPS) mania score ≤ 5; 3) psychotic spectrum schizoid score ≤ 11. ConclusionsA relatively high number of patients (n = 225, 86%) were persistent to A-LAI for at least 6 months. Not surprisingly, very severe patients were more unlikely to be persistent. However, it is noteworthy that a large number of subjects with high CGI score at the time when A-LAI was started (82% of subjects with CGI-S of 5, 73% of subjects with CGI of 6 and 90% of subjects with CGI of 7) were persistent. Larger, controlled, prospective and longer studies are warranted.

Nasal function and CPAP compliance

ObjectiveContinuous positive airway pressure (CPAP) is the mainstay therapy for patients with obstructive sleep apnea (OSA) however compliance with CPAP is variable. Nasal ailments, such as nasal congestion are frequently mentioned as a cause for CPAP non-compliance, and potentially could be addressed prior to CPAP initiation, however, no specific criteria or recommendations for the evaluation and management of these patients exist. The aim of this retrospective study is to evaluate the effects of nasal anatomic features and disease on adherence to CPAP therapy for patients with OSA and determine the indications for pre-CPAP nasal treatment by using data obtained at clinical examination. MethodsIn total, 711 adult patients with initial diagnosis of OSA and an apnea–hypopnea index of ≥20 who were amenable to CPAP were included. We analyzed nasal parameters, past history of nasal disease, subjective symptoms, and disease severity in addition to whether CPAP therapy had been initiated, rate of CPAP therapy use (initial and 1year), treatment continuation rate at 2 months and 1year, and nasal treatments for all patients. ResultsCPAP therapy was initiated in 543 of 711 patients. Nasal resistance was significantly higher in patients who discontinued therapy soon after CPAP initiation. Nasal disease and nasal parameters were not found to be predictors of treatment adherence at 1year.Allergic rhinitis, moderate to severe nasal congestion at bedtime, slight or extensive sinus opacification, and a high nasal septum deviation score were found to be independent predictors of nasal treatment, while strong awareness of nasal congestion, a past history of sinusitis, and a total nasal resistance (supine position) of ≥0.35Pa/cm3/s were independent predictors of surgical treatment. ConclusionLong-term CPAP therapy adherence in patients with OSA can be predicted from initial CPAP adherence. Nasal disease and nasal parameters are important factors for early CPAP therapy discontinuation and should be adequately treated before therapy initiation to ensure long-term adherence. Indications for pre-CPAP nasal treatment and nasal surgery for patients with OSA can be predicted from the data obtained at the first examination, and these patients should be treated differently from those without OSA.

Real-world use of sunitinib in Japanese patients with pancreatic neuroendocrine tumors: results from a post-marketing surveillance study

BackgroundSunitinib is approved for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNETs) in patients with unresectable, locally advanced or metastatic disease. Safety and efficacy data in Japanese patients are limited. We report outcomes from a post-marketing surveillance study of sunitinib treatment in Japanese patients.MethodsSunitinib 37.5 mg once daily was orally administered in Japanese patients aged ≥ 15 years with pNETs. The primary endpoints included adverse events (AEs) occurring during the observation period of 168 days and objective response rate (ORR).ResultsSunitinib was administered in 62 patients with pNETs. The median duration of treatment was 165 days. At 168 days from the start of treatment, 31 patients were still receiving sunitinib treatment and treatment continuation rate was 50.0%. Of the 31 patients who discontinued treatment, 18 (58.1%) discontinued because of AEs and 16 (51.6%) patients discontinued due to insufficient clinical effect. Of the 18 patients who discontinued due to AEs, 10 did so within 42 days of treatment initiation. The most common all-grade AEs were platelet count decreased (33.9%), diarrhea (29.0%), neutrophil count decreased (27.4%), hypertension (24.2%), and palmar-plantar erythrodysesthesia syndrome (24.2%). In the 51 patients eligible for the efficacy analysis, ORR was 13.7% (95% confidence interval, 5.7–26.3) and clinical benefit rate was 70.6%.ConclusionsThere were no new safety concerns in real-world use of sunitinib in Japanese patients with pNETs. The short treatment duration likely led to low tumor response. Appropriate AEs management through dose interruption/reduction is essential for sunitinib treatment success in this patient population.

The clinical impact of left gastric artery reconstruction/preservation during distal pancreatectomy with celiac axis resection for pancreatic body cancer

Background: For locally advanced pancreatic body cancer with contact to or close to the celiac axis, distal pancreatectomy with celiac axis resection (DP-CAR) is necessary to achieve R0 resection, and also postoperative adjuvant chemotherapy is important. To avoid ischemic complication and delayed administration of adjuvant chemotherapy, we have introduced the left gastric artery (LGA) reconstructing/preserving DP-CAR. Methods: This study reviewed 42 consecutive patients with pancreatic body cancer who underwent LGA reconstructing/preserving DP-CAR at our institution. If the distance between the tumor and the LGA was less than 1 cm, the LGA was cut and reconstructed. Results: Among 42 patients (24 men and 18 women with a median age of 68 years), the LGA was reconstructed in 20 patients and preserved in 22 patients, median blood loss was 590 ml and median surgical time was 446 min. 16 patients (38%) had neoadjuvant chemotherapy, R0 resection rate was 85%, and the perioperative blood transfusion rate was 0%. Ischemic gastropathy occurred in two patients (4.8%), no ischemic liver dysfunction or mortality occurred. Postoperative adjuvant chemotherapy was given 87% patients with median starting time of 67 postoperative days and the treatment continuation rate for half a year was 88%. For all 42 patients, the 1-, 3-, and 5-year overall survival rates were respectively 89.4, 44.5, and 22.9 %, and the median survival time was 28.3 months. Conclusion: LGA reconstructing/preserving DP-CAR is good approach for locally advanced pancreatic body cancer with high surgical radicality and preservation of organ function leading to smooth introduction of adjuvant therapy.

Analysis of Clozapine Use and Safety by Using Comprehensive National Data From the Japanese Clozapine Patient Monitoring Service.

The aim of this study was to investigate clozapine use and its associated adverse effects in patients in Japan. We analyzed data recorded from July 2009 to January 2016 (N = 3780 patients) in the Clozaril Patient Monitoring Service, which was established in Japan in 2009 and includes all Japanese patients who have been prescribed clozapine. The treatment discontinuation rate was 23.9% (869/3780 cases). The average ± SD treatment duration was 234.9 ± 306.9 days (median, 115 days), and the average ± SD dosage was 186.41 ± 151.6 mg/d. The estimated treatment continuation rates resulting from all-cause discontinuation were 78.2 after 1 year and 72.9% after 2 years of treatment. The incidence of neutropenia/leucopenia was 5.4% (206/3780 cases). The average ± SD dose before discontinuation was 233.36 ± 168.15 mg (median, 200 mg; range, 4-600 mg). The incidence of glucose intolerance was 15.4% (583/3780 cases). Of 3780 patients, 98 (2.67%) developed glucose intolerance before and after taking clozapine administration, whereas 485 patients (12.8%) developed glucose intolerance after taking clozapine. The average ± SD time from treatment initiation to new onset of glucose intolerance was 382.2 ± 420.2 days (median, 216 days; range, 4-2053 days). The data obtained in this study, particularly regarding the incidence of clozapine-induced adverse events, will enable the optimal and safe use of clozapine in Japanese patients with treatment-resistant schizophrenia.

Long-term efficacy of infliximab treatment and the predictors of treatment outcomes in patients with refractory uveitis associated with Behçet's disease.

To assess the long-term efficacy and safety of infliximab (IFX) treatment for refractory uveitis associated with Behçet's disease (BD) and to identify predictors of long-term IFX therapy outcomes. We retrospectively studied 44 consecutive BD patients with uveitis who were started on IFX therapy and analyzed the efficacy and safety of IFX and the treatment continuation rate. To determine predictors of IFX responsiveness, we analyzed the clinical characteristics of the patients who received regular maintenance therapy and those who required treatment intensification. The serum cytokine levels prior to IFX were measured through the Bio-Plex human cytokine assays. IFX significantly reduced the frequency of ocular attacks and improved the visual acuity of patients with BD-related uveitis. However, approximately half of the patients required dose escalations, necessitating a shortening of the intervals between IFX infusions due to loss of efficacy during the 5-year treatment. The frequency of ocular attacks was significantly higher in patients with complete BD than in patients with incomplete BD. A multiplex cytokine analysis revealed that patients with BD-related uveitis exhibited increased serum IL-2, IL-6, IL-8, and MCP-1 levels. Moreover, among BD patients, the serum IL-2 and IL-6 levels were particularly high in those who maintained remission and received regular IFX treatments. We confirmed the long-term efficacy and tolerability of IFX in patients with BD-related uveitis. Our results indicate that complete BD may be less responsive to IFX and that the pretreatment serum cytokine profiles may be useful for predicting the long-term IFX therapy outcomes.

Analysis of the efficacy and compliance of conventional immunotherapy and rush immunotherapy in patients with allergic rhinitis

Objective:To analyze the efficacy and compliance of conventional immunotherapy(CIT)and rush immunotherapy(RIT)in patients with allergic rhinitis.Method:This trial was a prospective study involved 404 patients with persistent AR who were allergic to house dust mite.328 patients were assigned to the conventional immunotherapy reaching the maintenance dose within 14 weeks,and 76 patients were assigned to the rush immunotherapy reaching the maintenance dose within 1 week.The visual analog scale(VAS)score and the patients' compliance were recorded during treatment and follow-up.Result:After CIT and RIT,the VAS score were significantly reduced in each group,but the decrement of VAS score of RIT group was more evident than that of CIT in half ayear(P<0.05).After 5 years follow-up,the VAS score of two groups was also significantly reduced.The rate of treatment continuation of CIT group in 1 year,2 years and 3 years were 18.5%,39.0% and 57.3%,higher than RIT group(11.8%,26.3%,42.1%),respectively.Conclusion:Both CIT and RIT were beneficial for allergic rhinitis patients,and the clinical efficacy lasts for at least 5 years.But RIT has the superiority of faster onset and better compliance.

Baseline Predictors of Antipsychotic Treatment Continuation and Response at Week 8 in Patients with Alzheimer's Disease with Psychosis or Aggressive Symptoms: An Analysis of the CATIE-AD Study.

The aim of the present study was to investigate predictors of atypical antipsychotic (AAP) treatment continuation and response by week 8 in patients with Alzheimer's disease (AD) who have psychotic/aggressive symptoms using the Clinical Antipsychotic Trials of Intervention Effectiveness-Alzheimer's Disease (CATIE-AD) dataset. Clinical data was utilized from 421 AD outpatients with psychotic/aggressive symptoms who needed interventional treatment. Logistic regression analyses were performed to examine which baseline sociodemographic and clinical characteristics contributed to treatment 'continuation' and 'response', the latter of which was evaluated by the Clinical Global Impression of Change (CGI-C), Neuropsychiatric Inventory (NPI), and Brief Psychiatric Scale (BPRS). The treatment continuation rate was 48.7%, and CGI-C, NPI, and BPRS response rate by the last observation carried forward method were 42.7%, 48.6%, and 37.5%, respectively. No significant predictor was identified for treatment continuation in the Caucasian patients (n = 331), while better treatment response was predicted by a lower Mini-Mental State Examination score, treatment with risperidone (versus olanzapine and quetiapine), history of diabetes mellitus, healthier physical status, and more severe initial psychotic symptoms. Comparatively high intolerability from AAPs in the short term was confirmed. We found that baseline clinical predictors to treatment response in Caucasian AD patients with psychotic/aggressive symptoms include treatment with risperidone (versus quetiapine and olanzapine), diabetes mellitus, global physical status, cognitive impairment, and psychotic symptoms. Going forward, these findings may help to determine treatment strategies or care plans.

Outcome predictors for patients with stage II/III gastric cancer who undergo gastrectomy and S-1 adjuvant chemotherapy.

Predictors of survival in patients with stage II/III gastric cancer (GC) who received tegafur/gimeracil/oteracil (S-1) adjuvant chemotherapy (ACT) subsequent to gastrectomy were examined. Additionally, the association between dose intensity of S-1 and survival rate was investigated. A total of 62 patients with stage II/III gastric cancer were retrospectively evaluated, each of whom had received a curative D2 gastrectomy and S-1 ACT. The relative performance (RP; administered/planned S-1 doses ×100%), body mass index (BMI), prognostic nutritional index (PNI) and body weight (BW) were calculated, and the association of survival with these factors and other clinicopathological parameters was examined. The 1-year treatment continuation rate for S-1 was 94.2%, excluding patients who experienced cancer recurrences during their ACT year. The initial S-1 reduction rate was 38.7%. Patients with stage II/IIIA disease exhibited significantly improved 5-year overall survival rates compared with patients with stage IIIB GC, 81.6/73.7 vs. 33.8% (P<0.01). No association between RP and survival was observed. BMI, BW and PNI were significantly decreased following surgery compared with preoperative states. In the univariate analysis, postoperative BW loss (BMI loss), pathological stage and >7 lymph node metastases were significantly associated with outcome (P<0.05); in the multivariate analysis, postoperative BW loss >10.6% and pathological stages were independent prognostic factors for survival. Continuing S-1 ACT for the full year exhibited a greater effect on survival compared with dosage. Early postoperative nutritional deterioration may decrease the survival rates in these patients.

Osteoporosis Liaison Service and nutrition counseling and education.

Nutritional counseling as part of the Osteoporosis Liaison Service(OLS)should provide active nutritional counseling and lifestyle guidance by referring to the detailed methods for conducting "nutritional status assessments", an item of OLS-7, a detailed activity outcome measure of the OLS. After conducting adequate nutritional assessments, the goals for each stage of behavior change should be established, aiming to set roughly one goal for a specified period of time and increasing the goals once improvements have been made. Incorporating feedback in the next improvement plan becomes very important. Good nutritional counseling will surely lead to achieving the OLS goals(improvement in treatment rates and treatment continuation rates). Moreover, it will contribute to decreasing the number of patients with fractures, eliminating sequential fractures and prolonging a healthy life expectancy in Japan.

Comparative Effectiveness of Blonanserin and Paliperidone in 93 In-patients with Acute- to Maintenance-phase Schizophrenia

When initiating treatment for acute-phase schizophrenia, careful consideration needs to be given to which drug will be used in the subsequent maintenance phase. Since blonanserin (BNS) and paliperidone (PAL) are both first-line treatments for acute-phase schizophrenia, our study retrospectively investigated the treatment continuation rate, dose levels, use of concomitant medications, clinical effects, and adverse drug reactions in 93 acute-phase schizophrenia patients receiving either of the monotherapies (BNS: n=40, PAL: n=53) to assess the treatment benefit of these drugs in acute - to maintenance-phase schizophrenia. The efficacy endpoints included the clinical global impression of severity (CGI-S), the clinical global impression of improvement (CGI-I) and the global assessment on function (GAF) scores assessed at Weeks 4, 8, 12, 24, and 52 after treatment initiation. Patients requiring involuntary hospitalization accounted for 75% of the BNS group and 90% of the PAL group and mostly comprised patients who had good social function before onset but relapsed because of poor drug adherence and hence received no residual benefit from their earlier treatment, as well as patients who were experiencing their first episode of schizophrenia. There were differences between the treatment groups in gender, age, and duration of illness. Notably, the BNS group had a higher proportion of females than the PAL group. In both groups, the CGI-S and CGI-I responses were affected by treatment in a majority of the patients who continued treatment, and the GAF score at Week 52 recovered to levels comparable to the pre-onset level in patients continuing treatment. The treatment continuation rate in this study (assessed by the Kaplan-Meier method) was 85% in the BNS group and 77% in the PAL group at Week 8 and 60.9% in the BNS group and 50.9% in the PAL group at Week 52. After Week 24, the number of dropouts in the BNS group decreased while the PAL group still had dropouts due to hyperprolactinemia-related adverse drug reactions. Treatment of schizophrenia requires careful selection of drugs in the acute phase that will ensure a good long-term prognosis and good drug adherence in the maintenance phase, and from this perspective, the results of this study suggest that BNS and PAL could be first-line drugs for the entire duration of treatment, from the acute phase to the maintenance phase.

Use of the osteoporotic therapeutic drug judging from a treatment continuation rate

Use of the osteoporotic therapeutic drug judging from a treatment continuation rate

Continuation and adherence rates on initially-prescribed intensive secondary prevention therapy after Rapid Access Stroke Prevention (RASP) service assessment

IntroductionConsistent adherence to treatment is essential for effective secondary prevention following TIA/ischaemic stroke. Representative data on long-term treatment continuation and adherence rates are limited. MethodsThis single centre study recruited patients attending our Rapid Access Stroke Prevention clinic in Ireland from 07/09/2006→30/11/2009. Demographic and clinical data, and prescribed medication regimens at initial assessment were recorded. All patients received copies of clinical correspondence containing clear ‘goal-directed treatment advice’ sent to their general practitioner or referring physician. Patients were subsequently interviewed with a standardised pro-forma to assess continuation and adherence rates; overall adherence rates with secondary prevention therapy were also assessed with a validated self-reporting tool (Morisky Scale). Recurrent vascular events during follow-up were recorded. ResultsOne hundred and fourteen patients were recruited; mean age: 64.5±13.8years; median duration of follow-up: 630days. Patients were prescribed aspirin (69.3%), alone (17.5%) or in combination with dipyridamole MR (51.8%), clopidogrel (18.2%), warfarin (16.7%), statins (76.3%) and anti-hypertensives (51.8%). During follow-up, the percentages of patients continuing treatment prescribed at the initial visit were: Aspirin (93.7%), dipyridamole MR (72.9%), clopidogrel (81%), warfarin (94.7%), statins (87.9%) and anti-hypertensives (89.8%). Overall, 99.1% reported taking their medication the preceding day. Morisky scale scores for all treatments revealed that 41.2% (N=47) were high, 36.8% (N=42) medium, and 12.3% (N=14) low adherers; 9.7% (N=11) had incomplete data. Two patients (1.8%) had recurrent cerebrovascular events, and two (1.8%) had myocardial infarctions. DiscussionThis novel study in European TIA/ischaemic stroke patients, who were provided with a goal-directed secondary prevention plan, showed high rates of medication-continuation and self-reported adherence with prescribed treatment, associated with a low incidence of recurrent vascular events during a median follow up of 1.7years.

Tadalafil 5 mg once daily for the treatment of erectile dysfunction during a 6-month observational study (EDATE): impact of patient characteristics and comorbidities.

BackgroundTo explore the impact of patient-characteristics and relevant comorbidities on treatment continuation rates, effectiveness, and satisfaction in patients with erectile dysfunction (ED) who started or switched to tadalafil 5 mg once daily (TAD-OaD) at baseline.MethodsIn the EDATE observational study, phosphodiesterase-type-5 (PDE5)-inhibitor pretreated or naïve ED patients who started or switched to TAD-OaD were prospectively followed for 6 months. Time to discontinuation of TAD-OaD was estimated using the Kaplan-Meier product-limit method at Months 2, 4, and 6 in subgroups stratified by age (18 − 65 years and >65 years), PDE5-inhibitor pretreatment, ED-severity (mild, moderate, severe), and presence or absence of relevant comorbidities (BPH, diabetes, CVD, hypertension, dyslipidemia). LSmean change from baseline in International Index of Erectile Function (IIEF) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores and associated 95 % CIs were assessed using a mixed-model for repeated measures. Visit, ED etiology, and subgroups were included as fixed-effects.ResultsOverall, 778 patients received prescriptions for initiating or switching to TAD-OaD at baseline. At Month 2, >90 % of patients remained on TAD-OaD, except those aged >65 years (86.7 %) and patients with severe ED (89.0 %). More than 80 % of patients in all subgroups, except those aged >65 years (75.0 %), continued TAD-OaD at Month 6. There was a significant LSmean negative effect on IIEF- EF domain-score improvement for BPH (LSmean effect [95 % CI]: −2.77 [−4.98, −0.55], p = 0.014), previous PDE5-inhibitor treatment (−2.13 [−3.33,-0.94], p < 0.001), and mild vs moderate ED (-2.00 [−3.54,-0.46], p = 0.011); the latter possibly linked with a bigger treatment-effect in those with more severe ED at baseline. The LSmean effect on change in IIEF-EF was significantly positive for diabetes (2.28 [0.64,3.92], p = 0.007), most likely because those with diabetes had more severe ED at baseline. For all other parameters, no statistically significant LSmean effects in IIEF-EF changes were observed. No comorbidity or baseline-characteristic except age (18 − 65 years vs >65 years: 11.25 [2.96,19.54], p = 0.008) affected changes in EDITS.ConclusionsUnder routine clinical conditions, treatment continuation rate or satisfaction does not seem to be significantly affected by the presence of comorbidities in men who choose ED-treatment with TAD-OaD. The magnitude of treatment effectiveness was affected by certain baseline characteristics and comorbid conditions.Trial RegistrationThe study (H6D-EW-LVIU) is registered in the German VfA Registry of Non-Interventional Studies (Verband Forschender Arzneimittelhersteller) since 06 December 2011; available at: http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb/nis-details/_741.Electronic supplementary materialThe online version of this article (doi:10.1186/s12894-015-0107-5) contains supplementary material, which is available to authorized users.

Comparison of efficacy and safety of tacrolimus and methotrexate in combination with abatacept in patients with rheumatoid arthritis; a retrospective observational study in the TBC Registry

Objectives. Tacrolimus (TAC) and abatacept (ABT) inhibit T-cells via different mechanisms and, in combination, may be effective against rheumatoid arthritis. However, they may also disrupt normal immune functions. We compared the efficacy and safety of ABT administered to patients in combination with TAC, methotrexate (MTX), or other drugs. Methods. This was a retrospective multicenter study conducted to compare the efficacy and safety of ABT in 211 patients: the drug was administered together with TAC (ABT+ TAC group; 22 patients), MTX (ABT+ MTX group; 102 patients), or patients treated without concomitant MTX or TAC (ABT mono group; 87 patients). The disease activity, treatment continuation rate, and reason for discontinuation of treatment were investigated. Results. The retention rate at Week 24 was similar in the three groups. There were no cases of discontinuation related to the appearance of adverse events in the ABT+ TAC group. At Week 24, according to the European League Against Rheumatism response criteria, the “good” response rates were 33.3%, 13.4%, and 13.4% in the ABT+ TAC, ABT+ MTX, and ABT mono groups, respectively. Statistically significant decreases in various disease activity scores/indices were observed in all the groups as early as Week 4. Conclusions. Although the sample size was small, the results of this retrospective study suggest that the ABT+ TAC combination therapy has at least comparable safety and efficacy to those of the ABT+ MTX combination, and that it can thus be a useful option for patients who cannot take MTX.

Individualized phenytoin therapy for Japanese pediatric patients with epilepsy based on CYP2C9 and CYP2C19 genotypes.

The aims of this study were to identify the target dose of phenytoin (PHT) and to compare the treatment continuation rate between patients receiving conventional therapy and patients receiving individualized therapy based on genotyping of the CYP2C9*3, CYP2C19*2, and CYP2C19*3 alleles. The operational definition for the target dose of PHT used in this study was the dose that yielded a steady-state PHT concentration within the range of 15-20 mcg/mL without dose-related adverse effects. We investigated 394 samples from 170 Japanese pediatric patients aged 9 months to 15 years to identify factors that influenced the target dose of PHT. We also analyzed the clinical records of 156 patients who commenced PHT therapy at our hospital and retrospectively assessed the time to treatment failure within 1 year after starting PHT therapy. During the study period, 17 patients underwent genotyping at the start of PHT therapy. If the patients had the CYP2C9*3, CYP2C19*2, or CYP2C19*3 alleles, the initial dose of PHT was reduced by 10%-50% according to previous reports. The other 139 patients received conventional PHT therapy. According to multiple regression analysis, the body weight, concomitant use of sulthiame, and the CYP2C9*3, CYP2C19*2, and CYP2C19*3 alleles influenced the target dose of PHT. Our model explained 74% of the interindividual variability of the target dose of PHT. The total withdrawal rate in the individualized therapy group and the conventional therapy group was 23.5% and 33.1%, respectively. The adjusted hazard ratio for withdrawal of PHT therapy in the individualized therapy group was 0.37 (95% confidence interval; 0.12-1.10, P = 0.074). These findings suggest that genotyping can help to estimate the optimum target dose of PHT and may contribute to avoid intoxication and concentration-dependent adverse effects.

Assessment of the effectiveness of golimumab 50-mg and 100-mg regimens in patients with rheumatoid arthritis in daily practice

Objectives. To assess the effectiveness of the golimumab (GLM) 50-mg and 100-mg regimens in patients with rheumatoid arthritis (RA) in daily practice. Methods. We retrospectively analyzed RA patients who started GLM between September 2011 and July 2012. Patients were divided into three groups: a 50-mg group; a 50/100-mg group (had a dose increase to 100 mg); and a 100-mg group (started GLM at 100 mg). We assessed Disease Activity Score 28 (DAS28) and treatment continuation rate. Risk factors associated with time to discontinuation of the 50-mg regimen were determined with proportional hazards analysis. Results. We analyzed 74 patients: 43 in the 50-mg group, 23 in the 50/100-mg group, and 8 in the 100-mg group. DAS28 improved from 4.0 ± 1.0, 4.8 ± 1.0, and 4.7 ± 1.9, respectively, at baseline to 2.4 ± 1.2, 3.3 ± 1.5, and 2.5 ± 0.7, respectively, at week 52. Treatment continuation rates at week 52 were 73.7%, 60.9%, and 87.5%, respectively. In the 50/100-mg group, the mean DAS28 improved significantly from 4.4 ± 1.2 before to 3.6 ± 1.3 12 weeks after the dose increase. Oral corticosteroid therapy ≥ 5 mg/day, previous use of two biologic agents, and DAS28 > 5.1 at initiation of GLM were significantly associated with discontinuation of the 50-mg regimen. Conclusions. Both GLM 50-mg and 100-mg regimens are effective in patients with RA in daily practice.

AB0462 Risk Factors Associated with Opioid Treatment of Patients with Rheumatoid Arthritis

BackgroundIn treat-to-target evaluation, approximately 80% of patients with RA request pain relief1. Opioid use was also approved in Japan for prevention of NSAID-related complications and elimination of pain (pregabalinin June...

Deferred use of bevacizumab for recurrent glioblastoma is not associated with diminished efficacy

The optimal timing to initiate bevacizumab (BV) therapy for recurrent glioblastoma (GBM) is currently unclear. To address this issue, we examined progression-free survival (PFS) and survival time (ST) in a large retrospective cohort of GBM patients treated with BV at different recurrences. We identified 468 primary GBM patients who underwent biopsy or surgery followed by radiation therapy and temozolomide (RT/TMZ), and then received BV. PFS and ST were compared between patients stratified by the recurrence that BV was initiated (upfront, first recurrence, second recurrence, or 3+ recurrences). We also examined the effect on PFS and ST of the addition of chemotherapy to BV. In a larger cohort of GBM patients, we determined overall treatment continuation rates at each recurrence and identified variables predictive of inability to continue treatment. BV PFS was similar for all 3 recurrence groups (median, 4.1 months). There were no differences in BV ST (median, 9.8 months). The addition of chemotherapy to BV improved PFS but not ST. Analysis of treatment continuation rates indicated that the number of patients unable to undergo further treatments is modest, and that patients unable to tolerate BV delay can be identified by age ≥60 years and low extent of resection. Deferred use of bevacizumab is not associated with diminished efficacy. Analysis of treatment continuation rates identified patients who may be unable to delay BV therapy. Our findings suggest that there is a fixed survival after BV initiation and that delayed BV treatment is preferable for most patients.

Patterns of 6-mercaptopurine and azathioprine maintenance therapy among a cohort of commercially insured individuals diagnosed with Crohn's disease in the United States.

Background and aimsThiopurines, including 6-mercaptopurine (6-MP) and azathioprine (AZA), are the mainstay of maintenance therapy for Crohn’s disease (CD). However, studies examining their effectiveness in routine practice among diverse patient populations are lacking. Among a cohort of new users of 6MP/AZA, we described treatment patterns and changes in subsequent therapy.MethodsUsing the Truven Health Analytics databases, we identified all individuals diagnosed with CD and initiating 6-MP/AZA monotherapy from 2001–2008 (n=3,657). We estimated the proportion of CD patients remaining on 6-MP/AZA monotherapy, using Kaplan–Meier methods, and identified predictors of treatment noncontinuation, using multivariable Cox regression. Among the “noncontinuers,” we described subsequent patterns of maintenance therapy and summarized the diagnosis and procedure codes and prescription drug claims preceding treatment discontinuation.ResultsThe 1-year 6-MP/AZA treatment continuation rate was 42%. Children (age ≤18 years) and individuals with no prior anti-tumor necrosis factor (TNF) use were more likely to continue 6-MP/AZA, while those dispensed more (>4) outpatient prescriptions for any drug before initiation of 6-MP/AZA were less likely to continue maintenance treatment. Overall, 1,128 (39%) and 105 (4%) individuals experienced a clinical event potentially indicating active disease or 6-MP/AZA-intolerance prior to discontinuation, respectively. Most patients discontinued therapy; among the remaining patients who failed to continue 6-MP/AZA, most augmented with an anti-TNF.ConclusionMost patients initiating 6-MP/AZA monotherapy did not continue beyond 1 year. In contrast to trial evidence showing 1-year remission rates of 40%–80%, this study observed a lower effectiveness of 6-MP/AZA treatment, possibly due to differences in disease severity, patient demographics, comorbidity, adherence, and health care utilization.