Treatment Persistence In Patients Research Articles

Comparison of Real-World On-Label Treatment Persistence in Patients with Psoriatic Arthritis Receiving Guselkumab Versus Subcutaneous Tumor Necrosis Factor Inhibitors.

Treatment persistence among patients with psoriatic arthritis (PsA) is essential for achieving optimal treatment outcomes. Guselkumab, a fully human interleukin-23p19-subunit inhibitor, was approved by the United States (US) Food and Drug Administration for the treatment of active PsA in July 2020, with a dosing regimen of 100 mg at week 0, week 4, then every 8 weeks. In the Phase 3 DISCOVER-1 and DISCOVER-2 studies of patients with active PsA, 94% of guselkumab-randomized patients completed treatment through 1 year and 90% did so through 2 years (DISCOVER-2). Real-world evidence is needed to compare treatment persistence while following US prescribing guidelines (i.e., on-label persistence) for guselkumab versus subcutaneous (SC) tumor necrosis factor inhibitors (TNFis). Adults with PsA receiving guselkumab or their first SC TNFi (i.e., adalimumab, certolizumab pegol, etanercept, or golimumab) between 14 July 2020 and 31 March 2022 were identified inthe IQVIA PharMetrics® Plus database (first claim defined the treatment start date [index date]). Baseline characteristics and biologic use (biologic-naïve/biologic-experienced) were assessed during the 12-month period preceding the index date. Baseline characteristics were balanced between cohorts using propensity-score weighting based on the standardized mortality ratio approach. The follow-up period spanned from the index date until the earlier of the end of continuous insurance eligibility or end of data availability. On-label persistence, defined as the absence of treatment discontinuation (based on a gap of 112 days for guselkumab or 56 days for SC TNFi) or any dose escalation/reduction during follow-up, was assessed in the weighted treatment cohorts using Kaplan-Meier (KM) curves. A Cox proportional hazards model, further adjusted for baseline biologic use, was used to compare on-label persistence between the weighted cohorts. The guselkumab cohort included 526 patients (mean age 49.8 years; 61.2% female) and the SC TNFi cohort included 1953 patients (mean age: 48.5 years; 60.2% female). After weighting, baseline characteristics were well balanced with a mean follow-up of 12.3-12.4 months across cohorts; 51.5% of patients in the guselkumab cohort and 16.7% in the SC TNFi cohort received biologics in the 12-month baseline period. Respective rates of treatment persistence at 3, 6, 9, and 12 months were 91.2%, 84.1%, 75.9%, and 71.5% for the guselkumab cohort versus 77.3%, 61.6%, 50.0%, and 43.7% for the SC TNFi cohort (all log-rank p<0.001). At 12 months, patients in the guselkumab cohort were 3.0 times more likely than patients in the SC TNFi cohort to remain persistent on treatment (p<0.001). Median time to discontinuation was not reached for the guselkumab cohort and was 8.9 months for the SC TNFi cohort. This real-world study employing US commercial health-plan claims data to assess on-label treatment persistence in PsA demonstrated that, at 12 months, guselkumab was associated with a 3 times greater likelihood of persistence compared with SC TNFi.

DOP07 Monitoring disease activity by intestinal ultrasound predicts biologic treatment persistence in patients with Inflammatory Bowel Disease

Abstract Background Current biomarker-based monitoring strategies have limited efficacy in predicting risk of biologic treatment failure in inflammatory bowel disease (IBD). Endoscopic assessment identifies patients at risk of disease progression but is expensive and poorly accepted by patients. Therefore, we examined how intestinal ultrasound (IUS) performed as part of a monitoring program to predict treatment persistence to biologics in IBD patients. Methods Data were generated as part of a 1-year prospective, observational, cohort study of patients on biologics comparing tight monitoring to a historic cohort (‘Time It´ study). Data used in the present analysis included Harvey Bradshaw index (HBI), simple clinical colitis activity score (SCCAI), CRP, f-calprotectin (FC), IUS, and ileocolonoscopy all done at inclusion. The following definitions were used: Treatment persistence: no need for dose escalation or switching to another biologic or small molecule; IUS transmural remission (TR): bowel wall thickness ≤3mm in all bowel segments and zero color Doppler activity; endoscopic remission (ER): simple endoscopic score (SES)-CD≤2 or Mayo endoscopic score 0; clinical remission (CR): HBI≤4 or SCCAI≤2; FC remission (FCR): FC≤250; CRP remission (CRPR): CRP≤10 mg/L. Chi-square tests and Kaplan-Meier statistics were used to compare baseline measures in treatment persistent and non-persistent patients. Results Of the 91 patients included in 'Time It’, 77 had IUS performed and 69 ileocolonoscopy. Of the 77 patients, 61% were on maintenance treatment at inclusion and 39% were included during induction (Table 1). COVID-19 restrictions were the main reason for missing IUS or endoscopy. As expected, more patients with ER had 1-year treatment persistence (87% vs. 41%; p&amp;lt;0.001). However, patients with IUS TR also had better treatment persistence (78% vs. 38%; p&amp;lt;0.001). CR or FCR were associated with treatment persistence (p&amp;lt;0.05 and p&amp;lt;0.01, respectively), but not CRPR. Combining TR and FCR performed numerically as well as ER (treatment persistence 85% vs. 41%, p=0.002). Survival analysis of TR showed a mean treatment persistence of 318 days vs. 221 days without TR (p&amp;lt;0.001); corresponding treatment persistence data were 327 days vs. 230 days for combined TR and FCR; and 338 days vs. 226 days for ER (both p&amp;lt;0.001; Figure 1). There was no difference in mean treatment persistence between TR and ER (318 vs. 338 days; p=0.36). Conclusion IUS alone or combined with FCR was comparable to endoscopy to identify patients with high biologic treatment persistence. Being a non-invasive, patient friendly, cost-effective modality, IUS monitoring may improve current disease monitoring programs aiming to increase treatment persistence.

A Medical Claims Database Study of Factors Associated with Medication Adherence and Treatment Persistence in Patients Receiving PCSK9 Monoclonal Antibodies.

To investigate medication adherence and treatment persistence in patients receiving proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in Japan. Using an anonymized claims database from January 2015 to December 2021, data on adult patients at high risk for atherosclerotic cardiovascular disease or with a history of coronary artery disease (CAD) who had at least 1 prescription for PCSK9-mAbs were retrieved. In total, 276 patients were analyzed. The cumulative treatment persistence rate after 1 year was 67.0%. A multivariate analysis revealed that better adherence to oral low-density lipoprotein cholesterol (LDL-C)-lowering therapy in the year before starting PCSK9-mAbs (adjusted odds ratio [OR] 2.16) and a history of CAD for secondary prevention (adjusted OR 2.44) were associated with better adherence to PCSK9-mAbs in the first year. Better adherence to oral LDL-C-lowering therapy in the year before starting PCSK9-mAbs (adjusted OR 2.32) and a history of CAD for secondary prevention (adjusted OR 3.03) were also associated with a lower rate of discontinuation of PCSK9-mAbs. Age, sex, comorbidity, number of tablets taken daily (all medications), and number of hospital or clinic visits in the year prior to starting PCSK9-mAbs did not affect the persistence rate or adherence to PCSK9-mAbs in the multivariate analyses. Better adherence to oral LDL-C-lowering therapy and secondary prevention were identified as factors associated with better medication adherence and treatment persistence in patients receiving PCSK9-mAbs within the first year.

Real-world treatment outcomes and safety of natalizumab in Finnish multiple sclerosis patients.

The primary objective was to evaluate long-term treatment persistence and safety of natalizumab in Finnish multiple sclerosis patients. The secondary objectives were to assess patient characteristics, use of natalizumab-related safety protocol, and treatment persistence in patients with different anti-John Cunningham virus antibody statuses (John Cunningham virus status). All adult multiple sclerosis patients in the Finnish multiple sclerosis register who started natalizumab between 1/2006 and 12/2018 were included in this study and followed retrospectively until treatment discontinuation or end of follow-up (12/2019). In total, 850 patients were included. Median duration of natalizumab treatment was 7.8 years in John Cunningham virus negative (n = 229) and 2.1 years in John Cunningham virus positive patients (n = 115; p < 0.001). The most common cause for treatment discontinuation was John Cunningham virus positivity. After natalizumab discontinuation, patients who had a washout duration of less than 6 weeks had fewer relapses during the first 6 months (p = 0.012) and 12 months (p = 0.005) compared with patients who had a washout duration of over 6 weeks. During the median follow-up of 3.6 years, 76% of patients remained stable or improved on their Expanded Disability Status Scale. Treatment persistence was very high among John Cunningham virus negative patients. The study supports long-term effectiveness of natalizumab and a washout duration of less than 6 weeks after discontinuation.

Real-World Persistence and Treatment Interval in Patients with Diabetic Macular Edema Treated with Anti-Vascular Endothelial Growth Factors in the USA.

There is little understanding of long-term treatment persistence in patients receiving anti-vascular endothelial growth factor (anti-VEGF) injections for diabetic macular edema (DME), particularly relating to treatment intervals. The aim of this study was to investigate the association between treatment interval and discontinuation rate after 24months of unilateral anti-VEGF treatment in patients with DME under routine clinical care in the USA. This was a non-interventional, retrospective cohort study to review the health insurance claims of adults with DME linked with the IBM MarketScan® Commercial and Medicare Supplemental databases, who were continuously enrolled in a health plan for at least 6months prior to their first anti-VEGF treatment and for a duration of at least 24months between July 2011 and June 2017. Patients were grouped on the basis of the injection interval they achieved at 24months of treatment. Discontinuation rate beyond 24months and its association with treatment intervals at 24months was estimated using the Kaplan-Meier method and Cox proportional hazards models. The overall discontinuation rate among the 1702 eligible patients from 24 to 60months after treatment initiation was 30%. At 60months, patients were more likely to remain on treatment in shorter (75.3% [4-week interval group]) versus longer treatment interval groups (62.1% [> 12-week interval group], difference = 13.2%, [95% confidence interval (CI) 1.06, 2.06], p = 0.01). Patients on a > 12-week interval were twice as likely to discontinue treatment compared with those on an 8-week interval (hazard ratio = 2.01 [95%CI 1.43, 2.82], p < 0.001). Patients with DME on longer anti-VEGF treatment intervals at 24months consistently had higher discontinuation rates in the following years than those on shorter treatment intervals.

Response to treatment in psoriatic arthritis, the effect of age: analysis of patients receiving ustekinumab in the PsABio real-world study

BackgroundThis post-hoc analysis of PsABio (NCT02627768) evaluated safety, effectiveness and treatment persistence in patients < 60 and ≥ 60 years of age receiving ustekinumab over 3 years.MethodsMeasures included adverse events (AE), clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) low disease activity (LDA) including remission, Psoriatic Arthritis Impact of Disease-12 (PsAID-12), Minimal Disease Activity, dactylitis, nail/skin involvement and time to treatment stop. Data were analysed descriptively.ResultsOverall, 336 patients < 60 and 103 ≥ 60 years received ustekinumab, with a similar gender balance. A numerically lower proportion of younger patients reported at least one AE: 124/379 (32.7%) vs 47/115 (40.9%) for patients < 60 and ≥ 60 years, respectively. Serious AEs were low (< 10%) in both groups. At 6 months, the proportion of patients with cDAPSA LDA was 138/267 (51.7%) and 35/80 (43.8%) for patients < 60 and ≥ 60 years, respectively, with the effectiveness being maintained through 36 months. PsAID-12 mean scores reduced for both groups from a baseline mean of 5.73 and 5.61 for patients < 60 and ≥ 60 years, respectively, to 3.81 and 3.88, respectively, at 6 months, and 2.02 and 3.24, respectively, at 36 months. Regarding treatment persistence, 173/336 (51.5%) vs 47/103 (45.6%) patients < 60 and ≥ 60 years, respectively, stopped or switched treatment.ConclusionFewer AEs were observed over 3 years for younger versus older patients with PsA. There were no clinically meaningful treatment response differences. Persistence was numerically higher in the older age group.

Real-world treatment persistence in patients with rheumatoid arthritis initiating DMARDs in Germany-ahealth insurance claims data analysis.

To investigate treatment patterns in patients with rheumatoid arthritis (RA) in Germany who had previously received conventional synthetic (cs) or biologic(b) disease-modifying antirheumatic drugs (DMARDs). Patients with RA who initiated treatment with acsDMARD, bDMARD, or Janus kinase (JAK) inhibitor between 2017 and 2018 and who had previously received csDMARD or bDMARD therapy were retrospectively selected from the Institute for Applied Health Research Berlin GmbH (InGef). Time on treatment and discontinuation risk were assessed using the Kaplan-Meier method. Cox regression identified variables associated with an increased discontinuation risk. Atotal of 990 patients had received prior csDMARD therapy; 375 had received prior bDMARD therapy. Tumor necrosis factor (TNF)-α inhibitors and JAK inhibitors were the most commonly prescribed DMARD class in those previously treated with acsDMARD or bDMARD, respectively. In both cohorts, more patients received DMARD monotherapy than combination therapy. In the prior csDMARD cohort, median time on treatment was 276, 252, and 148 days with JAK inhibitors, TNF‑α inhibitors, and csDMARDs, respectively, and those treated with JAK or TNF‑α inhibitors were less likely to discontinue treatment than those on csDMARDs (log-rank test p-value < 0.01 for both comparisons); no significant differences were found within the prior bDMARD cohort. This is among the first detailed analyses of RA treatment patterns in areal-world setting in Germany since the introduction of JAK inhibitors. TNF‑α inhibitors were the most commonly prescribed DMARD after failure of an initial csDMARD, while JAK inhibitors were the most common among patients previously treated with abDMARD. In both groups, monotherapy with bDMARD or targeted synthetic DMARD was common. In the prior csDMARD cohort, treatment duration was significantly longer with JAK or TNF‑α inhibitors than with csDMARDs.

P410 Long-term persistence and safety of biological drugs in patients with Inflammatory Bowel Disease. Differences between women and men: SEXEII study of ENEIDA

Abstract Background Female sex has been associated with a worse response to anti-TNF drugs and with discontinuation of these drugs in immune-mediated diseases. Data in Inflammatory Bowel Disease (IBD) are unclear. The aims of study are to assess possible differences in long-term treatment persistence and safety of biological drugs between women and men with IBD. Methods Multicenter observational study carried out with data from the ENEIDA registry. Patients diagnosed with Crohn's disease (CD) or ulcerative colitis (UC) who receive or have received biological drugs, and have had a minimum treatment follow-up of 6 months, were included. We evaluated the first biological treatment used in the patient. Statistic analysis; Regression logistic models were used for safety evaluation. Kaplan-Meier curves, Log-Rank test and COX regression were used to treatment persistance. Results A total of 51,595 patients with IBD were evaluated [ 25,947 with CD (13238 men and 12709 women) and 25,648 with UC (13596 men and 12052 women)]. Mean follow up of 13 years. Biologic use: 28.7% of the evaluated patients had been treated with at least one biologic drug. Biologics use in UC was less common in women than in men (15.5% vs. 17.2%, OR (95%CI): 0.88 (0.81-0.94), p= 0.001) and there were no differences between sexes in CD ( 45.7% in men, 44.7% in women). Infliximab (IFX) and adalimumab (ADA) were the most used drugs (in 8914 and 5269 patients, respectively). Safety evaluation. Women suffered more frequently adverse effects to IFX and ADA than men, being the withdrawal of IFX and ADA due to adverse effects also significantly more frequent in women than in men. Biological treatment persistence in patients with IBD was longer in men than in women [median 3.1 years vs. 2.3 years, p &amp;lt; 0.001]. Female sex was a risk factor of biologic discontinuation [adjusted hazard ratio [aHR] (95%CI): 1.20 (1.14-1.25), p&amp;lt;0.001]. Combotherapy with thiopurines and CD were protective factors for discontinuation [ combotherapy; aHR (95%CI): 0.46 ( 0.44-0.48), p&amp;lt;0.001; CD aHR (95%CI): 0.78 (0.74-0.82), p &amp;lt; 0.001]. In the analysis of each specific biological drug, female sex was identified as independent predictor for discontinuation of IFX [aHR (95%CI) 1.21; 1.13-1.30, p&amp;lt;0.001] and ADA [aHR (95%CI) 1.24; 1.14-1.35, p&amp;lt;0.001] in patients with CD and of IFX in patients with UC [aHR (95%CI): 1.16; 1.05-1.28, p=0.004]. Figure 1. Conclusion 1.The use of biologics in ulcerative colitis seems to be higher in men than in women. 2. Female sex is an independent risk factor for the development of adverse effects to IFX and ADA and for the discontinuation of these drugs. 3. The long-term persistence of IFX and ADA (as first biological treatments) is low, being higher in men compared to women.

Treatment persistence in patients with schizophrenia treated with lurasidone in Italian clinical practice

Background and rationaleTreatment persistence combines clinician and patient judgment of efficacy, tolerability and safety into a comprehensive measure of effectiveness and is defined as the act of continuing a treatment over time. Studies have reported poor treatment persistence to antipsychotic medications in patients with schizophrenia. This study evaluated treatment persistence to lurasidone (LUR) in patients with schizophrenia in a real-world Italian setting.MethodsThis was a retrospective observational study of patients with schizophrenia who started treatment with LUR ≥ 6 months before inclusion. Following informed consent, data were collected starting from the index date (start of LUR treatment) at all visits occurring as per clinical practice. The primary endpoint was treatment persistence during the first 6 months, defined as the time between index date and all-cause discontinuation. Patients treated with LUR > 180 days were considered persistent. As secondary endpoint, treatment persistence was evaluated for a period of ≥ 18 months.ResultsForty-five patients were enrolled and 41 (91.11%) completed the study. Forty-one patients (91.11%) were included in the eligible population as they initiated LUR treatment ≥ 6 months before data collection.Patients were 43.0 ± 15.89 years old and 61% were female. Twenty-two patients (53.66%) started LUR treatment in a hospital setting and 19 (46.34%) in an outpatient setting. Based on Clinical Global Impression—Severity scale (CGI-S) at LUR initiation, 12 patients (29.27%) were severely ill, 17.07% markedly ill, 19.51% moderately ill, 2.44% mildly ill and 4.88% borderline mentally ill. Thirty-two patients (78.05%) were treatment persistent for ≥ 180 days. Among the 19 patients observed for ≥ 18 months, 11 (57.89%) were persistent for ≥ 18 months. Among the 22 study patients observed for < 18 months, 12 (54.54%) were persistent. An improvement in schizophrenia severity according to CGI-S was observed at inclusion (following LUR therapy) compared to the index date. Six patients (14.63%) experienced at least one adverse drug reaction: akathisia (7.32%), extrapyramidal disorder (4.88%), hyperprolactinemia (2.44%), restlessness (2.44%), and galactorrhea (2.44%). None were serious.ConclusionsPersistence to LUR in patients with schizophrenia was relatively high: 78% and 58% of patients were still on LUR after 6 and 18 months of treatment, respectively. This may reflect LUR’s relatively favorable balance between efficacy and tolerability, as well as favorable patient satisfaction and acceptance.

P513 Treatment persistence in bio-naive patients with long-standing Crohn’s disease treated with first-line biologics: real-life data from a Croatian tertiary center

Abstract Background All available biologics have demonstrated efficacy and safety as first-line treatment options for bio-naive Crohn’s disease (CD) patients. Real-world data about persistence with biologic treatment in patients with CD are lacking. The aim of this study was to assess and to identify potential factors affecting treatment persistence with index biologic medication in our tertiary center. Methods A single-center, noninterventional, retrospective chart review study (January 2015-October 2020) was performed on real-life data of adult bio-naïve CD patients who were treated with infliximab, adalimumab, vedolizumab or ustekinumab for &amp;gt;12 months duration of drug exposure. Treatment persistence was assessed using Kaplan-Meier analysis for a 36 month period and t-test for independent samples was used to identify predictors of long-term biologic persistence rates. Results Out of 84 patients (51.7% female; median age 33) included in the study 38.4% were smokers, 34.5% had history of intestinal resection and 25.6% had extraintestinal manifestations of CD. At the start of the biologic-induction regime 35.7% of patients were treated with corticosteroids and 43.4% with concomitant immunomodulator (81.8 % azathioprine, 18.2 % methotrexate). The median of CD duration was 47 months and the mean duration of treatment persistence was 29 months. After 36 months of treatment duration, the persistence rates for ustekinumab, adalimumab and infliximab were 61.9%, 56% and 48.1% respectively. Vedolizumab results were omitted from final analysis due to the small number of patients treated with the drug (N=3). Factor associated with higher persistence was body mass index (BMI) &amp;gt; 25 kg/m2 at the time of biologic therapy induction (p=0.05). Concomitant therapy with immunomodulator numerically significantly prolongs the therapy persistence (33.6 vs. 24.5 months). No other patient or disease-related factors (including disease duration) were found to be associated with treatment persistence for studied biologics. Conclusion These real-world data suggest that infliximab, adalimumab and ustekinumab are effective and efficient therapeutic options for bio-naive patients with moderate to severe long-standing Crohn′s disease. Concomitant immunomodulatory therapy and BMI &amp;gt;25 kg/m2 at the time of therapy induction were factors associated with higher biologic treatment persistence in those patients.

Real-World Treatment Patterns and Clinical Outcomes of Baricitinib in Rheumatoid Arthritis Patients in Spain: Results of a Multicenter, Observational Study in Routine Clinical Practice (The ORBIT-RA Study).

IntroductionBaricitinib is an oral Janus kinase (JAK)1/JAK2 inhibitor approved to treat rheumatoid arthritis (RA). This study aimed to investigate patients’ characteristics, prescription patterns, effectiveness, and treatment persistence in patients receiving baricitinib in real-world practice in Spain.MethodsThis retrospective longitudinal cohort study conducted in five rheumatology units included adults with RA initiating baricitinib (Sep-2017–May-19) with at least a 6-month-follow-up. Demographic/clinical characteristics, prescription patterns, and changes in disease activity and pain level were collected until treatment discontinuation/end of follow-up. Treatment persistence was estimated by Kaplan–Meier methods.ResultsData from 182 patients were included (mean (SD)): 83.5% women, 62.2 (12.3) years, body mass index 26.8 (5.1), disease duration 13.2 (10.8) years and Charlson Comorbidity Index score 2.4 (2.0). All patients had received at least one conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) before starting baricitinib and 78.0% at least one biologic disease-modifying anti-rheumatic drugs (bDMARD). Furthermore, 90.1% started with baricitinib 4 mg/day; 43.4% in monotherapy. One hundred and twelve (61.5%) of patients continued baricitinib at data collection time; mean persistence was 14.1 (0.5) months. Overall treatment persistence was 79.7/64.8/59.1% at 6/12/18 months. Seventy (38.5%) patients discontinued baricitinib during follow-up due to loss of efficacy (68.6%) or adverse events (18.6%). In those patients with available scores at the different observed cut-off points, remission or low disease activity was reported in 71.6 and 76.3% of patients at 6/12 months at any index: Disease Activity Score 28 joints using erythrocyte sedimentation rate (DAS28-ESR) (73.1 and 73.5%), Simplified Disease Activity Index (SDAI) (62.4 and 75.0%), and Clinical Disease Activity Index (CDAI) (66.7 and 78.1%). Good or moderate European League Against Rheumatism (EULAR)-response was noted in 80.0 and 78.2% of patients, respectively. Improvement from baseline in pain (Visual Analog Scale) was 2.5 cm and 3.0 cm at 6/12 months, respectively.ConclusionsThis Spanish cohort of patients treated with baricitinib had a long-standing and refractory disease. Nevertheless, high persistence and improvements in disease activity and pain were found at 6 and 12 months after treatment initiation, independently of the composite disease activity measure used, reinforcing the effectiveness of baricitinib in routine clinical practice.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-021-00423-8.

Persistencia al tratamiento con metformina de marca vs. genérica en monoterapia para la diabetes tipo 2: estudio retrospectivo de vida real mediante propensity score matching

ObjectiveTo evaluate treatment persistence in patients with polymedicated type 2 diabetes (DM2) receiving new treatment with brand-name vs. generic metformin 850mg in usual clinical practice. Patients and methodsObservational, retrospective study based on the medical records of patients aged ≥50 years who initiated metformin treatment (brand-name vs. generic) between 01/01/2016 and 31/12/2017. The follow up was two years. Main measures: treatment persistence and clinical consequences (metabolic control [HbA1c] and hospital admissions). Each patient in the brand-name group (reference) was paired with a patient from the generic group using propensity score matching. A Cox proportional risk model was constructed (p<0.05). Results863 patients receiving brand-name metformin were matched (ratio 1:1) with patients receiving generic metformin. The median age was 60.8 years (SD: 8.8) years and 52.6% were female. Persistence at 24 months was 8.6% higher for brand-name vs. generic metformin (63.2% vs. 58.2%; p=0.034). The hazard ratio for brand-name metformin was 0.83 (95% CI: 0.71-0.96, p=0.013). During the follow-up there was a greater percentage reduction of HbA1c in the brand-name vs. generic group (−6.8% vs. −4.1%; p=0.013). There was a non-significant 19.1% reduction in hospital admissions in the brand-name vs. generic group (8.9% vs. 11.0%; p=0.148). ConclusionsPolymedicated patients who initiated new brand-name metformin treatment for DM2 had greater treatment persistence than those who initiated it with generic metformin and had better metabolic control (percentage reduction in HbA1c).

Real-world characteristics and treatment persistence in patients initiating CLES: Results from a cohort of 1290 patients in USA (2429)

Real-world characteristics and treatment persistence in patients initiating CLES: Results from a cohort of 1290 patients in USA (2429)

Effect of the Initial Maintenance Dose of Droxidopa on Treatment Persistence in Patients With Neurogenic Orthostatic Hypotension (1518)

Effect of the Initial Maintenance Dose of Droxidopa on Treatment Persistence in Patients With Neurogenic Orthostatic Hypotension (1518)

A pilot study of oral treprostinil pharmacogenomics and treatment persistence in patients with pulmonary arterial hypertension.

Background and aims:Treprostinil is a prostacyclin analog used to treat pulmonary arterial hypertension. Dosing is empiric and based on tolerability. Adverse effects are common and can affect treatment persistence. Pharmacogenomic variants that may affect treprostinil metabolism and transport have not been well-characterized. We aimed to investigate the pharmacogenomic sources of variability in treatment persistence and dosing.Methods:Patients were prospectively recruited from an IRB approved biobank registry at a single pulmonary hypertension center. A cohort of patients who received oral treprostinil were screened for participation. Pharmacogenomic analysis was for variants in CYP2C8, CYP2C9, and ABCC4. A retrospective review was conducted for demographics, clinical status, dosing, and response. Fisher’s exact test was used for categorical data and Kruskal–Wallis test or Wilcoxon rank sum were used for continuous data.Results:A total of 15 patients received oral treprostinil and were consented. Their median age was 53 years, 73% were female, and 93% were White. The median total daily dose was 22.5 mg (13.5, 41) at last clinical observation. 40% of patients discontinued treatment with a majority due to adverse effects. Approximately 27% of patients had a loss-of-function variant in CYP2C8 (*1/*3 or *1/*4), whereas 47% of patients had a loss-of-function variant in CYP2C9 (*1/*2, *1/*3, or *2/*2). Minor allele frequencies for ABCC4 (rs1751034 and rs3742106) were 0.17 and 0.43, respectively. Survival analysis showed that increased CYP2C9 activity score was associated with decreased risk for treatment discontinuation [hazard ratio (HR): 0.13; 95% confidence interval (CI): 0.02, 0.91; p = 0.04]. Genetic variants were not significantly associated with dosing.Conclusion:Genetic variants responsible for the metabolism and transport of oral treprostinil were common. Increased CYP2C9 activity score was associated with decreased risk for treatment discontinuation. However, dosing was not associated with genetic variants in metabolizing enzymes for treprostinil. Our findings suggest significant variability in treatment persistence to oral treprostinil, with pharmacogenomics being a potentially important contributor. The reviews of this paper are available via the supplemental material section.

Treatment persistence in patients with type 2 diabetes treated with glucagon‐like peptide‐1 receptor agonists in clinical practice in Sweden

AimTo compare treatment persistence in patients with type 2 diabetes initiating the glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) dulaglutide, exenatide once‐weekly (QW), liraglutide or lixisenatide in routine clinical practice in Sweden and assess clinical outcomes.Materials and MethodsWe performed a retrospective study using data from several nationwide Swedish health registries, including the National Diabetes Register and other mandatory and population‐based registries. Individual level data were collected from 17 361 patients who initiated GLP‐1 RA treatment from 23 May 2015 to 15 October 2017, up to 2.5 years postindex (treatment start date). Treatment persistence and modification, predictors of discontinuation, HbA1c and body weight were recorded. Non‐persistence was defined as a treatment gap of more than 45 days. Treatment modification included switching and augmentation. Confounding was addressed through the use of propensity scores.ResultsTreatment persistence was higher and treatment modifications were lower in patients initiating dulaglutide compared with those on exenatide QW, liraglutide and lixisenatide. Patients who remained on the same treatment for 1‐year postindex experienced greater HbA1c reductions and a steadier decrease in body weight.ConclusionsOur study suggests that in clinical practice in Sweden there is a greater persistence of treatment among patients initiating dulaglutide compared with those on exenatide QW, liraglutide and lixisenatide. Persistence with the index GLP‐1 RA was closely correlated with positive clinical outcomes and thus should be considered a critical factor of patient‐centric treatment in Sweden.

Real-world droxidopa or midodrine treatment persistence in patients with neurogenic orthostatic hypotension or orthostatic hypotension.

Neurogenic orthostatic hypotension (nOH) is a subtype of orthostatic hypotension (OH) observed in the presence of neuropathy and is associated with increased risk of falling, impaired function, and poor quality of life. Droxidopa and midodrine are approved in the United States to treat symptomatic nOH and OH in adults, respectively. In this study, we compared the treatment persistence of droxidopa and midodrine. A retrospective analysis of patients prescribed either droxidopa or midodrine was conducted using the Symphony Health Solutions database (Symphony Health Solutions, Phoenix, AZ, USA). Inclusion criteria were (1) a pharmacy insurance claim in at least 16 consecutive quarters from mid-2014 to 2018 and (2) an active prescription for droxidopa or midodrine of ≥30 days' duration during that period. Treatment persistence was defined as the time to the first break in drug coverage of ≥45 days and was capped at 365 days. Data from 2305 patients who received droxidopa and 117,243 patients who received midodrine were included in this analysis. Median (95% CI) treatment persistence was significantly longer in the droxidopa cohort versus the midodrine cohort (303 [274-325] vs 172 [169-176] days; P < 0.001). After adjustment for confounding factors, patients using droxidopa monotherapy (i.e., without any concomitant midodrine and/or fludrocortisone use) were 16% more likely to be persistent at any time point than patients using midodrine (P < 0.001). In this real-world data analysis, patients using droxidopa without concomitant medications for OH were more likely to remain on treatment than patients on midodrine.

Impact of immunomodulator use on treatment persistence in patients with ulcerative colitis: A claims database analysis.

Background and AimIt is unclear how adding an anti‐tumor necrosis factor alpha agent to immunomodulator (IM) treatment, as a step‐up strategy, affects long‐term outcomes in ulcerative colitis. This retrospective study investigated persistence associated with biologic anti‐tumor necrosis factor alpha agents combined with IMs versus biologic monotherapy in patients with ulcerative colitis.MethodsThis was a longitudinal cohort study of patients in the Japan Medical Data Center claims database who had been newly prescribed infliximab or adalimumab as induction (completed) and maintenance (2010–2016). Biologic persistence (i.e. no switch/discontinuation during maintenance) was compared among patients prescribed biologic monotherapy (Bio) and those prescribed a biologic combined with an IM, as step‐up (Bio + prior IM) or simultaneously (Bio + IM).ResultsThree hundred and sixty‐nine eligible patients were analyzed (233, 78, and 58 in the Bio, Bio + prior IM, and Bio + IM subgroups, respectively). Multivariate analysis showed a lower probability of nonpersistence during maintenance for infliximab‐treated patients in the Bio + prior IM versus Bio subgroup (hazard ratio: 0.53; 95% confidence interval: 0.29–0.99; P = 0.045). No such effect was seen in adalimumab‐treated patients (P = 0.222) or in the overall population (P = 0.398). The probability of nonpersistence during maintenance in the Bio + IM subgroup was not significantly different from that in the Bio subgroup in either the biologic subpopulation or in the overall population.ConclusionsAdding infliximab to an existing IM results in a lower probability of nonpersistence compared with infliximab monotherapy in ulcerative colitis patients. This effect is not seen in adalimumab‐treated patients.

Anti-citrullinated protein antibody titre as a predictor of abatacept treatment persistence in patients with rheumatoid arthritis: a prospective cohort study in Japan

Objective: Successful rheumatoid arthritis (RA) outcome depends on treatment efficacy in the early stages of the disease and its sustainability. It is thus critical to identify factors predicting treatment persistence with biological agents, such as abatacept. We compared clinical profiles, including early changes in autoantibody titres at 3 months, between patients with RA demonstrating sustained persistence and those discontinuing abatacept treatment.Method: We prospectively enrolled 71 and 78 active RA patients treated with abatacept and tumour necrosis factor inhibitors (TNF-Is), respectively, who had previous disease-modifying anti-rheumatic drug) failure. Clinical characteristics were compared between non-continuation and continuation groups stratified according to abatacept or TNF-I persistence for at least 12 months from treatment initiation.Results: Significantly larger decreases in rheumatoid factor titre and anti-citrullinated protein autoantibody (ACPA) titre were observed in the continuation group of abatacept therapy at 3 months, and early reduction in ACPA titre remained a significant and independent predictor of sustained persistence with abatacept in multivariate analysis. In addition, we obtained the area under the receiver operator characteristics curve of 0.904 from a model including baseline ACPA titre and reduction of ACPA titre at 3 months. Sustained reduction of RA disease activity score at 12 months was significantly and independently associated with reduced ACPA titre at 3 months.Conclusions: Persistence with abatacept and sustained therapeutic response are associated with an early reduction in ACPA titre. Prediction of abatacept continuation and efficacy will facilitate the optimal design of therapy in the early stages of RA.

Droxidopa and Midodrine Treatment Persistence in Patients With Orthostatic Hypotension (P3.6-047)

Droxidopa and Midodrine Treatment Persistence in Patients With Orthostatic Hypotension (P3.6-047)