Real-world Treatment Persistence Research Articles

Real-World Treatment Persistence Among Advanced Therapy-Naïve or -Experienced Patients with Ulcerative Colitis Initiated on Ustekinumab or Adalimumab.

Persistence on advanced therapies in ulcerative colitis (UC) is a useful real-world treatment performance measure. This study compared real-world persistence during the maintenance phase among advanced therapy-naïve and -experienced patients with UC initiated on ustekinumab or adalimumab. Claims data from the IQVIA PharMetrics® Plus de-identified database (01/01/2015-06/30/2022) were used to select adult patients with UC treated with ustekinumab or adalimumab based on the agent first initiated (index date) after 10/21/2019. Inverse probability of treatment weighting was used to balance cohorts on baseline characteristics. Persistence on the index agent (no gaps in days of supply of>120 days for ustekinumab or>60 days for adalimumab), persistence while corticosteroid-free, while on monotherapy, and persistence on the US labeled dose were described and compared during the 12-month period post-index using Kaplan-Meier analysis and Cox proportional hazards models. Outcomes were analyzed separately among advanced therapy-naïve and advanced therapy-experienced patients. At 12 months post-index, advanced therapy-naïve patients receiving ustekinumab (n=371) had higher persistence on the index agent [83.8% vs. 57.6%, hazard ratio (95% confidence interval) =3.09 (2.29-4.16); p<0.001), persistence while corticosteroid-free [2.00 (1.63-2.45); p<0.001], persistence while on monotherapy [2.67 (2.07-3.44); p<0.001], and persistence on the labeled dose [4.21 (2.76-6.44); p<0.001] versus those receiving adalimumab (n=1726). At 12 months post-index, advanced therapy-experienced patients receiving ustekinumab (n=693) had higher persistence on the index agent [78.1% vs. 59.2%, 2.44 (1.82-3.26); p<0.001], persistence while corticosteroid-free [1.24 (1.01-1.54); p=0.0447], persistence while on monotherapy [2.53 (2.00-3.21); p<0.001], and persistence on the labeled dose [4.77 (3.09-7.35); p<0.001] versus those receiving adalimumab (n=254). This claims-based analysis demonstrated significantly higher treatment persistence, including persistence while corticosteroid-free, persistence while on monotherapy, and persistence on the labeled dose, among both advanced therapy-naïve and advanced therapy-experienced patients with UC initiated on ustekinumab compared to adalimumab.

Real-world clinical outcomes and healthcare costs in patients with Crohn’s disease treated with vedolizumab versus ustekinumab in the United States

Objective To compare real-world treatment persistence, dose escalation, rates of opportunistic or serious infections, and healthcare costs in patients with Crohn’s disease (CD) receiving vedolizumab (VDZ) vs ustekinumab (UST) in the United States. Methods A retrospective observational study in adults with CD initiated on VDZ or UST on/after 26 September 2016, was performed using the IBM Truven Health MarketScan databases (1 January 2009–30 September 2018). Rates of treatment persistence, dose escalation, opportunistic or serious infection–related encounters, and healthcare costs per patient per month (PPPM) were evaluated. Entropy balancing was used to balance patient characteristics between cohorts. Event rates were assessed using weighted Kaplan-Meier analyses and compared between cohorts using log-rank tests. Healthcare costs were compared between cohorts using weighted 2-part models. Results 589 VDZ and 599 UST patients were included (172 [29.2%] and 117 [19.5%] were bio-naïve, respectively). After weighting, baseline characteristics were comparable between cohorts. No significant difference in rates of treatment persistence (12-month: VDZ, 76.5%; UST, 82.1%; p = .17), dose escalation (12-month: VDZ, 29.3%; UST, 32.7%; p = .97), or opportunistic or serious infection–related encounters were observed between VDZ and UST. Total mean healthcare costs were significantly lower for patients treated with VDZ vs UST (mean cost difference = –$5051 PPPM; p < .01). Findings were consistent in bio-naïve patients. Conclusions In this real-world study, similar treatment persistence, dose escalation, and rates of opportunistic or serious infections were observed with VDZ- and UST-treated patients with CD. However, VDZ was associated with a significantly lower cost outlay for healthcare systems.

S83 Real-World Treatment Persistence Among Advanced Therapy-Experienced Patients With Ulcerative Colitis Initiated on Ustekinumab or Adalimumab

S83 Real-World Treatment Persistence Among Advanced Therapy-Experienced Patients With Ulcerative Colitis Initiated on Ustekinumab or Adalimumab

S965 Real-World Treatment Persistence Among Bio-Naïve Patients With Ulcerative Colitis Initiated on Ustekinumab or Adalimumab

S965 Real-World Treatment Persistence Among Bio-Naïve Patients With Ulcerative Colitis Initiated on Ustekinumab or Adalimumab

Real-world treatment persistence of four commonly prescribed biologic therapies for moderate to severe psoriasis in Australia.

Australian data comparing biologic treatments for moderate to severe chronic plaque psoriasis are lacking. We compared persistence on therapy across four biologic therapies (adalimumab, guselkumab, secukinumab and ustekinumab) used to treat chronic plaque psoriasis. The impact of prior biologic use on persistence was also investigated. This retrospective cohort analysis of the Pharmaceutical Benefits Scheme (PBS) 10% sample included data from adult patients prescribed ≥1 biologic of interest by a dermatologist from 1 September 2015 to 31 December 2021. Persistence was defined as continued use until 180 days without a prescription. The index date was the date of the first claim of the biologic. Persistence was evaluated using Kaplan-Meier methods, log-rank tests, adjusted analyses using Cox's regressions, and propensity score matching. In total, 878 patients, with 1131 index prescriptions, were included. Guselkumab median persistence was not reached in the study period (PBS listed from February 2019). In the adjusted analysis, persistence to guselkumab was significantly greater than to adalimumab (n = 105; median 16 months, HR 2.71 (95% CI 1.94-3.8), p < 0.001), ustekinumab (n = 336; median 19 months, HR 2.91 (95% CI 2.22-3.82), p < 0.001) and secukinumab (n = 305; median 30 months, HR 1.8 (95% CI 1.36-2.38), p < 0.001). Bio-naïve patients had longer persistence on treatment than bio-experienced patients. The nationally representative PBS dataset can provide real-world insights into the persistence on biologic therapies for psoriasis in Australia, where eligibility criteria for reimbursed treatment are stringent. Persistence is an indirect marker of sustained treatment effectiveness and tolerability. Both unadjusted and adjusted analyses found longer persistence for guselkumab compared to adalimumab, secukinumab or ustekinumab.

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.

Comparative effectiveness of cladribine tablets versus other oral disease-modifying treatments for multiple sclerosis: Results from MSBase registry

Background: Effectiveness of cladribine tablets, an oral disease-modifying treatment (DMT) for multiple sclerosis (MS), was established in clinical trials and confirmed with real-world experience. Objectives: Use real-world data to compare treatment patterns and clinical outcomes in people with MS (pwMS) treated with cladribine tablets versus other oral DMTs. Methods: Retrospective treatment comparisons were based on data from the international MSBase registry. Eligible pwMS started treatment with cladribine, fingolimod, dimethyl fumarate, or teriflunomide tablets from 2018 to mid-2021 and were censored at treatment discontinuation/switch, death, loss to follow-up, pregnancy, or study period end. Treatment persistence was evaluated as time to discontinuation/switch; relapse outcomes included time to first relapse and annualized relapse rate (ARR). Results: Cohorts included 633 pwMS receiving cladribine tablets, 1195 receiving fingolimod, 912 receiving dimethyl fumarate, and 735 receiving teriflunomide. Individuals treated with fingolimod, dimethyl fumarate, or teriflunomide switched treatment significantly more quickly than matched cladribine tablet cohorts (adjusted hazard ratio (95% confidence interval): 4.00 (2.54–6.32), 7.04 (4.16–11.93), and 6.52 (3.79–11.22), respectively). Cladribine tablet cohorts had significantly longer time-to-treatment discontinuation, time to first relapse, and lower ARR, compared with other oral DMT cohorts. Conclusion: Cladribine tablets were associated with a significantly greater real-world treatment persistence and more favorable relapse outcomes than all oral DMT comparators.

Persistence and effectiveness of the IL-12/23 pathway inhibitor ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: 1-year results from the real-world PsABio Study

ObjectiveWe evaluated real-world treatment persistence and effectiveness at 1 year following initiation of IL-12/23 inhibitor ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis (PsA).MethodsPsABio (NCT02627768), a prospective,...

Real‐world persistence of erenumab for preventive treatment of chronic and episodic migraine: Retrospective real‐world study

ObjectiveTo describe the real‐world treatment persistence (defined as the continuation of medication for the prescribed treatment duration), demographics and clinical characteristics, and treatment patterns for patients prescribed erenumab for migraine prevention in Canada.BackgroundThe effectiveness of prophylactic migraine treatments is often undermined by poor treatment persistence. In clinical trials, erenumab has demonstrated efficacy and tolerability as a preventive treatment, but less is known about the longer term treatment persistence with erenumab.MethodsThis is a real‐world retrospective cohort study where a descriptive analysis of secondary patient data was conducted. Enrollment and prescription data were extracted from a patient support program for a cohort of patients prescribed erenumab in Canada between September 2018 and December 2019 and analyzed for persistence, baseline demographics, clinical characteristics, and treatment patterns. Descriptive analyses and unadjusted Kaplan–Meier (KM) curves were used to summarize the persistence and dose escalation/de‐escalation at different timepoints.ResultsData were analyzed for 14,282 patients. Median patient age was 47 years, 11,852 (83.0%) of patients were female, and 9443 (66.1%) had chronic migraine at treatment initiation. Based on KM methods, 71.0% of patients overall were persistent to erenumab 360 days after treatment initiation. Within 360 days of treatment initiation, it is estimated that 59.3% (KM‐derived) of patients who initiated erenumab at 70 mg escalated to 140 mg, and 4.4% (KM‐derived) of patients who initiated at 140 mg de‐escalated to 70 mg.ConclusionsThe majority of patients prescribed erenumab remained persistent for at least a year after treatment initiation, and most patients initiated or escalated to a 140 mg dose. These results suggest that erenumab is well tolerated, and its uptake as a new class of prophylactic treatment for migraine in real‐world clinical practice is not likely to be undermined by poor persistence when coverage for erenumab is easily available.

P.026 Erenumab associated with high persistence among Canadian patients for preventive treatment of chronic and episodic migraine in real-world practice

Background: Real world use of oral prophylactic migraine therapies is often limited by poor patient tolerance. The objective of this study was to describe the demographics and clinical characteristics of patients prescribed erenumab following its launch in Canada (September 2018) and to evaluate the real-world treatment persistence and dose management. Methods: This was a retrospective, descriptive analysis of de-identified secondary patient data that includes baseline demographics, clinical characteristics, plus erenumab treatment management, collected through Novartis’ Go Program® (Patient Support Program). Only data collected from patients with a documented informed consent were included in the analysis. Results: 14,282 patients met eligibility criteria. The mean age of patients was 46.3 years, 83.0% were female, and 66.1% reported having ≥15 monthly migraine days. 52.5% were initiated on the 140 mg dose of erenumab and 59.3% of those who initiated the 70 mg dose escalated to 140 mg within 360 days. After 360 and 450 days, the KM-derived persistence was 71.0% and 63.4%, respectively. Conclusions: The high persistence reported here suggests that erenumab has a meaningful degree of tolerability in the real-world setting and increases confidence that the real-world use and benefits of erenumab will not be undermined by the poor persistence observed with traditional migraine prophylactic agents.

An Australian Real-World Study of Treatment Persistence of Ustekinumab in Crohn's Disease.

IntroductionReal-world treatment persistence to ustekinumab for Crohn’s disease (CD) was studied using Australian Pharmaceutical Benefits Scheme (PBS) data. Demographic and treatment pattern characteristics were also investigated.MethodsOur retrospective cohort analysis included PBS 10% sample data for ustekinumab from September 2017 to March 2020, and for other biologics from October 2007 to capture earlier line(s) of therapy. Included patients received ustekinumab for CD prescribed by a gastroenterologist. Treatment persistence overall and by prior biologic experience, mono- or combination therapy, sex and age were estimated using Kaplan–Meier methods. A Cox proportional hazards regression analysis was performed to assess the effect of age, sex and line of therapy on persistence.ResultsData were available for 301 patients. Of these, 58.8% were female and 76.7% were aged 26–65 years. Median follow-up from first ustekinumab dispense was 16 months. Median persistence to ustekinumab had not been reached. Twelve-month persistence to ustekinumab was 82.6% (95% CI 78.1–87.5%). Patients receiving ustekinumab as their first biologic therapy had 12-month persistence of 88.0% (80.8–95.9%) compared to 80.6% (75.0–86.6%) for patients who had previously received other biologic therapies (p=0.059). The adjusted analysis showed a trend to longer persistence for patients receiving ustekinumab as their first biologic therapy compared to biologic experienced patients (HR 1.86 (95% CI 0.95–3.63), p=0.070). Males had higher persistence to ustekinumab than females (HR 0.36 (0.20–0.66), p<0.001). Receiving ustekinumab as a monotherapy or in combination with azathioprine, mercaptopurine, 5ASAs, methotrexate, or corticosteroids had no effect on persistence (p=0.22).ConclusionIn an Australian real-world setting, persistence to ustekinumab was demonstrated to be over 80% at 12 months. Use as monotherapy or in combination with other therapy for CD did not affect persistence. Differences in treatment persistence by gender and previous biologic use warrant further investigation as further long-term data becomes available.

Persistence with Early-Line Abatacept versus Tumor Necrosis Factor-Inhibitors for Rheumatoid Arthritis Complicated by Poor Prognostic Factors.

Background: Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling and destruction that leads to severe disability. There are no clear guidelines regarding the order of therapies. Gathering data on treatment patterns outside of a clinical trial setting can provide useful context for clinicians.Objectives: To assess real-world treatment persistence in early-line abatacept versus tumor necrosis factor-inhibitors (TNFi) treated patients with RA complicated by poor prognostic factors (including anti-cyclic citrullinated peptide antibodies [ACPA] and rheumatoid factor [RF] seropositivity).Methods: We performed a multi-center retrospective medical record review. Adult patients with RA complicated by poor prognostic factors were treated with either abatacept or TNFis as the first biologic treatment at the clinic. Poor prognostic factors included ACPA+, RF+, increased C-reactive protein levels, elevated erythrocyte sedimentation rate levels, or presence of joint erosions. We report 12-month treatment persistence, time to discontinuation, reasons for discontinuation, and risk of discontinuation between patients on abatacept versus TNFi. Select results among the subgroup of ACPA+ and/or RF+ patients are presented.Results: Data on 265 patients (100 abatacept, 165 TNFis) were collected. At 12 months, 83% of abatacept patients were persistent versus 66.1% of TNFi patients (P=0.003). Median time to discontinuation was 1423 days for abatacept versus 690 days for TNFis (P=0.014). In adjusted analyses, abatacept patients had a lower risk of discontinuing index treatment due to disease progression (0.3 [95% confidence interval (CI): 0.1-0.6], P=0.001). Among the subgroup of ACPA+ and/or RF+ patients (55 abatacept, 108 TNFis), unadjusted 12-month treatment persistence was greater (83.6% versus 64.8%, P=0.012) and median time to discontinuation was longer (961 days versus 581 days, P=0.048) in abatacept versus TNFi patients.Discussion: Patients with RA complicated by poor prognostic factors taking abatacept, including the subgroup of patients with ACPA and RF seropositivity, had statistically significantly higher 12-month treatment persistence and a longer time to discontinuation than patients on TNFis.Conclusions: In a real-world setting, RA patients treated with abatacept were more likely to stay on treatment longer and had a lower risk of discontinuation than patients treated with TNFis.

Persistence with Early-Line Abatacept versus Tumor Necrosis Factor-Inhibitors for Rheumatoid Arthritis Complicated by Poor Prognostic Factors

Background: Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling and destruction that leads to severe disability. There are no clear guidelines regarding the order of therapies. Gathering data on treatment patterns outside of a clinical trial setting can provide useful context for clinicians. Objectives: To assess real-world treatment persistence in early-line abatacept versus tumor necrosis factor-inhibitors (TNFi) treated patients with RA complicated by poor prognostic factors (including anti-cyclic citrullinated peptide antibodies [ACPA] and rheumatoid factor [RF] seropositivity). Methods: We performed a multi-center retrospective medical record review. Adult patients with RA complicated by poor prognostic factors were treated with either abatacept or TNFis as the first biologic treatment at the clinic. Poor prognostic factors included ACPA+, RF+, increased C-reactive protein levels, elevated erythrocyte sedimentation rate levels, or presence of joint erosions. We report 12-month treatment persistence, time to discontinuation, reasons for discontinuation, and risk of discontinuation between patients on abatacept versus TNFi. Select results among the subgroup of ACPA+ and/or RF+ patients are presented. Results: Data on 265 patients (100 abatacept, 165 TNFis) were collected. At 12 months, 83% of abatacept patients were persistent versus 66.1% of TNFi patients (P=0.003). Median time to discontinuation was 1423 days for abatacept versus 690 days for TNFis (P=0.014). In adjusted analyses, abatacept patients had a lower risk of discontinuing index treatment due to disease progression (0.3 [95% confidence interval (CI): 0.1-0.6], P=0.001). Among the subgroup of ACPA+ and/or RF+ patients (55 abatacept, 108 TNFis), unadjusted 12-month treatment persistence was greater (83.6% versus 64.8%, P=0.012) and median time to discontinuation was longer (961 days versus 581 days, P=0.048) in abatacept versus TNFi patients. Discussion: Patients with RA complicated by poor prognostic factors taking abatacept, including the subgroup of patients with ACPA and RF seropositivity, had statistically significantly higher 12-month treatment persistence and a longer time to discontinuation than patients on TNFis. Conclusions: In a real-world setting, RA patients treated with abatacept were more likely to stay on treatment longer and had a lower risk of discontinuation than patients treated with TNFis.

Real-World Treatment Persistence with Biologic Disease-Modifying Antirheumatic Drugs Among German Patients with Psoriatic Arthritis-A Retrospective Database Study.

IntroductionTo investigate drug survival for biologic disease-modifying antirheumatic drugs (bDMARDs) in a real-world cohort of German adult biologic-naïve patients with psoriatic arthritis (PsA).MethodsClaims data for patients with a diagnosis of PsA, a bDMARD claims record (index date) between 1 January 2014 and 31 December 2017, and no bDMARD prescription for 365 days before the index date were retrospectively analyzed. The primary outcomes were the overall and individual bDMARD persistence rates over 12 months. Nonpersistence was defined as a treatment gap exceeding the days of supply plus 60 days or switching to a bDMARD other than the index therapy. Sensitivity analysis was performed, wherein the treatment gap was found to vary depending on the bDMARD regimen. Kaplan–Meier curves were plotted to determine persistence; the log-rank test was used to evaluate differences in the persistence rate. Factors associated with treatment discontinuation were evaluated using Cox regression analysis.ResultsAmong 10,954 patients with a PsA diagnosis, 348 were eligible. The overall bDMARD persistence rate was 57.5%; individual bDMARD persistence rates were 81.3% for ustekinumab, 66.7% for infliximab, and 60.0% for golimumab. The mean (SD) overall persistence with bDMARDs was 289 (103) days; the mean persistence was 334 (72) days for ustekinumab, 309 (82) days for golimumab, and 305 (92) days for infliximab. The main reasons for nonpersistence were switching to another bDMARD (15.8%) and treatment discontinuation (26.7%). Male gender was significantly associated with a lower risk of treatment discontinuation (hazard ratio 0.54, 95% confidence interval 0.39–0.77; P < 0.001). The sensitivity analysis yielded similar results.ConclusionThe one-year persistence rate for bDMARDs in German PsA patients is modest, although the persistence rate depends on the bDMARD considered.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-021-00286-z.

Treatment persistence and colectomy-free outcomes in patients with ulcerative colitis receiving golimumab or adalimumab: a UK experience

ObjectiveTo examine real-world treatment persistence, colectomy-free survival and treatment switching patterns in UK patients with ulcerative colitis (UC) prescribed golimumab or adalimumab.DesignThis was a retrospective chart review study in adult...

Real-world treatment persistence of non-tumor necrosis factor inhibitors versus tumor necrosis factor inhibitors among patients with rheumatoid arthritis in South Korea

Aims: We aimed to assess treatment persistence of tumor necrosis factor (TNF) inhibitors and non-TNF inhibitors in two groups of rheumatoid arthritis (RA) patients: biologic disease-modifying antirheumatic drug (bDMARD) initiators and switchers.Patients and methods: This retrospective cohort study utilized a national health insurance claims database. Patients aged ≥18 years initiating/switching bDMARD between 1 December 2013 and 31 December 2014, the index period, were followed for 12 months. Initiators who began treatment with a bDMARD during the index period were defined as having no bDMARD prescriptions for the previous year. Switchers who changed treatment from the previous bDMARD to the index bDMARD were defined as having different bDMARDs during the index period. Treatment persistence rates during the follow-up period were measured, and factors associated with non-persistence were assessed with the Cox proportional hazard model.Results: Of 2684 patients, treatment persistence rates were the highest for abatacept in initiators (69.3%) and tocilizumab in switchers (77.0%), while adalimumab showed the lowest persistence rates for both initiators and switchers (48.2%, 28.8%), followed by etanercept (51.3%, 41.0%). Adalimumab and etanercept were significantly more likely to show non-persistence (HR 1.58, 95% CI 1.27–1.96; HR 1.42, 95% CI 1.14–1.76) compared to infliximab for initiators, while tocilizumab was significantly more likely to show persistence (HR 0.411, 95% CI 0.206–0.819) in switchers.Conclusions: Non-TNF inhibitors showed higher persistence rates than TNF inhibitors in South Korean RA patients, and tocilizumab especially was associated with higher persistence in patients with inadequate response to TNF inhibitors. Good persistence with non-TNF inhibitors indicates the potential for long-term efficacy as first-line treatment.

Real-world treatment persistence of golimumab in the management of immune-mediated rheumatic diseases in Europe: a systematic literature review

ObjectivesTo summarise real-world data from studies reporting golimumab persistence in European immune-mediated rheumatic disease (IMRD) populations and to report pooled estimates.DesignSystematic literature review.Data sourcesRelevant literature was identified through searching Medline...

Real World Treatment Persistence With Vedolizumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

Introduction: Vedolizumab (VDZ), a gut-selective monoclonal a4β7 integrin antibody, was approved in May 2014 to treat adult patients (pts) with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD). Treatment (Tx) persistence can be considered a marker of effectiveness and tolerability. We conducted a systematic review and meta-analysis of published studies of real-world persistence with VDZ in pts with inflammatory bowel disease (IBD). Methods: MEDLINE-, Cochrane-, and Embase-indexed publications and relevant IBD conference proceedings from May 1, 2014, to June 22, 2017, were searched for reports of real-world VDZ persistence or discontinuation rates. Reports with n <10, pts < 18 y old or off-label VDZ use were excluded. A meta-analysis was conducted using the DerSimonian-Laird random-effects method to obtain a weighted mean (95% confidence interval) of VDZ Tx persistence for UC and CD at 6 months (mo) and 12 mo. If multiple reports were from the same cohort, the most recent cohort with the most pts was selected for the meta-analysis. Results for biologic-naive pt subcohorts were evaluated separately. Results: Sixteen studies were identified (mean age, range: UC 34-43 y, CD 37-47 y; mean disease duration: UC 3-9 y, CD 6-17 y; prior anti-tumor necrosis factor alpha exposure: UC 44%-100%, CD 71%-100%). VDZ persistence at 6 mo ranged from 64%-94% in UC pts (8 studies) and 64%-88% in CD pts (9 studies). At 12 mo, VDZ persistence rates ranged from 52%-88% in UC pts and 40%-74% in CD pts (6 studies each). In UC pts, pooled VDZ persistence rates were 75% and 72% at 6 mo and 12 mo, respectively (Fig. 1). In CD pts, pooled VDZ persistence rates were 75% and 61% at 6 mo and 12 mo, respectively (Fig. 2). Two studies reported higher rates of VDZ Tx persistence in biologic-naive subcohorts (UC: 81%-100%; CD: 79%-100%). Eight studies reported reasons for VDZ discontinuation; among patients who discontinued VDZ, the most common reason was lack of response (4 studies, range: 16%-82%); and adverse events led to discontinuation in 8%-17% of pts (4 studies).650_A Figure 1 No Caption available.650_B Figure 2 No Caption available.Conclusion: At 12 mo, approximately three-quarters and nearly two-thirds of UC and CD pts, respectively, persisted with VDZ Tx despite utilization in largely biologic-refractory pts. Higher VDZ Tx persistence was seen in pts naive to prior biologic therapy. Observed Tx persistence rates support long-term effectiveness and tolerability of VDZ in real-world settings.

Treatment patterns among patients with rheumatic disease (rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) and undifferentiated arthritis (UnA)) treated with subcutaneous TNF inhibitors.

The aim was to describe the real-world treatment persistence of subcutaneous TNF inhibitors (TNFi) for patients with inflammatory rheumatic disease newly initiating treatment with biologic disease-modifying antirheumatic drugs (bDMARD). This was a retrospective cohort study that extracted data for new users of TNFi between 1 August 2010 and 31 August 2016 from the Australian Optimising Patient outcome in Australian RheumatoLogy (OPAL) registry. Patients were 1:1 propensity-score matched with golimumab based on their age, sex, year of index, C-reactive protein level, baseline treatment combination and disease. Treatment persistence was calculated. Data from 3749 patients were extracted (adalimumab n = 1518; certolizumab n = 298; etanercept n = 1068; golimumab n = 865). The mean (SD) ages of patients were 51.7 (14.2) years for adalimumab, 53.7 (14.0) years for certolizumab, 52.8 (14.3) years for etanercept and 52.3 (14.6) years for golimumab, with disease durations 7.7 (10.5), 8.8 (9.2), 8.1 (10.4) and 7.3 (9.7) years, respectively. Two thirds of the patients were women. There was no significant difference in treatment persistence by treatment in the overall population (adalimumab 33.6 [95% CI 28.6-40.7], certolizumab 24.8 [95% CI 21.3-42.1], etanercept 27.6 [95% CI 23.4-36.5], golimumab 30.3 [95% CI 23.26-36.5]; months, p = 0.545), or in the propensity score-matched population. No safety signals were detected. In this real-world biologic-naïve Australian inflammatory rheumatic disease cohort treated with subcutaneous TNF inhibitors during the period 2010-2016, there was no difference in treatment persistence between agents.

P635 Real-world treatment persistence and associated costs with biologic therapy in patients with inflammatory bowel disease (IBD): Results of a retrospective cohort analysis of 1,149 patients treated in Germany

Data on biologic treatment (Tx) persistence and switching in German IBD patients are sparse. The main objectives of this interim analysis of a retrospective claims database (7.5 Mio. insured, covering out- and inpatient care) were to describe rates of biologic Tx switching and discontinuation for anti-TNFα (adalimumab, golimumab, infliximab) and vedolizumab (VDZ) IBD patients and to report associated drug costs. Adult patients with a confirmed diagnosis of Crohn’s disease or ulcerative colitis (63% of 37%), initiating Tx with an anti-TNFα or VDZ between 1 July 2015 and 30 June 2016 and follow-up for 12 months (or death within 12 months) were included. Observation started with the first prescription in this period. First observed Tx discontinuation (prescription gap >90 days) and switching to another biologic were compared between anti-TNFα and VDZ patients, both unadjusted and adjusted (Cox regression). Drug costs, based on pharmacy retail prices, were reported per observed patient month for periods of continuous index Tx. 1149 out of 51,222 IBD patients started anti-TNFα or VDZ within the inclusion period. Of these, 582 patients were followed up for 12 months or until death (n = 4) in this interim analysis (476 anti-TNFα: mean age, 37.2 years, 53.9% female, 78.7% bio-naïve; 107 VDZ: mean age, 40.5 years, 55.1% female, 21.5% bio-naïve). During follow-up, 20.6% vs. 16.8% of anti-TNFα vs. VDZ patients (p = 0.227) switched to another biologic agent; 19.8% vs. 15.0% (p = 0.154) discontinued index Tx, and 59.4% vs. 67.6% (five patients censored; p = 0.060) continued Tx. VDZ Tx was associated with longer drug survival (mean 309 days) than anti-TNFα Tx (286 days; p = 0.028). In the multivariable Cox regression, female gender was associated with earlier Tx discontinuation and switch (HR = 1.490; 95% CI: 1.139–1.949), whereas VDZ Tx was associated with later discontinuation and switch (HR = 0.692; 95% confidence interval (CI): 0.480–0.998); prior biologic Tx and comorbidity were not significant. Drug costs per patient month were €2,561.66 for anti-TNFα and €2,314.74 for VDZ. 12-month treatment continuation of anti-TNFα vs. VDZ patients in a German claims database. In contrast to previous observational evidence, less than two-thirds of IBD patients continued Tx with a biologic agent after 12 months. There is a tendency towards a longer drug survival in VDZ patients, with comparable drug costs. Analysis of the full dataset including 1,149 patients will provide more detail, especially for subgroups (UC vs. CD and bio-naïve vs. bio-experienced).