Dataset Information

Comparative effectiveness of biologic monotherapy versus combination therapy for patients with psoriatic arthritis: results from the Corrona registry.

ABSTRACT: To characterise the comparative effectiveness of combination therapy (a tumour necrosis factor inhibitor (TNFi) and a conventional synthetic disease-modifying antirheumatic drug (csDMARD) such as methotrexate) and monotherapy (TNFi only) for psoriatic arthritis (PsA) from a large US registry.The analysis included adult patients with PsA who were enrolled in the Corrona database (ClinicalTrials.gov, NCT01402661), had initiated a TNFi, were biologic naïve, and had a follow-up visit ?90?days after drug initiation. The endpoints of the analysis were TNFi persistence (drug survival) and time to Clinical Disease Activity Index (CDAI) remission. All analyses were performed using propensity scoring, which were estimated using CDAI and patient sex, to control for channelling bias.Of 519 patients meeting the inclusion criteria (318 with combination therapy and 201 with monotherapy), the analysis population was 497 for TNFi persistence and 380 for time to remission. The difference between combination therapy (TNFi+methotrexate, 91% of patients; TNFi+other csDMARD, 9%) and monotherapy was not statistically significant for TNFi persistence (32 and 31?months, p=0.73) and time to remission (21 and 25?months, p=0.56). Predictors of TNFi persistence included Hispanic ethnicity (longer persistence), PsA duration (longer persistence), history of methotrexate use (shorter persistence), body mass index (shorter persistence) and disease activity (shorter persistence).Patients with PsA from a large US registry experienced similar TNFi persistence on combination therapy and monotherapy. Prospective, randomised clinical trials evaluating the efficacy of combination therapy versus monotherapy would provide much-needed clarity on treatment options for patients with PsA.NCT01402661.

SUBMITTER: Mease PJ

PROVIDER: S-EPMC4716450 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparative effectiveness of biologic monotherapy versus combination therapy for patients with psoriatic arthritis: results from the Corrona registry.

Mease Philip J PJ Collier David H DH Saunders Katherine C KC Li Guo G Kremer Joel M JM Greenberg Jeffrey D JD

RMD open 20151230 1

<h4>Objectives</h4>To characterise the comparative effectiveness of combination therapy (a tumour necrosis factor inhibitor (TNFi) and a conventional synthetic disease-modifying antirheumatic drug (csDMARD) such as methotrexate) and monotherapy (TNFi only) for psoriatic arthritis (PsA) from a large US registry.<h4>Methods</h4>The analysis included adult patients with PsA who were enrolled in the Corrona database (ClinicalTrials.gov, NCT01402661), had initiated a TNFi, were biologic naïve, and ha ...[more]

PMID: 26819748

Similar Datasets

Project description:IntroductionAnti-citrullinated protein antibodies (ACPAs) are highly specific serological biomarkers that are indicative of a poor prognosis in patients with rheumatoid arthritis (RA). The effectiveness of biologic disease-modifying antirheumatic drugs (bDMARDs) with different mechanisms of action may vary, based on patients' serostatus. The aim of this study is to compare the effectiveness of abatacept versus tumor necrosis factor inhibitors (TNFis) in patients with RA who were anti-cyclic citrullinated peptide antibody positive (anti-CCP+).MethodsAbatacept or TNFi initiators with anti-CCP+ status (≥ 20 U/ml) at or prior to treatment initiation were identified from a large observational US cohort (1 December 2005-31 August 2016). Using propensity score matching (1:1), stratified by prior TNFi use (0, 1 and ≥ 2), effectiveness at 6 months after initiation was evaluated. Primary outcome was mean change in Clinical Disease Activity Index (CDAI) score. Secondary outcomes included achievement of remission (CDAI ≤ 2.8), low disease activity/remission (CDAI ≤ 10), modified American College of Rheumatology 20/50/70 responses and mean change in modified Health Assessment Questionnaire score.ResultsAfter propensity score matching, the baseline characteristics between 330 pairs of abatacept and TNFi initiators (biologic naïve, n = 97; TNFi experienced, n = 233) were well balanced with absolute value standardized differences of ≤ 0.1. Both overall, and in the biologic-naïve cohort, there were no significant differences in mean change in CDAI score at 6 months. However, in the TNFi-experienced cohort, there was a significantly greater improvement in CDAI score at 6 months with abatacept versus TNFi initiators (p = 0.033). Secondary outcomes showed similar trends.ConclusionsImprovements in clinical disease activity were seen in anti-CCP+ abatacept and TNFi initiators. TNFi-experienced anti-CCP+ patients with RA had more improvement in disease activity with abatacept versus TNFis, whereas outcomes were similar between treatments in the overall population and in biologic-naïve patients.Trial registrationClinicalTrials.gov identifier: NCT01625650.FundingThis study is sponsored by Corrona, LLC and funded by Bristol-Myers Squibb. Bristol-Myers Squibb funded the publication of this manuscript.

Project description:ObjectiveMatching-adjusted indirect comparison (MAIC) can be used to assess the comparative effectiveness of two treatments indirectly using data from randomized placebo-controlled trials. This MAIC assessed the comparative effectiveness of secukinumab (an anti-interleukin-17A) and etanercept (a tumor necrosis factor inhibitor) in a target population of biologic-naïve patients with psoriatic arthritis (PsA).MethodsIndividual patient data pooled from FUTURE 2 (NCT01752634), FUTURE 3 (NCT01989468), and FUTURE 5 (NCT02404350) (secukinumab: 150 mg, n=458 and 300 mg, n=461) were matched to data from the population in the NCT00317499 trial (etanercept 25 mg, n=101) using MAIC methodology, by adjusting for clinical and demographic baseline characteristics. Recalculated outcomes from FUTURE 2, 3, and 5 (150 mg, effective sample size (ESS) post-matching=104; 300 mg, ESS=75; and placebo, ESS=159) were compared with the NCT00317499 trial. Pairwise comparisons using odds ratios (ORs) were performed for the American College of Rheumatology (ACR) 20, 50, and 70 response criteria at week 12 (placebo-adjusted) and week 24 (non-placebo-adjusted).ResultsAt week 12, there were no significant differences in ACR responses between secukinumab and etanercept. There was no significant difference between secukinumab 150 mg and etanercept at week 24 with respect to ACR 20 and 50 response rates; however, ACR 70 response rates were higher for secukinumab 150 mg (OR (95% confidence interval (CI)): 4.48 (2.01-9.99), p<0.001). ACR 20, 50, and 70 response rates were higher with secukinumab 300 mg than with etanercept at this time point (OR (95% CI): ACR 20, 3.28 (1.69-6.38), p<0.001; ACR 50, 1.90 (1.04-3.50), p=0.038; and ACR 70, 3.56 (1.51-8.40), p=0.004).ConclusionIn this MAIC, secukinumab was associated with higher ACR 20 and 50 (secukinumab 300 mg) and 70 (secukinumab 150 mg and 300 mg) response rates at week 24 than etanercept in biologic-naïve patients with active PsA, whereas no significant difference was observed in the short-term at week 12.

Project description:IntroductionThe Phase III FUTURE I and II trials demonstrated the clinical efficacy of secukinumab in active psoriatic arthritis (PsA). In the absence of head-to-head trials, this study compared the clinical efficacy and cost effectiveness of adalimumab 40 mg versus secukinumab 150 and 300 mg for the treatment of active PsA.MethodsA matching-adjusted indirect comparison was conducted using individual patient data from the ADEPT trial of adalimumab and published data from FUTURE I and II. To adjust for the cross-trial differences, individual patients in ADEPT were re-weighted so that the mean baseline characteristics (including age, weight, gender, race, baseline methotrexate use, psoriasis ≥3% body surface area, baseline PASI score, presence of dactylitis and enthesitis, and HAQ-DI) matched those in the FUTURE trials. Response rates relative to placebo and incremental costs per responder (CPR) over 24 weeks for ACR 20/50/70 and PASI 75/90 were compared between adalimumab and secukinumab 150 and 300 mg from the German social health insurance (SHI) perspective.ResultsAfter matching, mean baseline characteristics were balanced across the ADEPT and the FUTURE I and II populations. The mean differences between adalimumab and secukinumab 150 mg in relative ACR 20/50/70 and PASI 75/90 response rates were 9.5, 3.0, 6.0, 13.1, and 6.7%, respectively (p > 0.05 for all comparisons). Post-match relative ACR 20/50/70 and PASI 75 to placebo were also higher with adalimumab compared to secukinumab 300 mg. Adalimumab had lower incremental costs per responder over 24 weeks for all outcomes compared with secukinumab 150 and 300 mg.ConclusionsIn the absence of direct comparisons between adalimumab and secukinumab, this study provides valuable and reliable evidence for physicians and payers. After adjusting for cross-trial differences in baseline characteristics, adalimumab was associated with higher relative ACR and PASI rates and lower incremental CPRs compared with secukinumab 150 mg or 300 mg at week 24 among patients with active PsA.FundingAbbVie.

Project description:INTRODUCTION:Secukinumab and adalimumab are approved for adults with active psoriatic arthritis (PsA). In the absence of direct randomized controlled trial (RCT) data, matching-adjusted indirect comparison can estimate the comparative effectiveness in anti-tumor necrosis factor (TNF)-naïve populations. METHODS:Individual patient data from the FUTURE 2 RCT (secukinumab vs. placebo; N?=?299) were adjusted to match baseline characteristics of the ADEPT RCT (adalimumab vs. placebo; N?=?313). Logistic regression determined adjustment weights for age, body weight, sex, race, methotrexate use, psoriasis affecting???3% of body surface area, Psoriasis Area and Severity Index score, Health Assessment Questionnaire Disability Index score, presence of dactylitis and enthesitis, and previous anti-TNF therapy. Recalculated secukinumab outcomes were compared with adalimumab outcomes at weeks 12 (placebo-adjusted), 16, 24, and 48 (nonplacebo-adjusted). RESULTS:After matching, the effective sample size for FUTURE 2 was 101. Week 12 American College of Rheumatology (ACR) response rates were not significantly different between secukinumab and adalimumab. Week 16 ACR 20 and 50 response rates were higher for secukinumab 150 mg than for adalimumab (P?=?0.017, P?=?0.033), as was ACR 50 for secukinumab 300 mg (P?=?0.030). Week 24 ACR 20 and 50 were higher for secukinumab 150 mg than for adalimumab (P?=?0.001, P?=?0.019), as was ACR 20 for secukinumab 300 mg (P?=?0.048). Week 48 ACR 20 was higher for secukinumab 150 and 300 mg than for adalimumab (P?=?0.002, P?=?0.027), as was ACR 50 for secukinumab 300 mg (P?=?0.032). CONCLUSIONS:In our analysis, patients with PsA receiving secukinumab were more likely to achieve higher ACR responses through 1 year (weeks 16-48) than those treated with adalimumab. Although informative, these observations rely on a subgroup of patients from FUTURE 2 and thus should be considered interim until the ongoing head-to-head RCT EXCEED can validate these findings. FUNDING:Novartis Pharma AG.

Project description:Patients with active rheumatoid arthritis (RA) despite anti-tumor necrosis factor(anti-TNF)agent treatment can switch to either a subsequent anti-TNF agent or a biologic with an alternative mechanism of action, such as rituximab; however, there are limited data available to help physicians decide between these 2 strategies. The objective of this analysis was to examine the effectiveness and safety of rituximab versus a subsequent anti-TNF agent in anti-TNF-experienced patients with RA using clinical practice data from the Corrona registry.Rituximab-naive patients from the Corrona registry with prior exposure to ?1 anti-TNF agent who initiated rituximab or anti-TNF agents (2/28/2006-10/31/2012) were included. Two cohorts were analyzed: the trimmed population (excluding patients who fell outside the propensity score distribution overlap) and the stratified-matched population (stratified by 1 vs. ??2 anti-TNF agents, then matched based on propensity score). The primary effectiveness outcome was achievement of low disease activity (LDA)/remission (Clinical Disease Activity Index??10) at 1 year. Secondary outcomes included achievement of modified American College of Rheumatology (mACR) 20/50/70 responses and meaningful improvement (?0.25) in modified Health Assessment Questionnaire (mHAQ) score at 1 year. New cardiovascular, infectious and cancer events were reported.Estimates for LDA/remission, mACR response and mHAQ improvement were consistently better for rituximab than for anti-TNF agent users in adjusted analyses. The odds ratio for likelihood of LDA/remission in rituximab versus anti-TNF patients was 1.35 (95% CI, 0.95-1.91) in the trimmed population and 1.54 (95% CI, 1.01-2.35) in the stratified-matched population. Rituximab patients were significantly more likely than anti-TNF patients to achieve mACR20/50 and mHAQ improvement in the trimmed population and mACR20 and mHAQ in the stratified-matched population. The rate of new adverse events per 100 patient-years was similar between groups.In anti-TNF-experienced patients with RA, rituximab was associated with an increased likelihood of achieving LDA/remission, mACR response and physical function improvement, with a comparable safety profile, versus subsequent anti-TNF agent users.ClinicalTrials.gov NCT01402661 . Registered 25 July 2011.

Dataset Information

Comparative effectiveness of biologic monotherapy versus combination therapy for patients with psoriatic arthritis: results from the Corrona registry.

Publications

Comparative effectiveness of biologic monotherapy versus combination therapy for patients with psoriatic arthritis: results from the Corrona registry.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets