Clinical, functional and radiographic outcomes following up to 3 years of open-label adalimumab as monotherapy after 2 years of adalimumab+methotrexate.

Slides:



Advertisements
Similar presentations
PASI responder rates (A, B) and total resolution in (C) nail psoriasis, (D) enthesitis and (E) dactylitis in affected patients receiving CZP from Week.
Advertisements

Proportion of patients reporting scores ≥age-matched and gender-matched normative PRO values at baseline and 24 weeks in the (A) AMBITION and (B) ADACTA.
Mean change from baseline in (A) DAS28-4(ESR), (B) CDAI and (C) HAQ-DI
Change in secondary endpoints over time: (A) LS mean change from baseline in DAS28-CRP through Week 32, (B) mean change from baseline in CRP through Week.
Radiographic progression among three therapy groups (triple therapy group, anti-TNF treatment group and MTX responders) stratified by MBDA categories at.
Patients included in linear extrapolation and observed/last observation carried forward analyses at week 48. Patients who were rescued or discontinued.
Percentage of patients achieving DAS28 (CRP) < 3
Mean DAS (A), HAQ (B) and percentages in low disease activity, DAS remission and drug-free DAS remission (C) during 5 years in the DAS ≤2.4 steered (BeSt)
Percentage of patients achieving EULAR response
Clinical responses over time.
Efficacy end points: the percentage of patients achieving an improvement in American College of Rheumatology (ACR) of (A) 20% (ACR20), (B) 50% (ACR50)
Association of disease parameters at the time of methotrexate reinitiation during the OLE based on propensity score matching. Association of disease parameters.
Patient disposition of responders to adalimumab+methotrexate at year 2 (OLE entry) from the primary study who were in methotrexate non-use or use groups.
Improvement in PROs, TJC, SJC and PGA at month 6 in patients achieving (A) ACR50, (B) CDAI LDA and (C) HAQ-DI
Clinical and patient-reported outcomes for patients randomised to CZP 200 mg Q2W and CZP 400 mg Q4W to week 96. Clinical and patient-reported outcomes.
Changes in clinical disease activity over 24 months on a continuous scale in SWEFOT trial participants randomised to triple therapy or anti-TNF with available.
Correlations between observed patient-reported outcomes and disease activity scores at week 24. Correlations between observed patient-reported outcomes.
Frequency of patients in flare at each time point over 3 months
Disease activities evaluated as a comparison between abatacept plus MTX and placebo plus MTX groups. Disease activities evaluated as a comparison between.
HAQ-DI change from baseline and proportion of patients achieving MCID after 24 weeks in patients treated with PBO, IXEQ4W or IXEQ2W alone or in combination.
Univariate predictors of (A) ASDAS ID (<1
MTX-PG concentrations and hepatotoxicity.
ACR responder rates in patients receiving CZP from Week 0, stratified by prior anti-TNF exposure (A−C) and the proportion of patients receiving CZP from.
The severity of fatigue over 8 years of disease in early rheumatoid arthritis patients. The severity of fatigue over 8 years of disease in early rheumatoid.
OR for baseline predictors of MDA at weeks 12, 24, 48, 96 and 144 by univariate analysis of observed data. OR for baseline predictors of MDA at weeks 12,
OR for selected baseline predictors of MDA at weeks 12, 24, 48, 96 and 144 by multivariate analysis of observed data. OR for selected baseline predictors.
Efficacy outcomes in patients aged ≥65 years versus younger patients: ACR outcomes at (A) week 12 and (B) week 24. Efficacy outcomes in patients aged ≥65.
Percentage of patients reporting improvements ≥MCID and NNTs to achieve an MCID in (A) PtGA, (B) pain, (C) HAQ-DI, (D) FACIT-F and (E) SF-36 domains and.
Cumulative probability of time to achieve first sustained DAS28 (CRP) remission by conversion to ACPA seronegative status. Cumulative probability of time.
Box plot of HAQ-DI scores at baseline, week 96 and week 144 categorised by baseline PsA duration. Box plot of HAQ-DI scores at baseline, week 96 and week.
Response rates for patients achieving 50% (A), 70% (B), and 90% (C) improvement in ACR criteria, and normal physical function (D) over the course of 10.
Additional efficacy outcomes for the 12-week study of Japanese patients with rheumatoid arthritis treated with baricitinib or placebo. Additional efficacy.
Patient-reported outcomes: proportion of patients with clinically meaningful improvements in (A) SF-36 PCS and MCS at Week 52 and Week 104*†‡ and (B) HAQ-DI.
Different treatment strategies in rheumatoid arthritis in relation to radiographic progression (A) number of swollen joints (B) and fatigue severity over.
Column bar graphs showing Health Assessment Questionnaire (HAQ) scores and pain score on Visual Analogue Scale (VAS) (scale 0–10) that were collected at.
DAS28-CRP cut-off values corresponding to the DAS28-ESR cut-off values for remission, LDA and HDA, average of three statistical approaches. DAS28-CRP cut-off.
Independent baseline predictors of non-remission at 24 months of follow-up in the SWEFOT trial population. Independent baseline predictors of non-remission.
Matrix risk model showing the probability of SRP in patients with moderate disease activity after 3 years of MTX treatment. Matrix risk model showing the.
Multivariate analysis for SRP after 3 years in patients with moderate disease activity despite MTX treatment. Multivariate analysis for SRP after 3 years.
Clinical response in patients with early and established RA at month 24. *p
Patients with RA on csDMARDs with and without GC, bDMARDs/tofacitinib with and without GC on the x axis. Patients with RA on csDMARDs with and without.
Adjusted estimates of DAS28 (95% CI) and RAPID3 (95% CI) scores over time based on multivariate models a priori adjusted for possible confounders: age,
Kaplan-Meier One Minus Survival plot showing cumulative progression to clinical arthritis for patients with clinically suspect arthralgia divided in four.
Improvement in PROs, TJC, SJC and PGA at month 6 in patients achieving (A) ACR70, (B) CDAI REM and (C) SDAI REM. For tofacitinib 5 and 10 mg BID treatment.
Percentages of patients reporting improvements from baseline ≥minimum clinically important difference (MCID) and number needed to treat (NNT) in (A) patient-reported.
Percentage of patients with RA achieving DAS28(CRP)<2
ACR20 response rates. ACR20 response rates. ACR20 response rates based on non-responder imputation (NRI) for the 120/Q4W, 90/Q2W and placebo groups over.
Changes in erosion score (A), JSN (B), and mean mTSS (C) at years 2, 6, and 10, and percentage of radiographic nonprogressors (D) over time. Changes in.
Joint damage progression evaluated as a comparison between abatacept plus MTX (grey bar) and placebo plus MTX groups (open bar). Joint damage progression.
Relative treatment effects concerning efficacy endpoints in patients with inadequate response to methotrexate for triple therapy versus TNFi–methotrexate.
Cox proportional-hazards model of time to first RA flare after treatment withdrawal for patients who entered the re-treatment period (n=146). Cox proportional-hazards.
Rates of ACR50 response and prespecified MTX-related adverse events in patients in the (A) CONCERTO study over 26 weeks and (B) MUSICA study over 24 weeks. ACR50, American.
Percentage of patients achieving 20% improvement in the American College of Rheumatology criteria at week 12 by patient demographic and disease characteristics.
Percentage of responders at month 6 by (A) ACR50, SDAI/CDAI LDA, and HAQ-DI
Frequency of methotrexate (MTX) doses at 24 months (plot) and summary of MTX doses across the MTX dosing categories (low, medium, high) based on data at.
Patient disposition after 2 years of treatment.
Study design. *Randomisation stratified by corticosteroid use at baseline. Study design. *Randomisation stratified by corticosteroid use at baseline. DAS28-CRP,
Satisfaction with control of RA
Achievement of MDA over 144 weeks in patients initially receiving adalimumab or placebo during the double-blind period. Achievement of MDA over 144 weeks.
Explanatory power of the LPA solution for clinical and functional outcomes compared with the conventional threshold-based discordance definition. Explanatory.
Classification tree with the selected characteristics.
Mean profiles over 1 year from the observed Disease Activity Score 28 (DAS28) data for the methotrexate (MTX)-exposed patients after stratifying by predicted.
DAPSA LSM change from baseline (A), patients achieving DAPSA ≤28 (MDA) (B), DAPSA ≤14 (LDA) (C) or DAPSA ≤4 (REM) (D) after 24 weeks in patients treated.
Patient-level radiographic progression of structural joint damage at year 1 and year 2 by original randomisation. Patient-level radiographic progression.
Patient disposition over the 52-week study period
Multivariable model of adjusted
Percent of patients with ASDAS inactive disease grouped by normal or elevated CRP at baseline through week 156. §p
Improvement in BASDAI score in patients with normal or elevated CRP at baseline through week 156. *p
Percentage of patients achieving remission by conversion to ACPA seronegative status. Percentage of patients achieving remission by conversion to ACPA.
Post hoc analysis of differences from placebo in the percentage of patients reporting improvements ≥MCID at week 24. Post hoc analysis of differences from.
Presentation transcript:

Clinical, functional and radiographic outcomes following up to 3 years of open-label adalimumab as monotherapy after 2 years of adalimumab+methotrexate. Clinical, functional and radiographic outcomes following up to 3 years of open-label adalimumab as monotherapy after 2 years of adalimumab+methotrexate. (A) Percentages of MTX non-use and MTX use patients with remission (DAS28(CRP)<2.6) and LDA (left y-axis) and mean DAS28(CRP) score (right y-axis); (B) percentages of MTX non-use and MTX use patients with normal physical function measured as HAQ-DI <0.5 (left y-axis) and mean HAQ-DI score (right y-axis); (C) percentages of MTX non-use and MTX use patients with radiographic non-progression (ΔmTSS ≤0.5; left y-axis) and mean ΔmTSS score (right y-axis); (D) cumulative probability of ΔmTSS from OLE entry to OLE year 3 (study years 2–5) for the MTX non-use and MTX use (inset) populations. Percentage of patients reported for each time point as observed (solid lines) or NRI (dashed lines). Due to missing assessments, the change in mTSS from OLE entry to year 3 was calculated for only 58 and 43 patients in the methotrexate non-use and use groups, respectively. CRP, C reactive protein; DAS28(CRP), 28-joint Disease Activity Score using CRP; HAQ-DI, Disability Index of the Health Assessment Questionnaire; LDA, low disease activity; ΔmTSS, change in modified total Sharp score; MTX, methotrexate; NRI, non-responder imputation; OLE, open-label extension. Edward C Keystone et al. RMD Open 2018;4:e000637 Copyright © BMJ Publishing Group & EULAR. All rights reserved.