scholarly journals Effectiveness of an Outreach Model of Care for Rheumatology Specialty Clinics to an On-Reserve First Nations Community

2018 ◽  
Vol 13 (1) ◽  
pp. 157-167 ◽  
Author(s):  
Sujay Nagaraj ◽  
Margaret Kargard ◽  
Brenda Hemmelgarn ◽  
Marvin J. Fritzler ◽  
Tyler White ◽  
...  
Keyword(s):  
Disease Activity ◽  
First Nations ◽  
Patient Reported Outcomes ◽  
Model Of Care ◽  
Tender Joint ◽  
Patient Reported ◽  
Activity Measures ◽  
Tender Joint Counts ◽  
Disease Activity Measures

A model of care consisting of rheumatology specialty services embedded in the primary care system on a First Nations reserve was instituted to reduce barriers to care and improve inflammatory arthritis outcomes for patients. We assessed the effectiveness of this model of care on disease activity measures and patient-reported outcomes over 7 years. Patients were enrolled in a longitudinal cohort at the Siksika Nation in Alberta. Clinical characteristics, treatment recommendations and disease activity measures were systematically recorded over follow-up. Mixed-model regression was performed to determine rates of change for continuous measures. 59 participants (78% female; M = 47 years, SD = 13), predominantly with rheumatoid arthritis (RA; n = 36), were followed for an average of 29 months (SD = 23). Swollen and tender joint counts decreased significantly (change per month: -0.20, 95% CI -0.29 to -0.10, and -0.20, 95%CI -0.34 to -0.06, respectively) but pain, physician global and function scores did not significantly improve (all p > 0.05). Patient global evaluation scores worsened over time (change per month 0.08, 95%CI 0.029 to 0.131, p = 0.002). Inflammatory markers improved at a slower rate in patients with incident compared to incident disease. Disease-modifying agents were escalated for moderate or high disease activity at 64% of RA visits, with justifications for not escalating or application of local treatment approaches in all but one instance. Despite improvement in swollen and tender joint counts and adherence to current treatment paradigms, patient-reported outcomes did not significantly improve during follow-up. Further innovation is required to meet relevant outcomes.

scholarly journals Relationship of patient-reported outcomes with MRI measures in rheumatoid arthritis

2016 ◽  
Vol 76 (3) ◽  
pp. 486-490 ◽  
Author(s):  
Joshua F Baker ◽  
Philip G Conaghan ◽  
Paul Emery ◽  
Daniel G Baker ◽  
Mikkel Ostergaard
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Physical Function ◽  
Patient Reported Outcomes ◽  
Bone Erosion ◽  
Clinical Disease ◽  
Time Points ◽  
Patient Reported ◽  
Activity Measures ◽  
Disease Activity Measures

PurposeWe assessed whether MRI measures of synovitis, osteitis and bone erosion were associated with patient-reported outcomes (PROs) in a longitudinal clinical trial setting among patients with rheumatoid arthritis (RA).MethodsThis longitudinal cohort of 291 patients with RA was derived from the MRI substudy of the GO-BEFORE randomised controlled trial of golimumab among methotrexate-naïve patients. Correlations between RAMRIS scores (synovitis, osteitis, bone erosion) and physical function (Health Assessment Questionnaire (HAQ)), pain and global patient scores were determined at 0, 12, 24 and 52 weeks. Correlations between interval changes were also assessed. Multivariable regression models using robust generalised estimating equations evaluated associations over all time-points and their relationship to other clinical disease activity measures.ResultsGreater synovitis, osteitis and bone erosion scores were positively associated with HAQ at all time-points (all p<0.05) and with pain and patient global scores at 24 and 52 weeks. Over all visits, synovitis was associated with HAQ, pain and patient global scores (p≤0.03) independent of clinical disease activity measures. Improvements in synovitis and bone erosion were also associated with improvements in PROs. Less improvement in synovitis and progression in MRI erosion at 52 weeks were both independently associated with worsening in all PROs at 52 weeks while progression on X-ray was not associated. Similar associations were observed across treatment groups.ConclusionsMRI measures of inflammation and structural damage correlate independently with physical function, pain and patient global assessments. These observations support the validity of MRI biomarkers.Trial registration numberNCT00264537; Post-results.

scholarly journals Pain and Self-reported Swollen Joints Are Main Drivers of Patient-reported Flares in Rheumatoid Arthritis: Results from a 12-month Observational Study

2019 ◽  
Vol 47 (9) ◽  
pp. 1305-1313 ◽  
Author(s):  
Dorota Kuettel ◽  
Jette Primdahl ◽  
Ulrich Weber ◽  
Lene Terslev ◽  
Mikkel Østergaard ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Management Strategies ◽  
Self Management ◽  
Tender Joint ◽  
Patient Reported ◽  
Longitudinal Association ◽  
Activity Measures ◽  
Treatment Escalation ◽  
Disease Activity Measures

Objective.To examine prospectively self-reported flare characteristics and their longitudinal association with disease activity and patient-reported outcomes (PRO) in patients with rheumatoid arthritis (RA).Methods.Consecutive RA patients with 28-joint count Disease Activity Score based on C-reactive protein (DAS28-CRP) < 3.2 and no swollen joints were examined at baseline, Month 6, and Month 12. Assessments included joint counts, DAS28-CRP, visual analog scale–evaluator’s global assessment (EGA), and PRO. Every third month, patients completed the Flare Assessment in Rheumatoid Arthritis and RA Flare Questionnaire, and disclosed self-management strategies. Flaring and non-flaring patients were compared and longitudinal associations between self-reported flare status (yes/no) and disease activity, PRO, and treatment escalation were explored.Results.Among 80 patients with RA [74% females, mean (SD) age 63 (10) yrs, disease duration 11 (7) yrs, and baseline DAS28-CRP 1.9 (0.6)], 64 (80%) reported flare at least once during 12 months. Fifty-five percent of flares lasted less than 1 week. Common self-management strategies were analgesics (50%) and restricted activities (38%). Patients who reported being in flare had consistently higher disease activity measures and PRO compared to patients without flare. In a partly adjusted model, all flare domains, patient-reported swollen and tender joint counts and disease activity measures were associated with flares. In fully adjusted analyses, present flare was independently associated with pain (OR 1.85, 95% CI 1.34–2.60), patient-reported swollen joints (OR 1.18, 95% CI 1.03–1.36), and higher EGA (OR 1.15, 95% CI 1.04–1.28). Treatment escalation was associated with present flare (p ≤ 0.001).Conclusion.In RA, self-reported flares were frequent, mainly managed by analgesics, substantiated by higher disease activity measures, independently associated with pain and patient-reported swollen joints, and related to treatment escalation.

scholarly journals THU0207 SUSTAINABILITY OF RESPONSE TO UPADACITINIB AS MONOTHERAPY OR IN COMBINATION AMONG PATIENTS WITH RHEUMATOID ARTHRITIS AND PRIOR INADEQUATE RESPONSE TO CONVENTIONAL SYNTHETIC DMARDS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 327.1-328
Author(s):  
A. Kavanaugh ◽  
M. H. Buch ◽  
B. Combe ◽  
L. Bessette ◽  
I. H. Song ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Inadequate Response ◽  
Research Support ◽  
Two Phase ◽  
First Occurrence ◽  
Activity Measures ◽  
Disease Activity Measures

Background:The primary treatment goal for patients (pts) with rheumatoid arthritis (RA) is a state of sustained clinical remission (REM) or low disease activity (LDA).1,2Objectives:To assess the long-term sustainability of responses to upadacitinib (UPA), a JAK inhibitor, with or without background csDMARD(s) in pts with RA.Methods:Data are from two phase 3 randomized, controlled trials of UPA in RA pts with roughly similar baseline disease characteristics: SELECT-NEXT enrolled pts with an inadequate response (IR) to csDMARD(s) on background stable csDMARD(s) receiving UPA 15 mg or 30 mg once daily or placebo for 12 weeks (wks); SELECT-MONOTHERAPY enrolled methotrexate (MTX)-IR pts receiving UPA 15 mg or 30 mg monotherapy or blinded MTX for 14 wks. After 12/14 wks, pts could enter a blinded long-term extension and receive UPA 15 mg or 30 mg for up to 5 years. This post hoc analysis evaluated clinical REM (CDAI ≤2.8; SDAI ≤3.3), LDA (CDAI≤10; SDAI≤11), and DAS28(CRP) <2.6/≤3.2 at first occurrence before Wk 84; additionally, these measures were evaluated at 3, 6, and 12 months after the first occurrence for the total number of pts randomized to UPA 15 mg. Sustainability of response was evaluated by Kaplan-Meier only for those pts who achieved REM/LDA and was defined as time to the earliest date of losing response at two consecutive visits or discontinuation of study drug. The predictive ability of time to clinical REM/LDA was assessed using Harrell’s concordance (c)-index (for reference, an index ~ 0.5, indicates no ability to predict; an index of 1 or -1 would be a perfect prediction). The last follow up dates were 22 March, 2018 (SELECT-NEXT) and 25 May, 2019 (SELECT-MONOTHERAPY), when all pts had reached the Wk 84 visit.Results:Through Wk 84, the percent of treated pts achieving CDAI REM/LDA was 43%/79% for those receiving UPA 15 mg with background csDMARD(s) (SELECT-NEXT) and 37%/76% for those receiving UPA 15 mg without background csDMARD(s) (SELECT-MONOTHERAPY). 35%/25% of pts randomized to UPA 15 mg with background csDMARD(s) and 27%/23% of pts randomized to UPA 15 mg without background csDMARD(s) achieved sustained CDAI REM through 6/12 months after the first occurrence. 64%/56% of pts randomized to UPA 15 mg with background csDMARD(s) and 61%/56% of pts randomized to UPA 15 mg without background csDMARD(s) achieved sustained CDAI LDA through 6/12 months after the first occurrence (Figure 1). Time to initial clinical REM/LDA did not appear to be associated with sustained disease control. The c-indices (95%CI) for CDAI REM in the UPA 15 mg with background csDMARD(s) and UPA 15 mg without background csDMARD(s) groups were 0.541 (0.47, 0.62) and 0.568 (0.49, 0.65) and that of LDA were 0.521 (0.46, 0.58) and 0.498 (0.43, 0.56), respectively. Through last follow-up visit, 55% of pts receiving UPA 15 mg with background csDMARD(s) and 62% of pts receiving UPA 15 mg without background csDMARD(s) remained in CDAI REM while 72% and 70% of pts remained in CDAI LDA, respectively (Figure 2). Similar results were observed across other disease activity measures (SDAI REM/LDA and DAS28(CRP) <2.6/≤3.2).Conclusion:More than a quarter and more than a half of pts with RA and prior IR to csDMARD(s) receiving UPA with or without background csDMARD therapy achieved sustained clinical REM and LDA, respectively, across disease activity measures. Sustainability of responses appeared comparable among pts receiving UPA with or without background csDMARDs through up to 84 wks.References:[1]EULAR: Smolen JS, et al. Ann Rheum Dis 2017;76:960–977.[2]ACR: Singh et al. Arthritis & Rheumatology Vol. 68, No. 1, January 2016, pp 1–26.Disclosure of Interests: :Arthur Kavanaugh Grant/research support from: Abbott, Amgen, AstraZeneca, BMS, Celgene Corporation, Centocor-Janssen, Pfizer, Roche, UCB – grant/research support, Maya H Buch Grant/research support from: Pfizer, Roche, and UCB, Consultant of: Pfizer; AbbVie; Eli Lilly; Gilead Sciences, Inc.; Merck-Serono; Sandoz; and Sanofi, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, In-Ho Song Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Yanna Song Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Jessica Suboticki Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Peter Nash Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB

Changes in quality of life in relation to disease activity in systemic lupus erythematosus: post-hoc analysis of the BLISS-52 Trial

Lupus ◽  
2019 ◽  
Vol 28 (14) ◽  
pp. 1628-1639 ◽  
Author(s):  
M Jolly ◽  
N Annapureddy ◽  
L Arnaud ◽  
H Devilliers
Keyword(s):  
Disease Activity ◽  
Lupus Erythematosus ◽  
Patient Reported Outcomes ◽  
Patient Reported Outcome ◽  
Sf 36 ◽  
Patient Reported ◽  
Outcome Scores ◽  
Activity Measures ◽  
Flare Index ◽  
The Mean

Objectives To quantify changes in generic patient-reported outcomes against clinically meaningful, disease activity measures in systemic lupus erythematosus (SLE). Methods Using BLISS-52 trial data (867 SLE patients), we estimated the mean difference in change of patient-reported outcome scores (Medical Outcomes Study SF-36 and FACIT-fatigue) in relation to disease activity (SELENA-SLEDAI, SELENA-SLEDAI flare index, SLE responder index and British Isles Lupus Assessment Group (BILAG)), considering all study visits by the mean of multivariate mixed models. Predefined disease activity criteria were used to define for improvement and worsening. Results Mean changes in physical component summary/mental component summary and FACIT-fatigue in response to changes in SELENA-SLEDAI and SELENA-SLEDAI flare index were significantly lower than 2.5. New SELENA-SLEDAI flare index flare led to a significant change in all patient-reported outcome scores, except role emotional. Mean improvement in patient-reported outcomes with achievement of SLE responder index ranged between +6.2 (physical function) and +11.3 (bodily pain) for SF-36 domains, + 3.4 and +3.3 for mental component summary and physical component summary, and was +4.2 for FACIT-fatigue. When considering disease activity changes by organ system, changes in BILAG (constitutional) was independently associated with significant changes in FACIT-fatigue and all SF-36 domains (except physical function), changes in BILAG (musculoskeletal and hematological) were independently associated with significant changes in patient-reported outcome scores, except for role emotional (musculoskeletal) and general health/mental health (hematological). Mean changes in every SF-36 domain varied (and was >5) with SLE responder index attainment. Conclusions Knowledge of changes in patient-reported outcomes, against clinically meaningful changes in SLE disease activity measures, is crucial for designing of clinical trials, interpretation of results and shared decision-making for patient care.

scholarly journals Comparative analyses of responsiveness between the Rheumatoid Arthritis Impact of Disease score, other patient-reported outcomes and disease activity measures: secondary analyses from the ARCTIC study

RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000754 ◽  
Author(s):  
Karen Holten ◽  
Joseph Sexton ◽  
Tore K Kvien ◽  
Anna-Birgitte Aga ◽  
Espen A Haavardsholm
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Inflammatory Markers ◽  
Disease Duration ◽  
Treat To Target ◽  
Patient Reported ◽  
Short Disease Duration ◽  
Activity Measures ◽  
The Mean ◽  
Disease Activity Measures

ObjectiveTo evaluate the responsiveness of the Rheumatoid Arthritis Impact of Disease (RAID) score compared with other patient-reported outcome measures (PROMs), inflammatory markers and clinical disease activity measures in patients with early rheumatoid arthritis (RA).MethodsDisease-modifying antirheumatic drug–naïve patients with RA with short disease duration were included in the treat-to-target ARCTIC trial and followed for 24 months. The responsiveness of the RAID score was evaluated using standardised response mean (SRM) and relative efficiency (RE) with respect to tender joints by Ritchie Articular Index (RAI). SRMs and REs were also calculated for other PROMs, inflammatory markers and clinical outcome measures. An SRM with value above 0.80 was considered high.Results230 patients with RA were included. The mean±SD symptom duration was 7.1±5.4 months and the baseline mean±SD  RAID score was 4.49±2.14. At 3 months of follow-up, the mean±SD change score for RAID was −2.25±1.98  and the SRM (95%  CI) −1.13 (−1.33 to −0.96). The RAID score showed high responsiveness both at 3 and 6 months (SRM≥0.80) and was more sensitive in detecting change than the reference, tender joints assessed by RAI.ConclusionsThe RAID score proved to be highly responsive to change in patients with RA with short disease duration who followed a treat-to-target strategy. The RAID score was more efficient in detecting change than the reference (RAI) as well as most other PROMs.

scholarly journals Rheumatoid arthritis patients with predominantly tender joints rarely achieve clinical remission despite being in ultrasound remission

2021 ◽  
Author(s):  
Hilde Berner Hammer ◽  
Inger Marie Jensen Hansen ◽  
Pentti Järvinen ◽  
Marjatta Leirisalo-Repo ◽  
Michael Ziegelasch ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Laboratory ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Tender Joint ◽  
Subjective Assessments ◽  
Patient Reported ◽  
Changes Over Time ◽  
Tender Joint Counts

Abstract Objectives Since subjective variables may reduce remission by composite disease activity scores (CDAS), the main objectives were to explore whether rheumatoid arthritis (RA) patients with mainly tender versuss mainly swollen joints had differences in patient reported outcome measures (PROMs), clinical or ultrasound assessments as well as in achieving remission defined by CDAS or ultrasound. Methods In a Nordic multicentre study, RA patients initiating tocilizumab were assessed by PROMs, clinical, laboratory and ultrasound assessments (36 joints, 4 tendons) at baseline, 4, 12 and 24 weeks. Remission was defined according to CDAI/Boolean or no Doppler activity present. Tender-Swollen joint differences (TSJD) were calculated. Statistics exploring changes over time/differences between groups included Wilcoxon, Mann–Whitney, Kruskal-Wallis and Spearman. Results 110 patients were included (mean (SD) age 55.6 (12.1) years, RA duration 8.7 (9.5) years). All PROMs, clinical, laboratory and ultrasound scores decreased during follow-up (p &lt; 0.001). During follow-up, tender joint counts were primarily correlated with PROMs (r = 0.24–0.56 (p &lt; 0.05–0.001)), and swollen joint counts with ultrasound synovitis scores (r = 0.33–0.72 (p &lt; 0.05–0.001)). At 24 weeks patients with TSJD &gt; 0 had higher PROMs and CDAI (p &lt; 0.05–0.001) but lower ultrasound synovitis scores (p &lt; 0.05). Remission by CDAI/Boolean was seen in 26–34% and by Doppler 53%, but only 2–3% of patients with TSJD &gt; 0 achieved CDAI/Boolean remission. Conclusion Patients with more tender than swollen joints scored higher on subjective assessments but had less ultrasound synovitis. They seldom achieved CDAS remission despite many being in Doppler remission. If patients with predominantly tender joints do not reach CDAS remission, objective assessments of inflammation should be performed. Clinical trial identifier ClinicalTrials.gov, https://clinicaltrials.gov/, NCT02046616

scholarly journals Increased disease activity in early arthritis patients with anti-carbamylated protein antibodies

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Cristina Regueiro ◽  
Laura Nuño ◽  
Ana Triguero-Martinez ◽  
Ana M. Ortiz ◽  
Alejandro Villalba ◽  
...  
Keyword(s):  
Disease Activity ◽  
Early Arthritis ◽  
Prognostic Biomarkers ◽  
Short Term ◽  
Initial Management ◽  
Appropriate Treatment ◽  
Patient Reported ◽  
Activity Measures

AbstractThe initial management of rheumatoid arthritis (RA) has a high impact on disease prognosis. Therefore, we need to select the most appropriate treatment as soon as possible. This goal requires biomarkers of disease severity and prognosis. One such biomarker may be the presence of anti-carbamylated protein antibodies (ACarPA) because it is associated with adverse long term outcomes as radiographic damage and mortality. Here, we have assessed the ACarPA as short-term prognostic biomarkers. The study was conducted in 978 prospective early arthritis (EA) patients that were followed for two years. Our results show the association of ACarPA with increased levels of all the disease activity measures in the first visit after arthritis onset. However, the associations were more significant with the high levels in local measures of inflammation and physician assessment than with the increases in systemic inflammation and patient-reported outcomes. More notably, disease activity was persistently increased in the ACarPA positive patients during the two years of follow-up. These differences were significant even after accounting for the presence of other RA autoantibodies. Therefore, the ACarPA could be considered short-term prognostic biomarkers of increased disease activity in the EA patients.

scholarly journals Does autoimmune thyroid disease affects rheumatoid arthritis disease activity or response to methotrexate?

RMD Open ◽  
2020 ◽  
Vol 6 (2) ◽  
pp. e001282
Author(s):  
Kristin Waldenlind ◽  
Bénédicte Delcoigne ◽  
Saedis Saevarsdottir ◽  
Johan Askling
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Thyroid Disease ◽  
Autoimmune Thyroid Disease ◽  
Eular Response ◽  
Autoimmune Thyroid ◽  
Patient Reported ◽  
Activity Measures ◽  
Disease Activity Measures ◽  
Moderate Response

ObjectiveTo investigate if autoimmune thyroid disease (AITD) impacts rheumatoid arthritis (RA) disease activity or response to methotrexate.MethodsA nationwide register-based cohort study of 9 004 patients with new-onset RA from the Swedish Rheumatology Quality Register year 2006–2016, with linkage to other nationwide registers to identify comorbidity with AITD defined as thyroxine prescription before RA diagnosis, excluding non-autoimmune causes. We compared RA disease activity using 28-joint Disease Activity Score (DAS28) and its components, and EULAR response, between patients with and without AITD, using logistic regression.ResultsAt diagnosis, patient reported outcome measures (PROMs; patient global, Health Assessment Questionnaire Disability Index and pain) but not objective disease activity measures (erythrocyte sedimentation rate and swollen joint count) were significantly higher (p<0.05 for all PROMs) among RA patients with AITD compared with those without. The level of DAS28 was 5.2 vs 5.1. By contrast, AITD had little influence on EULAR response to methotrexate at 3 months (OR of non/moderate response=0.95, 95% CI 0.8 to 1.1), nor at 6 months. When stratified by age, however, AITD was more common among EULAR non/moderate responders at 3 and 6 months in patients below 45 years resulting in ORs of non/moderate response of 1.44 (0.76–2.76) and 2.75 (1.04–7.28).ConclusionAt diagnosis, RA patients with concomitant AITD score worse on patient reported but not on objective RA disease activity measures, while DAS28 was only marginally elevated. The overall chance of achieving a EULAR good response at 3 or 6 months remains unaffected, although among a limited subgroup of younger patients, AITD may be a predictor for an inferior primary response.

scholarly journals FRI0131 SUSTAINABILITY OF RESPONSE BETWEEN UPADACITINIB AND ADALIMUMAB AMONG PATIENTS WITH RHEUMATOID ARTHRITIS AND PRIOR INADEQUATE RESPONSE TO METHOTREXATE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 647.1-648
Author(s):  
P. Nash ◽  
A. Kavanaugh ◽  
M. H. Buch ◽  
B. Combe ◽  
L. Bessette ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Predictive Ability ◽  
Study Drug ◽  
Inadequate Response ◽  
Research Support ◽  
First Occurrence ◽  
Activity Measures ◽  
Disease Activity Measures

Background:The primary treatment goal for patients (pts) with rheumatoid arthritis (RA) is a state of sustained clinical remission (REM) or low disease activity (LDA).1,2Objectives:To assess the long-term sustainability of response to upadacitinib (UPA), a JAK inhibitor, and adalimumab (ADA), both with background methotrexate (MTX), among pts with RA and prior inadequate response to MTX.Methods:In the phase 3, randomized, placebo (PBO) and active-controlled SELECT-COMPARE trial, pts on stable background MTX received UPA 15 mg once daily, PBO, or ADA 40 mg every other week. Pts not achieving 20% improvements in tender/swollen joint counts (Weeks 14-22) or LDA (CDAI ≤10 at Week 26) were rescued from UPA to ADA or PBO/ADA to UPA; all non-rescued PBO pts were switched to UPA at Week 26. This post hoc analysis evaluated clinical REM (CDAI ≤2.8; SDAI ≤3.3), LDA (CDAI≤10; SDAI≤11), and DAS28(CRP) <2.6/≤3.2 at first occurrence before Week 72 or prior to treatment switch; additionally, these measures were evaluated at 3, 6, and 12 months after the first occurrence for the total number of pts randomized to UPA (n=651) or ADA (n=327). Sustainability of response was evaluated by Kaplan-Meier only for those pts who achieved REM/LDA and was defined as time to the earliest date of losing response at two consecutive visits, discontinuation of study drug, or losing response at the time of rescue. The predictive ability of time to clinical REM/LDA was assessed using Harrell’s concordance (c)-index (for reference, an index ~ 0.5, indicates no ability to predict; an index of 1 or -1 would be a perfect prediction). The date of the last follow up was 6 July, 2018, when all pts had reached the Week 72 visit.Results:Through Week 72, a significantly higher proportion of pts receiving UPA + MTX vs ADA + MTX achieved CDAI REM (41% vs 31%, p=.0035) as well as CDAI LDA (70% vs 59%, p=.0007). 26%/22% of pts randomized to UPA + MTX and 16%/14% of pts randomized to ADA + MTX achieved sustained CDAI REM at 6/12 months after the first occurrence. Additionally, 49%/46% of pts randomized to UPA + MTX and 36%/34% of pts randomized to ADA + MTX achieved sustained CDAI LDA at 6/12 months after the first occurrence (Figure 1). Time to initial clinical REM/LDA did not appear to be associated with sustained disease control. The c-indices (95% CI) for CDAI REM in the UPA +MTX and ADA + MTX groups were 0.528 (0.48, 0.58) and 0.510 (0.43, 0.59) and that of LDA were 0.601 (0.56, 0.64) and 0.555 (0.50, 0.61), respectively. Through last follow-up visit, 51% of UPA + MTX pts and 45% of ADA + MTX pts remained in CDAI REM while 65% of UPA + MTX pts and 58% of ADA + MTX pts remained in CDAI LDA, respectively (Figure 2). Similar results were observed across other disease activity measures (SDAI REM/LDA and DAS28(CRP) <2.6/≤3.2).Conclusion:A significantly greater proportion of pts with RA and prior inadequate response to MTX receiving UPA + MTX vs ADA + MTX achieved clinical REM or LDA across disease activity measures. REM and LDA were sustained through Week 72 in both treatment arms, with numerically higher proportions retaining response among UPA-treated pts.References:[1]EULAR: Smolen JS, et al. Ann Rheum Dis 2017;76:960–977.[2]ACR: Singh et al. Arthritis & Rheumatology Vol. 68, No. 1, January 2016, pp 1–26.Disclosure of Interests:Peter Nash Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Arthur Kavanaugh Grant/research support from: Abbott, Amgen, AstraZeneca, BMS, Celgene Corporation, Centocor-Janssen, Pfizer, Roche, UCB – grant/research support, Maya H Buch Grant/research support from: Pfizer, Roche, and UCB, Consultant of: Pfizer; AbbVie; Eli Lilly; Gilead Sciences, Inc.; Merck-Serono; Sandoz; and Sanofi, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, In-Ho Song Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Yanna Song Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Jessica Suboticki Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Roy Fleischmann Grant/research support from: AbbVie, Akros, Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer, IngelhCentrexion, Eli Lilly, EMD Serono, Genentech, Gilead, Janssen, Merck, Nektar, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Roche, Samsung, Sandoz, Sanofi Genzyme, Selecta, Taiho, UCB, Consultant of: AbbVie, ACEA, Amgen, Bristol-Myers Squibb, Eli Lilly, Gilead, GlaxoSmithKline, Novartis, Pfizer, Sanofi Genzyme, UCB

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