scholarly journals POS1182 MANAGEMENT OF DIFFICULT-TO-TREAT RHEUMATOID ARTHRITIS DURING THE COVID-19 PANDEMIC: EVIDENCE FROM THE ITALIAN EPICENTER

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 872.1-872
Author(s):  
F. Ingegnoli ◽  
A. F. Luppino ◽  
G. Cincinelli ◽  
E. Favalli ◽  
R. Caporali
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Control Strategy ◽  
Targeted Therapies ◽  
Activity Index ◽  
Real Life ◽  
Treat To Target ◽  
Tight Control ◽  
Face To Face

Background:Despite significant improvement in the RA management, up to twenty percent of patients with rheumatoid arthritis (RA) have a difficult-to-treat (D2T) disease. The COVID-19 related mitigation policies, for instance quarantine, and consequent difficult access to in-person visits, laboratory and imaging investigations, adversely affected the follow up of rheumatic patients. Although pandemic-imposed limitations could have negatively influenced disease management particularly in D2T patients, to what degree these restrictions affected the treat-to target (T2T) and tight-control strategy in this subgroup of RA patients has not been investigated yet.Objectives:To evaluate whether the switch to telehealth imposed by COVID-19 pandemic was effective in the management of D2T RA patients treated with targeted therapies.Methods:This observational retrospective real-life study was conducted from November 2019 through September 2020. Among RA patients treated with targeted therapies, RA D2T patients according to EULAR definition (1) were identified. Clinical Disease Activity Index (CDAI) of these patients was analysed retrospectively before, during and after lockdown (LD). During LD period, patients could choose whether to receive home drug delivery or to maintain their face-to-face consultations, and in the former rheumatologists provided virtual care. To evaluate the effect of LD on the percentage of patients in remission, logistic mixed effects regression models were fitted, with CDAI remission as response variable.Results:Data were extracted from a longitudinal observational registry, and at baseline, 52 patients treated with targeted therapies were classified as D2T RA. Among them, during pre-LD, LD, and post-LD 11.54% (N=6), 53.49% (N=23), and 46.15% (N=24) had CDAI remission/low disease activity, while 46 (88.46%), 20 (46.51%) and 28 (53.85%) had CDAI moderate/high. All the patients completed the follow-up. Median values of CDAI during pre-LD, LD, and post-LD were 14.5 [IQR 12-21], 9 [IQR 5.5-16], and 11 [IQR 6-19.2] respectively (see Figure 1 below).Conclusion:Telephone-based tight control strategy ensured satisfactory management of D2T RA treated with targeted therapies. This temporary approach has been a feasible compensation for the decline of face-to-face visits also in this challenging group of RA patients, thus reassuring for future months before the end of pandemic.References:[1]Nagy G, et al. EULAR definition of difficult-to-treat rheumatoid arthritis. Ann Rheum Dis 2021;80(1):31-35.Disclosure of Interests:Francesca Ingegnoli: None declared, Angela Flavia Luppino: None declared, Gilberto Cincinelli: None declared, Ennio Favalli Speakers bureau: AbbVie, Sanofi-Genzyme, Lilly, UCB, Pfizer, Novartis, Janssen, Paid instructor for: Roche, MSD, Consultant of: Lilly, Galapagos, Roberto Caporali Speakers bureau: Abbvie, Amgen, BMS, Celltrion, Galapagos, Gilead, Lilly, Pfizer, Roche, UCB, Sanofi, Fresenius Kabi, Samsung bioepis, MSD, Consultant of: Galapagos, Gilead, Lilly,Janssen, MSD.

scholarly journals POS1178 THE ROLE OF VIRTUAL TELEPHONE VISITS IN THE TIGHT CONTROL OF RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TARGETED THERAPIES DURING THE COVID-19 PANDEMIC

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 870-871
Author(s):  
F. Ingegnoli ◽  
G. Cincinelli ◽  
A. F. Luppino ◽  
E. Favalli ◽  
R. Caporali
Keyword(s):  
Rheumatoid Arthritis ◽  
Drug Delivery ◽  
Multivariate Analysis ◽  
Control Strategy ◽  
Targeted Therapies ◽  
Male Gender ◽  
Tight Control ◽  
Face To Face ◽  
Virtual Care

Background:Rheumatic patients’ follow-up in terms of treatment adherence, disease control achieved with treat-to-target (T2T) and tight-control strategy have been deeply influenced by nationwide mitigation strategies such as quarantine, travel restrictions, and inadequate access to routine visits, laboratory and imaging investigations. These restrictions could be potentially detrimental for patients’ care, but to what extent these measures affected the T2T and tight-control approach in rheumatoid arthritis (RA) is unknown.Objectives:This study investigated whether the adoption of telephone virtual care imposed by COVID-19 pandemic has been effective in maintaining remission in RA treated with targeted therapies and to identify factors associated with its maintenance.Methods:This observational retrospective real-life study was conducted from November 2019 through September 2020. Clinical Disease Activity Index (CDAI) of RA patients treated with targeted therapies was analysed retrospectively before, during and after the national lockdown (LD). During LD period, rheumatologists provided virtual care by telephone to assess the clinical status to guarantee the absence of current contraindications to therapy. Then, patients could choose whether to receive home drug delivery or to maintain their face-to-face consultations. Logistic mixed effects regression models were fitted, with CDAI remission as response variable. A multivariate analysis and a parsimonious model were finally obtained by stepwise selection procedure using AIC.Results:Data were extracted from a longitudinal observational registry, and at baseline, 502 RA patients were eligible for this study. 52 patients failed to complete their follow-up, 450 patients were included in the final analysis. During LD, 359 patients chose in-person visit, 91 patients home drug delivery and virtual visit. Our cohort did not show a statistically significant decrease in the number of patients fulfilling CDAI remission criteria all along the three periods. Among the 450 patients evaluated, the CDAI remission rate was 40.22% (N=181) and 43.78% (N=197) during pre-LD and post-LD, respectively. As for the 359 patients who choose in-person visits during LD, 43.18% (N=155) were in remission according to CDAI. The final model (step-wise selection) applied to the multivariate analysis of factors that potentially could interfere with disease control in patients with CDAI remission showed that the probability to maintain remission was associated with Caucasian ethnicity, male gender and absence of fibromyalgia (Table 1 below).Table 1.Adjusted OR (95% CI)p-valuePeriod (LD vs Pre-LD)1.24 (0.83 - 1.85)0.292Period (Post-LD vs Pre-LD)1.22 (0.84 - 1.77)0.299Gender (male vs female)2.26 (1.15 - 4.61)0.020Disease duration (≥10 years vs <10 years)0.65 (0.36 - 1.15)0.141Ethnicity (Hispanic/Asian vs Caucasian)0.32 (0.12 - 0.83)0.021Fibromyalgia (yes vs no)0.30 (0.11 - 0.82)0.021Conclusion:Telephone-based tight control strategy ensured satisfactory management of RA treated with targeted therapies during the first wave of COVID-19 pandemic. All along the three periods, we observed that the probability to be in CDAI remission was significantly associated with Caucasian ethnicity, male gender, and absence of fibromyalgia. This temporary approach has been a feasible compensation for face-to-face visits, thus reassuring for future months before the end of pandemic.Disclosure of Interests:Francesca Ingegnoli: None declared, Gilberto Cincinelli: None declared, Angela Flavia Luppino: None declared, Ennio Favalli Speakers bureau: AbbVie, Sanofi-Genzyme, Lilly, UCB, Pfizer, Novartis, Janssen, Paid instructor for: Roche, MSD, Consultant of: Lilly, Galapagos, Roberto Caporali Speakers bureau: Abbvie, Amgen, BMS, Celltrion, Galapagos, Gilead, Lilly, Pfizer, Roche, UCB, Sanofi, Fresenius Kabi, Samsung bioepis, MSD, Consultant of: Galapagos, Gilead, Lilly,Janssen, MSD.

scholarly journals Treatment patterns and achievement of the treat-to-target goals in a real-life rheumatoid arthritis patient cohort: data from 1317 patients

2020 ◽  
Vol 12 ◽  
pp. 1759720X2093713
Author(s):  
Konstantinos Thomas ◽  
Argiro Lazarini ◽  
Evripidis Kaltsonoudis ◽  
Alexandros Drosos ◽  
Ioannis Papalopoulos ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Real Life ◽  
Treatment Patterns ◽  
Treat To Target ◽  
Number Of Patients ◽  
Co Morbidity ◽  
Male Sex ◽  
Morbidity Index

Background: Data regarding the real-life predictors of low disease activity (LDA) in rheumatoid arthritis (RA) patients are limited. Our aim was to evaluate the rate and predictors of LDA and treatment patterns in RA. Methods: This was a multicenter, prospective, RA cohort study where patients were evaluated in two different time points approximately 12 months apart. Statistical analysis was performed in order to identify predictors of LDA while patterns of disease-modifying anti-rheumatic drug [DMARDs; conventional synthetic (csDMARD) or biologic (bDMARD)] and glucocorticoid (GC) use were also recorded. Results: The total number of patients included was 1317 (79% females, mean age: 62.9 years, mean disease duration: 10.3 years). After 1 year, 57% had achieved LDA (DAS28ESR<3.2) while 43% did not (34%: moderate disease activity: DAS28ESR ⩾3.2 to <5.1, 9%: high disease activity, DAS28ESR ⩾5.1). By multivariate analysis, male sex was positively associated with LDA [odds ratio (OR) = 2.29 p < 0.001] whereas advanced age (OR = 0.98, p = 0.005), high Health Assessment Questionnaire (HAQ) score (OR = 0.57, p < 0.001), use of GCs (OR = 0.75, p = 0.037) or ⩾2 bDMARDs (OR = 0.61, p = 0.002), high co-morbidity index (OR = 0.86, p = 0.011) and obesity (OR = 0.62, p = 0.002) were negative predictors of LDA. During follow-up, among active patients (DAS28ESR >3.2), 21% initiated (among csDMARDs users) and 22% switched (among bDMARDs users) their bDMARDs. Conclusion: In a real-life RA cohort, during 1 year of follow-up, 43% of patients do not reach treatment targets while only ~20% of those with active RA started or switched their bDMARDs. Male sex, younger age, lower HAQ, body mass index and co-morbidity index were independent factors associated with LDA while use of GCs or ⩾2 bDMARDs were negative predictors.

scholarly journals AB0278 REAL LIFE EXPERIENCE OF DISEASE ACTIVITY AND QUALITY OF LIFE IN PATIENTS TREATED WITH BIOLOGICAL DMARDS VERSUS TOFACITINIB.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1438.2-1438
Author(s):  
V. Boyadzhieva ◽  
N. Stoilov ◽  
E. Kurteva ◽  
R. Stoilov
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Real Life ◽  
Disease Activity Index ◽  
Significant Difference ◽  
One Year

Background:Assessment of disease activity and quality of life are one of the main indicators for determining the effectiveness of treatment with disease-modifying antirheumatic drugs. In recent years, a new group has entered the market - target synthetic DMARDS, which prove their effectiveness in treating RA comparable to that of biological products.Objectives:The aim of this study is to evaluate the disease activity and quality of life of patients with rheumatoid arthritis (RA) treated with biological agents in comparison with Tofacitinib (real life data from Bulgarian population) and determine whether or not the benefits of different therapies were sustained over a follow up period of 1 year.Methods:164 patients were selected with a mean age 55.34 ± 16SD years, meeting the 1987 ACR and /or ACR/ EULAR (2010) classification criteria for Rheumatoid arthritis (RA). Patients were arranged according to treatment regimens: Tocilizumab (TCL) 30 patients, Certolizumab (CZP) 16, Golimumab (GOL) 22, Etanercept (ETN) 20, Adalimumab (ADA) 20, Rituximab (RTX) 16, Infliximab (INF) 20, Tofacitinib (TOF) 20. Disease activity and quality of life was the primary concern. Independent joint assessor evaluated 28 joints on baseline, 6th and 12th month’s thereafter. CRP was used to measure the inflammatory process.DAS28-CRP, clinical disease activity index (CDAI) and simplified disease activity index (SDAI)were calculated. On baseline all of the patients’ groups had severe disease activity (mean DAS28-CRP > 5.2, mean CDAI > 22, mean SDAI > 26. The quality of life was evaluated via EQ-5D.All of the patients were on stable therapy according to the inclusion criteria, and didn’t interrupt any of the medications including biological or target synthetic treatment.Results:Significant clinical improvement and statistically significant reduction in disease activity were observed in patients treated with bDMARDS and tsDMARDS within 6 months (p <0.005) of treatment and after 12 months of follow-up (p=0.039). The mean value of DAS28-CRP after one year follow up showed an non-inferior effect of Tofacitnib (3.04± 0.81) in comparison to biological treatment (TCL: 3.07 ± 0.73; CZP: 3.06 ± 0.65; GOL: 2.49 ± 0.76; ETN: 2.85 ± 0.55; ADA: 3.15 ± 0.82; RTX: 2.90 ± 0.70; INF: 3.14; ± 0.61; TOF: 3.04± 0.81). An improvement was also observed for the 6 to 12 months of follow-up as we did not detect a significant difference in the activity of the disease assessed by CDAI among the different drug groups.The mean values showing the change of the SDAI over the study period also outline comparable profiles. All of the treatment groups achieved a rapid reduction in disease activity that continued to decrease through the 6 and 12 months period, respectively, as supported by changes in SDAI.The quality of life evaluated with EQ-5D revealed significant improvement on the 6-th month of follow up as well as after 12th month (p<0.005) without significant difference between the observed groups.Conclusion:Real-life data show that patients on biological treatment as well as those on Tofacitinib therapy achieve a significant decrease in disease activity after one year of follow-up. This gives us reason to accept the importance of non-inferior effect of jak-inhibitors and their place in treatment of Rheumatoid arthritis.Disclosure of Interests:Vladimira Boyadzhieva: None declared, Nikolay Stoilov: None declared, Ekaterina Kurteva: None declared, Rumen Stoilov Grant/research support from: R-Pharm

scholarly journals Predicting achievement of the treatment targets at 6 months from 3-month response levels in rheumatoid arthritis: data from real-life follow-up in the NOR-DMARD study

RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000773 ◽  
Author(s):  
Vibeke Norvang ◽  
Joseph Sexton ◽  
Eirik K Kristianslund ◽  
Inge C Olsen ◽  
Till Uhlig ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Real Life ◽  
Disease Activity Index ◽  
Current Treatment ◽  
Treat To Target ◽  
Likelihood Ratios ◽  
Treatment Targets ◽  
Factor Inhibitor

ObjectiveWhen initiating a new therapy in patients with rheumatoid arthritis (RA), current treatment recommendations suggest escalating therapy in case of poor clinical improvement by 3 months or if the treatment target has not been reached by 6 months. We investigated which disease activity improvement levels at 3 months predicted achievement of the treatment targets at 6 months in a real-life clinical setting.MethodsWe included 1610 patients with RA enrolled in the NOR-DMARD study between 2000 and 2012. Analyses were performed for the total group of patients and repeated for subgroups stratified by baseline disease activity, disease duration or treatment with methotrexate or a tumour necrosis factor inhibitor. We used a diagnostic test approach to explore the associations between 3-month response and 6-month outcome.ResultsNot achieving 50% improvement in Simplified Disease Activity Index (SDAI) by 3 months significantly decreased the likelihood of reaching remission at 6 months in all subgroups (negative likelihood ratios (LRs−) 0.15–0.36). Patients with high disease activity when initiating treatment were likely to fail reaching remission if they achieved less than SDAI 70% response by 3 months (LR− 0.25 and negative predictive value 0.98). Achieving a major response (SDAI 85%) at 3 months significantly increased the likelihood of reaching remission at 6 months (LRs+ 6.56).ConclusionLevels of 3-month disease activity improvement can inform clinicians when deciding to continue or adjust ongoing therapy in a treat-to-target strategy aiming for remission or low disease activity within 6 months. The required levels of 3-month improvement varied with baseline disease activity.

scholarly journals AB0330 HIGH REMISSION RATES IN RA – REAL LIFE DATA FROM BARITICINIB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1463.2-1464
Author(s):  
S. Bayat ◽  
K. Tascilar ◽  
V. Kaufmann ◽  
A. Kleyer ◽  
D. Simon ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Cox Regression ◽  
Real Life ◽  
Inadequate Response ◽  
Research Support ◽  
Das 28 ◽  
Patient Reported ◽  
One Year

Background:Recent developments of targeted treatments such as targeted synthetic DMARDs (tsDMARDs) increase the chances of a sustained low disease activity (LDA) or remission state for patients suffering rheumatoid arthritis (RA). tsDMARDs such as baricitinib, an oral inhibitor of the Janus Kinases (JAK1/JAK2) was recently approved for the treatment of RA with an inadequate response to conventional (cDMARD) and biological (bDMARD) therapy. (1, 2).Objectives:Aim of this study is to analyze the effect of baricitinb on disease activity (DAS28, LDA) in patients with RA in real life, to analyze drug persistance and associate these effects with various baseline characteristics.Methods:All RA patients were seen in our outpatient clinic. If a patient was switched to a baricitinib due to medical reasons, these patients were included in our prospective, observational study which started in April 2017. Clinical scores (SJC/TJC 76/78), composite scores (DAS28), PROs (HAQ-DI; RAID; FACIT), safety parameters (not reported in this abstract) as well as laboratory biomarkers were collected at each visit every three months. Linear mixed effects models for repeated measurements were used to analyze the time course of disease activity, patient reported outcomes and laboratory results. We estimated the probabilities of continued baricitinib treatment and the probabilities of LDA and remission by DAS-28 as well as Boolean remission up to one year using survival analysis and explored their association with disease characteristics using multivariable Cox regression. All patients gave informed consent. The study is approved by the local ethics.Results:95 patients were included and 85 analyzed with available follow-up data until November 2019. Demographics are shown in table 1. Mean follow-up duration after starting baricitinib was 49.3 (28.9) weeks. 51 patients (60%) were on monotherapy. Baricitinib survival (95%CI) was 82% (73% to 91%) at one year. Cumulative number (%probability, 95%CI) of patients that attained DAS-28 LDA at least once up to one year was 67 (92%, 80% to 97%) and the number of patients attaining DAS-28 and Boolean remission were 31 (50%, 34% to 61%) and 12(20%, 9% to 30%) respectively. Median time to DAS-28 LDA was 16 weeks (Figure 1). Cox regression analyses did not show any sufficiently precise association of remission or LDA with age, gender, seropositivity, disease duration, concomitant DMARD use and number of previous bDMARDs. Increasing number of previous bDMARDs was associated with poor baricitinib survival (HR=1.5, 95%CI 1.1 to 2.2) while this association was not robust to adjustment for baseline disease activity. Favorable changes were observed in tender and swollen joint counts, pain-VAS, patient and physician disease assessment scores, RAID, FACIT and the acute phase response.Conclusion:In this prospective observational study, we observed high rates of LDA and DAS-28 remission and significant improvements in disease activity and patient reported outcome measurements over time.References:[1]Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Annals of the rheumatic diseases. 2015 Feb;74(2):333-40.[2]Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, et al. Baricitinib in Patients with Refractory Rheumatoid Arthritis. The New England journal of medicine. 2016 Mar 31;374(13):1243-52.Figure 1.Cumulative probability of low disease activity or remission under treatment with baricitinib.Disclosure of Interests:Sara Bayat Speakers bureau: Novartis, Koray Tascilar: None declared, Veronica Kaufmann: None declared, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Johannes Knitza Grant/research support from: Research Grant: Novartis, Fabian Hartmann: None declared, Susanne Adam: None declared, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, EIT Health, EU-IMI, DFG, Universität Erlangen (EFI), Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB

scholarly journals Do Poor Prognostic Factors in Rheumatoid Arthritis Affect Treatment Choices and Outcomes? Analysis of a US Rheumatoid Arthritis Registry

2018 ◽  
Vol 45 (10) ◽  
pp. 1353-1360 ◽  
Author(s):  
Evo Alemao ◽  
Heather J. Litman ◽  
Sean E. Connolly ◽  
Sheila Kelly ◽  
Winnie Hua ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Prognostic Factors ◽  
Disease Activity ◽  
Clinical Outcomes ◽  
Activity Index ◽  
Functional Limitation ◽  
Disease Activity Index ◽  
Treat To Target ◽  
Work Status ◽  
Logistic Regression Models

Objective.To characterize patients with rheumatoid arthritis (RA) by number of poor prognostic factors (PPF: functional limitation, extraarticular disease, seropositivity, erosions) and evaluate treatment acceleration, clinical outcomes, and work status over 12 months by number of PPF.Methods.Using the Corrona RA registry (January 2005–December 2015), biologic-naive patients with diagnosed RA having 12-month (± 3 mos) followup were identified and categorized by PPF (0–1, 2, ≥ 3). Changes in medication, Clinical Disease Activity Index (CDAI), and work status (baseline–12 mos) were evaluated using linear and logistic regression models.Results.There were 3458 patients who met the selection criteria: 1489 (43.1%), 1214 (35.1%), and 755 (21.8%) had 0–1, 2, or ≥ 3 PPF, respectively. At baseline, patients with ≥ 3 PPF were older, and had longer RA duration and higher CDAI versus those with 0–1 PPF. In 0–1, 2, and ≥ 3 PPF groups, respectively, 20.9%, 23.2%, and 26.5% of patients received ≥ 1 biologic (p = 0.011). Biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) use was similar in patients with/without PPF (p = 0.57). After adjusting for baseline CDAI, mean (standard error) change in CDAI was −4.95 (0.24), −4.53 (0.27), and −2.52 (0.34) for 0–1, 2, and ≥ 3 PPF groups, respectively. More patients were working at baseline but not at 12-month followup in 2 (13.9%) and ≥ 3 (12.5%) versus 0–1 (7.3%) PPF group.Conclusion.Despite high disease activity and worse clinical outcomes, number of PPF did not significantly predict biologic/tsDMARD use. This may warrant reconsideration of the importance of PPF in treat-to-target approaches.

scholarly journals Switching between Janus kinase inhibitor upadacitinib and adalimumab following insufficient response: efficacy and safety in patients with rheumatoid arthritis

2020 ◽  
pp. annrheumdis-2020-218412
Author(s):  
Roy M Fleischmann ◽  
Ricardo Blanco ◽  
Stephen Hall ◽  
Glen T D Thomson ◽  
Filip E Van den Bosch ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Kinase Inhibitor ◽  
Activity Index ◽  
Disease Activity Index ◽  
Initial Therapy ◽  
Janus Kinase ◽  
Treat To Target ◽  
Efficacy And Safety ◽  
Insufficient Response

ObjectivesTo evaluate efficacy and safety of immediate switch from upadacitinib to adalimumab, or vice versa, in patients with rheumatoid arthritis with non-response or incomplete-response to the initial therapy.MethodsSELECT-COMPARE randomised patients to upadacitinib 15 mg once daily (n=651), placebo (n=651) or adalimumab 40 mg every other week (n=327). A treat-to-target study design was implemented, with blinded rescue occurring prior to week 26 for patients who did not achieve at least 20% improvement in both tender and swollen joint counts (‘non-responders’) and at week 26 based on Clinical Disease Activity Index (CDAI) >10 (‘incomplete-responders’) without washout.ResultsA total of 39% (252/651) and 49% (159/327) of patients originally randomised to upadacitinib and adalimumab were rescued to the alternate therapy. In both switch groups (adalimumab to upadacitinib and vice versa) and in non-responders and incomplete-responders, improvements in disease activity were observed at 3 and 6 months following rescue. CDAI low disease activity was achieved by 36% and 47% of non-responders and 45% and 58% of incomplete-responders switched to adalimumab and upadacitinib, respectively, 6 months following switch. Overall, approximately 5% of rescued patients experienced worsening in disease activity at 6 months postswitch. The frequency of adverse events was similar between switch groups.ConclusionsThese observations support a treat-to-target strategy, in which patients who fail to respond initially (or do not achieve sufficient response) are switched to a therapy with an alternate mechanism of action and experience improved outcomes. No new safety findings were observed despite immediate switch without washout.

scholarly journals Clinical and ultrasound remission after 6 months of treat-to-target therapy in early rheumatoid arthritis: associations to future good radiographic and physical outcomes

2018 ◽  
Vol 77 (10) ◽  
pp. 1421-1425 ◽  
Author(s):  
Nina Paulshus Sundlisæter ◽  
Anna-Birgitte Aga ◽  
Inge Christoffer Olsen ◽  
Hilde Berner Hammer ◽  
Till Uhlig ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Radiographic Progression ◽  
Activity Index ◽  
Power Doppler ◽  
Disease Activity Index ◽  
Treat To Target ◽  
Good Outcome ◽  
Grey Scale

ObjectiveTo explore associations between remission, based on clinical and ultrasound definitions, and future good radiographic and physical outcome in early rheumatoid arthritis (RA).MethodsNewly diagnosed patients with RA followed a treat-to-target strategy incorporating ultrasound information in the Aiming for Remission in rheumatoid arthritis: a randomised trial examining the benefit of ultrasound in a Clinical TIght Control regimen (ARCTIC) trial. We defined 6-month remission according to Disease Activity Score, Disease Activity Score in 28 joints-erythrocyte sedimentation rate, American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean criteria, Simplified Disease Activity Index, Clinical Disease Activity Index and two ultrasound definitions (no power Doppler signal, grey scale score ≤2). Two outcomes were defined: no radiographic progression and good outcome (no radiographic progression+physical function≥general population median), both sustained 12–24 months. We calculated the ORs of these outcomes for the remission definitions.ResultsOf 103 patients, 42%–82% reached remission at 6 months, dependent on definition. Seventy-one per cent of patients had no radiographic progression and 37% had good outcome. An association between 6-month remission and no radiographic progression was observed for ACR/EULAR Boolean remission (44 joints, OR 3.2, 95% CI 1.2 to 8.4), ultrasound power Doppler (OR 3.6, 95% CI 1.3 to 10.0) and grey scale remission (OR 3.2, 95% CI 1.2 to 8.0). All clinical, but not ultrasound remission criteria were associated with achievement of a good outcome.ConclusionsOur data support ACR/EULAR Boolean remission based on 44 joints as the preferred treatment target in early RA. Absence of ultrasound inflammation was associated with no radiographic progression.Trial registration numberNCT01205854; Post-results.

OP129 Predictors Of Effectiveness In Patients With Rheumatoid Arthritis

2017 ◽  
Vol 33 (S1) ◽  
pp. 59-60
Author(s):  
Jéssica dos Santos ◽  
Haliton Oliveira ◽  
Francisco Acurcio Michael da Silva ◽  
Alessandra Almeida ◽  
Flávia Rodrigues ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Univariate Analysis ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Chi Square ◽  
Low Disease Activity ◽  
Gender Education

INTRODUCTION:Biological disease-modifying anti-rheumatic drugs (bDMARDs) have become firmly established in the management of patients with rheumatoid arthritis (RA), but some patients do not improve despite therapy. This study evaluated the predictors of effectiveness of the bDMARDs on a cohort of patients with rheumatoid arthritis (RA) in the Brazilian Public Health System.METHODS:RA individuals treated with bDMARDs, were included in the open prospective cohort study. The Clinical Disease Activity Index (CDAI) was used to assess the effectiveness comparing results at baseline and after 6 months of follow-up. The association between socio-demographic and clinical characteristics with the disease activity measured by the CDAI was also investigated. The bDMARDs was considered effective when the patient achieved remission or low disease activity and considered not effective when there was still moderate or high disease activity. Pearson's chi-square was applied for the univariate analysis to evaluate the association of effectiveness measured by the CDAI with the socio-demographic (gender, education, marital status and race) and clinical variables (type of drug, EuroQol (EQ)-5D and Health Assessment Questionnaire (HAQ)). Logistic regression was applied in the multivariate analysis of the variables that presented a p< .20 value during the univariate analysis.RESULTS:All 266 RA patients completed six months of follow-up. The most widely used bDMARDs was adalimumab (57.1 percent), with etanercept used by 22.2 percent, golimumab by 7.5 percent, abatacept by 4.5 percent, tocilizumab by 3.4 percent, infliximab by 2.6 percent, certolizumab by 1.5 percent, and rituximab by 1.1 percent. The bDMARDs reduced disease activity as measured by CDAI at six months of follow-up (p<.001). The percentage of patients achieving remission or low disease activity was 40.6 percent. bDMARDs were more effective in patients with better functionality (Odds Ratio, OR = 2.140 / 95 percent Confidence Interval, CI 1.219 - 3.756) at beginning of treatment and in patients who not had a previous bDMARDs (OR = 2.150 / 95 percent CI 1.144 - 4.042).CONCLUSIONS:In this real-world study, functionality and use of previous bDMARDs are predictors in patients with RA treated with bDMARDs.

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