scholarly journals OP0154-HPR EFFECT OF NURSE-LED-CARE ON PATIENT OUTCOMES IN RHEUMATOID ARTHRITIS IN GERMANY: A MULTICENTRE RANDOMISED CONTROLLED TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 97-98
Author(s):  
J. R. Hoeper ◽  
G. Gauler ◽  
D. Meyer-Olson ◽  
K. Rockwitz ◽  
P. Steffens-Korbanka ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Standard Of Care ◽  
Research Support ◽  
Current Standard ◽  
Clinical Nurse ◽  
Clinical Nurse Specialists ◽  
The Mean ◽  
Secondary Outcomes ◽  
Over Time

Background:Inflammatory rheumatic disorders are very complex and require high medical resources. However, there is a shortage of care for these patients, which results in suboptimal reach of therapy objectives. Nevertheless, these very objectives need to be pursued quickly to prevent permanent joint damage. In order to ensure adequate care, multidisciplinary teams which include clinical nurse specialists are required. These clinical nurse specialists play an important role in improving standard-of-care in addition to the rheumatologist. The current standard of care ensures that essential medical provision remains intact, however, psychological, social, rehabilitative and educational needs are often skipped due to time constraints. While studies from e.g. the UK and Denmark have already supported the non-inferiority of nurse-led care (NLC)1, no such studies have yet been published in Germany.Objectives:To demonstrate the non-inferiority of NLC to the current standard-of-care, rheumatologist-led care (RLC), for patients with seropositive rheumatoid arthritis (RA) with induction, escalation or change of therapy regarding disease activity as well as different patient reported outcomes (PROs).Methods:This trial was conducted as a prospective multi-centered RCT with a non-inferiority design over the course of 12 months. Based on power calculations, 236 adults with RA were included in the study and randomized to either NLC or RLC. The primary outcome measure is disease activity (DAS28), assessed at baseline (T0), 6 weeks (T1), 3,6, 9, and 12 months (T3, T6, T9, T12). Secondary measures are health related quality of life (RAID), functionality (FFbH) and depression (PHQ9).Results:There are no significant differences between intervention group (IG) (n=117) and control group (CG) (n=119) at baseline. The mean age of the IG is 58.80 years (SD=12.09) and of the CG 58.34 years (SD=11.72). 72.4% of the IG and 78.1% of the CG are female. The mean duration of symptoms was 147 months (SD=144.63) for the IG and 116 months (108.89) for the CG. The mean DAS28 for the IG is 4.36 (SD=1.24) and 4.51 (SD=1.24) for the CG.A mixed one-way repeated measures ANOVA showed that the DAS28 improves significantly over time, Huyn-FeldtF(4.42, 751.72) = 105.701,p< .001, partialη2= 0.383, but the interaction of the DAS28 and the randomization is not significant, Huyn-FeldtF(4.42, 751.72) = 1.464,p= 0.260, partialη2= 0.009. No main effect for randomization was found, meaning that the IG and CG did not differ significantly,F(1, 170) = 1.005,p= 0.317, partialη2= 0.006.The Mann-Whitney-Test showed that the change of the secondary outcomes does not depend on the randomization FFbHU= 4978.50,Z= -.755,p=.450. RAIDU= 5121.00,Z= -.539,p=.590. PHQ9U= 4800.50,Z= -1.281,p=.200. The secondary outcomes improve significantly over time, as shown by a Wilcoxon Signed Rank test for the FFbHZ= -5.589,p< .001, the RAIdZ= -9.884,p< .001 and the PHQ9Z= -7.960,p< .001.Conclusion:The results support the non-inferiority of NLC in the management of RA regarding the primary and secondary outcome measures and provide first evidence that NLC could improve care and help carry the doctors’ workflow.Figure 1.Figure 2.References:[1]de Thurah A, Esbensen BA, Roelsgaard IK, et al. Efficacy of embedded nurse-led versus conventional physician-led follow-up in rheumatoid arthritis: a systematic review and meta-analysis. RMD Open 2017;3:e000481.Disclosure of Interests:Juliana R Hoeper: None declared, Georg Gauler Consultant of: Abbvie, Lilly, MSD, Speakers bureau: Abbvie, Celgene, Novartis, Sanofi,, Dirk Meyer-Olson Grant/research support from: Novartis, Sandoz Hexal, Consultant of: Abbvie, Amgen, Bristol Myers Squibb, Chugai, Lilly, Mylan, Novartis, Sandoz Hexal, Sanofi, Speakers bureau: Abbvie, Bristol Myers Squibb, Chugai, Lilly, Novartis, Pfizer, Sandoz Hexal, Sanofi, Karin Rockwitz Consultant of: Janssen Cilag, Speakers bureau: Janssen Cilag, Patricia Steffens-Korbanka Consultant of: Abbvie, Chugai, Novartis, Sanofi, Mylan, Lilly, Speakers bureau: Abbvie, Chugai, Novartis, Sanofi, Lilly, Carsten Stille: None declared, Jochen Walter Consultant of: Pfizer, Speakers bureau: AbbVie, Frauenhofer Institut, Gilead, Janssen-Cilag, Medac, Novartis, Pfizer, Martin Welcker Grant/research support from: Abbvie, Novartis, UCB, Hexal, BMS, Lilly, Roche, Celgene, Sanofi, Consultant of: Abbvie, Actelion, Aescu, Amgen, Celgene, Hexal, Janssen, Medac, Novartis, Pfizer, Sanofi, UCB, Speakers bureau: Abbvie, Aescu, Amgen, Biogen, Berlin Chemie, Celgene, GSK, Hexal, Mylan, Novartis, Pfizer, UCB, Joerg Wendler Consultant of: Janssen, AbbVie, Sanofi, Speakers bureau: Roche, Chugai, Janssen, AbbVie, Novartis, Jan Zeidler: None declared, Kirsten Hoeper Consultant of: AbbVie, Celgene,, Speakers bureau: Abbvie, Chugai, Novartis, Lilly, Celgene, Sandoz Hexal

scholarly journals FRI0020 CLINICAL TREATMENT RESPONSE STILL DOES NOT MATCH PATIENT REPORTED IMPROVEMENT, EVEN IN EARLY RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 582.1-582
Author(s):  
S. Pazmino ◽  
A. Lovik ◽  
A. Boonen ◽  
D. De Cock ◽  
V. Stouten ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Health Assessment ◽  
Sustained Remission ◽  
Research Support ◽  
Early Ra ◽  
Severity Scores ◽  
Patient Reported ◽  
Over Time

Background:Commonly used disease activity scores in rheumatoid arthritis (RA) include one patient reported outcome (PRO) -the patient’s global health assessment (PGA). Exploratory factor analysis (EFA) was performed on data from the 2 year Care in early Rheumatoid Arthritis (CareRA) trial to explain the evolution of disease burden extracting 3 factors.1Objectives:To assess the evolution and relative responsiveness over time of clinical, laboratory and patient assessments included in composite scores, together with other PROs like pain, fatigue and functionality in patients with early RA (≤1 year) treated to target (T2T) within the CareRA trial.Methods:DMARD naïve patients with early RA (n=379) were included, randomized to remission induction with COBRA-like treatment schemes (n=332) or MTX monotherapy (n=47) and T2T.Components of disease activity scores (swollen/tender joint count (S/TJC), C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), and physician (PhGH) or patient (PGA) global health assessment), pain and fatigue (both on 0-100 scale) and HAQ were recorded at every visit.Missing data was handled with multiple imputation (n=15). Clustering was removed with multiple outputation (n=1000), then each of the 15 000 datasets was analyzed by EFA with principal component extraction and oblimin rotation. The analyses were combined after re-ordering the factors by maximizing factor congruence. The 3 extracted factors and their individual components (with their loadings) were: 1. Patient containing PGA (0.87), pain (0.86), fatigue (0.90) and HAQ (0.5) 2.Clinical with SJC (0.92), TJC (0.89) and PhGH (0.76) and 3.Laboratory with CRP(0.87) and ESR (0.78).1(Pazmino, ACR 2019 abstract, Table 3)Afterwards, variables were first normalized to a 0-1 scale, then multiplied -weighted- by the factor loadings previously obtained.1For each Patient, Clinical and Laboratory severity score, the weighted variables belonging to each score were summed together and then re-scaled to 0-1 (higher values suggest more burden).The percentage (%) improvement from baseline to week 104 and the area under the curve (AUC) across time points were calculated per factor.Differences in % improvement and AUC were compared between patients not achieving and achieving early and sustained (week 16 to 104) disease activity score remission (DAS28CRP <2.6) with ANOVA. Bonferroni correction was used for multiple testing.Results:Severity scores of Patient, Clinical and Laboratory factors improved rapidly over time (Figure 1). In patients achieving sustained remission (n=122), Patient, Clinical and Laboratory scores improved 56%, 90% and 27% respectively. In patients not achieving sustained remission (n=257) the improvement was 32%, 78% and 9% respectively (p<0.001 only for clinical improvement).Patients in CareRA who achieved sustained remission had an AUC of 15.1, 3.4 and 4.7 in Patient, Clinical and Laboratory scores respectively, compared to 32.3, 10.0, and 7.2 in participants not achieving sustained remission (p<0.001 for all comparisons).Conclusion:Patient, Clinical and Laboratory severity scores improved rapidly over time in patients achieving rapid and sustained disease control. However, overall, Patient burden seemed not to improve to the same extent as Clinical burden. Patient’s unmet needs in terms of pain, fatigue, functionality and overall well-being should thus be given more attention, even in patients in sustained remission.References:[1]Pazmino S,et al.Including Pain, Fatigue and Functionality Regularly in the Assessment of Patients with Early Rheumatoid Arthritis Separately Adds to the Evaluation of Disease Status [abstract]. ACR. 2019.Disclosure of Interests:Sofia Pazmino: None declared, Anikó Lovik: None declared, Annelies Boonen Grant/research support from: AbbVie, Consultant of: Galapagos, Lilly (all paid to the department), Diederik De Cock: None declared, Veerle Stouten: None declared, Johan Joly: None declared, Delphine Bertrand: None declared, Rene Westhovens Grant/research support from: Celltrion Inc, Galapagos, Gilead, Consultant of: Celltrion Inc, Galapagos, Gilead, Speakers bureau: Celltrion Inc, Galapagos, Gilead, Patrick Verschueren Grant/research support from: Pfizer unrestricted chair of early RA research, Speakers bureau: various companies

scholarly journals Long-term effectiveness and safety of infliximab, golimumab and golimumab-IV in rheumatoid arthritis patients from a Canadian prospective observational registry

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Proton Rahman ◽  
Philip Baer ◽  
Ed Keystone ◽  
Denis Choquette ◽  
Carter Thorne ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Randomized Clinical Trials ◽  
Disease Duration ◽  
Routine Care ◽  
Treatment Modalities ◽  
The Mean ◽  
Over Time

Abstract Background Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care. Methods RA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival. Results Of the 890 IFX-, 530 GLM- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0–86.6%, the mean ages from 55.8–57.7 and the mean disease duration from 6.5–8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM- and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM- and GLM-IV-treated patients, respectively. Conclusion Differences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM. Trial registration ClinicalTrials.gov Identifier: NCT00741793 (Retrospectively registered on August 26, 2008).

scholarly journals Long-Term Effectiveness and Safety of Infliximab, Golimumab and Golimumab-IV in Rheumatoid Arthritis Patients from a Canadian Prospective Observational Registry

2020 ◽  
Author(s):  
Proton Rahman ◽  
Philip Baer ◽  
Ed Keystone ◽  
Denis Choquette ◽  
Carter Thorne ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Randomized Clinical Trials ◽  
Disease Duration ◽  
Routine Care ◽  
Treatment Modalities ◽  
The Mean ◽  
Over Time

Abstract Background: Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care.Methods: RA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival.Results: Of the 890 IFX-, 530 GLM-SC- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0-86.6%, the mean ages from 55.8-57.7 and the mean disease duration from 6.5-8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM-SC and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM-SC and GLM-IV-treated patients, respectively. Conclusion: Differences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM.Trial Registration: NCT00741793

Utilization Trends of Tumor Necrosis Factor Inhibitors Among Patients with Rheumatoid Arthritis in a United States Observational Cohort Study

2009 ◽  
Vol 36 (8) ◽  
pp. 1611-1617 ◽  
Author(s):  
SUSAN J. LEE ◽  
HONG CHANG ◽  
YUSUF YAZICI ◽  
JEFFREY D. GREENBERG ◽  
JOEL M. KREMER ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Tumor Necrosis Factor ◽  
Disease Activity ◽  
Tumor Necrosis ◽  
Tnf Inhibitors ◽  
Tnf Inhibitor ◽  
Early Ra ◽  
The Mean ◽  
Necrosis Factor ◽  
Over Time

Objective.Studies have suggested that early institution of tumor necrosis factor (TNF) inhibitors improves functional status and slows radiographic progression among patients with rheumatoid arthritis (RA). To determine whether these findings have altered practice patterns, we used the Consortium of Rheumatology Researchers of North America (CORRONA) registry to assess the pattern of TNF inhibitor utilization in the US over time.Methods.Demographics and disease activity data were collected for patients with RA. The trend of TNF inhibitor use during 2002–06 was evaluated prospectively using linear and logistic regression models.Results.Of the 11,397 patients with RA, 66% and 34% had established RA and early RA (disease duration < 3 yrs), respectively. The majority of patients were female and Caucasian. Despite comparable levels of disease activity, more of the patients with established RA were taking TNF inhibitors than those with early RA (40% vs 25%; p < 0.0001). The majority of patients (70%) taking TNF inhibitors were also receiving disease modifying antirheumatic drugs. The use of TNF inhibitors increased at a rate of 2.8% per year in established RA and 1.2% per year in early RA. The mean Clinical Disease Activity Index at the start of TNF inhibitors decreased at a rate of −0.233 per quarter (p = 0.006), while the mean Disease Activity Score decreased at a rate of −0.04 per quarter (p = 0.022).Conclusion.Utilization of TNF inhibitors in this multicenter, observational US cohort is increasing in both early and established RA, although it is more prominent among patients with established RA. The level of disease activity at which TNF inhibitors were initiated decreased over time in patients with both established and early RA.

scholarly journals Long-Term Effectiveness and Safety of Infliximab, Golimumab and Golimumab-IV in Rheumatoid Arthritis Patients from a Canadian Prospective Observational Registry

2020 ◽  
Author(s):  
Proton Rahman ◽  
Philip Baer ◽  
Ed Keystone ◽  
Denis Choquette ◽  
Carter Thorne ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Randomized Clinical Trials ◽  
Disease Duration ◽  
Routine Care ◽  
Treatment Modalities ◽  
The Mean ◽  
Over Time

Abstract Background Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care. Methods RA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival. Results Of the 890 IFX-, 530 GLM-SC- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0-86.6%, the mean ages from 55.8-57.7 and the mean disease duration from 6.5-8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM-SC and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM-SC and GLM-IV-treated patients, respectively. Conclusion Differences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM.

scholarly journals POS0305 PHYSICIAN AND PATIENT ATTITUDES TOWARDS TREAT-TO-TARGET, ITS IMPLEMENTATION AND STATED TREATMENT GOALS IN PATIENTS WITH RHEUMATOID ARTHRITIS IN A REAL-WORLD SETTING ACROSS EUROPE

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 378-379
Author(s):  
B. Fautrel ◽  
R. Caporali ◽  
E. Holdsworth ◽  
B. Donaghy ◽  
M. Khalid ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Real World ◽  
Current Treatment ◽  
High Disease Activity ◽  
Clinical State ◽  
Treat To Target ◽  
Treatment Goals ◽  
Research Support ◽  
Reduction Of Pain

Background:The principles of treat to target (T2T) include defining an appropriate treatment target, assessed at pre-defined intervals, with a commitment to changing therapeutic approach if the target is not met (1). T2T is recommended as a key strategy for the treatment of rheumatoid arthritis (RA).Objectives:To explore attitudes towards T2T, its implementation and stated treatment goals among physicians and their patients with RA.Methods:The Adelphi RA Disease Specific Programme™ was a large, quantitative, point-in-time survey conducted amongst rheumatologists (n=296) and their consulting patients with RA (n=3042) in Europe (France, Germany, Italy, Spain, UK) between Q4 2019–Q3 2020. Physicians were recruited via publicly available lists, completing an online survey and medical record extraction for their next 10–12 consecutive patients. The same patients were invited to voluntarily complete a self-report questionnaire (n=1098, 36% response), collecting data on attitudes towards T2T and treatment goals.Results:Physicians reported that 76% of patients were in remission (DAS28: <2.6) or had low disease activity (DAS28: 2.6 – 3.2), and 24% had moderate-high disease activity (DAS28: >3.2). Patient mean age was 53.0 years (SD 14.0), mean time since diagnosis was 7.2 years (SD 7.2). The proportion of patients currently receiving an advanced therapy (AT; defined as biologic or targeted synthetic DMARD) was 68%, of whom 70% were on a first line AT. No difference was observed between disease activity groups.In the physician survey, 86% of physicians stated they followed T2T principals in at least some of their RA patients, and would utilize a T2T approach in RA patients with moderate-high disease activity (61%), the most uncontrolled patients (37%) and those who do not respond well to initial therapy (34%). In this sample of real-world RA patients, 66% were reported by physicians to be on a T2T plan at the time of data collection. The most common physician-reported targets were remission (DAS28: <2.6) (75%), improvement of quality of life (QoL) (41%) and reduction of pain (31%), with 85% of physicians perceiving these treatment goals were fully or partially met. The most stated reasons for not implementing T2T was physician preference not to adjust current treatment (34%), patient preference not to adjust current treatment (23%), and there are no achievable goals for this patient (16%).Overall, 29% of patients reported they were involved in setting their T2T goals, while 34% stated their T2T goals were set by their physicians only, and 29% perceived no T2T goal had been set (n=620). The most common overall T2T goals from the patient perspective were remission (61%), controlling symptoms (41%), and reducing impact on QoL (34%). Of those patients who acknowledged a T2T goal had been set (n=407), 77% reported their T2T goal was fully or partially achieved.Of 719 patients who had moderate-high disease activity, 57% were on a T2T plan, with 46% of physicians perceiving these treatment goals were fully or partially met. The most common physician-stated reason for not implementing T2T was a lack of achievable targets (29%).Conclusion:Rheumatologists in this study reported a strong belief in T2T. The most common physician-set T2T goals were remission, improvement of QoL and reduction of pain, corresponding with T2T goals as reported by patients. However, a third of patients in this cohort were not aware of a defined T2T objective in their management, which may be a result of a perceived lack of achievable goals by physicians. It may be desirable to promote more patient involvement in defining achievable targets amongst those with moderate-high disease activity who despite best efforts may not reach a clinical state of remission. Further research is needed to identify and understand goals important to RA patients.References:[1]van Vollenhoven R. Treat-to-target in rheumatoid arthritis - are we there yet? Nat Rev Rheumatol. 2019;15(3):180-6.Acknowledgements:This study was funded by Galapagos NV, Belgium.Medical writing support was provided by Gary Sidgwick, PhD (Adelphi Real World, Bollington, UK) and editorial support was provided by Debbie Sherwood, BSc, CMPP (Aspire Scientific, Bollington, UK), both funded by Galapagos NV.Disclosure of Interests:Bruno Fautrel Consultant of: AbbVie, Amgen, Biogen, BMS, Celgene, Celltrion, Fresenius Kabi, Gilead, Janssen, Lilly, Medac, MSD, Mylan, NORDIC Pharma, Novartis, Pfizer, Roche, Sandoz, Sanofi-Genzyme, SOBI, UCB, Grant/research support from: AbbVie, Lilly, MSD, Pfizer, Roberto Caporali Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Galapagos, Gilead, Lilly, Pfizer, Roche, UCB, Sanofi, Fresenius Kabi, Samsung Bioepis, MSD, Consultant of: Galapagos, Gilead, Lilly, Janssen, MSD, Elizabeth Holdsworth Employee of: Adelphi Real World, Bethany Donaghy Employee of: Adelphi Real World, Mona Khalid Shareholder of: Galapagos, Employee of: Galapagos, Mark Moore Shareholder of: Gilead Sciences, Speakers bureau: Gilead Sciences (only as employee), Paid instructor for: Gilead Sciences (only as employee), Consultant of: Gilead Sciences (only as employee), Grant/research support from: Gilead Sciences (only as employee), Employee of: Gilead Sciences, and previously Sanofi and AstraZeneca, Katrien Van Beneden Shareholder of: Galapagos, Employee of: Galapagos, Yves Piette Consultant of: AbbVie, Amgen, Galapagos, Grünenthal and Sandoz, Grant/research support from: Amgen, Mylan and UCB, Susana Romero-Yuste Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Grunenthal, Kern Pharma, Lilly, Roche, Sandoz, Sanofi, UCB, Janssen, Consultant of: AbbVie, Biogen, Fresenius, Galapagos, Gebro, Janssen, Lilly, Grant/research support from: Bristol Myers Squibb, MSD, Novartis, Pfizer, Jasper Broen Shareholder of: Pharming Group, Consultant of: Galapagos, Gilead, Novartis, Peter C. Taylor Consultant of: AbbVie, Biogen, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Pfizer, Roche, Sanofi, Nordic Pharma, Fresenius, UCB, Grant/research support from: Celgene, Galapagos, Gilead, Lilly

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 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

scholarly journals SAT0039 ADAPTIVE DEEP LEARNING FOR THE PREDICTION OF INDIVIDUAL DISEASE ACTIVITY IN PATIENTS WITH RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 950.1-950
Author(s):  
M. Hügle ◽  
G. Kalweit ◽  
U. Walker ◽  
A. Finckh ◽  
R. Muller ◽  
...  
Keyword(s):  
Neural Network ◽  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Deep Neural Networks ◽  
Disease Duration ◽  
Research Support ◽  
Disease Characteristics ◽  
Individual Disease ◽  
Active Disease ◽  
Research Grant

Background:Rheumatoid arthritis (RA) lacks reliable biomarkers that predict disease evolution on an individual basis, potentially leading to over- and undertreatment. Deep neural networks learn from former experiences on a large scale and can be used to predict future events as a potential tool for personalized clinical assistance.Objectives:To investigate deep learning for the prediction of individual disease activity in RA.Methods:Demographic and disease characteristics from over 9500 patients with 65.000 visits from the Swiss Quality Management (SCQM) database were used to train and evaluate an adaptive recurrent neural network (AdaptiveNet). Patient and disease characteristics along with clinical and patient reported outcomes, laboratory values and medication were used as input features. DAS28-BSR was used to predict active disease and future numeric individual disease activity by classification and regression, respectively.Results:AdaptiveNet predicted active disease defined as DAS28-BSR>2.6 at the next visit, with an overall accuracy of 75.6% and a sensitivity and specificity of 84.2% and 61.5%, respectively. Apart from DAS28-BSR, the most influential characteristics to predict disease activity were joint pain, disease duration, age and medication. Longer disease duration, age >50 or antibody positivity marginally improved prediction performance. Regression allowed forecasting individual DAS28-BSR values with a mean squared error of 0.9.Conclusion:Deep neural networks have the capacity to predict individual disease outcome in RA. Low specificity remains challenging and might benefit from alternative input data or outcome targets.References:[1] Hügle M, Kalweit G, Hügle T, Boedecker J. A Dynamic Deep Neural Network For Multimodal Clinical Data Analysis. Be Publ Stud Comput Intell Springer Verl. 2020.Figure 1.Examples of true disease activity and corresponding predictions of AdaptiveNet by regression analysis. Predictions are made step to step from the current to next visit.Disclosure of Interests:Maria Hügle Paid instructor for: Lilly, Gabriel Kalweit: None declared, Ulrich Walker Grant/research support from: Ulrich Walker has received an unrestricted research grant from Abbvie, Consultant of: Ulrich Walker has act as a consultant for Abbvie, Actelion, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, MSD, Novartis, Pfizer, Phadia, Roche, Sandoz, Sanofi, and ThermoFisher, Paid instructor for: Abbvie, Novartis, and Roche, Speakers bureau: Abbvie, Actelion, Bristol-Myers Squibb, Celgene, MSD, Novartis, Pfizer, Phadia, Roche, Sandoz, and ThermoFisher, Axel Finckh Grant/research support from: Pfizer: Unrestricted research grant, Eli-Lilly: Unrestricted research grant, Consultant of: Sanofi, AB2BIO, Abbvie, Pfizer, MSD, Speakers bureau: Sanofi, Pfizer, Roche, Thermo Fisher Scientific, Rudiger Muller Consultant of: AbbVie, Nordic, Sandoz, Almut Scherer: None declared, Joschka Boedecker: None declared, Thomas Hügle Grant/research support from: Abbvie, Novartis, Consultant of: Abbvie, Pfizer, Novartis, Roche, Lilly, BMS

scholarly journals POS1430 EPIDEMIOLOGY OF LUPUS NEPHRITIS IN BRAZIL: FINDINGS FROM THE MACUNAÍMA STUDY - A NATIONWIDE MULTICENTRIC STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 999.1-999
Author(s):  
M. Abreu ◽  
O. Monticielo ◽  
V. Fernandes ◽  
A. Cristovão Maiorano ◽  
F. Dos Santos Beserra ◽  
...  
Keyword(s):  
Lupus Nephritis ◽  
Disease Activity ◽  
Systemic Lupus ◽  
Research Support ◽  
Multicentric Study ◽  
Factors Associated ◽  
Type Iv ◽  
Damage Accrual ◽  
History Of ◽  
The Mean

Background:Lupus nephritis (LN) is one of the most serious organic manifestations of systemic lupus erythematosus (SLE). Ethnicity can contribute to disparities in the prevalence and disease activity of LN.Objectives:To assess the prevalence of LN in Brazilian patients with SLE and to determine factors associated with LN activity across the country.Methods:This cross-sectional study (GSK Study 207353) was carried out through face-to-face interviews and review of medical records (12-month study period). Adult patients with SLE (American College of Rheumatology [ACR] criteria, 1997) were included. Five SLE reference teaching centres were selected: North (NO), Northeast (NE), Midwest (CO), Southeast (SE), and South (SU). Patients with another disease whose morbidity surpassed SLE were excluded. LN was defined as reported in the medical record or history of confirmed renal biopsy; disease activity by pre-defined changes in SLE Disease Activity Index (SLEDAI) or the patient’s kidney disease during the study. Activity was assessed during (T0), 6 months before (T6), and 12 months before (T12) the interview. Systemic Lupus International Collaborating Clinics/ACR Damage Index score mapped damage accrual. Two pairings were performed, aiming to discriminate factors associated with LN and its activity, respectively. Matching technique was used to select similar individuals based on propensity scores, obtained from a logistic regression model. A bootstrapping method explored characteristic variables associated with the risk of progressing to LN.Results:Overall, 300 Brazilian patients with SLE were included in the study. Two groups were paired: LN group (N=150) and non-LN group (N = 141). The prevalence of LN in the paired sample (N=291) was 51.5%, with a disparity between centres (p<0.001; Figure 1A). Most patients were female (LN: 92.7%; non-LN: 94.3%) and the mean (standard deviation [SD]) age for the LN and non-LN groups was 39.46 (11.86) and 43.96 (12.18), respectively. History of serositis was associated with the presence of LN (42 [28.0%] vs 21 [14.9%] non-LN; p=0.010). Type IV histological class predominated in both groups, with no disparity between centres. Social disparities were noted between groups. Non-active workers prevailed among the LN group (115 [76.7%] vs 98 [69.5%] for non-LN, p=0.024).When pairing for disease activity at T12, 73 (50.3%) patients with LN (N=145) had active disease. There was regional disparity in terms of disease activity (Figure 1B), with a predominance of active LN in the NO (28 [68.3%]) and SU (16 [55.2%], p=0.026). Type IV histological class was the component most associated with active LN (active: 32 [43.8%]; non-active: 11 [15.3%], p<0.001). Variation in SLEDAI during the study period discriminated between active and non-active LN. The mean (SD) SLEDAI score at T12 was substantially higher in those with active LN compared with non-active LN (7.18 [4.83] vs 2.47 [4.63], p<0.001). As for the pattern of care, corticosteroids users prevailed in those with active LN (62 [84.9%] vs 45 [62.5%] for non-active LN, p=0.004). There was no disparity in the use of immunosuppressants, with the exception of cyclophosphamide use, noted among 16 (21.9%) patients with active LN and 6 (8.3%) patients with non-active LN (p=0.041). Psychotropic or anticonvulsant use was higher in patients with non-active LN (32 [44.4%] vs 17 [23.3%] patients with active LN, p=0.012). Consultation with a neurologist was verified in 15 (20.8%) patients with non-active LN and 6 (8.2%) with active LN (p=0.055). Hospitalisation occurred in 17 patients with non-active (23.6%) and active (23.3%) LN.Conclusion:Disparities in the prevalence of LN and its activity were evident between the regions across Brazil, highlighting differences in clinical factors, regional factors, and patterns of care.Funding:GSKFigure 1.Prevalence of A) LN among regional centres, comparing them to disease activity profile and prescriptive practice, and B) Active and non-active LN according to prescriptive practiceCQ, chloroquine; HCQ, hydroxychloroquine*At T12Acknowledgements:Medical writing assistance was provided by Helen Taylor, Fishawack Indicia Ltd., UK, part of Fishawack Health, and was funded by GSK.Disclosure of Interests:Mirhelen Abreu Grant/research support from: GSK, Amgen, Biogen, Libbs, Odirlei Monticielo Speakers bureau: GSK, AbbVie, UCB, Roche, Novartis, Consultant of: GSK, AbbVie, Janssen, Vander Fernandes Speakers bureau: Janssen, Novartis, Roche, AbbVie, Pfizer, Grant/research support from: Novartis, GSK, Pfizer, Alexandre Cristovão Maiorano: None declared, Fernando dos Santos Beserra: None declared, Flavia Lamarao Employee of: GSK, Nathalie David Shareholder of: GSK, Employee of: GSK, Bruna de Veras Employee of: GSK, Blanca Bica: None declared, Domingos Sávio Nunes de Lima Grant/research support from: GSK, Marta Maria das Chagas Medeiros: None declared

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