Shared care or nurse consultations as an alternative to rheumatologist follow-up for rheumatoid arthritis (RA) outpatients with stable low disease-activity RA: cost-effectiveness based on a 2-year randomized trial

2014 ◽  
Vol 44 (1) ◽  
pp. 13-21 ◽  
Author(s):  
J Sørensen ◽  
J Primdahl ◽  
HC Horn ◽  
K Hørslev-Petersen
2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 98.2-99
Author(s):  
A. De Thurah ◽  
C. Skovsgaard ◽  
T. Maribo ◽  
N. H. Hjøllund ◽  
M. Kruse

Background:The clinical effectiveness of a patient-reported outcome (PRO) based telehealth intervention offered to rheumatoid arthritis (RA) patients with low disease activity or remission has previously been reported1. The TeRA study showed that PRO-based telehealth follow-up in RA achieved similar disease control as conventional outpatient follow-up among patients with low disease activity or remission. The degree of disease control did not differ between telehealth follow-up offered by rheumatologists or rheumatology nurses.Objectives:To compare the cost-effectiveness of PRO–based telehealth follow-up to patients with RA performed by rheumatologists or rheumatology nurses with conventional outpatient follow-up.Methods:A total of 294 patients were randomized (1:1:1) to either PRO-based telehealth follow-up carried out by a nurse (PRO-TN) or a rheumatologist (PRO-TR), or conventional outpatient follow-up by physicians. Quality of life (EQ-5D) was measured at baseline and at follow-up after one year. The primary outcome was a change in the Disease Activity Score, C-reactive Protetin in 28 joints (DAS-28, CRP).The focus in the health economic evaluation was on the relation between costs and EQ-5D in the period between one year prior to and one year after the intervention. All costs were measured at the individual level and consisted of: intervention costs, health and social care costs, and productivity costs. All cost data were retrieved from Danish population-based registers. Incremental cost-effectiveness rates (ICERs) were calculated on the basis of a comparison of the development in costs and effects in the two intervention groups (separately and combined) with the control group. Bootstrap with 10,000 replications were used to access significance.Results:The difference in health and social care costs during the intervention period compared to the year before were €1,072, - €50 and €519 for the control group, the PRO-TR group and the PRO-TN respectively. Hence, the change in health and social care costs was lower for both intervention groups. The PRO-TR group had a small decrease and it was significantly lower than for the control group (p=0.0027). The difference between health and social care costs in the PRO-TN group compared to the control group was only borderline significant (p=0.067). No statistically significant differences were found in QALY’s between the three groups, all three groups experienced minor, non-significant, declines in QALY over the intervention period. ICER’s were not statistically significant but below known threshold values for the PRO-RN group (ICER=€17,121).Conclusion:It is difficult to obtain statistically significant results for cost-effectiveness in small samples. However, the results point towards a possible cost-saving impact of PRO interventions in patients with low disease activity or remission. The study was unable to conclude if PRO-TR or PRO-TN were most cost-effective. Other relevant considerations, like patient satisfaction or organisational issues, should determine the way of organizing RA disease management in these patients.References:[1]de Thurah A, Stengaard-Pedersen K, Axelsen M, et al. Tele-Health Follow-up Strategy for Tight Control of Disease Activity in Rheumatoid Arthritis: Results of a Randomized Controlled Trial.Arthritis care & research2018;70(3): 353-60.Disclosure of Interests:Annette de Thurah Grant/research support from: Novartis (not relevant for the present study)., Speakers bureau: Lily (not relevant for the present study)., Christian Skovsgaard: None declared, Thomas Maribo: None declared, Niels Henrik Hjøllund: None declared, Marie Kruse: None declared


2017 ◽  
Vol 33 (S1) ◽  
pp. 59-60
Author(s):  
Jéssica dos Santos ◽  
Haliton Oliveira ◽  
Francisco Acurcio Michael da Silva ◽  
Alessandra Almeida ◽  
Flávia Rodrigues ◽  
...  

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.


2015 ◽  
Vol 74 (Suppl 2) ◽  
pp. 709.1-709 ◽  
Author(s):  
M. Ghiti Moghadam ◽  
H.E. Vonkeman ◽  
P.M. Ten Klooster ◽  
P.L. van Riel ◽  
M.A. van de Laar ◽  
...  

Author(s):  
Shunsuke Mori ◽  
Yukinori Koga ◽  
Mineharu Sugimoto

We treated 21 patients with organizing pneumonia (OP) associated with rheumatoid arthritis (RA) or related to biological disease-modifying antirheumatic drugs (DMARDs) at our institution between 2006 and 2014. Among these cases, 3 (14.3%) preceded articular symptoms of RA, 4 (19.0%) developed simultaneously with RA onset, and 14 (66.7%) occurred during follow-up periods for RA. In the case of OP preceding RA, increased levels of anti-cyclic citrullinated peptide antibodies and rheumatoid factor were observed at the OP onset. RA disease activity was related to the development of OP in the simultaneous cases. In the cases of OP developing after RA diagnosis, 10 of 14 patients had maintained low disease activity with biological DMARD therapy at the OP onset, and among them, 6 patients developed OP within the first year of this therapy. In the remaining four patients, RA activity was not controlled at the OP onset. All patients responded well to systemic steroid therapy, but two patients suffered from relapses of articular and pulmonary symptoms upon steroid tapering. In most of the RA patients, DMARD therapy was introduced or restarted during the steroid tapering. We successfully restarted a biological DMARD that had not been previously used for patients whose RA would otherwise have been difficult to control. In this study, we also perform a review of the literature on RA-associated or biological DMARD-related OP and discuss the pathogenesis and management of OP occurring in RA patients.


2019 ◽  
Vol 8 (10) ◽  
pp. 1548 ◽  
Author(s):  
Mueller ◽  
Hasler ◽  
Popp ◽  
Mattow ◽  
Durmisi ◽  
...  

: Introduction: Tofacitinib is an oral JAK inhibitor indicated for the treatment of rheumatoid arthritis (RA). The efficacy and safety of tofacitinib have been shown in several randomized clinical trials. The study presented here aimed to assess the clinical tolerability and effectiveness of tofacitinib among RA patients in real life. Methods: Consecutive patients between January 2015 and April 2017 with RA who fulfilled the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria were included in a prospectively designed analysis of retrospective data. Patients were initiated on tofacitinib 5 mg bid. The primary objective was to analyze the safety of tofacitinib in a real-life cohort. Safety was assessed by the reasons to stop tofacitinib during follow up and changes of liver enzymes, hemoglobin, and creatinine. The secondary outcome was to analyze the frequency of and time to achieve low disease activity (LDA) and remission as defined by 28 joint count disease activity score (DAS28). Results: A total of 144 patients were treated with tofacitinib. A total of 84.9% of patients were pre-exposed to at least one biological agent. The average DAS28 at the initiation of tofacitinib was 4.43. A total of 50.0% of patients were positive for rheumatoid factor and 49.0% for ACPA. The mean follow up was 1.22 years (range 10d–3.7a) after initiation of tofacitinib treatment. A total of 94 (64.4%) patients remained on tofacitinib during follow-up. The average time to stop tofacitinib was 190.0 days. Reasons to stop tofacitinib were: insufficient response (n = 23), gastrointestinal symptoms (n = 18), infection (n = 5), myalgia (n = 2), remission (n = 2), headache (n = 2), cough, blue finger syndrome, intolerance, heartburn, psoriasis, and increased liver enzymes (all n = 1). Increased alanine amino transferase (ALAT) or aspartate amino transferase (ASAT) > 2× upper limit of normal (ULN) were detected in 3.3% and 4.4% of patients, respectively. Hemoglobin decrease of >10% was detected in 15.1% of the patients and decreased lymphocytes <500/μL in 3.4%. An increase of creatinine >20% was detected in 9.4% of patients. A total of 62.9% and 50.0% of the patients achieved low disease activity (LDA) or remission after a median of 319 and 645 days, respectively. These rates were significantly higher in patients naïve to biologic agents as compared to patients pre-exposed to biologics (LDA: naïve 100% 92 d, pre-exposed 57.0% 434 d, p ≤ 0.001; remission: naïve 86.7% 132 d, pre-exposed 44.1%, 692 d, p = 0.001). Conclusions: Tofacitinib is a safe and effective treatment option for patients with RA. Tofacitinib may induce high rates of LDA and remission in patients with active disease, even after the use of one or more biologics, though the rate appeared higher in patients naïve to biologics. Tofacitinib may be a valuable option in a treat-to-target approach. Our data demonstrate that Janus kinase (JAK) inhibitors are safe and efficacious in real life patients.


RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e000994 ◽  
Author(s):  
Denis Mongin ◽  
Kim Lauper ◽  
Carl Turesson ◽  
Merete Lund Hetland ◽  
Eirik Klami Kristianslund ◽  
...  

ObjectiveTo compare several methods of missing data imputation for function (Health Assessment Questionnaire) and for disease activity (Disease Activity Score-28 and Clinical Disease Activity Index) in rheumatoid arthritis (RA) patients.MethodsOne thousand RA patients from observational cohort studies with complete data for function and disease activity at baseline, 6, 12 and 24 months were selected to conduct a simulation study. Values were deleted at random or following a predicted attrition bias. Three types of imputation were performed: (1) methods imputing forward in time (last observation carried forward; linear forward extrapolation); (2) methods considering data both forward and backward in time (nearest available observation—NAO; linear extrapolation; polynomial extrapolation); and (3) methods using multi-individual models (linear mixed effects cubic regression—LME3; multiple imputation by chained equation—MICE). The performance of each estimation method was assessed using the difference between the mean outcome value, the remission and low disease activity rates after imputation of the missing values and the true value.ResultsWhen imputing missing baseline values, all methods underestimated equally the true value, but LME3 and MICE correctly estimated remission and low disease activity rates. When imputing missing follow-up values at 6, 12, or 24 months, NAO provided the least biassed estimate of the mean disease activity and corresponding remission rate. These results were not affected by the presence of attrition bias.ConclusionWhen imputing function and disease activity in large registers of active RA patients, researchers can consider the use of a simple method such as NAO for missing follow-up data, and the use of mixed-effects regression or multiple imputation for baseline data.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1456.1-1457
Author(s):  
D. Iacono ◽  
I. Pantano ◽  
D. Birra ◽  
G. Scalise ◽  
M. A. Coscia ◽  
...  

Background:EULAR recommendations focus the importance of Methotrexate (MTX) therapy as a key element in the treatment of patients with Rheumatoid Arthritis (RA), alone as first line therapy and in combination with biological Disease Modifying Anti-rheumatic Drug (bDMARDs). Abatacept (CTLA4-Ig) in Europe is approved for the treatment of moderate to severe active RA in combination with MTX. Several patients, however, discontinue MTX for intolerance, side effects or contraindications, and real-life data demonstrate how, even in patients receiving therapy with MTX, compliance could be suboptimal. The only data on the use of abatacept in monotherapy come from the ORA-Registry, where a worse performance is observed in monotherapy patients.Objectives:To evaluate a multicenter cohort of RA patients treated with Abatacept in patients underwent combined MTX therapy vs monotherapy.Methods:We retrospectively evaluated RA patients, referring to 2 Italian rheumatology centers, treated with Abatacept monotherapy or in combination with MTX. We compared both persistence in therapy and the rate of remission/low disease activity according to Clinical Disease Activity Index (CDAI) between the 2 groups.Results:We enrolled 147 patients, out of them 66 patients were on monotherapy with Abatacept due to intolerance or controindications and 81 in therapy with Abatacept plus MTX. The two cohorts appeared homogeneous in age, gender, disease duration and baseline activity indexes, with the only difference being higher baseline Physician Global assessment (PhGA) values in monotherapy patients. During the follow-up (median duration 24±14 months), the retention rate of Abatacept treatment was 71.2% in MTX patients (median duration 27–15.6 months) and 62.1% in monotherapy patients (median duration 25.2–17.5; p=ns). No differences between the two groups in terms of retention rate, low-disease activity and CDAI remission (log rank p=ns), Breslow p=ns) were detected.Conclusion:In patients with RA with intolerance or contraindication to MTX use, Abatacept monotherapy could be an efficient and safe option even in the long term follow-up.References:[1]Abatacept monotherapy compared with abatacept plus disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients: data from the ORA registry.Truchetet ME et al. Arthritis Res Ther. 2016 Mar 30;18:72.Disclosure of Interests:DANIELA IACONO Speakers bureau: PFIZER, BRISTOL MAYERS SQUIBB, SANOFI, Ilenia Pantano: None declared, domenico birra: None declared, GIUSEPPE SCALISE: None declared, Melania Alessia Coscia: None declared, VALENTINA MESSINITI: None declared, Gabriella Loi: None declared, Anna Merchionda: None declared, Paolo Moscato: None declared, francesco ciccia Grant/research support from: pfizer, novartis, roche, Consultant of: pfizer, novartis, lilly, abbvie, Speakers bureau: pfizer, novartis, lilly, abbvie


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1388.2-1388
Author(s):  
R. Hassan ◽  
M. Cheikh ◽  
H. Almoallim ◽  
H. Faruqui ◽  
R. Alquraa ◽  
...  

Background:National Registries are essential to direct current practice and design appropriate management strategies1. Rheumatoid arthritis (RA) registries in the middle east and north Africa remain scarcely represented2.Objectives:Our objective is to describe the Saudi RA population and to compare the findings to internationally reported data.Methods:This is a cross sectional, analytical study that was conducted at Doctor Soliman Fakeeh Hospital (DSFH). The study ran from December of 2014 and concluded in December of 2018 using a pool of 433 patients. Inclusion criteria included adults older than 18 years of age who fulfilled the 2010 American College of Rheumatology criteria for diagnosis of RA3. Data were collected from patients and entered in a specially designed program for this registry. They included main demographic details,, lag times to final disease diagnosis. Disease Activity Score-28-C Reactive Protein (DAS-28-CRP) was calculated on presentation and on subsequent visits with intervals ranging from three to six months between them. Multiple regression model was used to assess the predictors of disease activity. We charted the lines of medications given, including conventional and biologic disease modifying antirheumatic drugs (DMARDs), following treat to target strategies4.Results:Out of 430 patients, 76.68% were female, while only 23.32% were male and the mean age was found to be 49.26 years with SD±11.At initial presentation, 45.5% had demonstrated active disease (moderate or high disease activity) based on DAS-28-CRP scores while 54.5% were in remission or low disease activity. Out of the total number of clinic visitors, 330 had regular follow ups for more than 1 year while 103 patients were either irregularly visiting the rheumatology clinic or had lost follow up. The remission rates after 1 year had increased to 79.7% (263 patients), while 9.7% (32 patients) had low disease activity and no patients had sustained high disease activity at the end of follow up. It was also found that the female gender, higher Health Assessment Questionnaire-Disability Index (HAQ-DI) and a longer lag1/lag2 period were associated with higher disease activity in our population. Biologic medications had been used by 129 patients (29.7%) while conventional DMARDs were given to 304 patients (70.3%).Conclusion:We described a population of RA patients in a single center in SA. We detected higher remission rates at one year of follow up. This could be attributed to many factors, including good referral systems and treat to target strategies with easier access to biologic medications.References:[1]Singh JA, Saag KG, Bridges SL Jr, Akl EA, Bannuru RR, Sullivan MC, Vaysbrot E, McNaughton C, Osani M, Shmerling RH, Curtis JR, Furst DE, Parks D, Kavanaugh A, O’Dell J, King C, Leong A, Matteson EL, Schousboe JT, Drevlow B, Ginsberg S, Grober J, St Clair EW, Tindall E, Miller AS, McAlindon T. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis.Arthritis Rheumatol.2016 Jan;68(1):1-26.[2]Smolen, Josef S., et al. “EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update.”Annals of the rheumatic diseases73.3 (2014): 492-509.[3]Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis.Arthritis Rheum2008;59: 762–84.[4]Hussain W, Noorwali A, Janoudi N. From symptoms to diagnosis: an observational study of the journey of rheumatoid arthritis patients in Saudi Arabia.Oman Med J.2016;31(1):29.Disclosure of Interests:Rola Hassan Grant/research support from: Pfizer pharmaceuticals, Mohamed Cheikh Grant/research support from: Pfizer pharmaceuticals, Hani Almoallim Grant/research support from: Pfizer pharmaceuticals, Hanan Faruqui Grant/research support from: Pfizer pharmaceuticals, Reem AlQuraa Grant/research support from: Pfizer pharmaceuticals, Ayman Eissa Grant/research support from: Pfizer pharmaceuticals, Aous Alhazmi Grant/research support from: Pfizer pharmaceuticals, Nahid Janoudi Grant/research support from: Pfizer pharmaceuticals


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