Actualización del Documento de Consenso de la Sociedad Española de Reumatología sobre el uso de terapias biológicas en la artritis reumatoide

Molina, Jesús Tornero; Sala, Raimón Sanmartí; Valverde, Vicente Rodríguez; Mola, Emilio Martín; Fuente, José Luís Marenco de la; Álvaro, Isidoro González; Fernández, Santiago Muñoz; Carnota, Juan Gómez-Reino; Pérez, Luis C. Velázquez; Gualda, Enrique Batllé; Criado, Alejandro; Andreu, José Luís; Álvaro‐Gracia, José María; López, Juan Antonio Martínez; Santamaría, Estibaliz Loza

doi:10.1016/j.reuma.2009.10.006

Cited by 72 publications

(8 citation statements)

References 83 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The rheumatologists involved in the study largely follow the treatment recommendations of the Spanish Society of Rheumatology for RA [5], [41], considered especially pro-active in a comparative study of RA management in different European countries [3]. Another shortcoming is that information about RF and ACPA reactivity was only collected as qualitative variables; It is likely that the performance of ACPA, and especially RF, would improve if they were managed as quantitative variables.…”

Section: Discussionmentioning

confidence: 99%

“…The optimal strategy to manage rheumatoid arthritis (RA) is currently to start an early and intensive treatment adjusted to a specific target [1], [2], [3], [4], [5]. However, the widespread use of treatment with disease modifying anti-rheumatic drugs (DMARD) in combination may expose some patients with early arthritis (EA) to unjustified risks, while the first line use of biological agents for non-selected patients may be not cost-effective.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Interleukin 15 Levels in Serum May Predict a Severe Disease Course in Patients with Early Arthritis

et al. 2011

View full text Add to dashboard Cite

BackgroundInterleukin-15 (IL-15) is thought to be involved in the physiopathological mechanisms of RA and it can be detected in the serum and the synovial fluid of inflamed joints in patients with RA but not in patients with osteoarthritis or other inflammatory joint diseases. Therefore, the objective of this work is to analyse whether serum IL-15 (sIL-15) levels serve as a biomarker of disease severity in patients with early arthritis (EA).Methodology and ResultsData from 190 patients in an EA register were analysed (77.2% female; median age 53 years; 6-month median disease duration at entry). Clinical and treatment information was recorded systematically, especially the prescription of disease modifying anti-rheumatic drugs. Two multivariate longitudinal analyses were performed with different dependent variables: 1) DAS28 and 2) a variable reflecting intensive treatment. Both included sIL-15 as predictive variable and other variables associated with disease severity, including rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (ACPA). Of the 171 patients (638 visits analysed) completing the follow-up, 71% suffered rheumatoid arthritis and 29% were considered as undifferentiated arthritis. Elevated sIL-15 was detected in 29% of this population and this biomarker did not overlap extensively with RF or ACPA. High sIL-15 levels (β Coefficient [95% confidence interval]: 0.12 [0.06–0.18]; p<0.001) or ACPA (0.34 [0.01–0.67]; p = 0.044) were significantly and independently associated with a higher DAS28 during follow-up, after adjusting for confounding variables such as gender, age and treatment. In addition, those patients with elevated sIL-15 had a significantly higher risk of receiving intensive treatment (RR 1.78, 95% confidence interval 1.18–2.7; p = 0.007).ConclusionsPatients with EA displaying high baseline sIL-15 suffered a more severe disease and received more intensive treatment. Thus, sIL-15 may be a biomarker for patients that are candidates for early and more intensive treatment.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Interleukin 15 Levels in Serum May Predict a Severe Disease Course in Patients with Early Arthritis

et al. 2011

View full text Add to dashboard Cite

show abstract

“…TCZ was administered every 4 weeks at a typical dose of 8 mg/kg and could be adapted according to EULAR and local recommendations [ 20 , 21 ]. The average dose of MTX was 16.1 ± 6.0 mg/week (median 15.0 mg/week; range 7.5–25).…”

Section: Methodsmentioning

confidence: 99%

Comparative Effectiveness of Tocilizumab with either Methotrexate or Leflunomide in the Treatment of Rheumatoid Arthritis

et al. 2015

View full text Add to dashboard Cite

ObjectiveIn agreement with EULAR recommendations, a DMARD in combination with a biotherapy is the reference treatment because of the superior long-term clinical and radiographic outcomes. Methotrexate (MTX) is the cornerstone of combination therapy but is in some cases contra-indicated or poorly tolerated. This observational study aimed to compare the effectiveness and safety of TCZ in combination with either MTX or leflunomide (LEF) in the treatment of patients with active rheumatoid arthritis (RA) and an inadequate response to one or more DMARDs and/or biological agents in a real-world setting.MethodsWe performed an ambispective review of 91 patients with active RA who were routinely treated with TCZ plus MTX or LEF. A comparative study between the two combinations of treatment was performed at 6 months of follow-up considering 3 outcomes: improvement of RA disease activity, evolution of functional disability, and tolerability and side effect profile.ResultsOf the 91 patients, 62 received TCZ with MTX and 29 received TCZ with LEF. Eighty-one patients were followed for 6 months, and the remaining 10 patients discontinued treatment due to serious adverse events. At baseline, there were no significant differences between the groups in terms of the main clinical and laboratory data or in the number of previous DMARDs and biological agents used. At 6 months, there were no significant differences between the combinations in terms of disease activity and functional disability. Serious adverse events occurred in 11% and 10% of the patients treated in combination with MTX and LEF, respectively.ConclusionOur preliminary data support the argument that LEF is an effective and safe (equivalent) alternative to MTX for combination treatment with TCZ.

show abstract

“…certolizumab pegol, adalimumab, golimumab, infliximab and etanercept, which target TNFα, a proinflammatory cytokine believed to play a major role in the pathogenesis of RA [ 5 ]. TNF inhibitors or tocilizumab, an antibody directed against the interleukin-6 receptor, administered alone or in combination with methotrexate, are the first treatment option after small-molecule DMARDs [ 6 , 7 ]. Other biological agents used in Spain are anakinra, abatacept and rituximab, which are used in patients with RA who do not respond to methotrexate and in patients with active RA despite treatment with TNF inhibitors [ 6 , 7 ].…”

Section: Introductionmentioning

confidence: 99%

Cost-utility analysis of certolizumab pegol versus alternative tumour necrosis factor inhibitors available for the treatment of moderate-to-severe active rheumatoid arthritis in Spain

Hidalgo

Villoro

Blasco³

et al. 2015

Cost Eff Resour Alloc

View full text Add to dashboard Cite

BackgroundCertolizumab pegol, a PEGylated tumour necrosis factor (TNF)-inhibitor, improves the clinical signs and symptoms of rheumatoid arthritis (RA) when used in combination with methotrexate or as monotherapy. This study evaluatedthe cost-utility of certolizumab pegol versusTNF-inhibitors plus methotrexate in the treatment of moderate-to-severe RA in Spain.MethodsA Markov cohort health state transition model was developed to evaluate the cost-utility (costs and quality-adjusted life years [QALYs]) of certolizumab pegol versus other TNF-inhibitors licensed in Spain in 2009. Efficacy was measured using the American College of Rheumatology (ACR) responses at 6 months, based on adjusted indirect comparisons from published clinical trials. Utilities were derived from EQ-5D data from certolizumab pegol RA clinical trials. Clinical history and resource use data came from published literature. Unit costs were taken from Spanish databases or published data (cost year 2009). Base case analyses were conducted from the payer perspective, with a lifetime horizon, 3.5 % annual discounting rates for costs and outcomes, and 3 % inflation rate for 2009 onwards. One-way sensitivity analyses were conducted.ResultsThe average lifetime costs for certolizumab pegol, etanercept, adalimumab (every 2 weeks and weekly) and infliximab (3 mg/kg and 5 mg/kg) in combination with methotrexate were €140,971, €141,197, €139,148, €164,741, €136,961 and €152,561, respectively. The QALYs gained were 6.578, 6.462, 6.430 (for both adalimumab doses), 6.430, and 6.318 (for both infliximab doses), respectively. At a €30,000/QALY willingness-to-pay threshold, certolizumab pegol plus methotrexate dominated adalimumab weekly, etanercept, and infliximab 5 mg/kg, and was cost-effective versus adalimumab every 2 weeks and infliximab 3 mg/kg (all with methotrexate), with estimated ICERs of €12,346/QALY and €15,414/QALY, respectively. Certolizumab pegol monotherapy was more cost-effective versus adalimumab, and less expensive with similar health gains versus etanercept (6.416 QALYs vs 6.492). Univariate analysis showed ICERs to be sensitive to changes in time horizon, ACR response time point, baseline Heath Assessment Questionnaire (HAQ) score, and rate of HAQ-disability index deterioration after discontinuing treatment.ConclusionsThis analysis shows that certolizumab pegol is cost-effective compared with other TNF-inhibitors recommended in Spain for the treatment of RA.

show abstract

Actualización del Documento de Consenso de la Sociedad Española de Reumatología sobre el uso de terapias biológicas en la artritis reumatoide

Abstract: We present an update on the SER recommendations for the use of biologic therapy in patients with RA.

Cited by 72 publications

References 83 publications

Interleukin 15 Levels in Serum May Predict a Severe Disease Course in Patients with Early Arthritis

Interleukin 15 Levels in Serum May Predict a Severe Disease Course in Patients with Early Arthritis

Comparative Effectiveness of Tocilizumab with either Methotrexate or Leflunomide in the Treatment of Rheumatoid Arthritis

Cost-utility analysis of certolizumab pegol versus alternative tumour necrosis factor inhibitors available for the treatment of moderate-to-severe active rheumatoid arthritis in Spain

Contact Info

Product

Resources

About