Documento SER de consenso sobre el uso de terapias biológicas en la espondilitis anquilosante y otras espondiloartritis, excepto la artritis psoriásica

Roura, Xavier; Montejo, Pedro Zarco; Sanz, Jesús; Fernández, Santiago Muñoz; Mendoza, Juan Mulero; Ferrando, Luis Francisco Linares; Masmitjá, Jordi Gratacós; Vicuña, Rosario García de; Carballido, Cristina Fernández; Estévez, E. Collantes; Gualda, Enrique Batllé; Ariza, Rafael Ariza; Santamaría, Estibaliz Loza

doi:10.1016/j.reuma.2010.12.002

Cited by 36 publications

(10 citation statements)

References 104 publications

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“…The primary study objective is to assess, when considering patients with axial spondyloarthritis who have achieved sustained clinical remission with anti-TNF, whether the proportion of patients reaching an acceptable therapeutic goal after 1 year is greater than or equal in patients receiving reduced doses of anti-TNF to patients using standard anti-TNF doses, according to the summary of product characteristics. For this study, an acceptable therapeutic goal will be BASDAI <4, physician global assessment <4 and patient <4 and axial night pain <4) [ 27 ]. The key main secondary objective is to assess whether the proportion of patients who remain in remission after one year (the ideal therapeutic goal defined by BASDAI ≤ 2, physician global assessment ≤ 2, and patient global assessment ≤ 2) [ 27 ] is noninferior in patients receiving reduced doses of anti-TNF to that of patients using standard anti-TNF doses; this objective will require that the primary endpoint is reached for formal assessment.…”

Section: Methodsmentioning

confidence: 99%

“…For this study, an acceptable therapeutic goal will be BASDAI <4, physician global assessment <4 and patient <4 and axial night pain <4) [ 27 ]. The key main secondary objective is to assess whether the proportion of patients who remain in remission after one year (the ideal therapeutic goal defined by BASDAI ≤ 2, physician global assessment ≤ 2, and patient global assessment ≤ 2) [ 27 ] is noninferior in patients receiving reduced doses of anti-TNF to that of patients using standard anti-TNF doses; this objective will require that the primary endpoint is reached for formal assessment. The study outcome variables and definitions are listed in Table 1 .…”

Section: Methodsmentioning

confidence: 99%

“… Unplanned change of the assigned anti-TNF regimen decided by the investigator due to lack of efficacy, safety issues or treatment-related reasons. End of study NSAIDs use Dougados criteria (42) 1 and 2 years post-randomization, End of study Patient function (BASFI) Change from baseline in the BASFI scores 1 and 2 years post-randomization, End of study Ankylosing Spondylitis Quality of Life (ASQoL) Change from baseline in the ASQoL (Spanish validated version of ASQoL (41)) 1 and 2 years post-randomization, End of study Proportion of patients with any related severe adverse event ≥1 severe adverse events with causality assessment at least possibly related to anti-TNF Time to related severe adverse event Number of days from randomization to first symptom of a severe adverse event with causality assessment at least possibly related to anti-TNF Radiological progression mSASSS *According to SER consensus [ 27 ]. SER: Sociedad Española de Reumatología (Spanish Society of Rheumatology).…”

Section: Methodsmentioning

confidence: 99%

“… *According to SER consensus [ 27 ]. SER: Sociedad Española de Reumatología (Spanish Society of Rheumatology).…”

Section: Methodsmentioning

confidence: 99%

“…The main study hypothesis is that the use of reduced anti-TNF doses is not inferior to the use of full doses in patients with axial spondyloarthritis in persistent clinical remission with anti-TNF, as assessed by the proportion of patients who meet clinical remission defined by the SER at one year [ 27 ].…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial

Pontes

Gratacós

Avendaño

et al. 2015

Trials

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BackgroundDose reduction schedules of tumor necrosis factor antagonists (anti-TNF) as maintenance therapy in patients with spondyloarthritis are used empirically in clinical practice, despite the lack of clinical trials providing evidence for this practice.Methods/DesignTo address this issue the Spanish Society of Rheumatology (SER) and Spanish Society of Clinical Pharmacology (SEFC) designed a 3-year multicenter, randomized, open-label, controlled clinical trial (2 years for inclusion and 1 year of follow-up). The study is expected to include 190 patients with axial spondyloarthritis on stable maintenance treatment (≥4 months) with any anti-TNF agent at doses recommended in the summary of product characteristics. Patients will be randomized to either a dose reduction arm or maintenance of the dosing regimen as per the official labelling recommendations. Randomization will be stratified according to the anti-TNF agent received before study inclusion. Patient follow-up, visit schedule, and examinations will be maintained as per normal clinical practice recommendations according to SER guidelines. The study aims to test the hypothesis of noninferiority of the dose reduction strategy compared with standard treatment. The first patients were recruited in July 2012, and study completion is scheduled for the end of April 2015.DiscussionThe REDES-TNF study is a pragmatic clinical trial that aims to provide evidence to support a medical decision now made empirically. The study results may help inform clinical decisions relevant to both patients and healthcare decision makers.Trial registrationEudraCT 2011-005871-18 (21 December 2011)Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0828-5) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

“… *According to SER consensus [ 27 ]. SER: Sociedad Española de Reumatología (Spanish Society of Rheumatology).…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial

Pontes

Gratacós

Avendaño

et al. 2015

Trials

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Standards of care for patients with spondyloarthritis

Abad¹,

Ariza²,

Aznar³

et al. 2014

Rheumatol Int

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To define and give priory to standards of care in patients with spondyloarthritis (SpA). A systematic literature review on SpA standards of care and a specific search in relevant and related sources was performed. An expert panel was established who developed the standards of care and graded their priority (high, mild, low, or no priority) following qualitative methodology and Delphi process. An electronic survey was sent to a representative sample of 167 rheumatologists all around the country, who also gave priority to the standards of care (same scale). A descriptive analysis is presented. The systematic literature review retrieved no article specifically related to SpA patients. A total of 38 standards of care were obtained-12 related to structure, 20 to process, and 6 to result. Access to care, treatment, and safety standards of care were given a high priority by most of rheumatologists. Standards not directly connected to daily practice were not given such priority, as standards which included a time framework. The standards generated for the performance evaluation (including patient and professionals satisfaction) were not considered especially important in general. This set of standards of care should help improve the quality of care in SpA patients.

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Standards of care and quality indicators for multidisciplinary care models for psoriatic arthritis in Spain

et al. 2018

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To define and give priority to standards of care and quality indicators of multidisciplinary care for patients with psoriatic arthritis (PsA). A systematic literature review on PsA standards of care and quality indicators was performed. An expert panel of rheumatologists and dermatologists who provide multidisciplinary care was established. In a consensus meeting group, the experts discussed and developed the standards of care and quality indicators and graded their priority, agreement and also the feasibility (only for quality indicators) following qualitative methodology and a Delphi process. Afterwards, these results were discussed with 2 focus groups, 1 with patients, another with health managers. A descriptive analysis is presented. We obtained 25 standards of care (9 of structure, 9 of process, 7 of results) and 24 quality indicators (2 of structure, 5 of process, 17 of results). Standards of care include relevant aspects in the multidisciplinary care of PsA patients like an appropriate physical infrastructure and technical equipment, the access to nursing care, labs and imaging techniques, other health professionals and treatments, or the development of care plans. Regarding quality indicators, the definition of multidisciplinary care model objectives and referral criteria, the establishment of responsibilities and coordination among professionals and the active evaluation of patients and data collection were given a high priority. Patients considered all of them as important. This set of standards of care and quality indicators for the multidisciplinary care of patients with PsA should help improve quality of care in these patients.

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Documento SER de consenso sobre el uso de terapias biológicas en la espondilitis anquilosante y otras espondiloartritis, excepto la artritis psoriásica

Cited by 36 publications

References 104 publications

Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial

Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial

Standards of care for patients with spondyloarthritis

Standards of care and quality indicators for multidisciplinary care models for psoriatic arthritis in Spain

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