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- 1. TRATAMIENTO SOBRE OBJETIVOS T2T MARIA JOSE JANNAUT P INTERNISTA-REUMATOLOGA CLINICA REINA SOFIA BOGOTA
- 4. Agenda OBJETIVOS METODOLOGIA REVISION SISTEMATICA DE LA LITERATURA RECOMEDACIONES PERSPECTIVAS
- 5. OBJETIVOS Y CONTROL ESTRICTO EN AR
- 8. Conclusion: Intensive therapy was successfully carried out in the present trial by an expert team of diabetologists, nurses, dietitians, and behavioral specialists, and the time, effort, and cost required were considerable. Because the resources needed are not widely available, new strategies are needed to adapt methods of intensive treatment for use in the general community at less cost and effort. Meanwhile, the health care system should provide the support necessary to make intensive therapy available to those patients who will benefit. NEJM 1993;329:977-86
- 9. Niveles de Hba1c NEJM 1993;329:977-86
- 10. Incidencia acumulada de cambios sostenidos de retinopatia (>=3 pasos para >=6 months) Primary Intervention Secondary Intervention 76% reduction 54% reduction NEJM 1993;329:977-86
- 12. Agenda OBJETIVO METODOLOGIA REVISION SISTEMATICA DE LA LITERATURA
- 13. T2T : Pasos principales Les experts Objetivos Metodologia Selección de las preguntas principales EULAR estudio Revisión sistemática de la literatura: tratamiento guiado por objetivos Recomendaciones provisionales Steering Committee
- 14. T2T : Steering group Coordinador general J. Smolen (Austria) Comite asistente D. Aletaha (Austria), B. Haraoui (Canada), E. Keystone (Canada), B. Combe (France), M. Dougados (France), G. Burmester (Germany), J. Kalden (Germany), D. Boumpas (Greece), M. Cutolo (Italy), C. Montecucco (Italy), T. Kvien (Norway), J. Gomez-Reino (Spain), E. Martin-Mola (Spain), J.W.J. Bijlsma (The Netherlands), F. Breedveld (The Netherlands), M. de Wit (The Netherlands), D. Van der Heijde (The Netherlands), P. Emery (UK), I. MacInnes (UK), A. Gibofsky (USA) Fellow M. Schoels (Austria)
- 15. Recomendaciones T2T : Proceso de consenso Presentación/discusión: - Resultados del SLR - Recomendaciones provisionales Discusión Reformulación Nuevas formulaciones Técnica Delfi Recomendaciones finales Nivel de consenso Invitación a 46 expertos adicionales :Europa, Norte y Latinoamérica, Japon y Australia, incluyendo 5 pacientes
- 16. T2T: Grupo de consenso Argentina: Guillermo Tate Australia: Peter Nash, Evangelos Romas Austria: Daniel Aletaha, Winfried Graninger, Monika Schoels, Josef Smolen Belgium: Patrick Durez Brazil: Ieda Maria Laurindo Canada: Vivian Bykerk, Hani El Gabalawy, Boulos Haraoui, Jamie Henderson, Edward Keystone Cyprus: Marios Kouloumas (patient) Czech Republic: Karel Pavelka Denmark: Kim Hørslev-Peterson, Mikkel Østergaard Finland: Pekka Hannonen, Marjatta Leirisalo-Repo, Tuulikki Sokka France: Bernard Combe, Maxime Dougados, Bruno Fautrel, Laure Gossec Germany: Harald Burkhardt, Gerd Burmester, Jochen Kalden Greece: Dimitrios Boumpas, Alexandros Drosos, Athanasios Tzioufas Italy: Maurizio Cutolo, Gianfranco Ferracioli, Carlomaurizio Montecucco, Luigi Sinigaglia Japan: Tsutomu Takeuchi Mexico: Mario Humberto Cardiel Rios Norway: Clara Gjesdal, Espen Haavardsholm, Sesilie Halland (patient), Wenche Koldingsnes, Tore Kvien Poland: Ewa Stanislawska-Biernat Portugal: Joao-Eurico Fonseca, José Peirera da Silva Romania: Minisoara Codruta-Zabalan (patient) Spain: Jose-Luis Andreu, Hector Corominas, Jesus Gomez-Reino, Emilio Martin-Mola Switzerland: Cem Gabay, Peter Villiger The Netherlands: Johannes Bijlsma, Ferry Breedveld, Maarten de Wit, Marieke Scholte (patient), Désirée Van der Heijde UK: Paul Emery, Cristina Estrach, Andrew Ostor, Duncan Porter, Enid Quest (patient) USA: Martin Bergman, Roy Fleischmann , Alan Gibofsky, Jonhatan Kay, Iain MacInnes
- 17. Agenda OBJETIVOS METODOLOGIA REVISION SISTEMATICA DE LA LITERATURA RECOMENDACIONES PERSPECTIVES
- 19. Proceso de selección y recolección de estudios 5883 76 21 Schoels et al (submitted)
- 23. Content OBJECTIVE METHODOLOGY SYSTEMATIC LITERATURE RESEARCH RESULTS RECOMMENDATIONS PERSPECTIVES
- 24. Categorization of evidence and strengths of T2T recommendations Shekelle, et al. BMJ 1999; 318:593-6 Category of evidence I a Evidence from meta-analyses of randomized controlled trials I b Evidence from at least one randomized controlled trial II a Evidence from at least one controlled study without randomization II b Evidence from at least one type of quasi-experimental study III Evidence from descriptive studies, such as comparative, correlation, or case–control IV Evidence from expert committee reports or opinions or clinical experience of respected authorities, or both Strength of Recommendation A Directly based on category I evidence B Directly based on category II evidence or extrapolated recommendations from category I evidence C Directly based on category III evidence or extrapolated recommendation from category I or II evidence D Directly based on category IV evidence or extrapolated recommendation from category II or III evidence
- 26. The Overarching Principles Smolen et al (submitted) A. The treatment of rheumatoid arthritis must be based on a shared decision between patient and rheumatologist. B. The primary goal of treating the patient with rheumatoid arthritis is to maximize long term health-related quality of life through control of symptoms, prevention of structural damage, normalization of function and social participation. C. Abrogation of inflammation is the most important way to achieve these goals. D. Treatment to target by measuring disease activity and adjusting therapy accordingly optimizes outcomes in rheumatoid arthritis.
- 31. Final set of 10 recommendations on treating rheumatoid arthritis to target based on both evidence and expert opinion Smolen et al (submitted) 1. The primary target for treatment of rheumatoid arthritis should be a state of clinical remission. 2. Clinical remission is defined as the absence of signs and symptoms of significant inflammatory disease activity. 3. While remission should be a clear target, based on available evidence low disease activity may be an acceptable alternative therapeutic goal, particularly in established, long-standing disease. 4. Until the desired treatment target is reached, drug therapy should be adjusted at least every 3 months.. 5. Measures of disease activity must be obtained and documented regularly, as frequently as monthly for patients with high/moderate disease activity or less frequently (such as every 3 to 6 months) for patients in sustained low disease activity or remission. 6. The use of validated composite measures of disease activity, which include joint assessmen ts , is needed in routine clinical practice to guide treatment decisions.
- 32. Final set of 10 recommendations on treating rheumatoid arthritis to target based on both evidence and expert opinion Smolen et al (submitted) 7. Structural changes and functional impairment should be considered when making clinical decisions, in addition to assessing composite measures of disease activity. 8. The desired treatment target should be maintained throughout the remaining course of the disease. 9. The choice of the (composite) measure of disease activity and the level of the target value may be influenced by considerations of co-morbidities, patient factors and drug related risks. 10. The patient has to be appropriately informed about the treatment target and the strategy planned to reach this target under the supervision of the rheumatologist.
- 33. Algorithm to treat RA to Target Active RA Main target Alternative target Remission Sustained Remission Low disease activity Sustained low disease activity Adapt therapy according to disease activity Adapt therapy according to disease activity Adapt therapy if state is lost Use a composite measure of disease activity every 1-3 months Assess disease activity about every 3-6 months Adapt therapy If state is lost Smolen et al (submitted)
- 44. Content OBJECTIVE METHODOLOGY SYSTEMATIC LITERATURE RESEARCH RESULTS RECOMMENDATIONS PERSPECTIVES
- 47. Back-up
- 48. As a reminder… DAS (Disease Activity Score based on 28-joint evaluation) DAS28 with 4 variables: DAS28 = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.70 Ln (ESR) + 0.014 (GH) DAS28 with 3 variables: DAS28 = [ 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.70 Ln (ESR) ]1.08 + 0.16 Cut-points • High disease activity > 5.1 • Low disease activity < 3.2 • Remission < 2.6 TJC28: 28 joint count for tenderness SJC28: 28 joint count for swelling Ln (ESR): natural logarithm of Westergren's Erythrocyte Sedimentation Rate GH: General Health or Patient's Global Assessment of disease activity on a Visual Analogue Scale of 100mm Van der Heijde et al, J Rheumatol 1993;20:579-581. Prevoo et al, Arthritis Rheum 1995;38:44-48.
- 49. As a reminder… SDAI (Simplified Disease Activity Index) SDAI=TJC + SJC + PGA + EGA + CRP Cut-points • High disease activity > 26 • Moderate disease activity > 11 - 26 • Low disease activity > 3.3 - 11 • Remission < 3.3 TJC: tender joint count based on a 28-joint assessment SJC: swollen joint count based on a 28-joint assessment PGA: patient global assessment of disease activity [ PGA visual analogue scale (VAS) 0–10 cm] EGA: evaluator (physician) global assessment of disease activity (MDGA VAS 0–10 cm) C-reactive protein (CRP in mg/dl) Smolen, et al. Rheumatology 2003; 42: 244-257.
- 50. As a reminder… CDAI (Clinical Disease Activity Index) CDAI=TJC + SJC + PGA + EGA Cut-points • High disease activity > 22 • Moderate disease activity > 10 - 22 • Low disease activity > 2.8 - 10 • Remission < 2.8 TJC: tender joint count based on a 28-joint assessment SJC: swollen joint count based on a 28-joint assessment PGA: patient global assessment of disease activity [ PGA visual analogue scale (VAS) 0–10 cm] EGA: evaluator (physician) global assessment of disease activity (MDGA VAS 0–10 cm) Smolen, et al. Rheumatology 2003; 42: 244-257. Aletaha D Arthritis Rheum 2005; 52: 2625-36
- 51. For information… New ACR/EULAR remission criteria: in preparation Aletaha et al (submitted)
Notas do Editor
- We have today unprecedented outcomes, that can be achieved for our patients. Over the last decade or two, we’ve had major advances in therapies, totally novel therapies, targeted therapies have emerged and being used by all of us. We had significant advances in the way we measure all the various characteristics of the disease. In part by radiographics and functional assessment, but also, and that’s where many of the advancements have occurred, by using composite measures of disease activity that have been validated. And especially over the last few years, there has been an enhanced understanding of ‘how to approach the therapy of rheumatoid arthritis strategically’, to achieve an optimal outcome. However, these insights have not yet been clearly formulated in a set of recommendations. Consequently, many of these changes have not been brought into effect in most of the countries in Europe and other parts of the world
- So, it is important that these treatment targets are adopted, but also that we can demonstrate that not only short term, but especially in long term, that we indeed can make a difference with the patients.
- And then, these are the first results. If you look to the achieved level of HbA1c then you see in the conventional treatment, it remained very high over time, around 9, and in the intensive treatment there was fast reduction and then it remained a bit around 7, so they did not really reach their targets, 6.05, but they could maintain it around a level of 7.
- And what are the consequences of that? So if you look to the retinopathy, you see that in the primary prevention, you can see already after two years that there is a distinction, between the two groups. And not only in the primary intervention, but also in the secondary prevention, you can see that there is a significant reduction in retinopathy in those groups of patients over a long period of time.
- In rheumatology we also have a number of publications indicating that targeted therapy, employing tighter disease control improves patients’ outcome. But the challenge is still to define the target that will be acceptable in daily practice, will be acceptable for all of us, and will also be implementable in daily practice. Because many things we accept, but bringing them into reality in our everyday patient care is sometimes not so easy.
- Steering Committee: 20 rheumatologists and a patient with RA, identified on the basis of their expertise in treating RA, participation in clinical trials, development of consensus statements and regional distribution across Europe and North America;
- Consensus group: steering committee and 40 additional experts from Europe, North and Latin America, Japan and Australia, including 5 patient representatives.
- When we started the literature search, we had to make a few definitions. We had to define what is studied that investigates the effectiveness of treating to target. The first thing is we defined treat to target trials as trials that investigate the value of using a pre-defined target for a therapeutic intervention. So some numerical thresholds that need to be reached within that trial, and if they’ve not been reached, there’s some consequence to it. That’s actually a second bullet point. And within the trial, and that was an important additional requirement, the “steered” therapy would need to be compared to some arm in the trial that was not using this steered approach, so you can assess, not the efficacy of the drug intervention, but assess the efficacy of the intervention to treat to target.
- This is the flow of the search. As you can see here, the initial retrieval was about 6,000 hits. When you excluded those that were non-human, non-English and non full-text, you got to about 3,500 hits. But Monika had to look at the title and abstracts of these three and a half thousand articles to identify whether they are useful or not, and below, in the boxes here, you can see the reasons why she would exclude some or many of the studies within each of the searches. So the next boxes here are really the ones that we retrieved for more detailed reviews. So those were the articles that we really had to read in detail and extract data and summarize data. That was 76 articles, and from those, obviously, after you read the article, you find out that there’s some reasons why this is not what you needed, and you can see the reasons for exclusion after the thorough assessment. They are listed in these boxes, and really this line, you can see down here, it’s 21 studies that really came out of the process.
- And from these, really six studies are what we called core treat to target studies that for RCTs compared a really T2T approach versus some routine approach: there was one randomized control trial testing two targeted treatment approaches, in two arms there was one study that compared targeted treatment approach to an historical routine control in an observational manner the rest of the studies were providing some circumstantial evidence And I will briefly touch on the difficulty of interpreting these results in terms of looking at the effectiveness of looking at Treat To Target.
- I’m really going to focus on the core trials. There are the 6 trials. As you can see, you are probably going to be familiar with all of them, there is: the TICORA study comparing a targeted approach to routine the CAMERA study the study by Fransen the study by Symmons I will go into some more detail of these studies in a moment And there’s a study by van Tuyl, which is the one that compares two different targeted approaches and the observational study by Stenger.
- To sum up … - Most of the core trials used the state of the target. - Mostly the state was low disease activity. - The timeframe for assessment of the target was one to four months, at most - Most of the studies were actually in early RA - And all studies showed, at least those studies comparing the T2T with the routine approach, showed that clinical outcomes were significantly improved. Future Research Question -The effect of T2T on functional and radiographic outcomes needs further investigation -More studies are needed in established/late RA
- Shekelle, et al. BMJ 1999; 318:593-6
- The 10 statements 1. The primary target for treatment of rheumatoid arthritis should be a state of clinical remission. 2. Clinical remission is defined as the absence of signs and symptoms of significant inflammatory disease activity. 3. While remission should be a clear target, based on available evidence low disease activity may be an acceptable alternative therapeutic goal, particularly in established, long-standing disease. 4. Until the desired treatment target is reached, drug therapy should be adjusted at least every 3 months.. 5. Measures of disease activity must be obtained and documented regularly, as frequently as monthly for patients with high/moderate disease activity or less frequently (such as every 3 to 6 months) for patients in sustained low disease activity or remission. 6. The use of validated composite measures of disease activity, which include joint assessments, is needed in routine clinical practice to guide treatment decisions. 7. Structural changes and functional impairment should be considered when making clinical decisions, in addition to assessing composite measures of disease activity. 8. The desired treatment target should be maintained throughout the remaining course of the disease. 9. The choice of the (composite) measure of disease activity and the level of the target value may be influenced by considerations of co-morbidities, patient factors and drug related risks. 10. The patient has to be appropriately informed about the treatment target and the strategy planned to reach this target under the supervision of the rheumatologist.
- The 10 statements 1. The primary target for treatment of rheumatoid arthritis should be a state of clinical remission. 2. Clinical remission is defined as the absence of signs and symptoms of significant inflammatory disease activity. 3. While remission should be a clear target, based on available evidence low disease activity may be an acceptable alternative therapeutic goal, particularly in established, long-standing disease. 4. Until the desired treatment target is reached, drug therapy should be adjusted at least every 3 months.. 5. Measures of disease activity must be obtained and documented regularly, as frequently as monthly for patients with high/moderate disease activity or less frequently (such as every 3 to 6 months) for patients in sustained low disease activity or remission. 6. The use of validated composite measures of disease activity, which include joint assessments, is needed in routine clinical practice to guide treatment decisions. 7. Structural changes and functional impairment should be considered when making clinical decisions, in addition to assessing composite measures of disease activity. 8. The desired treatment target should be maintained throughout the remaining course of the disease. 9. The choice of the (composite) measure of disease activity and the level of the target value may be influenced by considerations of co-morbidities, patient factors and drug related risks. 10. The patient has to be appropriately informed about the treatment target and the strategy planned to reach this target under the supervision of the rheumatologist.