Rheumatology Advance Access originally published online on September 15, 2008
Rheumatology 2008 47(11):1698-1703; doi:10.1093/rheumatology/ken348
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Eligibility of rheumatoid arthritis patients for anti-TNF-
therapy according to the 2005 recommendations of the French and British Societies for Rheumatology
1Department of Rheumatology, University Teaching Hospital Pitié-Salpêtrière, Paris 2Department of Rheumatology, University Teaching Hospital Roger Salengro, Lille and 3Department of Rheumatology, University Teaching Hospital La Cavale Blanche, Brest, France.
Correspondence to: B. Fautrel, Service de Rhumatologie, Groupe Hospitalier Pitié-Salpêtrière, 83, boulevard de l'Hôpital, 75651 Paris Cedex 13, France. E-mail: bruno.fautrel{at}psl.ap-hop-paris.fr
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Abstract |
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Objectives. Several anti-TNF-
prescription guidelines in RA have been published, among which those issued by the British (BSR) and French (SFR) Societies for Rheumatology in 2005 are the most comprehensive. Objectives of the PRISME II survey were to assess and compare eligibility for anti-TNF- therapy of RA patients consulting their usual rheumatologist according to (i) the SFR and BSR guidelines and (ii) the rheumatologist's opinion.
Methods. PRISME II was a postal, cross-sectional, observational survey proposed to all office-based rheumatologists practising in France in 2005. Rheumatologists were to include three consecutive consulting anti-TNF--naïve RA patients. Disease activity was assessed using the disease activity score 28 (DAS28). Structural damage progression was estimated based on the reading by the usual rheumatologist. The factors determining eligibility in the rheumatologists’ opinion were identified by a logistic regression analysis.
Results. Four hundred and thirty-four rheumatologists included 1132 patients. Ongoing RA structural progression was reported for 41% of the patients. According to the SFR and BSR criteria, 64 patients (7.0%) and 10 patients (0.9%), respectively, were eligible for anti-TNF- therapy, while 10% were deemed eligible according to the rheumatologists’ opinion. Determinants of eligibility according to the rheumatologists were: high disease activity (DAS28 >5.1), ongoing structural progression and elevated daily corticosteroid intake. These three determinants feature in the SFR guideline.
Conclusions. The proportion of RA patients eligible for anti-TNF- therapy varies greatly according to the BSR or SFR guidelines. In France, there is a remarkable convergence between rheumatologists’ opinion and SFR guideline regarding the main factors to consider for initiation of an anti-TNF- therapy.
KEY WORDS: Rheumatoid arthritis, DMARD, Anti-TNF- therapy, Biologics, Eligibility criteria, Prescription habits, Daily practice, Cross-sectional observational survey, Guidelines
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Introduction |
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RA is the most common inflammatory joint disease, with a prevalence of about 0.3% in France [1]. It conveys a significant human and socioeconomic burden due to the substantial functional impairment and disability caused by joint destructions and to the increase in cardiovascular events (ischaemic heart disease or stroke) related to systemic inflammation [2, 3]. RA management has been greatly advanced over the last several years, with the development of new optimized strategies and the availability of new therapies, especially TNF-
-blocking therapies [4, 5].
Due to the potential adverse effects of anti-TNF- agents, prescription guidelines have been drawn up at both the national and international levels [5–12]. The broadest and most comprehensive guidelines are those proposed in 2005 by the British Society for Rheumatology (BSR) in the United Kingdom and by the French Society for Rheumatology (SFR) in France [10, 13]. These guidelines were developed in quite different backgrounds. Both BSR and SFR guidelines were produced on the basis of scientific evidences. In the United Kingdom, BSR ones were subsequently revisited in a health economic perspective by the National Institute for Clinical Excellence (NICE) to finally become legally binding. In France, SFR recommendations did not include any economic considerations; they remained only informative for rheumatologists and were not endorsed by any governmental agency.
The BSR recommendations acknowledge only one level of disease activity—very active RA based on the simplified disease activity score 28 (DAS28) [14, 15]—for considering initiation of an anti-TNF- therapy, whereas the SFR guidelines introduce several nuances such as objective clinical and biological signs of inflammation, very active disease as in the United Kingdom or moderately active disease associated with structural progression or dependency on elevated corticosteroid daily intake, namely >0.1–0.2 mg/kg/day of prednisone equivalent (Table 1).
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In fact, several years after the introduction of anti-TNF-
agents in therapeutics, only limited information is available about the RA patients who are potential candidates for an anti-TNF- therapy as well as about rheumatologists’ attitude towards initiation of an anti-TNF- therapy. The PRISME II survey, which was carried out in France in 2005 among office-based rheumatologists, afforded the opportunity to study the eligibility for anti-TNF- therapy of RA patients consulting their rheumatologist, on the one hand according to the 2005 SFR and BSR guidelines and on the other hand according to the usual rheumatologist's opinion. |
Patients and methods |
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Survey design
The PRISME surveys were two observational, cross-sectional studies of similar design, carried out in France in 2003 and 2005. The results of the first wave (PRISME I) have been reported elsewhere [16]. For the second wave, which constitutes the basis of the present article, 1800 rheumatologists working in private practice (either full-time or part-time) were contacted by mail and offered participation in the survey.
The survey was carried out by the polling institute TNS SOFRES (Montrouge, France). During 1 week (from 23 to 28 May 2005), i.e. prior to the presentation and publication of the SFR and BSR guidelines, participating rheumatologists were to include the first three patients consulting for RA and fulfilling the following inclusion criteria: RA diagnosis based on the 1987 ACR criteria [17], and no previous history of biological therapy. Participating rheumatologists were also asked to keep a registry of all RA patients consulting during the same week.
Survey questionnaires
The participating rheumatologists were to fill in two questionnaires: (i) a personal questionnaire exploring physician's demographics and professional activity; (ii) a comprehensive patient questionnaire for each RA patient included in the survey. At the time of the survey, neither the SFR nor the BSR guideline had been published and no information about anti-TNF- guidelines or prescription was included in the survey documents.
The rheumatologist questionnaire consisted of eight items relating to physician's demographics, practice settings, participation in a health care network for RA and existence of a hospital correspondent. Moreover, participating rheumatologists had to provide information about every RA patient seen in consultation during the survey week, such as: age and date of RA diagnosis and existence of a previous treatment with either MTX or an anti-TNF- agent.
The 30-item patient questionnaire queried about fulfilment of inclusion criteria, patient demographics, medical history, current clinical status, disease activity as evaluated by the rheumatologist on a visual analogue scale (VAS) from 0 to 100, variables required for the computation of the DAS28 (disease activity assessed by the patient, independently from the rheumatologist, on a 0–100 VAS; numbers of tender and swollen joints on a list of 28, ESR) [14, 15], CRP level, extra-articular manifestations, X-ray examination findings, past and ongoing treatments and possible consideration of starting an anti-TNF- therapy within the coming weeks.
Data analysis
Characteristics of the participating rheumatologists were compared with those of the whole population of office-based rheumatologists practising in France to assess sample representativeness.
RA patients were categorized into four disease activity levels based on the DAS28 value: remission when DAS28 was <2.6, low activity when DAS28 was 
2.6 and 
3.2, medium activity when DAS28 was >3.2 and 5.1, and high activity when DAS28 was >5.1 [5, 14, 15, 18, 19]. The daily doses of corticosteroids were expressed in milligrams of prednisone equivalent. Structural damage progression was assessed on hand and foot X-rays as performed in usual care, i.e. by comparing the last and next to last X-rays.
Patients’ eligibility for anti-TNF- therapy was defined according to the SFR and the BSR criteria, respectively. Both BSR and SFR guidelines require persistently high disease activity, i.e. DAS28 >5.1 on two occasions a month apart; however, for convenience reason in this cross-sectional survey, only one DAS28 value was used. However, a recent study conducted in the United Kingdom showed that DAS28 values assessed a month apart are highly correlated in patients with high disease activity [20]. In addition, eligibility was also defined according to the usual rheumatologist's personal judgement, based on a positive rheumatologist's response to the following question: ‘For this patient, do you consider today the initiation of an anti-TNF- therapy?’ The factors significantly associated with eligibility were identified by a logistic regression analysis.
Categorical variables were expressed as the numbers and percentages. Between-group differences were statistically evaluated using the Z-test. Continuous variables were described by the usual statistics, i.e. number of observations, mean and S.D. Where appropriate, between-group differences were compared using the Student's t-test. Probability values <0.05 were considered statistically significant.
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Results |
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Development of the survey
A total of 434 rheumatologists (24.1% of all recruited rheumatologists) participated in the survey, of whom 429 (23.8%) actually returned 1143 patient questionnaires. One physician sheet and 11 patient questionnaires were not assessable (blank, not assessable or for unmet patient inclusion criteria). Thus, data from 428 physicians and 1132 patients were considered for analysis.
Survey sample of rheumatologists
In comparison with the whole population of office-based rheumatologists practising in France, survey rheumatologists were more often female and older and had been practising rheumatology for a longer time. Most of them lived in urban (44.6%) or semi-urban (41.4%) areas, and the majority (52.3%) practised part-time in hospital in addition to private office practice. Most survey rheumatologists (82%) had a specific hospital correspondent and 35% participated in a health care RA network.
Survey population of RA patients
During the survey week, rheumatologists examined a mean number of 4.9 ± 3.4 RA patients, with a mean age of 59 ± 14.1 yrs and mean time since RA diagnosis of 9.4 ± 9.3 yrs. Of these patients, 77% had already been treated (previous or ongoing treatment) with MTX, 24% with LEF. In addition, 16% of the patients seen during the survey period were already treated with a biological therapy, thus were not included in the study.
Most patients included in the survey were women (78%). Mean patient age was 59 ± 13.9 yrs. Mean time since disease onset was 9 ± 9.0 yrs (range 1–52 yrs), mean time since RA diagnosis was 8 ± 8.6 yrs (range 1–52 yrs) and mean time interval between the first symptoms and RA diagnosis was 1 ± 2.3 yrs (range 1–35 yrs). More than half of survey patients (57%) had never consulted in hospital or been hospitalized because of RA.
Mean RA activity assessed on a 0–100 VAS was 33 ± 21.7 [median 28; interquartile range (IQR) 15–47] when evaluated by the rheumatologist and 39 ± 24.3 (median 36; IQR 18–55) when evaluated by the patient. Mean numbers of tender and swollen joints were 4.9 ± 5.3 (median 2.6; IQR 0.57–6.5) and 2.8 ± 3.7 (median 0.9; IQR 0–3.6), respectively. Thirty-four per cent of the patients had no tender joint, 17% had no swollen joint and 14% neither swollen nor tender joints. Mean ESR was 23 ± 17.2 mm/1 h (range 1–98) and ESR was 28 mm/1 h for 29% of the patients. Mean CRP level was 13 ± 16.8 mg/l (range 1–117) and this level was 15 mg/l for 23% of the patients. DAS28 could be calculated for 1066 patients (94.2%): the numbers of patients with RA in either remission, low, medium or high activity were 513 (48%), 184 (17%), 328 (31%) and 41 (4%), respectively. Extra-articular manifestations were present in 13% of the patients (nodules in 9%).
Erosive disease was visible on X-rays for 54% of the patients (60% of those with RA of medium or high activity). Structural damage progression, as assessed by the comparison of the last and the next to last X-rays, was detected in 41% of the patients, with a mean time interval between the two X-rays of 2 ± 2.1 yrs.
A previous treatment with MTX had been discontinued in 16% of the patients, mainly for intolerance (57% of cases) or inefficacy (33%). Ongoing treatments included corticosteroids administered alone (7% of patients), DMARDs alone (39%) or combined with corticosteroids (49%), or other treatments not combined with corticosteroids (2%). Overall, 60% of the patients (59% of those with RA of medium or high activity) were currently treated with MTX at a mean dose regimen of 11.5 ± 3.5 mg/week (20% of the patients with a dose regimen 15 mg/week), while 56% received a corticosteroid treatment (62% of those with RA of medium or high activity) at a mean dose regimen of 7.4 ± 4.8 mg/day (21% of the patients with a dose regimen 7.5 mg/day).
Patient eligibility for an anti-TNF- therapy according to the SFR and BSR criteria
Patient eligibility according to the SFR criteria
All survey patients satisfied the ACR 1987 criteria for RA [17] and were assessed by a rheumatologist, i.e. a physician experienced in RA management. The data required for DAS28 computation as well as information about disease progression were available for 913 patients (100.0%). Anti-TNF- agents were contraindicated for 49 patients (5.4%).
Among the 864 remaining patients, 34 showed high disease activity (DAS28 >5.1): all these patients displayed objective signs of inflammation, which made them eligible for anti-TNF- agents. Furthermore, 266 patients displayed medium disease activity (3.2 < DAS28 5.1) with objective signs of inflammation for 228: 101 of these patients received a daily dose of corticosteroid >0.1 mg/kg and 85 were reported as having structural progression, which made them eligible for anti-TNF- agents. Finally, among 564 patients with no or low disease activity, 94 displayed structural progression and were thus eligible for anti-TNF- therapy.
Overall, taking account of inefficacy, intolerance or contraindication to MTX, 64 patients (7.0%) were found eligible for anti-TNF- therapy according to the SFR criteria (Table 2).
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Patient eligibility according to the BSR criteria (Table 3)
All 1132 survey patients (100%) had available DAS28, but 52 had at least one contraindication to anti-TNF-
therapy.
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According to the BSR criteria, all patients with DAS28
5.1 (1040 patients, 91.9%) were not eligible for anti-TNF- therapy. On the other hand, those patients with DAS28 >5.1, who experienced failure of MTX (previous treatment discontinuation for inefficacy or intolerance, or ongoing treatment since at least 6 months, at the standard dose) and failure or intolerance to at least one other DMARD, were eligible for anti-TNF- therapy. Ten patients (0.9%) were eligible for anti-TNF- therapy according to the BSR criteria.
Patient eligibility for anti-TNF- therapy in the opinion of survey rheumatologists
Survey rheumatologists considered initiation of an anti-TNF- therapy for 10% of the survey RA patients. The reasons mentioned by the rheumatologists for considering or not considering an anti-TNF- therapy are presented in Table 4.
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Nine variables were included in the logistic regression model exploring the determinants significantly associated with anti-TNF-
eligibility according to the rheumatologist's opinion: patient's sex and age, RA history duration, DAS28 (three categories), ongoing corticosteroid treatment at a dose >0.1 mg/kg/day, existence of a formal contraindication to anti-TNF- therapy, existence of erosive radiographic lesions, structural progression between the last two X-ray examinations and number of previous DMARD treatments (three categories). Results of the logistic regression analysis are presented in Table 5. Four factors appeared to have positively influenced the rheumatologist's opinion in favour of anti-TNF- therapy initiation: DAS28 >5.1, structural progression, experience of three or more previous DMARDs and ongoing treatment with a high dose of corticosteroid, namely >0.1 mg/kg/day. In contrast, increasing age appeared to be negatively associated with anti-TNF- eligibility according to the usual rheumatologist.
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Discussion |
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TopAbstractIntroductionPatients and methodsResultsDiscussionAcknowledgementsReferences |
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The PRISME II survey provided a snapshot picture of RA patients cared for in rheumatology private practice in France, at a time when neither the BSR nor the SFR clinical practice guideline had been published. Dramatic differences were noted as regards the proportions of RA patients found eligible for an anti-TNF-
therapy according to the BSR criteria (0.9%) and or the SFR criteria (7%), i.e. a ratio of 1:7.8. Of importance, for both guidelines, this percentage may be slightly overestimated since only one single DAS28 value was used to define high disease activity instead of two measures of DAS28 >5.1, 2 months apart.
No information was available about the number of RA patients, potentially candidates to anti-TNF- therapies in France prior to the PRISME I and II studies. In the UK, a study conducted in the Birmingham area revealed that 6.2% of 113 RA patients seen in two hospitals fulfilled the BSR guidelines for treatment with anti-TNF- [21]. Subsequently, a larger study included 1441 RA patients in 12 rheumatology centres and reported a 5.6% anti-TNF- eligibility rate [22]. The observed difference between these data and ours might be partly explained by an overall better control of the disease in mid-2000 than in 2000 or 2001 when the two UK studies were performed. Another potential explanation might be the differences in patients’ recruitment; in the UK studies, patients were identified among the hospital outpatient departments, although in the present study, they were recruited directly in private practice offices. It is quite possible that some RA patients fulfilling anti-TNF- eligibility criteria remained untreated because they never have access to the hospital for any reasons, either personal reasons or gap in medical networks.
The SFR eligibility criteria essentially differ from the BSR eligibility criteria by the weight lent to disease progression as assessed by the evolution of structural lesions on successive radiographs [11, 13]. Results from the PRISME II survey indicate that disease progression may be preponderant for eligibility for anti-TNF- therapy according to the SFR guideline. As a matter of fact, 22 patients (i.e. approximately one-third of all patients found eligible) were deemed eligible on the grounds of disease progression, although RA was in remission or of low activity (Table 2). Furthermore, since most patients with active RA (RA of medium or high activity) had in reality RA of medium activity (
90%), most of the 26 patients of this category found eligible because of disease progression were in fact patients with RA of medium activity. Another specificity of the SFR guideline is the accounting for eligibility of patients with RA of medium activity if control of disease activity requires the administration of elevated doses of corticosteroids (<0.1 mg/kg/day of prednisone equivalent). This point might represent high importance since a previous study conducted in the United Kingdom has shown that 68.2% of the patients with DAS28 5.1 were treated by steroids vs only 49.3% of the patients with DAS28 >5.1, suggesting that a substantial number of patients may be maintained in moderate activity by steroids due to which long-term side-effects might be not negligible [22]. All these factors largely explain the higher proportion of patients deemed eligible for anti-TNF- therapy according to the SFR criteria compared with the BSR criteria.
The sample of RA patients included in PRISME II appeared representative of the RA population cared for in private practice in France. The RA patients included in the survey were indeed quite comparable with the RA patients seen in the same rheumatology offices during the same week in terms of age (59 yrs in both groups), length of time since RA diagnosis (8 yrs vs 9 yrs) and history of treatment with DMARDs. A striking finding of PRISME II is the low proportion of RA patients found with RA of high activity in 2005 (4%). In the PRISME I survey carried out in 2003 according to a similar design, a higher proportion of highly active patients (7%) was observed [16]. This reduction over a 2-yr period of time may indicate an improvement in RA management resulting in better control of disease activity [23, 24]. This possible improvement in RA severity may be parallelized with the rather low proportion of patients reported with erosive disease (54%); previous data from different cohorts were likely to report over 70% patients with erosive disease after 2 yrs of evolution [25]. The apparent difference might be due to the difference in patients’ inclusion period as well as to their recruitment in private practice offices where patients have usually less aggressive and progressive disease than in hospital centres.
The PRISME II survey also showed good agreement between the SFR eligibility criteria and the determinants of eligibility for anti-TNF- therapy in the opinion of French rheumatologists. It is remarkable that, besides a high DAS28 value, two factors identified by the rheumatologists (progression of radiographic lesions, treatment with an elevated dose of corticosteroid) also feature amongst the SFR eligibility criteria.
Our study has some limitations. PRISME II was based on rheumatologist-reported data, which made information about structural damage and structural progression less precise than the information that could be obtained in a randomized controlled trial with standardized and centralized X-ray assessment.
In conclusion, PRISME II results indicate that the proportion of patients eligible for anti-TNF- therapy varies greatly according to the criteria used to define eligibility in clinical practice. The SFR criteria for assessment of eligibility for anti-TNF- therapy are consistent with the opinion of the French rheumatologists. It would be interesting to investigate how the BSR guideline is perceived by the British rheumatologists.
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Acknowledgements |
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Funding: This study was supported by a research grant from Wyeth Pharmaceuticals, France.
Disclosure statement: The authors have declared no conflicts of interest.
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