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Jean-Francis Maillefert

Publications and source records attributed to Jean-Francis Maillefert.

12 recordsLinked to original sources
PubMed2006

Clinical practice format for choosing a second-line disease modifying anti-rheumatic drug in early rheumatoid arthritis after failure of 6 months' first-line DMARD therapy.

BACKGROUND: The objective was to develop a clinical practice format for choosing a second-line disease-modifying anti-rheumatic drug (DMARD) after a 6-month course of a first-line DMARD in patients with early RA. METHODS: A panel of 34 experts selected treatment option from various scenarios using the Thurstone pairwise method. The experts had to choose between two proposed DMARDs without proposing other options. The scenarios were obtained using the three items: DAS28, rheumatoid factor status and radiographic structural damage. A sample of 240 among 480 scenarios for each expert was taken at random. Responses given by at least 20% of the experts were considered pertinent. RESULTS: Recommendations for choosing a second DMARD for early RA after failure of a 6-month course of a first-line DMARD were established according to 4 parameters: type of first-line DMARD, activity, RF status and radiographic joint damage. The results of this study suggest that in patients with early RA who fail a 6-month course of first-line DMARD therapy, the best options may be addition of corticosteroid when disease activity is moderate to high and switching to a biologic agent when further radiographic joint damage occurs, particularly in patients with positive tests for RF. CONCLUSION: Although our scenarios did not include step-up (add instead of substitute) strategies, except for corticosteroids, we feel that the format presented here can optimise the management of patients with early RA seen in clinical practice.

Antirheumatic Agents↗
PubMed2006

TNFalpha antagonist therapy in ankylosing spondylitis and psoriatic arthritis: recommendations of the French Society for Rheumatology.

OBJECTIVES: To develop recommendations for TNFalpha antagonist therapy in patients with spondyloarthropathies. METHODS: The Delphi consensus procedure was used to select questions, to which evidence-based answers were sought in the literature. Expert opinion was used when needed to estimate the risks and benefits of TNFalpha antagonists. TNFalpha antagonists exert potent antiinflammatory effects but fail to provide a definitive cure. RESULTS: Recommendations were developed for patients with ankylosing spondylitis (AS) or psoriatic arthritis (PsA). The following criteria for TNFalpha antagonist therapy were selected: definitive diagnosis of AS or PsA, active disease for at least 4 consecutive weeks documented during two physician visits, overall physician's assessment of disease activity>/=4/10 and BASDAI>/=4/10 in axial disease or at least three tender and swollen joints in peripheral disease, failure to respond adequately to at least three nonsteroidal antiinflammatory drugs given in optimal dosages for at least 3 months in axial disease or at least one disease-modifying antirheumatic drug (methotrexate, leflunomide, sulfasalazine) for at least 4 months, with local glucocorticoid injections if appropriate, in peripheral disease. Effectiveness and safety should be evaluated by a rheumatologist. The frequency of monitoring depends on the drug. Lack of effectiveness should be defined as inadequate improvement after 6-12 weeks, with a less than two-point decrease in the BASDAI in axial disease or a less than 30% decrease in the tender and swollen joint counts in peripheral disease. CONCLUSION: These clinical practice recommendations should help rheumatologists in their everyday decisions regarding the use of TNFalpha antagonist therapy in patients with AS or PsA.

Anti-Inflammatory Agents↗
PubMed2006

Methotrexate therapy for rheumatoid arthritis: clinical practice guidelines based on published evidence and expert opinion.

OBJECTIVES: To develop clinical practice guidelines for the use of methotrexate in rheumatoid arthritis (RA), using the evidence-based approach and expert opinion. METHODS: A scientific committee used a Delphi procedure to select five questions, which formed the basis for developing recommendations. Evidence providing answers to the five questions was sought in the Cochrane databases, PubMed, and proceedings of meetings of the French Society for Rheumatology, European League Against Rheumatism, and American College of Rheumatology. Using this evidence, a group of rheumatologists developed and validated the recommendations. For each recommendation, the level of evidence and the extent of agreement among experts were specified. RESULTS: The recommendations were as follows: 1: The starting dosage for methotrexate in patients with RA should not be less than 10 mg/week and should be determined based on disease severity and patient-related factors; 2: When a patient with RA shows an inadequate response to methotrexate, the dosage should be increased at intervals of 6 weeks, up to 20 mg/week, according to tolerance and patient-related factors; 3: When starting methotrexate treatment in a patient with RA, preference should be given to the oral route. A switch to the intramuscular or subcutaneous route should be considered in patients with poor compliance, inadequate effectiveness, or gastrointestinal side effects; 4: At present, there is no evidence indicating that a change in methotrexate dosage is in order when a TNF antagonist is given concomitantly; 5: The investigations that are mandatory before starting methotrexate therapy in a patient with RA consist of a full blood cell count, serum transaminase levels, serum creatinine with computation of creatinine clearance, and a chest radiograph. In addition, serological tests for the hepatitis viruses B and C and a serum albumin assay are recommended. In patients with a history of respiratory disease or current respiratory symptoms, lung function tests with determination of the diffusing capacity for carbon monoxide are recommended; 6: Investigations that are mandatory for monitoring methotrexate therapy in patients with RA consist of full blood cell counts and serum transaminase and creatinine assays. These tests should be obtained at least once a month for the first 3 months then every 4-12 weeks; 7: Folate supplementation can be given routinely to patients treated with methotrexate for RA. In practice, a minimal dosage of 5 mg of folic acid once a week, at a distance from the methotrexate dose, is appropriate; 8: In the event of respiratory symptoms possibly related to methotrexate toxicity, the drug must be stopped and symptom severity evaluated. Should evidence of serious disease be found, the patient should be admitted immediately or advice from a pulmonologist should be obtained immediately. CONCLUSION: Recommendations about methotrexate therapy for RA were developed. These recommendations should help to improve practice uniformity and, ultimately, to improve the management of RA.

Arthritis, Rheumatoid↗
PubMed2005

Concomitant therapies as an outcome measure. Part 1: Drugs.

Concomitant therapy intake (i.e., drugs other than the study drug) could potentially be used as an outcome measure in therapeutic trials in musculoskeletal disorders. The objective of this Special Interest Group (Part 1) was to investigate this possibility. Concomitant therapy intake could be used as an outcome measure in 2 ways: either as an associated outcome measure if it was determined there was interaction between the study drug and the concomitant drug, or as an outcome measure in itself if concomitant drug intake was deemed important in its own right and fulfilled the OMERACT filter requirement. These 2 aspects were discussed in the session and then put to a vote.

Endpoint Determination↗
PubMed2005

Concomitant therapy: an outcome variable for musculoskeletal disorders? Part 2: total joint replacement in osteoarthritis trials.

Interest has grown in using the requirement of total joint replacement (TJR) as a "hard" outcome measure. Limitations exist, however, in the use of such an outcome, in particular the variability in the decision to perform surgery, length of surgical waiting lists, and sensitivity to change. This special interest group is exploring ways of retaining the clinical relevance of TJR but overcoming the problems--2 alternative outcomes are being considered: "time to physician's decision to recommend surgery" and "time to fulfilling criteria for total joint replacement."

Arthroplasty, Replacement↗
PubMed2005

Measurement of joint space width and erosion size.

Measurement of radiographic abnormalities in metric units has been reported by several investigators during the last 15 years. Measurement of joint space in large joints has been employed in a few trials to evaluate therapy in osteoarthritis. Measurement of joint space width in small joints has been reported by several investigators but has not yet found a place in clinical trials in rheumatoid arthritis or osteoarthritis. We review methods for measuring joint space width in finger, toe, and wrist joints; special attention is given to how the joint edges are found, the method used to measure distance between joint margins, size of an area of the sampled joint, and reproducibility of measurements. Methods for measurement of erosion size, which have had less attention, are briefly discussed.

Arthrography↗
PubMed2004

Costs of workups for the diagnosis of early arthritis: results of a nationwide survey.

OBJECTIVE: To evaluate the costs of workups to diagnose early arthritis. METHODS: In 2000, the French Society for Rheumatology conducted a survey of a representative sample of French and Belgian rheumatologists (n = 239). The respondents were asked to consider 2 hypothetical scenarios, 1 describing undifferentiated arthritis and the other more suggestive of rheumatoid arthritis. They were then asked what diagnostic workup they would order. Costs for each study were determined in 2001 euros, according to the French public health system fee schedules. RESULTS: In total, 151 rheumatologists participated in the study (63%). The mean +/- SD diagnostic costs were 406.5 +/- 194.3 euro for the case with no diagnostic clues, and 280.7 +/- 154.3 euro for the case suggestive of early RA. Responses were very heterogeneous. The 2 main sources of expenditure were immunology tests and imaging. Hospital staff physicians tended to order more expensive workups, and costs tended to vary inversely with physician experience. The most important predictor of cost was diagnostic doubt, as estimated by the number of diagnoses proposed by respondents in each case; each additional diagnosis cost an additional 19.1-26.1 euro. CONCLUSION: Diagnostic workups after a first medical visit for early polyarthritis result in substantial direct costs. This observation and the great variability observed in physicians' practices point out the need for consensus on the appropriate workups for these patients.

Adult↗
PubMed2004

[Reflex sympathetic dystrophy: still a poorly defined entity].

The reflex sympathetic dystrophy (algodystrophy) constitutes a large nosological field of which the main characteristics are the appearance of algic and vasomotor symptoms at a segmental level of a limb, in consequence to diverse pathologies (trauma, cardiovascular disease, etc.). The widely accepted theory of a dysregulation of the sympathetic nervous system is nowadays counter-balanced by recent work highlighting the preponderant role of polymodal afferent nerves in the pathophysiology of this disease. The diagnosis, being above-all clinical, is marked by two distinct phases appearing in a variable chronology; a warm phase associating fluctionating pain, stiffness and vasomotor symptoms, and then a cold phase characterized by fibrosis, leading to disabling trophic symptoms. Spontaneous recovery is usual and can be delayed by up to two years, however irreversible sequelae can occur. Paraclinical investigations are necessary to confirm the diagnosis: absence of a biological inflammatory syndrome, early hyperfixation on bone scintography or an abnormality in the MRI signal in the sub-chondral zones. The X-ray shows late local demineralization that is often non-homogenous. The treatment is poorly codified. First-line treatment in France, other than antalgics, often rests on the calcitonins. Intravenous diphosphonates are proposed by some in case of treatment failure. Regional venous blocks are sometimes performed in resistant and disabling forms. Rehabilitation and psychological support have a primordial place throughout the evolution of the illness.

Acute Disease↗
PubMed2004

Joint symptoms in patients on bupropion therapy.

OBJECTIVE: To describe joint symptoms related to bupropion therapy. METHODS: We retrospectively reviewed adverse events in bupropion-treated patients reported to the Bourgogne Drug Surveillance Center, France, between October 2001 and December 2002. Joint symptoms classified by the causality assessment as related to bupropion were identified and examined. RESULTS: Four cases were found. Three patients had semi-delayed hypersensitivity reactions resembling serum sickness, manifesting as urticaria and arthralgia with or without a fever. The remaining patient had an unusual presentation consisting in acute monoarthritis of the wrist that started a few days after bupropion initiation. CONCLUSION: Hypersensitivity reactions to bupropion are fairly common and include rare cases of serum sickness-like reaction. Urticaria and incapacitating arthralgia are at the forefront of the clinical picture and may require a brief period of inpatient care. Antihistamines are the treatment of choice. Other manifestations such as acute monoarthritis might occur, although this awaits confirmation as we identified a single case.

Adult↗
PubMed2004

The methods for handling missing data in clinical trials influence sample size requirements.

OBJECTIVE: Results of studies estimating osteoarthritis progression may be affected by missing values. In clinical trials assessing disease-modifying osteoarthritis drugs, sample sizes should be calculated using close estimates of outcome variables. STUDY DESIGN AND SETTING: Supposing a two-parallel group design in hip osteoarthritis clinical trials, we estimated sample sizes using the joint space width (JSW), number of patients with JSW progression >0.5 mm (JSN), time to total hip arthroplasty (THA), and time to JSN or THA using several approaches to deal with missing data. RESULTS: Three-year clinical trials testing a treatment effect of 50%, with a power of 80%, could require sample sizes of 121 patients for JSW, 57 for JS progression using multiple imputation for handling missing values; 200 for THA; and 47 for JSN or THA. These numbers vary greatly depending on the approach chosen for handling missing data. CONCLUSIONS: These results can help investigators plan clinical trials to select the primary outcome and a priori specify the way missing data will be handled.

Aged↗
PubMed2003

Is time to joint replacement a valid outcome measure in clinical trials of drugs for osteoarthritis?

Each of the five sets of criteria for THA mentioned in this article should be regarded as preliminary. They require validation in future studies conducted in various cohorts of patients and in different countries. Moreover, a set of generally accepted criteria is badly needed. The number of proposed sets of criteria listed in this article indicates clearly that no consensus presently exists with respect to the optimal time for a patient who has hip OA to undergo THA.

Arthroplasty, Replacement, Hip↗