Safety and efficacy of tocilizumab as monotherapy or in combination with methotrexate in Tunisian patients with active rheumatoid arthritis and inadequate response to disease-modifying anti-rheumatic drugs in conditions close to clinical practice.

OBJECTIVES: We aimed to assess the safety and efficacy of tocilizumab as monotherapy or in combination with methotrexate in a routine clinical practice setting in Tunisian patients with RA who did not respond to conventional treatment with disease-modifying anti-rheumatic drugs (DMARDs-IR). METHOD: A total of 51 DMARDs-IR adult patients with moderate to severe RA participated in a phase IIIb, open-label clinical trial. Patients received 8 mg/kg of tocilizumab every 4 weeks in combination with a DMARD or as monotherapy during 24 weeks. The study was extended to 24 other weeks for those who had at least a moderate response at the end of the initial phase. Safety and efficacy of tocilizumab were analysed. RESULTS: Four patients discontinued treatment prematurely due to an adverse event. The most common AEs were hypercholesterolemia (18 cases), increased triglycerides (17 cases), increased transaminases (15 cases), rash (14 cases), neutropenia (7 cases), digestive disorders (3 cases) and respiratory disorders (3 cases). After 52 weeks, 90.5% of patients responded to treatment. At the end of the study, 61.9% of the patients had a mild RA and almost 50% of patients were in remission. Overall, 29.2, 6.3 and 4.3% of patients achieved ACR20, ACR50 and ACR70 responses, respectively. Additionally, the study showed a significant improvement in all individual parameters of ACR core data. CONCLUSIONS: Treatment with tocilizumab was well tolerated and showed a fast and sustained efficacy in Tunisian patients with moderate to severe active RA who had an inadequate response to DMARDs.Key Points• Up to 40% of RA patients remain inadequate responders to a prior csDMARD or a tumour necrosis factor α inhibitor (TNFi) biological agent. A non-TNF biological agent like tocilizumab with or without methotrexate is recommended in those patients.• In this study, tocilizumab treatment improved the number of responders, the number of patients in remission, and the evolution of disease activity. The meaningful clinical improvement seen denotes a rapid and sustained response to treatment.• Tocilizumab presented a favourable safety profile with few withdrawals due to AEs, consistently with what was observed in other trials.• This study provides new information about the safety and efficacy of tocilizumab in a patient population resembling that expected in clinical practice among the Tunisian population.

Bilateral septic arthritis of the sternoclavicular joint complicating infective endocarditis: a case report.

BACKGROUND: Septic arthritis is an infectious disease that commonly affects weight-bearing or proximal joints such as the knee and the hip. The sternoclavicular joint is an unusual site of this entity. It usually occurs in patients with diabetes mellitus, intravenous drug abusers, or those with rheumatoid arthritis. Analysis of the previous literature showed few articles and these described essentially cases of unilateral presentation. CASE PRESENTATION: We report a rare case of a bilateral septic arthritis of the sternoclavicular joint sustained by a 71-year-old Tunisian woman whose medical history was significant for methicillin-resistant Staphylococcus aureus infective endocarditis 6 months ago. Imaging investigations revealed destruction of the medial extremities of her two clavicles and bilateral collections in the soft tissues around her sternoclavicular joints. She was treated successfully by needle aspiration drainage combined with a 12-week antibiotherapy. CONCLUSIONS: Bilateral septic arthritis of the sternoclavicular joint is an extremely rare entity, with a paucity of literature. Only early diagnosis, which is obtained from the culture of the joint fluid using needle aspiration, allows satisfactory functional outcome and a good prognosis. Osteoarticular infections should be considered in patients with recent infective endocarditis in cases of fever recurrence.

[Solitary bone plasmacytoma: about 3 cases and review of the literature]. / Le plasmocytome solitaire osseux: à propos de 3 cas et revue de la littérature.

Solitary plasmocytomas are rare, accounting for less than 5% of all plasmocytes proliferations. Its diagnosis is based on the presence of localized tumor of monoclonal plasma cells cytologically identical to those of multiple myeloma, in the absence of other signs of a disseminated form. This study aims to carry out a retrospective study of three cases of solitary bone plasmocytomas associated with a detailed review of the literature describing the diagnostic, therapeutic and evolving characteristics of this rare entity.

Evaluation of the posture and muscular strength of the trunk and inferior members of patients with chronic lumbar pain.

OBJECTIVE: We examine the postural profile and muscular forces of the trunk and inferior members of patients with chronic low back pain. METHODS: In this study, we include 60 subjects forming two groups: a first group (G1) of 30 patients with chronic low back pain and a second group (G2) of 30 healthy subjects. Every subject profited from an isokinetic evaluation of the muscular forces of the trunk (at 60 and 90°.s(-1)) and knees (at 60 and 120°.s(-1)) and of a postural evaluation. The isokinetic evaluation was carried out using Cybex(®) Norm II dynamometer with its Trunk Extension/Flexion (TEF) module set in concentric mode. The parameter under study was the torque peak. The postural evaluation was accomplished using the platform SATEL for the balance analysis associated with four conditions: static on stable plan open eyes (OE) then closed eyes (CE) and static on unstable plan OE then CE. The parameters under study were the averages of the total lengths, total surfaces, and the X and Y means. RESULTS: The averages of the torque peaks of the trunk flexor and extensor muscles at the speeds of 60 and 90°.s(-1) were inferior in group G1 as compared to G2. The differences were statistically insignificant only for the extensor muscles (p<0.005). The averages of the torque peaks of the knee flexors and extensors at 60 and 120°.s(-1) were the lowest in group G1. The differences were significant (p<0.05). The averages of postural parameters were more important in group G1, indicating a postural deficit in this group. CONCLUSION: We showed deficits of the posture and muscles of the trunk and knees of patients with chronic lumbar pain. The muscular deficit of the trunk predominates on extensors.

Clinical and diagnostic value of ribosomal P autoantibodies in systemic lupus erythematosus.

OBJECTIVE: To analyse prospectively the diagnostic sensitivity and specificity as well as the clinical relevance of ribosomal P (anti-P) autoantibodies in a large cohort of SLE patients. METHODS: The anti-P autoantibodies were evaluated in the serum of 200 Tunisian SLE patients at disease onset and 130 various control subjects by a sensitive immunodot assay. A complete laboratory evaluation and clinical examination were performed in each SLE patient. During the follow-up, the patients were regularly monitored for clinical parameters. Global SLE activity was measured by the ECLAM. RESULTS: The sensitivity and specificity of anti-P testing for SLE were 23.5 and 98.4%, respectively. The anti-P-positive samples 14/47 (29.8%), 27/47 (57.4%) and 5/47 (10.6%) were negative for anti-dsDNA, anti-Sm or both antibodies, respectively. The anti-P-positive patients showed more active disease activity and a much higher prevalence of arthritis. An association between IgG aCLs and anti-P antibodies was also found. However, anti-P antibodies were not associated with neuropsychiatric manifestations or lupus nephritis. CONCLUSION: This study does not seem to confirm the described association of anti-P antibodies with neuropsychiatric manifestations of SLE. However, it supports the anti-P antibody association with arthritis and disease activity as well as the presence of aCL. Based on our study and other related studies, we propose that, akin to anti-Sm and anti-dsDNA, anti-P antibodies detected by one agreed method may be considered for inclusion as a criterion for the classification of SLE.

[Functional disability indexes: translation difficulties and cross cultural adaptation problems]. / Les indices d'incapacité fonctionnelle: difficultés de traduction et problèmes d'adaptation transculturelle.

OBJECTIVES: To summarize the difficulties involved in translating tests in Arabic and to describe the translation methods and to apply those to functional indexes. METHOD: Four functional indexes were translated and then subjected to the following test validation methods: back translation, pre-test, and review by an expert committee. RESULTS: Translation problems were underlined. These include in particular the different types of equivalence between the source language and the target language (semantics, idioms, conceptual... equivalences). Problems related to comprehensive literal words were the most observed. CONCLUSION: The current method combining translation with back translation is not sufficient and must be used with, a pre-test and a review committee.