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Clinical Conference Microemulsion formulation of cyclosporin (Sandimmun Neoral) vs Sandimmun: comparative safety, tolerability and efficacy in severe active rheumatoid arthritis. On behalf of the OLR 302 Study Group. free! 2000
Yocum DE, Allard S, Cohen SB, Emery P, Flipo RM, Goobar J, Jayawardena S, Job-Deslandre C, Jubb RW, Krüger K, Lopes Vaz A, Manger B, Mur E, Nygaard H, Weiner SM, Rainer F, Sack MR, Schiff MH, Schnitzer TJ, Trigg LB, Whatmough I, Schmidt AG. · Arizona Arthritis Center, University of Arizona, Tucson, Arizona, USA. · Rheumatology (Oxford). · Pubmed #10725065 links to free full text
Abstract: OBJECTIVE: To compare the safety, tolerability and efficacy of the new oral microemulsion formulation of cyclosporin A (CyA; Sandimmun Neoral) and the original CyA formulation (Sandimmun), in patients with severe active rheumatoid arthritis (RA), over a 12-month period. METHODS: In this double-blind, multicentre study, patients were randomized to treatment with Neoral or Sandimmun, starting with 2.5 mg/kg/day, with dose adjustments after 4 weeks. Primary efficacy criteria included patients' assessment of disease activity. Pharmacokinetic and safety assessments were performed at regular intervals. RESULTS: Compared with Sandimmun, Neoral showed a consistent trend towards greater clinical efficacy from week 12 onwards, including a significant difference in patients' assessment of disease activity at the study end-points. A significantly lower increase in dose from baseline was observed with Neoral at week 24. Pharmacokinetic assessments at week 24 showed increased absorption and decreased variability with Neoral. No differences in safety were found between treatment groups. CONCLUSION: These observations indicate that Neoral is as safe and at least as effective as Sandimmun and have important implications for patient management given the increasing role for CyA in the treatment of severe, active RA.
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Article Sites of inflammation in painful rheumatoid shoulder assessed by musculoskeletal ultrasound and power Doppler sonography. 2008
Stegbauer J, Rump LC, Weiner SM. · Medizinische Klinik I, Marienhospital Herne, Ruhr-University, Bochum, Germany. · Rheumatol Int. · Pubmed #17924110 No free full text.
Abstract: Ultrasonography (US) and power Doppler sonography (PDS) was used to investigate causes of new onset of shoulder pain and sites of shoulder inflammation in 157 shoulders of 99 patients with rheumatoid arthritis (RA). US detected effusion and/or synovitis in 92/157 glenohumeral joints, subdeltoid bursitis in 56/157 shoulders and tenosynovitis of biceps tendon in 55/157 shoulders. Bursitis and/or tenosynovitis were accompanied by glenohumeral synovitis in 68/90 shoulders. 68% of serologically active and 12% of serologically inactive patients had glenohumeral synovitis. PDS showed increased microvascular blood flow in 33 of the 44 investigated shoulders. Glenohumeral synovitis was correlated to elevated C-reactive protein levels (p = 0.0001) and microvascular blood flow assessed by PDS (p = 0.02). This study shows that rheumatoid shoulder pain is not caused by glenohumeral synovitis in 32% of patients, despite serologically active RA. US and PDS are mandatory to elucidate the origin of inflammatory and noninflammatory shoulder pain.
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