RESEARCH - An open-label, single dose study of cyclosporine, MTX, and Remicade

[Guest guest]

Ann Rheum Dis. 2005 Aug 26; [Epub ahead of print]

An Open-label, Single-dose Study to Evaluate the Safety, Efficacy and

Effects on CD25 Expression of Cyclosporine in Patients with Rheumatoid

Arthritis and Active Disease in spite of Treatment with Methotrexate and

Infliximab.

Sidiropoulos PI, Siakka P, Raptopoulou A, Mamoulaki M, Choulaki C, Koutala

H, Kouroumali H, Kritikos H, Boumpas DT.

Department of Rheumatology, Clinical Immunology and Allergy, Medical School,

University of Crete, Greece.

BACKGROUND: Anti-TNF therapy has considerably improved the management of

rheumatoid arthritis. However, a subgroup of patients on anti-TNF and

methotrexate may experience treatment failures in spite of adjustments in

therapy. Combining anti-cytokine with a T-cell directed agent such as

cyclosporine (CsA) may rescue these refractory patients. Patients- METHODS:

This was an open label, pilot study to explore the safety, efficacy and

lymphocyte activation of a triple therapeutic regime with infliximab,

methotrexate and CsA. Nineteen patients (mean age 52.9 years) with

considerable residual disease activity (mean DAS28 7.3) after a mean of 16.8

infliximab infusions and dose adjustments of both infliximab (mean dose 4,2

mg/kg every 6weeks) and MTX (mean dose 17.1 mg/week) were enrolled.

Cyclosporine (mean dose 2.7 mg/kg/d) was added to a stable therapeutic

regime. Disease activity was evaluated by the DAS28 index. Lymphocyte

activation was evaluated assessing CD25 expression on peripheral blood

mononuclear cells (PBMCs). Primary end-points were safety and efficacy

according to the EULAR response criteria at 24 weeks. RESULTS: Eight

patients (42%) discontinued treatment, because of adverse events (3),

inefficacy (2) or non compliance (2). One patient died because of a stroke.

Five out of 11 patients (45%) that completed 24 weeks of treatment were

moderate responders. CD25 expression, both on unstimulated and PHA

stimulated PBMCs in five patients assessed, was reduced (mean values from

37+-34% to 15+-10% and from 50+-15% to 29+-20% respectively).

CONCLUSION: In this highly active, refractory group of patients, addition of

CsA reduced lymphocyte activation, and resulted in a modest response and a

high rate of discontinuation. In such patients, other novel approaches need

to be explored.

PMID: 16126800

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

6126800 & dopt=Abstract

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org