RESEARCH - The efficacy and safety of Rituxan in patients with active RA despite MTX

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Arthritis Rheum. 2006 May;54(5):1390-400.

The efficacy and safety of rituximab in patients with active rheumatoid

arthritis despite methotrexate treatment: results of a phase IIB randomized,

double-blind, placebo-controlled, dose-ranging trial.

Academic Unit of Musculoskeletal Disease, Chapel Allerton Hospital, Leeds,

UK. p.emery@...

OBJECTIVE: To examine the efficacy and safety of different rituximab doses

plus methotrexate (MTX), with or without glucocorticoids, in patients with

active rheumatoid arthritis (RA) resistant to disease-modifying

antirheumatic drugs (DMARDs), including biologic agents. METHODS: A total of

465 patients were randomized into 9 treatment groups: 3 rituximab groups

(placebo [n = 149], 500 mg [n = 124], or 1,000 mg [n = 192] on days 1 and

15) each also taking either placebo glucocorticoids, intravenous

methylprednisolone premedication, or intravenous methylprednisolone

premedication plus oral prednisone for 2 weeks. All patients received MTX

(10-25 mg/week); no other DMARDs were permitted. RESULTS: Significantly more

patients who received 2 500-mg or 2 1,000-mg infusions of rituximab met the

American College of Rheumatology 20% improvement criteria (achieved an ACR20

response) at week 24 (55% and 54%, respectively) compared with placebo (28%;

P < 0.0001). ACR50 responses were achieved by 33%, 34%, and 13% of patients,

respectively (P < 0.001), and ACR70 responses were achieved by 13%, 20%, and

5% of patients (P < 0.05). Changes in the Disease Activity Score in 28

joints (-1.79, -2.05, -0.67; P < 0.0001) and moderate to good responses on

the European League Against Rheumatism criteria (P < 0.0001) reflected the

ACR criteria responses. Glucocorticoids did not contribute significantly to

the primary efficacy end point, ACR20 response at 24 weeks. Intravenous

glucocorticoid premedication reduced the frequency and intensity of first

infusion-associated events; oral glucocorticoids conferred no additional

safety benefit. Rituximab was well tolerated; the type and severity of

infections was similar to those for placebo.

CONCLUSION: Both rituximab doses were effective and well tolerated when

added to MTX therapy in patients with active RA. The primary end point

(ACR20 response) was independent of glucocorticoids, although intravenous

glucocorticoid premedication improved tolerability during the first

rituximab infusion.

PMID: 16649186

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?itool=abstractplus & db=pubmed & cmd=R\

etrieve & dopt=abstractplus & list_uids=16649186

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