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

[Guest guest]

Interesting articles about Rituxan! Thanks for posting. The article I

read today only said that the FDA's concern was for lupus patients -- it

seems to be a good alternative for people with RA. And the people with

lupus who were adversely affected by the drug may have had brain

involvement due to the lupus.

Take care,

[Guest guest]

,

Thank you for all the interesting articles-very

informative!

Stacey

--- <Matsumura_Clan@...> wrote:

> 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

>

>

>

>

>

>

>

> 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

>

>

>

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