New Treatments on the Horizon? | Arthritis Information

 

While talking to my friend to get advice on injecting the MTX, I learned that she was recently taken off it because of elevated liver panels.  She has ankylosing spondylitis and has been through the gamut of all the usual drugs and the MTX was the only thing she could tolerate because of various other health issues.  Now she can't take anything except pain killers and is waiting for something new to try.  I remember reading here something about new medications on the horizon but a search came up empty.  Anyone remember who posted it?  An internet search didn't find what I want either.  She has a very good attitude about the whole thing but I'd still like to forward some hopeful news about possible new treatments for her to try in the not-too-distant future. 

New Actemra data shows significant benefit for patients suffering from rheumatoid arthritis
TOWARD study, presented at major US congress ACR, confirms IL-6 receptor inhibition plays a key role in the treatment of RA
The innovative new rheumatoid arthritis drug Actemra (tocilizumab) has been shown to significantly improve the signs and symptoms of rheumatoid arthritis (RA) in patients who failed to achieve an adequate response to traditional disease modifying agents (DMARDs). Exciting new data from the TOWARD1 study, being presented as a late breaker, at the American College of Rheumatology (ACR) Annual Scientific Meeting in Boston, November 6-11, reinforce the benefit of tackling RA through the inhibition of the IL-6 pathway.

In the TOWARD trial, 61% of patients in the Actemra plus DMARD group achieved a 20% reduction in RA symptoms (ACR202 response) compared with only 25% of patients in the control group. Around one in three patients achieved clinical remission in the Actemra group, as assessed using DAS28 <2.63 .These results are consistent with the results of another Actemra trial, the OPTION4 study, which were previously reported and which will be the subject of further presentations at ACR. The OPTION study showed that 59% of patients in the Actemra treatment arm experienced a 20% reduction in RA symptoms (ACR20 response) versus only 27% of patients in the control group.

"We are very encouraged by the findings of this new TOWARD data which suggest that Actemra plus DMARDs demonstrates significant improvement in RA symptoms compared with DMARDs alone," said Mark C. Genovese, M.D., lead study investigator of the TOWARD trial and associate Professor of Medicine at Stanford University School of Medicine. "These data further establish the efficacy of Actemra and confirm that inhibiting the interleukin-6 (IL-6) receptor is a novel method of reducing RA symptoms."

"These results show that remission rates achieved with Actemra compare favourably with current RA therapies indicating the medicine's potential to become a very effective new treatment option," said Dr. Urs Schleuniger, Head of Inflammatory Diseases, Roche. "Findings from the TOWARD and OPTION studies will be part of the application to Regulatory Authorities that we intend to submit by the end of the year."

http://www.eurekalert.org/pub_releases/2007-11/cwl-nad110807.php

http://www.drugs.com/nda/actemra_071121.html



UCB Reports US FDA to Review Cimzia® License Application for Treatment of RAFebruary 11, 2008
by Dario Liu
UCB (BRUSSELS, Belgium) announced that the US FDA agreed to accept, for filing and review, a Biologics License Application (BLA) for Cimzia® (certolizumab pegol), a PEGylated and Fc-free anti-TNFα antibody-fragment therapeutic, for the treatment of adult patients with active rheumatoid arthritis (RA). Submission preparation continues for a Marketing Authorization Application (MAA) to the European Medicines Agency for Cimzia in the treatment of RA, with filing planned in the first half of 2008.

The BLA is based on data from >2367 patients and includes three multicenter, placebo-controlled phase III trials. In the studies, Cimzia given with methotrexate was shown to be significantly more effective than methotrexate alone for inhibiting joint damage progression in patients with active RA. Results were observed as early as 24 weeks (RAPID 1 and RAPID 2). The agent rapidly reduced the signs and symptoms of active RA with peak ACR-50 and -70 responses achieved at 14 and 16 weeks, respectively. Improvement in physical function and quality of life measures were also seen for up to 1 year (RAPID 1). Cimzia administered as monotherapy showed significant improvement in signs and symptoms of RA from week 1 and this benefit was maintained through week 24 (Study 011). The most commonly occurring adverse reactions were headache, nasopharyngitis, and upper respiratory tract infections. Reported serious adverse reactions were infections (including tuberculosis) and malignancies (including lymphoma), consistent with findings from other anti-TNF class trials.

Cimzia was approved in Switzerland for the treatment of Crohn's disease in September 2007, and the agent was marketed in January 2008. Additionally, in late 2007, UCB announced its intent to appeal the negative opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in the EU for the agent in treating Crohn's disease. A decision resulting from the CHMP re-examination of the MAA submission is expected during the first half of 2008. Pending US FDA approval of the agent in treating Crohn's, UCB has initiated an additional short-term clinical study to confirm clinical response in moderate-to-severe active disease. UCB expects the results in the second half of 2008. The initial development program met all primary endpoints with statistical significance. Therefore, whether the additional study, which was not part of the pivotal trials program initially agreed upon with the FDA, will be a pre-approval requirement or a post-approval commitment, is still the subject of the ongoing communications with the FDA.

UCB completed a phase II re-treatment study for the agent in psoriasis patients who relapsed during the initial off-treatment period of the study. Results show that the majority of those re-treated were able to recapture response: 72% for the low dose group (200 mg eow) and 91% for the high dose group (400 mg eow) reached PASI 75. Re-treatment with Cimzia was well tolerated and UCB is finalizing development plans for the agent in psoriasis, with an update expected in the first half of 2008.
Lynn492008-03-06 14:45:30Wonderful.  Thank you so much Lynn.  I'll send this to her along with anything that comes up here. 
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