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Are biologics useful

Q: Are any of the biologics helpful in Sjogren's Syndrome?

A: There are no current FDA approved biologics for Pimary Sjogrens. B cell agents are currently of most interest. Phase III  results which tests the efficacy of new drugs was recently published in Arthritis & Rheumatism (Meijer et al 2010; 62:960-968) using Rituximab (approved for B cell lymphoma & RA). Small double blind study (29F, 1M). Rituxan (20 pt), Placebo 10 pt). Protocol used the RA protocol (1000 mg/wk x 2), not the lymphoma protocol (375 mg/m2/weekly x 4), and used higher doses of steroids to prevent infusion rxns/serum sickness. There was improvement in unstimulated salivary flow (primary endpoint) and other symtoms and markers. As more studies are published, Rituxan is likely to see increased off-label use in Sjs. An older (2007) review by Meijer (Nethrlands) reviews previous trials with Interferon-alpha and TNF blockers (ie Remicade, Enbrel). Although, TNF is upregulated in salivary glands and initial uncontrolled studies suggested blocking agents would help Sjs symptoms-they did not. Patients with RA and secondary Sjogrens have their arthritis symptoms improve markedly with TNF blockers, but not their dryness symptoms.

There is a small trial of the B cell agent, epratuzumab/CD 22, in Sjogrens and BAFF/BLys agents in development for Lupus and holds hope for Sjs patients.  Stay tuned!  The Sjogrens Syndrome Foundation (www.sjogrens.org ) is developing a Clinical Trials Consortium that will help facilitate clinical trials in Sjogrens.

dr c

dr c

Printed from: http://www.sjogrensforum.com/medications/are-biologics-useful/ .
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4 Comments   »

  • Michelle says:

    I have sjogren's and have been using Enbrel for 6 years. However, my sjogren's is not typical. Similar to RA, my sjogren's symptoms disappear whenever I become pregnant. Doctor's did not believe me for 2 years until someone finally took a chance and put me on Enbrel. It has resolved all of my symptoms and even more that I didn't realize were due to the underlying condition.
    I have tried going off Enbrel, but within a week I have a migraine headache. I feel wonderful since being on it.
    I hope this helps someone else as well.

  • rfremes says:

    Michelle

    Thank you for your information. It makes sense that your symptoms would improve with pregnancy, as cortisol levels (prednisone effect) kick-in, and after delivery they fall-thus a flair. The response to Enbrel is very interesting as the clinical trial data did not support it's effectiveness. This was also the case with another TNF blocker Remicade. It points to how individual effective treatment plans can be. I am glad you had a physician who would work with you! dr c

  • vasculitis symptoms says:

    I AM A HEALTHCARE WORKER IN NY AND AM MANDATED TO HAVE THE FLU VACCINE. I AM ALARMED BECAUSE I SEE THIS AS A SET UP FOR MANDATORY SWINE FLU VACCINATIONS. I OPPOSE BOTH FOR MYSELF BUT MY JOB IS ON THE LINE IF I REFUSE. ANY SUGGESTION?

  • Yohana says:

    I am trying to use diet as a smtpleuenpary treatment for my RA also. Right now I am starting a clean eating plan which at its heart is an anti-inflammatory diet. It is incouraging to see that someone has successfully found that a better diet allows them to cope with this disease better.

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