Biologics Treatment Criteria: What are they for Sjogrens Patients?

[markt]

Hi all,

Thought I would canvass the wealth of knowledge here regarding prescriptions for Biologics...

I was curious if there was an answer as to what criteria Rheumatologists/Immunologists use when determining if a Sjogrens patient is in fact a good candidate for treatment with Biologics.  Is there anything of particular interest to them regarding pathology/lab-work, types of symptoms being presented, disease progression (organ involvement, etc.), or other objective criteria  that is being used?

I understand that Biologics are usually for people that have another Primary AI disease (RA / SLE); however, there are folks out there that have experienced control/improvement of their Secondary Sjogrens with use of such treatment (as evidenced in past/ongoing clinical trails).  There are even some here who are sero-negative for Sjogrens that have had such treatments prescribed by their healthcare provider...  my question is what did you say/do/show to convince them of the need?   

[Pete0211]

It probably varies from doctor to doctor, but for most, I'd expect most are inclined to use a biologic only after trying the more common treatments.

During my first or second visit to the rheumy I was seeing (who had just returned from the clinical research side to a private practice), it seemed as if she really wanted to get me started on Rituxin - as in go directly to Rituxan, don't pass Plaquenil, don't collect methotrexate.

I guess it depends on their experience with dealing with Sjogren's patients and various treatments.

[SjoDry]

I agree with Pete..it will depend upon the doc, how "up" they are on SS and specific patient variables.

In my case, I researched the meds & let the doc know why I was not willing to go on a biologic, he agreed with me. For some patients, they are having luck with IVIG infusions. For patients with immune deficiency conditions, we are given replacement IVIG infusions for the condition, but some docs are also giving IVIG infusions for neuropathy (in much large doses than for the CVID), and in some cases using it when Plaquenil or other biologics don't work. My Rheumy said that he will try IVIG when other biologics aren't working for a patient or if there are special circumstances, as in my situation.

It is hard to know how much my IVIG might be helping my SS since I never know which med to attribute any positive changes to. I will say that my biggest improvement in years was going on to the low dose Naltrexone on August 22nd. I have not been functioning this well in years. I definitely can attribute the positive changes to starting LDN.

Best of luck to you.
SjoDry

[SjoGirl]

Agree with Pete and others, it depends on the doc. In my experience docs want to try everything short of a biologic before using the big guns to save them in case the disease progresses or other drugs stop working.

Some of this is insurance related as well, because companies will often not pay for a more expensive treatment until less expensive ones have been tried and failed (see AARDA American Autoimmune and Related Diseases for information on this topic).

[markt]

It's interesting to see what the American College of Rhuematologies agreed-to "company line" is with regards to Biologic treatment guidelines:

http://www.rheumatologynetwork.com/sjogrens-syndrome/new-sjogrens-guidelines-outline-19-treatment-recommendations

Rituximab uses in Sjogrens syndrome:
- Rituximab may be considered as a therapeutic option for keratoconjunctivitis sicca in patients with primary Sjogrens syndrome for whom conventional therapies (topical moisturizers, secretagogues, antiinflammatory agents, immunomodulators, and punctual occlusion) have proven insufficient.
- Rituximab may be considered as a therapeutic option for xerostomia in patients with primary Sjogrens syndrome with evidence of residual salivary production and significant evidence of oral damage for whom conventional therapies have been insufficient.
- Rituximab may be considered as a therapeutic option for adults with primary Sjogrens syndrome and any of the following:  vasculitis, severe parotid swelling, inflammatory arthritis, pulmonary disease, and peripheral neuropathy.
- Rituximab to treat dry eyes and/or dry mouth would only be appropriate in severe cases and with the input from the patients ocular and/or oral medicine specialist.

Fact is, systemic inflammation over time does irreparable damage to glands and oral tissue necessary for everyday human function, let alone to be comfortable.  I don't understand why Biologics (the ones we have) are being reserved (by most Rheumatologists it seems) until some form of inevitable damage has begun to occur, i.e. organ involvement.

My best guess is we are sort of a liability to their practice... as a lot of us have very unfortunate "hallmark symptoms", but do meet ACR accepted clinical "criteria" to even be a Sjogrens patient, let alone be prescribed Biologic type medications. 

[warmwaters]

Here's the link to Sjogren's Organization's recommendations on treating Sjogren's.

http://www.sjogrens.org/files/research/CPGSystemic.pdf

There was also a paper published, but I don't have a link to hand. Biologics are not the first thing to try, but are a good thing to try under certain circumstances.

[cccourt1942]

Markt: THANK YOU for your last post/Rituximab uses. This is an answer for so many people who cannot take the usual meds for xerostoma and dry eye meds. I am not one of those people--but this board is filled with people who suffer as they can't use regular meds for dryness.  THX...your post should be pinned by the moderators!
ccc

[markt]

No problem, my intent was just to try and to get this idea "out there" for discussion... as it is usually an abrupt one when discussing these treatment options with Rheumatologists. Maybe rightfully so, treatment with biologics can be pretty consequential. That, and at the present there is limited clinical info for establishing the efficacy of using Orencia, etc. specifically for pSS. That part seems to be changing though if you read about current trials of targeted biologics.

But yes, I suppose the other point was that some of us are not "typical" Sjogrens patients and have a different, or higher level of disease activity/symptom severity than others... to the point that treatment options like this are actually pretty necessary.  Maybe this discussion can help us find the right words to use when explaining to our providers that we have crossed that "threshold" and need to explore another treatment. 

On another note... is age a consideration for this type of treatment?  i.e., I am looking into this (at least until the good Lord allows something better to come along) and I am 31.  I suppose taking this medication for prolonged periods of time is not ideal by any means.  But, I do know that lots of folks with RA/SLE have been taking biologics for years... and it is administered in a very controlled environment.  Can anyone comment on that?