Rituxan and RA

[paul80]

I was wondering if anyone knows in what circumstances rituximab is used for Rheumatoid arthritis? My mother has this disease and she wasn't offered it, she is being treated with a drug called methotrexate.

 

[Daffodil]

i think its used when first line drugs fail. I think methotrexate is tried first. maybe methotrexate isn't as dangerous or expensive or doesn't have to be given IV?

 

[Gingergrrl]

I am curious about this as well. I am wondering if anyone knows if there is a list of medical conditions in which RTX is officially approved for (like RA and Lupus, etc)? A close friend of mine was given RTX for Lupus many years ago (and it did not help her at all) but I know it was offered and approved for her.

Am wondering if it is ever approved for rarer auto-antibodies, that are not those of classic autoimmune diseases, like RA or Lupus?

 

[zzz]

The following is from the prescribing information for Rituxan. In the prescribing information in the U.S., indicated treatments are those treatments for which FDA approval has been secured, and those uses are what is officially approved. Everything else is off label (since this is effectively the label). Note that lupus is not an officially approved indication.

Am wondering if it is ever approved for rarer auto-antibodies, that are not those of classic autoimmune diseases, like RA or Lupus?

An individual doctor may approve it for use for whatever condition that he or she wants to, but such use is not official, and if it's not in the following list, it is by definition off label.

As far as insurance goes, insurance will approve most drugs for off label usage, especially since these companies usually don't really know for what purpose the drug has been prescribed. But for certain drugs, including typically very expensive ones, the insurance company's pre-approval is required, and in many cases, that means that the drug must be used for an FDA-approved condition. In general, this whole question is very dependent on what drug is being considered and what the policy of the individual insurance company is.

Occasionally, a drug manufacturer will go back to the FDA to get other indications added to the list of approved indications for a drug's use. But like the initial drug approval, this is an expensive process, so the drug company will often just let that drug be used off label instead. By law, though, drug companies are not allowed to promote the use of drugs for off label uses.

Now from the prescribing information:

1 INDICATIONS AND USAGE

1.1 Non–Hodgkin’s Lymphoma (NHL)

Rituxan® (rituximab) is indicated for the treatment of patients with:

• Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
• Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line
chemotherapy and, in patients achieving a complete or partial response to Rituxan in
combination with chemotherapy, as single-agent maintenance therapy.
• Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single
agent after first-line CVP chemotherapy
• Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or
other anthracycline-based chemotherapy regimens

1.2 Chronic Lymphocytic Leukemia (CLL)
Rituxan® (rituximab) is indicated, in combination with fludarabine and cyclophosphamide (FC),
for the treatment of patients with previously untreated and previously treated CD20-positive CLL.

1.3 Rheumatoid Arthritis (RA)
Rituxan® (rituximab) in combination with methotrexate is indicated for the treatment of adult
patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate
response to one or more TNF antagonist therapies.

1.4 Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic
Polyangiitis (MPA)
Rituxan® (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult
patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic
Polyangiitis (MPA).

1.5 Limitations of Use
Rituxan is not recommended for use in patients with severe, active infections.

 

[Nielk]

I was wondering if anyone knows in what circumstances rituximab is used for Rheumatoid arthritis? My mother has this disease and she wasn't offered it, she is being treated with a drug called methotrexate.

I have RA and was prescribed Rituximab when other RA meds were not successful. Unfortunately, it did not help with my RA nor my ME symptoms.

 

[paul80]

I have RA and was prescribed Rituximab when other RA meds were not successful. Unfortunately, it did not help with my RA nor my ME symptoms.

Sorry to hear that. Have you read anything about the people who claim a low dose antibiotic over years helps with RA? My mum told me about this but the methotrexate is working for her just now so she is sticking to that.

 

[Gingergrrl]

The following is from the prescribing information for Rituxan. In the prescribing information in the U.S., indicated treatments are those treatments for which FDA approval has been secured, and those uses are what is officially approved. Everything else is off label (since this is effectively the label). Note that lupus is not an officially approved indication.

@zzz Sorry for my slow reply and thank you so much for this information. I had no idea that RTX was not officially approved for Lupus and that was a big surprise for me!

An individual doctor may approve it for use for whatever condition that he or she wants to, but such use is not official, and if it's not in the following list, it is by definition off label.

Makes sense and my case will definitely be off-label as I expected.

I have RA and was prescribed Rituximab when other RA meds were not successful. Unfortunately, it did not help with my RA nor my ME symptoms.

@Nielk I am so sorry to hear that and did not realize that you'd had RTX for both conditions and it did not help. Did your doctor have any idea if you would be a good candidate in advance? I do not have RA but have several pathogenic autoantibodies that we believe are messing with my neuromuscular and breathing ability and RTX is my next step after a series of six (or hopefully more!) IVIG's that I am slowly building up to an autoimmune dosage. I will look for your prior posts on this topic and am so sorry again that it did not help.

 

[Nielk]

@Nielk I am so sorry to hear that and did not realize that you'd had RTX for both conditions and it did not help. Did your doctor have any idea if you would be a good candidate in advance? I do not have RA but have several pathogenic autoantibodies that we believe are messing with my neuromuscular and breathing ability and RTX is my next step after a series of six (or hopefully more!) IVIG's that I am slowly building up to an autoimmune dosage. I will look for your prior posts on this topic and am so sorry again that it did not help.

They did not know in advance if I would be a good candidate for Rituximab. I had tried a few other treatments/biological which didn't work. I told my rheumatologist that I would want to try Rtx since it has shown to work for some ME patients. She thought it was a good idea to try it for me.

 

[Gingergrrl]

They did not know in advance if I would be a good candidate for Rituximab. I had tried a few other treatments/biological which didn't work. I told my rheumatologist that I would want to try Rtx since it has shown to work for some ME patients. She thought it was a good idea to try it for me.

@Nielk Thank you for explaining and I was just curious. Do you know if you have any other auto-antibodies besides those for RA and do you have any muscle weakness? I am so sorry again that it did not work.

 

[Nielk]

@Nielk Thank you for explaining and I was just curious. Do you know if you have any other auto-antibodies besides those for RA and do you have any muscle weakness? I am so sorry again that it did not work.

I have high anti- CPP which is a marker for RA. I have muscle weakness but I think that's from ME. I have swollen and painful hands/fingers and feet/ankles which are my RA symptoms.

Btw - I have had ME for 13 years and RA for three.