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Posts Tagged ‘Food and Drug Administration’

My rheumatologist reiterated with me yesterday that I have a tough to treat case of RA – called refractory RA. She displayed disappointment that all of the treatment plans we’ve tried over the years have not had the intended impact. We’ve cycled through four TNF inhibitors (Enbrel, Cimzia, Humira, and Remicade), Orencia, and Actemra. And that’s in addition to various DMARDs including sulphasalzine, azathioprine, and leflunomide (Arava). The reasons for stopping the use of these drugs runs the gamut of lack of efficacy to intolerable side effects. My doctor was apologetic, felt bad I wasn’t helped by all of the treatment plans, and genuinely expressed concern for the impact RA has had on my life recently. But I reassured her that I trusted her medical judgement and that the impact comes over time allowing time to adjust. I appreciated her empathy and deep desire to help.

We discussed the few remaining options which includes Xeljanz, Kineret, and Rituxan. Xeljanz (tofacitinib) was approved in the United States but not approved in Europe. We both felt that more data was needed on this “oral biologic” before giving it a try. Kineret, or anakinra is a biological response modifier that targets interleukin 1. My rheumy said that is not used that much anymore because of more effective options. A recently published report indicates that a Swedish company just purchased the rights for Kineret from biological pharmaceutical giant Amgen. Such a move seems like Amgen is dumping the drug likely because it is not profitable and is moving onto other new drugs. After much discussion, we both agreed to try Rituxan and I will continue to inject 20mg of methotrexate weekly. 

As I was describing my new treatment regimen to friends and family, I found myself trying to explain the drugs, how they are administered, how they act to treat RA, and the possible side effects. As I read more about these drugs, it struck me as interesting that both medicines were originally developed to treat certain forms of cancer. Methotrexate is a chemotherapy drug developed in the 1950s and is still used to treat forms of leukemia, breast cancer, lung cancer, non-Hodgkin lymphoma, and head and neck cancers (see American Cancer Society). It stops the growth of cancer cells by affecting their metabolism. Given the immunosuppressing nature of methotrexate, it is now commonly used in lower doses to treat various autoimmune diseases including rheumatoid arthritis. It’s also used to treat tubal ectopic pregnancies by inducing abortion. In spite of the low doses used in treating RA, some of the chemotherapy side effects remain including hair loss and nausea. This paints a picture of a rather toxic medicine! But I’ve been injecting 20mg weekly for some time now and seem to tolerate it rather well.

Rituxan is also known by the names MabThera and Rituxamab. This monoclonal antibody is a biological medicine that was originally developed in the late 1990s to target the protein CD20 present in certain phases of B lymphocytes. It was originally approved for the treatment of B cell related lymphomas and leukemias (see the Rituxan website). In the early 2000s, it was shown in clinical trials to be effective in treating rheumatoid arthritis and gained FDA approval for use in refractory RA cases in 2006. The involvement of B cells in autoimmune diseases likely led to the investigation of Rituxan as a treatment for RA. The side effect profile appears similar to other biologicals but with some additional infusion side effects requiring some pre-medications along with a few more rare serious infections.

The use of cancer drugs to treat RA points to the connection of both diseases to the immune system. It also demonstrates the serious nature of RA. Given the fact that both methotrexate and Rituxan were originally designed to treat certain cancers, and that they are now secondarily being used to treat RA, may point to the fact that a much larger proportion of research funding goes to cancer (see this earlier post). While I don’t mind receiving the “leftovers” or being an “afterthought” if the medicines effectively treat RA, the ideal would be for the development of new treatments or even cures specifically designed for the processes involved in autoimmune diseases. In the meantime, I’ll go to the infusion clinic and begin Rituxan infusions along with cancer patients and see if it can take care of this refractory case of RA!

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PIK512x664As I mentioned in an earlier post, it’s oftentimes difficult to validate the barrage of information on the internet about health issues and diseases. There are some trustworthy sites for RA such as the Johns Hopkins University RA site. But much of the information on the internet is designed to provide basic information and not detailed and current scientific and research-based results. I recently found an excellent site that can help fill in these gaps. The Projects in Knowledge program is a continuing education program for doctors that is totally online and freely available to patients and other interested parties. All board certified doctors and other medical practitioners must complete ongoing training to maintain licensure. The Projects in Knowledge provides continuing education for medical practitioners. There are accrediting bodies that oversee these programs thereby maintaining quality, accuracy, and currency. Projects in Knowledge has a specialty devoted solely to RA. The rheumatology section is edited by Dr. Phillip Mease who is a clinician at Swedish Hospital in Seattle and a researcher associated with the University of Washington. Each specialty contains interactive modules, video lectures, readings, and other materials. The content is based on the most current research literature. They also have an iPad app called Rheumatoid Arthritis-A Living Medical Textbook where you can go through each interactive module. Granted, much of the information is highly technical but it can provide an excellent background in RA for those who are interested in learning more. Check it out!

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2154575545_f58be7229d

As the New Year comes upon us, it’s time to reflect on the previous year and consider the upcoming
year. Here is a summary of topics from this blog – both general and personal.

  1. A third ankle surgery and other RA symptoms was the straw that broke the camel’s back on being physically active. My snow skiing days seem to be over but I won’t give up fishing.
  2. I went through a variety of medicines this year. It began with Humira, then Orencia for 11 months, and ended with Actemra in the search for a treatment that would work. In terms of DMARDs, I stopped using Arava and am now taking Imuran. I’m not alone because many RA patients experience the same search for the right treatment.
  3. I experienced receiving monthly infusions in a clinic. The process is not bad, the nurses are knowledgeable and nice, and I’m pretty well off compared to the some of the cancer patients in the clinic.
  4. Biological treatments are crazy expensive and I’m so thankful for health insurance.
  5. RA and its treatments bring about many side effects. The immune suppressing drugs contributed to recurring sinus infections and ultimately, sinus surgery.
  6. A change in rheumatologist was the best decision made in years. Lesson learned – don’t always go with the first doctor you find and spend time seeking out recommendations, patient reviews, and nominations by regional media for best doctor awards
  7. I met many other bloggers who struggle with RA. A close relationship and support system exists among the RA blog community and I’m very thankful for these friends.
  8. Misinformation and incomplete information about RA continues to pervade media. We must continue to work at advocating for RA patients.
  9. This blog was listed as one of the best 22 RA blogs by Healthline and summarily nominated for their best health blog of 2012.
  10. The first new oral medication for RA, Xeljanz, received approval by the United States Food and Drug Administration.
  11. There are numerous new biological treatments for RA in the clinical trial pipeline bringing the possibility of new treatment options.
  12. Much research continues into the genetic and biochemical processes involved with RA which may eventually lead to better treatments or even a cure.
  13. Autoimmune diseases including RA, while impacting a large proportion of the population, continue to receive a disproportionate amount of research funding when compared to cancer and heart disease.
  14. While the currently available biological treatments for RA bring much needed relief, they do not work for approximately 20-40% of RA sufferers.

Thanks to all those who took time to read and comment on this blog. I wish everyone a wonderful and healthy 2013!

Andrew

Creative Commons Photo Credit: http://www.flickr.com/photos/sally_12/2154575545/sizes/m/

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8198569526_3f28555551Having gone through a slew of treatments options for rheumatoid arthritis in the past four years, it’s easy to begin to feel like a failure especially as I read about other fortunate RA sufferers who receive great benefit or even remission from first line medications like methotrexate and TNF blockers such as Enbrel and Humira. This feeling was exacerbated today when staying home because I felt too bad to go into work. In a period of no less than one hour, four commercials for Orencia and Humira came on the television (oh, as I was writing this sentence, a fifth commercial just came on!). These commercials show healthy, happy, and energetic looking people engaged in all types of activities that may be difficult for those with RA. Funny thing is, both of these medications failed to bring much impact let alone remission to me. I’m not alone as researchers discovered that 30% of patients on TNF blockers fail to reach even the minimal threshold for efficacy.[i] For some, including myself, there is some initial positive response but the impact diminishes over time. And for others, negative side effects or a reaction to the drug prevents them from taking it any longer.

After trying a boatload of RA treatments, I’m off to try a combination of RA medications that tend to be reserved for “failures” like me! My insurance approved Actemra in a fairly short time period – six days! I will have my first infusion tomorrow afternoon. According Genentech’s website,

“Actemra is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).”[ii]

And the American College of Rheumatology repeats this “failure” mantra…

“Tocilizumab has been approved by the Food and Drug Administration (FDA) for use in patients with rheumatoid arthritis who have active disease despite having been treated with one or more of five other biologic modifier drugs that block another cytokine, tumor necrosis factor (TNF), or who have been unable to tolerate such drugs.”[iii]

The good thing is that I should know fairly quickly if it is working since it is reported to start working within a few weeks.[iv]

The other medication that I started taking today is azathioprine (trade name Imuran). Once again, it appears that this drug, originally designed as an immunosuppressant for organ transplants, tends to be reserved for RA patients who do not respond or cannot take other more common DMARDS like methotrexate and leflunomide (Arava).[v]

Rheumatoid arthritis affects everyone differently as do the various treatments. This is evident in the many new medications being tested (see earlier post) and the recent approval of Xeljanz. I just have to keep reminding myself that I’m not a failure and that some combination of treatments will work! I’ll write a post about tomorrow’s Actemra infusion.

Creative Commons Photo Credit: http://www.flickr.com/photos/quinnanya/8198569526/

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Measurement of Erythrocyte Sedimentation Rate ...

The answer to this question eluded me over the years with the wide variety of RA medicines I’ve taken. It came up this week when my wife asked it again after seeing me go through a particularly long and nasty flare. I reminded her that there is no cure, only treatments for RA. But it did raise my curiosity.

In an attempt to answer this question, I went back to the Orencia package insert[i] – those 20 page, 5 point font documents that every pharmaceutical company puts inside their medicines – to try to find some answers. Bristol Myers Squibb likes to include a copy of these inserts every time they send me something in the mail. Most people probably don’t read these lengthy, highly technical documents that include information on dosage, indications, administration, warnings, side effects, and efficacy. There are likely some regulatory guidelines from the government dictating their contents since at the bottom of the document it says, “The Instructions for Use has been approved by the U.S. Food and Drug Administration”.  I dug through the insert until finding the section on clinical response – in other words, how well does it work?

Most clinical researchers use a variety of tools to gauge RA drug efficacy. The Health Assessment Questionnaire – Disability Index (HAQ-DI) which is a short version of the full HAQ is one such measure.[ii] Here’s a link to an online version of the HAQ. Many rheumatologists have their patients complete a HAQ and I remember doing this at my very first visit. Another commonly used tool to assess is the Disease Activity Score 28 or DAS28. It uses a count of the number of tender and swollen joints plus either a sedimentation rate (ESR) or c-reactive protein (CRP) blood test of inflammation. There is also an online version of DAS28 and an app for the iPhone. According to one site, “A DAS28 score higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6.”[iii]

According to the online DAS28, I currently have high disease activity. One of the clinical studies on Orencia reported in the insert, “…a greater proportion of patients treated with ORENCIA plus methotrexate achieved a low level of disease activity as measured by a DAS28-CRP less than 2.6 at 12 months compared to those treated with methotrexate plus placebo.” The proportions reported were 41% of patients on Orencia/Methotrexate reached a DAS28 of less than 2.6 compared to 23% of placebo patients. That means that a larger proportion of patients, 59%, did not reach remission.

I’ve been on Orencia plus Arava for 11 months now and am not currently in that minority who reached remission. In fact, just the opposite has happened. It’s hard to tell at this point if this combination of disease modifying drugs is not working for me or it’s just a nasty flare induced by too much work in the past few months. But this will be a conversation my rheumy and I will have at our next visit in early December. I am very hesitant to try yet another treatment regimen as I’ve already been through a truck load. But my rheumy encouraged me there’s still hope and other treatments to try and her goal is remission.


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