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Posts Tagged ‘Cimzia’

ACR 1I recently had the privilege to attend the annual meeting of the American College of Rheumatology. Considerable time was spent in the exhibit hall since, in addition to presenting a research paper, I was also volunteering at the booth of the Rheumatoid Patient Foundation.

The exhibit hall was overwhelming and the cavernous room was dominated by pharmaceutical companies. There were dozens of exhibits from large to small companies including, but not limited to, the following who provide many of the major biological treatments for RA:

ACR 2These pharmaceutical companies commanded the majority of the space and had professionally designed exhibits replete with multimedia presentations, large colorful signs and displays hanging from the ceiling, leather lounge chairs, espresso bars, snacks, colorful print materials, conference rooms, and an army of 20-30 sales representatives each. The rumor floating around was that these traveling exhibits cost upwards of $100,000 each in addition to the staff and other associated costs. They replace them every year. It is evident that the big pharmaceutical companies, especially those with expensive biological drugs on the market for RA, have vast amounts of funds to spend on sales and these exhibits. Based on this level of spending, it is obvious that this is big business and it is important for these companies to interact with the doctors and other health care providers who attend this conference in an effort to increase the sales of their drugs.

I enjoyed free espressos from Genentech/Roche each day – the manufacturer of my current RA medication Rituxan. One day while drinking my coffee and looking over research materials on Rituxan, a sales representative approached me obviously expecting me to be a doctor. I told her that I was a patient advocate who was actually taking Rituxan. She literally took a step backwards and told me that she was sorry and hoped I felt better. I laughed and said thanks and grabbed some print materials on clinical trail results and side effects. This awkward moment drove home the potential disconnect between the company sales force and patients. In spite of this brief and awkward interaction, the pharmaceutical companies must be commended for several things.

ACR 3Most of the research and development (R&D) behind these biological treatments for RA were paid for by the pharmaceutical companies. Oftentimes, the basic research, paid for by government or private foundation money, starts with a university-based researcher. These basic ideas lead to potential new treatments and the drug companies take over the onerous and lengthy task of developing and trying out new drugs. For biological drugs, this process may take years. And for every drug that makes it to market, there may be dozens that fail. Such development processes are extremely expensive and those costs are passed onto the patient in the cost of the drug. During the conference I was able to speak with several companies about RA treatments that are in Phase III Clinical trails (the last phase before seeking government approval). The concern is about who is going to pay for the R&D once pharmaceutical companies go over the so-called patent cliff in the next few years when their patents run out and they start to loose market share and profits.

Another patient benefit provided by the pharmaceutical companies for expensive biological treatments for RA are co-pay assistance plans. All of the companies listed above have such plans and they pay out millions of dollars each year helping patients be able afford treatments that can cost between $16,000 – $40,000 a year. This assistance, while extremely beneficial to those who need it, also demonstrates the large profit margins built into the “retail” costs of the drugs.

During the conference, I also met several consultants who are contracted by pharmaceutical companies to conduct research related to patient reactions and opinions about their products. While one may cynically infer that the companies are simply trying to increase their market share by pressuring the patients to ask for their drug, it was clear from the consultants that they genuinely want to increase the positive interactions between patients and the pharmaceutical companies in an effort to improve patient care and future drug development.

Yes, pharmaceutical companies are huge for-profit entities with a major goal of making money for shareholders. And the companies with major biological treatments for RA make enormous profits (Humira sales alone for the 4th quarter of 2012 were $2.7 billion). But they also bear the brunt of the R&D process, help with co-pays, and appear to seek patient interaction. As the patent cliff approaches, time will tell how it will impact these companies and the future of RA drug development.

ACR 4

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For those who live with type I diabetes, injecting insulin multiple times a day becomes a regular routine. But rheumatoid arthritis patients are also likely to face using needles to administer a variety of medications.

After receiving a diagnosis, there is a progression of RA treatments recommended by the American College of Rheumatology (ACR)[i] that usually begin with chemical-based disease modifying drugs (DMARDs) like methotrexate, sulfasalazine, leflunomide (Arava), and hydroxychloroquine (Plaquenil). All of these drugs are available in pill form. Even though available in pill form, many people cannot tolerate the side effects of the most commonly used DMARD, methotrexate, as it is prone to cause nausea. Methotrexate is also available in an injectable liquid form and many rheumatologists will prescribe this form when side effects can’t be tolerated. If this is the case, the patient must learn to self-inject…

…Read more at http://rheumatoidarthritis.net/living/prepare-poked-needles-ra-treatments-go-hand-hand/

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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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Ever since the H1N1 swine flu scare a few years ago, I make it a point to get a flu vaccine every autumn. When receiving a regular physical exam from my general practitioner last week, the doctor suggested that a pneumococcal polysaccharide vaccine be added…

To check out the rest of this post, go to the newly launched website rheumatoidarthritis.net. I will be writing posts for this site periodically as a Patient Advocate and will continue to make regular posts at this personal blog.

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fragment of antibodyWith the research net being cast widely and deeply by researchers and pharmaceutical companies, it’s clear that the currently approved treatments for rheumatoid arthritis are not having the intended impact on all patients (see this recent post on lack of remission). Unlike some infectious diseases where there is a treatment that often results in a cure (e.g. tuberculosis) or eradication via a vaccine (e.g. polio), no such remedy currently exists for RA. Last year I wrote a post about the large variety of biological treatments for RA that are currently in the development and testing pipeline. And this did not even include the myriad of small molecule drugs being developed to target the so-called JAK-STAT pathways of which Xeljanz (tofacitinib) is the only one currently approved in the United States but not approved in Europe.

The vast majority of approved RA biological treatments focus on inhibiting the tumor necrosis factor (TNF) alpha molecule which is overactive in autoimmune patients. The TNF blockers Enbrel, Remicade, and Humira account for the majority of biological prescriptions and control a vast portion of the market. The newer TNF blockers Simponi and Cimzia have recently joined the fray. Other parts of the involved biological pathways have been targeted for treatment including costimulatory protein CD-40 (Rituxan), interleukin 6 or IL-6 (Actemra), and T cell lymphocytes (Orencia).

In spite of the major focus on TNF alpha, a Belgium company called Ablynx now proposes that over the next few years, the “Anti-IL-6 pathway will dominate as the preferred biologic after anti-TNFα treatment.” They predict that 16% of the RA biological market will consist of IL-6 inhibitors by the year 2021. This focusing on IL-6 signaling pathways was proposed in 2008. In addition to Actemra (tocilizumab) which is currently approved in the U.S. and Europe, other antibody treatments targeting IL-6 are being developed including sarilumab by Sanofi and Regeneron, sirukumab by GlaxoSmithKline, and clazakizumab by Bristol Myers Squibb.

Ablynx is currently completing Phase II clinical trials of an IL-6 inhibitor called ALX-0061 and the results show strong treatment efficacy and safety profiles. Instead of being made of large monoclonal antibody (MAB) molecules like most of the current biological medicines, the company Ablynx focuses on producing smaller components called “nanobodies” or fragments of antibodies (FAB) (see this Scientific American article). FABs are cheaper to produce, may produce fewer side effects, and are less prone to breakdown in harsh environments. Ablynx clones the human FABs in llamas before isolating the molecules (see this report).

It is heartening that much research continues on the development and testing of treatments for RA.

Creative Commons photo credit, public domain: http://commons.wikimedia.org/wiki/File:1K4C.png

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20121205-061120.jpgI received an official rheumatoid arthritis diagnosis almost four years ago. In that period of time I went through multiple treatment schemes (see the My Meds page) including four biologicals (Enbrel, Cimzia, Humira, and Orencia) and three DMARD chemicals (sulphsalazine, methotrexate, and Arava) in addition to numerous NSAIDS and the obligatory prednisone. As mentioned in blog posts over the past couple of months, it became increasingly apparent that the combination of Orencia and Arava was just not working. Sticking my head in the sand and ignoring the signs could only last so long while my wife and doctor tried to convince me that it was time to try something else. The evidence was becoming overwhelming…unrelenting fatigue beyond comprehension, increase in the number and intensity of swollen and tender joints, new joints including one shoulder and both hips presenting with signs of attack by RA, missed work, and a level of brain fog never experienced before. In addition, it felt like the monthly Orencia infusions might just as well have been plain saline solution as there was no improvement afterwards. On top of that, Arava was wrecking havoc on my digestive system and the bathroom and I became quite friendly.

While driving into the doctor’s office today, the inevitable started sinking in and I got nervous wondering what would happen. Most of this anxiety is probably grounded in the fact that I’ve been through a slew of treatments and I was feeling like options were beginning to run out. After an exam and conversation about symptoms, my rheumatologist emphatically stated that it’s time to change treatment. She continually expresses hope that we can find a medicine combination that will work for me. She got out a piece of paper and made two lists. The one on the left was for DMARDS that I haven’t tried yet and she wrote down Imuran and Cellcept. On the right she listed biologicals that I haven’t tried and she listed Remicade, Rituxin, and Actemra. In the middle she listed the newly approved oral biological Xeljanz which she dismissed as a possibility for now stating that she wanted to see more long-term data on efficacy and safety before widely using it. She recommended Imuran since it’s been around longer and has better efficacy data for treating RA. Imuran is an immunosuppressant commonly used to help organ transplant patients avoid tissue rejection. It is also used to treat many autoimmune diseases including RA, lupus, and MS. Since three TNF blockers didn’t seem to work well for me, she argued against Remicade but said that we’d keep that option on the list just in case we want to try it later. She said that Rituxan helps some of her RA patients but not as many as she would like. Actemra is the newest antibody biological for RA approved in the United States and she said that she’s seen it help some of her patients. It’s different from the TNF blockers and Orencia in that it targets interleukin 6 which is part of the autoimmune processes linked to RA. So we landed on the Imuran/Actemra combination and await insurance approval to begin the infusions. A trip to the lab for blood tests to establish baselines were ordered. In the meantime, doses of prednisone are prescribed to knock down inflammation.

Changing treatments brings about many questions but also hope that maybe it will provide some relief. Because relief would be a good thing right now!

Creative Commons photo credit: http://www.flickr.com/photos/busy-pochi/5170100206/

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Towards the end of a whirlwind of recent travels, a never ending headache set in. Many factors historically caused me headaches including migraines, stress, and reaction to medications (see earlier post re. Humira). When I was driving home from work yesterday, I began to connect together a set of other symptoms…constantly clogged left side of nose, pressure around my left eye, pain on the molars on the left side, and a recent spate of colds that made the rounds with my children. A sinus infection seemed to be the culprit. By Friday afternoon, the medical options are pretty slim but I swung into the local urgent care. Surprisingly they were not busy and within a few moments I was diagnosed with a sinus infection. I was prescribed the fast acting antibiotic Azithromycin and I coupled that with a decongestant and a neti pot to cleanse the sinuses. Upon waking this morning, the headache and pressure was gone and it remained that way all day!

As an autoimmune disease, RA is treated by medicines that suppress the immune system. If the immune system can be suppressed, then it will be less likely to attack itself and the symptoms of RA can be controlled. Drugs used to treat RA like methotrexate and the biologicals are immunosuppressant drugs. I’ve been on an immunosuppressant for the past 1 ½ years…Enbrel, Cimzia, and now Humira. According to Humira’s website,

HUMIRA is a TNF-blocker medicine that can lower the ability of your immune system to fight infections.” [i]

Before starting on a biological, a negative tuberculosis test is required. Upper respiratory infections, including sinus infections, are first on the list for common side effects for Humira.[ii] This isn’t my first infection while being on a biological medicine. I had a urinary tract infection about 8 months ago and had a couple months of swollen lymph glands around my neck which was attributed to some unknown infection (likely viral). Lower on the list of side effects are cancers like lymphomas. Although it’s easy to get freaked out by such statements and decide not to take a biological treatment for RA, the chances for this occurring are very low and the benefits outweigh the risks for most people.

On one hand, I’m thankful for Humira and its impact on treating my RA. I’ve had pretty decent energy and bone erosion in the fingers seems to be halted (see earlier post). (Although I’m starting to debate Humira’s effectiveness because of ongoing problems with my ankles. It’s just impossible to tell what things would be like without Humira). On the other hand, I don’t like the fights with infections that are likely caused by having an suppressed immune system. There always seems to be a set of tradeoffs when it comes to the imperfect science of medical treatments.

 

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