I’ve been on seven – count them – seven different biologic medicines since being diagnosed with rheumatoid arthritis. I started with several anti-TNF biologics and then moved to several others even bouncing back to try another anti-TNF before eventually trying Rituxan. I’ve self-injected with auto-inject pens, self-injected with needles, and seems like I’ve had every type of infusion possible. This is probably something of a record although similar stories emerge on discussion boards from time to time. With some of the biologics, I would respond for a period of time and then it would stop working. With others, there was never a response. With yet others, there would be some adverse side-effect causing cessation. This is not all to unusual as it is widely know in the rheumatology community that upwards of 30% of RA patients do not positively respond to anti-TNF biologic medicines.
Posts Tagged ‘Orencia’
Posted in Uncategorized, tagged AbbVie, Actemra, American College of Rheumatology, Amgen, Biotechnology and Pharmaceuticals, Bristol-Myers Squibb, Cimzia, clinical trial, enbrel, Genentech, humira, Jansenn, medicine, Orencia, Pfizer, Pharmaceutical industry, remicade, rheumatoid arthritis, Rheumatoid Patient Foundation, Rituxan, Roche, Simponi, Xeljanz on November 6, 2013| 5 Comments »
I 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:
- Jansenn (maker of Remicade and Simponi and a subsidiary of Johnson & Johnson)
- AbbVie (maker of Humira)
- Genentech/Roche (maker of Actemra and Rituxan)
- Amgen (maker of Enbrel)
- Bristol-Myers Squibb (maker of Orencia)
- Pfzier (maker of Xeljanz)
- UCB (maker of Cimzia)
These 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.
Most 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.
Posted in Uncategorized, tagged Arava, Azathioprine, bacteria, CDC, Centers for Disease Control, Cimzia, corticosteroids, enbrel, humira, immune system, immunocompromised, immunosuppressed, infection, methotrexate, Orencia, RA, remicade, Rituxan, Simponi, vaccine, virus on August 30, 2013| 6 Comments »
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.
Posted in Uncategorized, tagged Ablynx, Actemra, autoimmune, biologicals, Bristol-Myers Squibb, Cimzia, enbrel, humira, Interleukin-6, Orencia, research, rheumatoid arthritis, tnf, TNF blocker, Tocilizumab, Tumor necrosis factor-alpha on August 23, 2013| 5 Comments »
With 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
Posted in Uncategorized, tagged Actemra, Arava, biologicals, c reative protein, DAS28, Disease, fatigue, inflammation, infusion, joint, Orencia, rheumatoid arthritis, rheumatologist, Rheumatology, Rituxin, Tocilizumab, treatment, Xeljanz on April 9, 2013| 12 Comments »
A weird thing happened at my Actemra (tocilizumab) infusion last Friday…I was dog tired and started dozing off in the chair when all of a sudden about half way through the infusion I got a rapid burst of energy. I went home feeling great and even mowed my front yard! But by Saturday night it was all over and I was back to feeling terrible – it was a great tease!
My rheumatologist always states that her goal is for me to not pay much attention to RA throughout the day. If the RA is causing issues to which I must attend during the day, then she believes that the medications aren’t working well. For the past five months since starting Actemra, I can clearly state that RA persistently reminds me that it’s present. I knew in the back of my mind that a change may be needed. But after being through so many RA treatments over the past 4 ½ years, I’m very hesitant to switch medications because I’m getting to the point where choices are limited. Below are some factors that are working towards a change.
- Doctor recommendation. I don’t tend raise the issue of switching medicines and instead rely on my rheumatologist to broach the subject. Call me gun shy – I just want to make sure that we give a treatment a fair shot before moving on. Part of that hesitancy is based on the fact that we’re running out of options. After last month’s discussion and a recent set of blood tests a few days ago, my rheumatologist contacted me and wants me to stop the current combination of Actemra infusions and leflunomide (Arava).
- Your body. My rheumatologist always asks me how I’m feeling in terms of joint pain, swelling, fatigue. She understands that I know my body better than anyone else and takes that into account. She even asked me yesterday, “Do you think the Actemra is working – if not, I’m fleshing out a super Plan B.” I have to admit that it does not seem to be working well. I’ve had increasing joint pain and swelling with over 28 joints impacted. Using the ubiquitous DAS28 tool for measuring RA disease activity (an online calculator is available), I currently have high disease activity.
- Increase in Inflammatory Blood Markers. A sharp increase in inflammatory blood markers may demonstrate that the disease is becoming more active (see this study on the correlation). For the first time ever since being diagnosed with RA, I had a high C Reactive Protein test last week. While blood tests like sedimentation rate and C reactive protein are not always accurate indicators of disease as some RA patients like myself tend to not show high results (see this study), they can serve as some gauge of disease activity and are used for clinical trials (see this post from RA Warrior for more info). If the level of general inflammation in my body is increasing while taking certain medications, it may be a sign that they are not working well.
- Side Effects. Many side effects of RA medications are tolerable. But sometimes side effects can have too great of an impact. Such is my case with Actemra as we’ve seen a steady increase in cholesterol, triglycerides, and blood pressure since starting infusions. Roche, the maker of Actemra, lists these side effects in the prescribing information as “Adverse Reactions” seen in at least 5% of the population taking the drug. While these side effects are not listed as “Warnings” which include more acute issues like serious infections and gastrointestinal perforations, my rheumatologist believes that they are serious enough to warrant a switch in medication.
- Others Around You. Sometimes we can’t see the “forest for the trees” so to speak and we need others to observe how we are doing. I will tend to put my head in the sand and march on like nothing is wrong. As the British say, “hold a stiff upper lip” or “keep calm and carry on.” I’m fortunate to have a wife who can observe changes over time and call it like it is. She recently questioned the efficacy of the Actemra/Arava combination.
All of the information above tends to be pointing towards the fact that Actemra is not working for me and that it’s time to move on. The choices are becoming limited as it appears that Rituxin infusions and the newly approved Xeljanz are the only biological treatments currently on the market that I haven’t yet tried. Rituxan is an entirely different kind of biological which is usually reserved for patients who don’t respond to the more common biological treatments. Xeljanz is brand new and lacks long term efficacy and safety data in the open market.
Last December I wrote a post about how Orencia was not working and the switch over to Actemra. Five short months later I’m at the same place of limbo trying to figure out the next plan of attack.
Creative Commons Photo Credit: http://www.flickr.com/photos/carolyncoles/4109461394/sizes/m/