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Posts Tagged ‘Xeljanz’

It appears that my 2.5 year journey with Rituxan is coming to an end. A scheduled infusion was cancelled at the last minute by my rheumatologist due to side effects from the last infusion and lack of efficacy. For anyone who knows my journey with RA, it’s no secret that I’ve been through a gamut of treatment options. The list of previous treatments reads like a who’s who of pharmaceuticals for autoimmune diseases. I’ve tried the following in chronological order:

  • sulphasalazine (oral)
  • methotrexate (oral)
  • Enbrel (self-injection)
  • Meloxicam (oral)
  • Salsalate (oral)
  • Cimzia (self-injection)
  • Humira (self-injection)
  • Orencia (infusion)
  • Imuran (oral)
  • Leflunomide (oral)
  • Actemra (infusion)
  • methotrexate (self-injection)
  • Remicade (infusion)
  • CellCept (oral)
  • Rituxan (infusion)

That’s two NSAIDs, five DMARDs, and seven biologics. The reasons for stopping these treatments varied from experiencing side effects to lack of efficacy. Side effects included serious infections, low lymphocyte counts and infusion reaction – persistent migraine, nausea, flu-like aches and pains. I’m very hesitant to switch treatments as the options are getting rather slim. I’ve probably resisted dropping Rituxan longer than I should’ve for this reason.

The latest treatment being recommended by my rheumatologist is the newer drug Xeljanz which is called an “oral biologic”. My rheumatologist and I talked about this drug several years ago when it was first approved in the United States. But she wanted to wait until there was more information and experiences. It was not approved by a European drug agency for safety and efficacy reasons. Xeljanz works by inhibiting a molecule called kinase. Kinases are molecules linked to a cellular pathway, called the Jak-STAT pathway, that produce inflammation-causing cytokine proteins. In RA, it’s these cytokines that ultimately cause the tissue destroying symptoms. Potential side effects are pretty typical of immune suppressing medicines, such as increased risk of infections, but also include perforations in the stomach and intestines. I’m waiting for insurance approval and shipment from a speciality pharmacy. In the meantime, I’ll sign up for the co-pay assistance plan from Pfizer.

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In an earlier post, I documented some of the new biologic medicines for RA in the development pipeline. There continues to be a constant stream of biologic drugs in research and development. But in the past few years, a new line of research led to the investigation of a set of molecules called kinases that are involved in the complex biological processes of RA. The development of kinase inhibitors is based on the theory that inhibition can slow down the production of inflammatory cytokines thereby controlling the disease processes. These processes are linked to the so-called JAK-STAT pathway that is being studied in numerous diseases.

Currently, there is only one kinase inhibitor approved for RA in the United States. Xeljanz, or tofacitinib, was developed and is marketed by Pfizer. The European Medicines Agency did not approve Xeljanz because of lack of efficacy and safety. Some European and Arab countries including Russia approved it.

Below is a list of some of the Kinase inhibitors currently in the development and trial pipeline. There are many others that died in the development pipeline.

Baricitinib by Eli Lilly and Incyte Corporation. Currently in Phase III clinical trials.

Fostamatinib by Rigel. In Phase II clinical trials. Efficacy is questioned.

CC-292 by Cellgene. In Phase II clinical trials.

PLX5622 by Plexxikon. In Phase I clinical trials.

AB494 by Abbvie. In Phase II clinical trials.

HM71224 by Hanmi. In Phase I clinical trials.

It remains to be seen whether or not JAK-STAT inhibitors will become a fruitful treatment option for those with rheumatoid arthritis.

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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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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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struktura infliximabu

struktura infliximabu (Photo credit: Wikipedia)

It is becoming increasingly clear that a substantial proportion of RA patients fail to respond to the more common treatment regimens including combinations of DMARDs (methotrexate, Arava, etc.) and TNF inhibitors (Enbrel, Humira, Remicade, etc). As recently noted by researchers,

“However, about 20% to 40% of patients treated with a TNF inhibitor fail to achieve a 20% improvement in American College of Rheumatology criteria, and more lose response over time (secondary failure or acquired therapeutic resistance) or experience adverse events following treatment with a TNF inhibitor.” (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2669237/)

The television advertisements in the United States for these drugs show happy, active people. It is heartening that many RA patients receive excellent results from DMARDs and anti-TNF medications. But I seem to have found myself in the 20-40% group of non-responders. Apparently there is a name for this…Refractory RA.

Refractory in the medical sense means “resistant to treatment or cure” (http://www.merriam-webster.com/dictionary/refractory). According to the National Institutes of Health,

“Refractory disease is defined as failure to attain a predefined target, which is now accepted to be remission or, at least, a low disease activity state.” (http://www.ncbi.nlm.nih.gov/pubmed/21570496)

Since remission is embedded within this definition, it must be clearly operationalized. The predefined target for remission of RA is from the recently revised ACR-EULAR criteria. In order to be technically in remission,

At any time point, patient must satisfy all of the following:

Tender joint count – equal or less than 1
Swollen joint count – equal or less than1
C-reactive protein – equal or less than 1 mg/dl
Patient global assessment – equal or less than 1 (on a 0–10 scale) (p. 581)

These are the stringent criteria applied for clinical trials of newly developed drugs. But applied to currently approved drugs, do patients on these drugs reach remission status? In a review of several studies, the use of traditional DMARDs like methotrexate result in between 35-65% of patients reaching remission. Other comparison studies demonstrated remission rates within a range of 24% with methotrexate alone to 64% with Humira. In one recently published study in China, only 25% of patients achieved remission status using the ACR-EULAR criteria. Many of the remission rate studies were conducted using the old criteria before 2010. Whatever standard is used, it is clear that there are a considerable number of patients who are not in remission.

Biological medicines that are not in the TNF inhibitor class like Xeljanz, Rituxan, and Actemra, are commonly recommended for refractory RA (see studies linked to each medicine above). In the United Kingdom, failure of TNF inhibitors leads to a recommendation to use Rituxan (see http://guidance.nice.org.uk/TA195). But these “second tier” biologicals don’t always result in patients reaching remission status. All one needs to do is read the prescribing information for each of these drugs to quickly realize that many patients in the clinical trials did not reach ACR-EULAR remission status. This is actually the case for all approved RA drugs.

Rheumatology researchers in Portugal recently stated,

“During the last decade we have experienced exciting developments regarding the approval of new treatment options but few patients are reaching sustained remission and refractory patients continue to be a problem. Thus, it is critical to understand how clinicians can decrease the risk of refractoriness by closely monitoring disease activity, using well defined and accepted composite measures, and by early and optimized use of DMARDs, including biologics.” (http://www.ncbi.nlm.nih.gov/pubmed/21570496)

This quote sums up the problem which remains. A large proportion of RA patients who are currently on biological and DMARD medication combinations do not achieve remission status – they have Refractory RA. This evidence lends credence to the fact that more work needs to be done in order to develop treatments that result in true remission. Ultimately, a cure should be the goal for this insidious disease.

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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.

  1. 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).
  2. 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.
  3. 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.
  4. 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.
  5. 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.

4109461394_1be7f99342All 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/

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It seems that with the FDA approval of Xeljanz this week, most of the attention for new treatments for RA is focused on orally administered protein kinase inhibitors.[i] This attention is not unwarranted in that Xeljanz is the first oral treatment for RA approved in over 10 years. The kinase inhibitor drugs are complex molecules that impact some part of the biological pathways involved in cancer and immune diseases.[ii] With all the hoopla around Xeljanz, I wondered what was going on in the world of new biological treatments for RA.

antibodies

Most biological treatments for autoimmune diseases are focused on signaling pathways involved with immune cells. These signals are typically carried by proteins including cytokines. In autoimmune diseases, it is thought that the pathways and associated cytokines are out of whack resulting in an overactive immune response in which a person’s own tissue comes under attack. Tumor necrosis factor (TNF) is a cytokine that has been the target of many recent biological treatments for RA. The most popular biological treatments for RA are Enbrel, Humira, and Remicade which all attempt to block TNF with antibody proteins. The large size of these sensitive proteins means that they must be injected or infused into the body rather than be ingested orally. Other biological treatments approved for RA include Orencia targeting the protein called B7 which reduces T cell stimulation, Rituxan which targets the protein CD-20 in B cell pathways, and the newest one Actemera which targets interleukin 6 (IL-6).

There are literally thousands of clinical trials related to RA occurring around the world[iii] and finding specific information related to new possible biological treatments is difficult for someone outside the research community. It seems that pharmaceutical companies are somewhat elusive with drug development. They want to maintain some level of trade secrecy, publish results in the peer-reviewed research world, and give out just enough information for investors to get excited. With a little snooping that would not have been possible 15 years ago in the early stages of the internet, I found that there are some important clinical trials going on for new biological treatments. In some cases, I had to create a login to access certain journals or use my university library access to find information.

B cell lymphocytes and their signaling proteins appear to be one of the main targets of recent biological drug development.[iv][v]. It seems that IL-6 and CD-20 are the most researched parts of the RA biochemical pathway. I found 17 biologicals that show promise and are in various stages of testing. Below is a list of some of the biologicals I found. Most of their scientific names end in “MAB” because they are monoclonal antibodies meaning that they are cloned proteins coming from one type of immune cell. Genetically engineered mice are used in the complex production process.

We see the usual set of major pharmaceutical players, who already have the lion’s share of the RA drug market, doing most of the testing of these new drugs demonstrating that there is big money to be had in this area. Sometimes smaller companies develop the drug and the rights are purchased by a large company who then funds the extensive clinical trails. Not all of these experimental drugs will obtain approval and make it to market.

It is a good thing for patients that the search for new biological and chemical treatments for RA continues. The wide variety of biologicals targeting different biochemical pathways may ultimately result in more patients responding to treatment. With over 1.5 million RA patients and as one of the leading causes of disability in the United States, treatments are needed that improve the quality of life and reduce disability. In spite of the proliferation of treatments, I still hold out hope for a real cure to this insidious disease.

IL-6 Inhibitors

Sarilumab is being developed by Sanofi in Europe. It shows promise in clinical trials in treating RA with infections the most common side effect.[vi]

BMS-945429 is an experimental drug from Bristol Meyers Squibb that also targets IL-6.[vii] It is made in yeast cells instead of the standard medium for making other biologicals-hamster ovaries. It shows promise in treating RA.[viii]

Sirukumab, being tested by GlaxoSmithKline, is an IL-6 inhibitor to which RA patients show a good response.[ix] Side effects include infections, gastrointestinal problems, and blood problems.[x]

Olokizumab is being developed in Europe by UCB which also developed the TNF blocker Cimzia. [xi] It shows promise in early trials with side effects including headache and blood problems.[xii]

GSK315234, also from GlaxoSmithKline, targets interleukin 6 (IL-6) and is in early clinical trials. [xiii] [xiv]

CD-20 Inhibitors

Like Rituxin, the antibody Ofatumumab (trade name Azerra also known as HuMax-CD20) targets the B cell protein CD-20. It is already approved for leukemia but is being tested in clinical trials for rheumatoid arthritis.[xv] It is produced by GlaxoSmithKline.

Pfizer, in partnership with Emergent, announced the development of a biological which also targets CD-20. It is currently called SBI-087 (PF-05230895).[xvi] It is in clinical trial for the treatment of RA.[xvii]

While not a completely new biological, Pfizer is testing an antibody called PF-05280586 that is similar to Rituxin. These are called “biosimilars” and other companies around the world are trying to get in on the action by developing their own Rituxin look-alikes.[xviii]

IL-20 Inhibitors

The monoclonal antibody NNC 0109-0012 targets interleukin 20 (IL-20). Clinical trials occurred in Europe and are funded by the company Novo Nordisk. Early results show that this biological positively impacted RA symptoms while showing the typical safety profile of other biologicals including increased infections and injection reactions.[xix]

IL-17 Inhibitors

Secukinumab, developed by Novartis, targets the cytokine interleukin 17 (IL-17).[xx] It is in clinical trial for several autoimmune diseases including RA in which some improvement was seen with typical side effect profiles for other biologicals.[xxi] [xxii]

Ixekizumab, from Eli Lily and Co., also targets IL-17 and is being tested for RA and plaque psoriasis.[xxiii] Early results demonstrate impact on RA symptoms along with typical side effects including infections.[xxiv]

B Cell Activating Factor (BAFF) Inhibitors

Tabalumab, from Eli Lily and Co., is being developed as a treatment for autoimmune diseases and some cancers. It shows some efficacy at reducing RA symptoms yet includes infections as a side effect.[xxv]

Others

Pateclizumab, by Genentech and Roche, targets a set of cytokines called lymphotoxin (LT)-alpha Inhibitors. It shows promise in treating RA. It is also being tested by co-administering it along with a TNF blocker like Enbrel. Side effects include headache and gastrointestinal issues but no serious infections.[xxvi]

Denosumab is an antibody from Amgen that targets the production of RANKL, a protein that signals bone erosion. It is currently approved under the trade name Prolia for the treatment of osteoporosis and is currently under clinical trial for the treatment of RA.[xxvii] But problems with the drug have held up the use of Denosumab for osteoporosis let alone other diseases.[xxviii]

Ozoralizumab, developed by Ablynx in Europe, is a new TNF blocker that shows promise in treating RA and may compete with Humira and Enbrel if approved.[xxix][xxx]

Stelara (Ustekinumab), developed by Janssen, is already approved for the treatment of psoriasis. It targets interleukins 12 and 23 (IL-12, IL-23). It is in clinical trial for RA.[xxxi]

Fezakinumab, being developed by Pfizer, targets interleukin 22 and is in clinical trial for RA.[xxxii]

Creative Commons Photo Credit: http://commons.wikimedia.org/wiki/File:Chimeric_and_humanized_antibodies.svg

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