Everything You Need to Know About How Biologics Treat RA
我们削减了“Med Speak”并获得了正确的点。生物学有能力带来缓解。这是他们的工作方式以及当你在他们身上时可能发生的事情。
Picture a wheel.Now picture that wheel in continuous motion, rolling on and on.
Then the wheel stops.
为什么它停止？逻辑上，因为某些东西已经停止了它。
The wheel is the inflammation in your body from rheumatoid arthritis (RA).
The thing that stopped it from rolling on, damaging your joints and causing pain in the process—what’s that?
That’s a biologic medication.
You’ve just read one of the ways that Victoria Ruffing, R.N., director of nursing and patient education at the Johns Hopkins Arthritis Center in Baltimore, explains how biologics target the abnormal immune response that leads to inflammation and RA. The immune system is complex, she says. Using a simple analogy can help people grasp what, exactly, these medications do. By thinking of inflammation as a wheel in motion, always present, you can better imagine how a biologic would stop that process in its tracks.
但这只是一开始。这是您的生物制剂教育下一流的内容。
What Are Biologics and How Do They Work?
They’re lab-made proteins that work like antibodies (your natural antibodies fight viruses and bacteria). Biologics also have specifc targets, but instead of germs they lock onto cytokines. These immune-system messengers are part of the chemical cascade that causes inflammation, says Daniel H. Solomon, M.D., professor of medicine in the division of rheumatology at Brigham and Women’s Hospital in Boston.
“如果我们阻止这些信使，我们可以抑制炎症，这是类风湿性关节炎引起的疼痛和残疾的驱动因素，”他解释道。
Biologics aren’t just for RA—they’re used to treat many inflammatory conditions including psoriasis, psoriatic arthritis, ankylosing spondylitis, and inflammatory bowel disease. They’re part of the disease-modifying antirheumatic drugs, or DMARDs, used in RA patients. The U.S. Food and Drug Administration (FDA) has approved eight biologics for RA. Each biologic is in a specific “class,” targeting a different cytokine. For the drugs to be most effective, you need to start taking them and not stop (as long as they're working well for you). So yes, you might have to take biologics for a long time.
“当我和新诊断的病人说话,I am optimistic about their prognosis,” Dr. Solomon says. "However, most patients will stay on treatments probably for the rest of their lives. Some patients will be able to stop, but that’s the minority,” he says
这就是为什么迈克尔乔治，M.D.，风湿病学家和费城宾邦医学的流行病学教授，讲述患者不会看起来太远。他鼓励他们专注于今天，注意他们的生物学是否正在努力在湾痛苦痛苦，当然，尽可能多地。
“It is impossible to predict what someone’s disease will be like in a few years or what new treatments may have come along. The search for a cure continues,” Dr. George says.
Dr. Solomon adds that we’re in a “period of rapid growth of biologic DMARDs” for RA. Always encouraging to hear.
我的身体如何（可能）如何应对生物学？
每个人都不同，所以每个人都在他或她自己的时间表上对生物学反应不同。平均而言，症状减少大约需要四周或多周，令人沮丧。
乔治博士说，你可能没有响应你尝试的第一个测试，而且没有任何测试能够帮助医生更好地确定哪种药物能够与你的ra一起使用哪种药物。“有时它需要一些试验和错误来找到最佳治疗方法。幸运的是，即使第一次生物学不起作用，患者往往会对不同的生物学作出反应，“他解释道。好消息你有选择。
Another thing to know: You can stop experiencing good symptom control with biologics—even after years using the drug. Sometimes your body develops its own antibodies against the drug, blocking its effects (some people develop an allergic-type reaction), or you may eventually need a higher dose to maintain improvement. Staff at Johns Hopkins Arthritis Center focus on the positive aspects of the medication working, while also following a patient’s progress at regular three-month visits, Ruffing says. They check how many joints are swollen and tender, monitoring for any trends in symptoms.
“We don’t say from the beginning, ‘This drug may eventually fail.’ I think we know intuitively that not everything is going to work for all people and it may not work for all time,” she says. “Yet we have people on these medications for 10, 15 years.”
那么你如何知道它是否有效？第一个迹象Ra症状中的一个症状在她看到的患者人口中是易受的：较少的疲劳。“他们觉得他们有更多的能量，”Ruffing说。“他们只是觉得他们尽可能多地拖着。然后，从那里镇定炎症和任何疼痛或晨刚度的减少，“她说。
What’s the Goal of These Drugs?
简单：缓解。并且它定义为没有疾病活动，没有明显的症状和RA的症状，或最小的症状和症状。所以你可以有一些招标或肿胀的关节，药物仍被认为有效。
When you hear “remission,” you might think of cancer remission, but it’s not exactly the same kind of remission, he says. Some cancer types have the possibility for a cure, but it’s likely a different story in RA.
“We continue to treat most RA patients[for life]因此，我们认识到，如果他们的药物停止，所罗门博士的说明，大多数达到缓解的患者将含有类风湿性关节炎的另一个火炬。“
Am I Candidate for Biologics?
You’re a candidate for a biologic if you have moderate-to-severe RA and have been on DMARDs, but your symptoms are not improving. RA patients often start treatment with methotrexate, an immunosuppressive medication. Doctors have been prescribing this pill for more than 30 years to RA patients, and it works for a large group of people as “monotherapy,” medical speak for just one treatment, according to Dr. Solomon. When it doesn’t, it can be combined with other DMARDs such as leflunomide and sulfasalazine. It can also be combined with biologics for improved results.
Methotrexate is the “cornerstone therapy” for RA because it’s typically the first drug given, has so many years of prescribing behind it to show safety and efficacy, and can be combined with other drugs, Dr. Solomon says.
“Patients who aren’t doing well on methotrexate monotherapy who don’t want to take additional pills on top of the methotrexate would be typical candidates for biologics,” he explains. “Combining several types of pills, so-called triple therapy, works about as well as a biologic.”
How Do I Take Biologics?
Usually, by infusion (which is given by IV) or injection under the skin, called a subcutaneous injection. These drugs currently can’t be given orally because their molecules are too large to cross the stomach or intestinal lining easily. And they’re typically given either only as an infusion or only as an injection after the initial first “loading dose,” (meaning the higher dose of a drug used at the start of treatment, before a lower maintenance dose is given).
Infusions can be done at infusion centers, some of which are affiliated with hospitals, as well as at home, with the help of a home-care nurse. If patients are nervous about having an IV medication on a regular basis (dosing can differ by patient and drug), Dr. George reassures them that infusions are quite safe: “Most patients have no problems at all with the infusion. Some patients may have an infusion reaction, such as flushing or palpitations, but if anything like this happens, the nurses at the infusion center will know how to treat this.”
注射通常在家做,first dose sometimes done at an office setting with a nurse instructing or assisting. Some drug companies send a nurse to your home to show you how to use the injectable.
“如果[patients]are anxious about their first treatment, it might be a good idea to come into the office to have a nurse help with the first injection. After doing it once or twice, they will realize how easy this is to do,” says Dr. George.
Because these injections are given under the skin, they don’t go as deep as intramuscular injections, which require larger needles and can be more painful. They also are typically given with a pen injector, with retractable needles, meaning you don’t see the needle itself as you use it. You place the pen on your skin (commonly your thigh, stomach, arm, or leg), press the release button, wait the allotted time for the medication’s release, dispose of the injector in an FDA-cleared sharps disposal container, apply a bandage if needed, and you’re done.
Are There Side Effects?
Yes. Patients can experience side effects including (but not limited to) an increase in (often serious) infections, irritation at the injection site, headache, and nausea. In rare cases, some types of cancer, including lymphoma, have been reported, as well as heart issues in people with pre-existing heart conditions, and problems in the nervous system.
But in the 21 years since Enbrel came on the market, the side effect profile has been “remarkably safe,” Dr. Solomon says. Also, it should be noted: “There’s no medicine that we give in medical practice, including aspirin, that doesn’t have potential for side effects.”
“这并不意味着他们在每个人都有安全的，”他说生物学。“但在数百万患者接受了这些药物，大多数患者毫无困难地容忍他们。”
Ruffing teaches patients how to identify the signs of common infections, such as how a sinus infection or urinary tract infection feels and what an infected cut looks like, in case they experience one while on a biologic. She tells patients to call their doctor’s office if they suspect they have one of these infections.
乔治博士说，生物制剂的人往往是谨慎的感染，但他告诉他们，与生物学相关的严重感染的风险实际上是低：“基于我们所知道的，如果100人被这些药物中的一种治疗一年来，大约一个额外的人可能有严重的感染 - 例如，肺炎足够严重需要去医院。“
如果生物学有助于减少泼尼松剂量或改善疾病活动，您可以降低乔治博士的感染风险。
How Do I Get Biologics?
So: These drugs are live cells, rendering them expensive to make—synthetic chemical drugs, like the common over-the-counter meds we all know (think aspirin or acetaminophen), are far cheaper to produce.
As a result, biologics are pricy.
For example: One carton of Enbrel (or four SureClick autoinjectors) retails at the average price of $5,560.61. So if you take one injection a week, that’s about $1,390 for your weekly medication, or $198 a day.
Most private insurers cover these medications, often requiring prior authorization, including that the patient has tested negative for tuberculosis and Hepatitis B (if a patient has active disease, it can seriously worsen on biologics); been on a cheaper synthetic drug first like methotrexate, sulfasalazine, or hydroxychloroquine; and has moderate-to-severe RA, Ruffing says.
For your infusion, your center will typically have your medication, and a nurse will prep it; though sometimes patients have to provide their medication to their nurse, Dr. Solomon says.
But, typically, you don’t go to your local pharmacy to pick this medication up, Ruffing says. The prescription for an injectable usually goes through a specialty pharmacy and arrives by mail order, delivered by a package carrier like UPS or FedEx, in a Styrofoam cooler with ice packs, because it needs to stay refrigerated. It often comes in a 90-day supply, approved for one year before the insurance company will review, to ensure that the biologic is still working.
对病人与无二次insuran医疗保险ce, receiving these expensive medications can be more difficult than for those privately insured, Ruffing says, sometimes requiring other means of funding, such as patient foundations.
“大多数公司确实有程序非常慷慨地试图帮助患者造成的患者。但即便如此，我们必须花很多时间吸引和写信，不幸的是，我们所有的时间都花在患者上试图获得药物，这都不是可偿还的。她说，这对我们来说真的是非常负担的负担，“她说。
What Else Should I Know?
以下是我们对RA的生物制剂所说的一些最终思想。
所罗门博士发现这些毒品现在有希望，并进入未来。
“最多[RA]patients are going to find that, whether through non-biologic therapies, or biologic therapies, that there is a medicine that helps them. Not every patient is able to go into remission, but the vast majority of patients are able to get significant improvement in their symptoms and many, many patients get to low-disease activity or remission,” he says.
If patients are concerned about going on a medication that they might have to take forever, Dr. George tells them: “Most patients do very well on these medications without side effects,” he says.
And finally, Ruffing says that with careful monitoring and changes as-needed, RA patients can receive safe and effective treatment with biologics.
“我们对生物学有很多信心，”她说。“We follow the guidelines from the American College of Rheumatology, and if we’re not seeing improvement within what we think is a reasonable amount of time, then we’re either switching or adding or making a change to somebody’s treatment plan to make sure we’re preventing any kind of destruction or loss of function that patients might have.”
