Patient And Public Involvement
Patients and the general public were involved in the full health technology assessment according to IQWiGs methods, which are described in its methods paper.14 After the publication of the preliminary protocol and preliminary report, patients and the general public were asked to comment on the protocol and report. The comments and changes resulting from the comments are discussed in detail in separate German language documents available on the IQWiG website.13 A major change from the preliminary to the final protocol was the adaption of the definitions for clinical remission and inclusion of the corresponding definitions for low disease activity according to the current guidelines of the leading rheumatoid arthritis societies.
Which Biological Medicines Are Usually Prescribed
A biological medicine that blocks TNF-alpha , other biological DMARD , or a targeted synthetic DMARD is recommended if there has been an inadequate response to combination therapy with conventional DMARDs.
Rituximab in combination with methotrexate is an option for patients with severe active rheumatoid arthritis who have had an inadequate response to, or are intolerant of other DMARDs, including at least one TNF-alpha inhibitor.
Sometimes people have side-effects to these medicines in the first three months of treatment. If this happens, your doctor may try you on one of the other medicines that block TNF, or you may be given one of the other biological medicines that work in a slightly different way . Your doctor will advise.
Biological medicines cannot be taken as a tablet or a liquid to swallow because they would be broken down in the gut and would not work. Some biological medicines are given by an injection under the skin – for example, etanercept. You can either learn to inject yourself, or a nurse in the hospital will do it for you. Other biological medicines are given in the hospital by a drip into a vein in the arm. How often they are given depends on which one you are prescribed – it can vary from once a week to once every eight weeks.
Unanswered Questions And Future Research
The PRISMA extension statement for reporting systematics reviews containing network meta-analyses includes a clear requirement only with regard to the check of consistency.21 The information on the check of the similarity and homogeneity assumptions is less precise and, while the elaboration document of the statement suggests reporting information on study characteristics and heterogeneity tests, it does not seem to require that these assumptions are met as a prerequisite for a network meta-analysis. Since the network meta-analysis concept relies on the similarity and homogeneity assumptions,46 further discussion is needed on reporting requirements and on approaches to ensure that these assumptions are met.
Owing to a very low number of direct comparisons in our networks, we were not able to assess the consistency of direct and indirect effect estimates for most of the contrasts. Therefore, we could only derive conclusions of low certainty. This finding underlines the fact that a network meta-analysis cannot compensate a lack of direct comparisons a sufficient number of direct comparisons is required to fully exploit the potential of this type of analysis.
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When Are Biological Medicines Usually Prescribed For Rheumatoid Arthritis
Biological medicines are usually prescribed when you have taken at least two DMARDs for six months and your rheumatoid arthritis has not improved. They are only prescribed by doctors in a hospital who specialise in treating rheumatoid arthritis .
If your doctor thinks that a biological medicine would work for you then you are usually asked to take a DMARD called methotrexate at the same time. Some people cannot take methotrexate and they may be asked to take a different DMARD.
TNF blocking medicines for moderate rheumatoid arthritis – NICE updateThe National Institute for Health and Care Excellence has issued guidance about some of the TNF blockers.
Until now, these medicines were usually reserved for people with severe rheumatoid arthritis, whose symptoms had not got better with other DMARDs. Now NICE has recommended that three of these medicines – adalimumab, etanercept and infliximab – can be considered for people with moderate disease .
You may be offered these medicines in combination with methotrexate if you have moderate disease and your symptoms have not been controlled with at least two other DMARDs. If you cannot take methotrexate, you may be offered adalimumab or etanercept on its own.
You can find out more about NICE’s recommendations from the further reading list below.
What Are The Potential Risks And Benefits Of Injectable Medications For Rheumatoid Arthritis
Biologic agents used to treat RA need to be injected. The biggest benefit of these drugs is that they are very effective.
- Biologics not only relieve symptoms but also halt damage to joints and generally provide quick relief.
- The biggest drawback of biological agents is cost. Patients can spend thousands of dollars a month using biologics.
- Other drawbacks include side effects, which may be severe because biologics suppress the immune system, enhancing the possibility of infections.
- In addition, patients may not like receiving injections.
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What To Expect When You Take A Biologic
The FDA has approved these medications to treat rheumatoid arthritis. You might take a biologic alone or with another arthritis drug. As a general rule, you shouldn’t take different biologic therapies at the same time.
Abatacept . This medication is a selective co-stimulation modulator. It works by works by blocking T cells. You get it in a shot every week or by IV once a month. The most common side effects include headache, a cold, a sore throat, and nausea. Before you start taking it, your doctor should test you for infections such as tuberculosis and hepatitis. They should check you for infections while you’re taking it, too.
Adalimumab , adalimumab-adaz, adalimumab-adbm ,adalimumab-afzb , adalimumab-atto , adalimumab-bwwd , adalimumab-fkjp . These medications target tumor necrosis factor . You get them as a shot once every 1-2 weeks. The most common side effects are colds, a sinus infection, headache, and rash. Before you start taking it, your doctor should test you for infections like tuberculosis and hepatitis. They should check you for infections while you’re taking it, too.
Anakinra . This medicine targets interleukin-1 . You take it as a shot once a day. The most common side effects are pain or skin reactions in the area where you get the shot, colds, headache, and nausea. Before you start taking it, your doctor should test you for infections like tuberculosis and hepatitis. They should check you for infections while you’re taking it, too.
Comparison With Other Studies
Several network meta-analyses of biological medicines in rheumatoid arthritis are available, including two recent Cochrane reviews.173940 A major difference between these network meta-analyses and our analysis seems to be the approach for testing the assumptions for the network meta-analyses, specifically similarity and homogeneity. For instance, while we extensively analysed patient characteristics and treatments to identify similar studies before inclusion in the network meta-analysis, Singh et al17 did not report an assessment of similarity and included more heterogeneous study pools. Furthermore, they did not report tests for homogeneity in the pairwise meta-analyses included in the networks. Although they performed sensitivity analyses for several factors, overall it remains unclear to what extent the assumptions for a network meta-analysis were met in their analyses. Hazlewood et al3940 reported more detailed data on study and patient characteristics and reported tests for homogeneity in pairwise meta-analyses. However, like Singh et al, the authors did not report measures or quantitative results to assess or test the network meta-analysis assumptions . Thus, it also remains unclear to what extent the assumptions for network meta-analysis were met in their analyses.
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Nutritional Supplements And Dietary Changes
There’s no strong evidence to suggest that specific dietary changes can improve rheumatoid arthritis, although some people with rheumatoid arthritis feel their symptoms get worse after they have eaten certain foods.
If you think this may be the case for you, it may be useful to try avoiding problematic foods for a few weeks to see if your symptoms improve.
But it’s important to ensure your overall diet is still healthy and balanced. A Mediterranean-style diet, which is based on vegetables, fruits, legumes, nuts, beans, cereals, grains, fish and unsaturated fats such as olive oil, is recommended.
There’s also little evidence supporting the use of supplements in rheumatoid arthritis, although some can be useful in preventing side effects of medicines you may be taking.
For example, calcium and vitamin D supplements may help prevent osteoporosis if you’re taking steroids, and folic acid supplements may help prevent some of the side effects of methotrexate.
There’s some evidence to suggest that taking fish oil supplements may help reduce joint pain and stiffness caused by rheumatoid arthritis.
Further information
- National Rheumatoid Arthritis Society : diet and rheumatoid arthritis
Page last reviewed: 28 August 2019 Next review due: 28 August 2022
Im Able To Do Simple Things Like Vacuum My Carpet Without Worrying About Pain
In 2019 when she was diagnosed with rheumatoid arthritis, Carrie Zamudio, 27, had a hard time accepting that the stiffness and pain shed been feeling in her joints might never go away completely. I thought, Theres got to be a way to find relief, Zamudio tells SELF.
In early 2021, Zamudio started taking a steroid and a biologic. Within two weeks, she noticed that her pain and stiffness was getting betterto the point where she can try to take the caps off of bottles .
Now, shes so grateful to be able to do things that many people might find mundane. After the treatment, I feel like I can do things that everyone else can do, she says. Im able to do simple things like vacuum my carpet without worrying about pain.
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What Are The Types Of Biologics
There are several. They include:
- B-cell inhibitor. They affect B cells, which are white blood cells that carry a protein that can trigger your immune response
- Interleukin-1 blocker. Stops production of an inflammatory chemical your body makes
- Interleukin-6 or interleukin-17 blocker. Stops inflammatory chemicals from attaching to cells
- Selective co-stimulation modulators. Blocks T-cell activity in your body
- T-cell inhibitor. Blocks communication between T cells, a type of white blood cell
- Tumor necrosis factor inhibitor. Blocks a chemical your body makes that drives the inflammation process
Quality Of Life Measures
The most commonly used outcome measures for assessing RA disease activity are the American College of Rheumatology and European League Against Rheumatism criteria for remission and low disease activity used by clinicians ACR20 is commonly used in clinical trials, which is a composite measure involving a set of five criteria. These tend to have a large contribution from measures looking at the reduction in inflammation. However, a common problem seen among patients is the persistence of fatigue and pain, even if inflammation is well controlled. This highlights the importance of considering an alternative perspective: how bDMARDs compare to each other for improving specific quality of life measures. The authors have not been able to identify any published research addressing this question, though there is some suggestion that different bDMARDs may contrast in their ability to treat certain aspects of RA. For instance, in the AMPLE trial adalimumab had a greater reduction in pain assessment score than abatacept.4 A head-to-head trial is currently underway to investigate this finding further .16
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What Are The Possible Side
It is not possible to list all of the adverse effects of each biological medicine in this leaflet. However, as with all medicines, there are a number of side-effects that have been reported with each of the biological medicines. If you want more information specific to your biological medicine then you should read the information leaflet that comes with your medicine.
Most biological medicines make you more prone to infections. These can be quite serious and some people have had severe infections such as infection of the blood , as well as tuberculosis and hepatitis B reactivation. Screening for hepatitis B is now recommended before starting rituximab, whether you are at risk of infection or not. If the screen shows you are carrying hepatitis B you will be referred to a liver specialist. The specialist will do more tests to help decide if rituximab is right for you.
Some biological medicines may also cause damage to the blood-producing cells.
You should tell your doctor or nurse straightaway if you develop any of the following after starting a biological medicine:
- Any other symptoms of infection.
- Unexplained bruising.
- Injection site reactions.
Most hospitals will give you a biological therapy alert card to carry with you at all times. This is important because, if you become unwell, the doctor or nurse treating you needs to know you are being treated with a biological medicine, making you more at risk of infection.
How Do Different Biologics Compare
There have been no head-to-head trials of biologic treatment in RA, and it is difficult to compare results from different trials due to differences in patient groups involved . However, there have been some systematic comparisons of results from existing randomized, controlled clinical trials of different biologics. One review considered five different biologics, infliximab, rituximab, etanercept, adalimumab, and abatacept.5 All of these agents were significantly more effective than placebo in achieving disease control, defined as the rate of ACR50 response . There were no significant differences between individual biologics in terms of rates of ACR50 response. However, when individual agents were compared, some were more likely than others to result in this level of disease control.2
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What New Research May One Day Help
Scientists are continuing to explore the roles that different immune cells and molecules play in the development and treatment of RA.
Further understanding the role of JAK inhibitors is one focus of research, and scientists are currently developing a number of additional JAK inhibitors.
Vagal nerve stimulation is another area to watch for new developments.
Eventually, early diagnosis, targeted intervention, induction of remission, and reduced need for chronic maintenance therapy may move us forward to a cure.
In the meantime, a number of very effective therapies for for RA are available.
Comparing Biological Therapies In Terms Of Efficacy
Being the oldest class of bDMARDs, TNF inhibitors are well-studied, which, along with their low cost, makes them a popular choice for clinicians. Therefore, the contrasting lack of data for newer forms of therapy can pose difficulties for making reliable comparisons. The most useful conclusions can be drawn from head-to-head trials that directly compare one agent to another within the same patient cohort as opposed to using data from placebo-controlled trials or making comparisons between trials on different patient cohorts.
To date, there have only been a handful of head-to-head trials directly comparing different biological therapies. These can either be in the form of superiority trials, which are powered to determine if one therapy is better than the other, and non-inferiority trials, which investigate whether one therapy is at least as good as the other. In two superiority trials, the IL-6 inhibitors tocilizumab and sarilumab were found to be more effective than adalimumab when used as a monotherapy additionally, in the RA-BEAM trial, baricitinib was found to have significantly greater clinical improvements than adalimumab.2,3 Table 1 summarises findings from hitherto head-to-head trials.
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Biological Dmards Under Development
As per treat-to-target strategies, clinical remission, or at least low disease activity, are now widely accepted management goals in the treatment of RA. This is a realistic goal for a significant proportion of patients with RA, in stark contrast to previously when RA was a highly disabling disease with limited therapeutic options. However, for the remaining patients who struggle to achieve treatment targets, additional therapies are required. Fortunately, the ongoing improved understanding of the pathogenesis of RA is facilitating exploration of new molecular targets. Approximately seventy potential drug targets are currently in development, with the majority of these being bDMARDs and tsDMARDs.66 Promising bDMARD targets include cytokines such as interleukins and granulocyte-monocyte colony stimulating factor, transmembrane activator and calcium modulator and cyclophilin ligand interactor which is involved in B cell differentiation and proliferation, and agents targeting T cell activation or B and T cell costimulation.66
Further research into potential biomarkers that act as predictors of response to treatment is also required to facilitate precision medicine. At present, when selecting a targeted treatment, a trial-and-error approach is adopted taking into consideration patient factors and drug preference. The discovery of biomarkers predicting medication response will simplify management pathways, improve outcomes and reduce healthcare costs.
Recommendations For The Use Of Biological Agents
Opinion is divided on which biological agent should be used to start with when active rheumatoid arthritis is diagnosed. Among typical rankings for the use of biological agents, there is the 2012 recommendation of the American College of Rheumatology .
According to this recommendation, in the United States the first biological agent recommended for treatment of early rheumatoid arthritis with disease duration of less than 6 months is a TNF inhibitor. For treatment of established RA with disease duration of 6 months or more, a TNF inhibitor and abatacept or rituximab are recommended as the 1st Bio.
Figure 5.
American College of Rheumatology 2012 Recommendation
On the other hand, the British National Institute for Health and Clinical Excellence specifies the following guidance on usage :
Figure 6.
*1The annual cost of the biological agent is also specified and does not exceed 9,295 a year.
*2If certolizumab pegol is the 1st Bio, there should be a system wherein the manufacturer provides the first 12 weeks for free .
*3If golimumab is used as the 1st Bio, compensation from the manufacturer is necessary so that the drug price of 50 mg and 100 mg is the same .
*4Tocilizumab can be used as the 1st Bio with a discount provided by the manufacturer. Therefore, whichever biological agent is used first, the annual cost of any is 9,295 or less [ 27
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