Adalimumab

Adalimumab is either used by itself or in tandem with certain other medications for the relief of certain bowel conditions, specific types of arthritis, and some kinds of skin disorders, most of which fall into the category of autoimmune diseases.

Overview

Adalimumab, also known by its brand name Humira, is a drug which is commonly used to counteract pain and swelling which may result from certain kinds of arthritis, to treat specific skin disorders, and also to help manage some kinds of bowel conditions, as well as a specific type of eye disease.

The kinds of arthritis that Adalimumab is most effective on are juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis. The skin disorders which Adalimumab is most effective on are psoriasis and hidradenitis suppurativa. Certain kinds of bowel problems can be managed by Adalimumab, if they are classified as ulcerative colitis or Crohn's disease. The specific eye disease referenced above which Adalimumab can help with is known as uveitis.

Adalimumab belongs to a classification of drugs known as TNF blockers, and it works by blocking a tumor necrosis factor, or TNF, which is a protein found in the body's immune system. This protein is sometimes responsible for causing swelling and damage in some of the joints of the body, in addition to triggering patches of red scaly skin, which can be itchy and uncomfortable.

These types of autoimmune these diseases cannot be cured, but the pain and inflammation are manageable with medications such as Adalimumab. Biologic drugs like Adalimumab are usually obtained from living organisms, for instance microorganisms or yeast, animals, and even humans, and the antibodies included in them are developed using DNA technology, i.e. genetic engineering.

Autoimmune diseases are those which are detected by the body's immune system and attacked, without any legitimate threat really being present, in other words, a false attack. This kind of false attack can lead to a whole slew of problems and medical conditions which become very real and must be treated.

Science has yet to discover the precise cause of autoimmune diseases, although there appears to be a strong connection between tumor necrosis factor alpha (TNFA) and the resulting inflammation and pain which develops. Tumor cruises factor alpha triggers inflammation situations when the body is considered to be threatened, with the autoimmune system springing into action promptly for protection.

It is thought that excessive tumor necrosis factor alpha may be responsible for the attack on healthy tissue and the subsequent generation of inflammation and pain. Adalimumab is a drug which binds itself to tumor necrosis factor alpha and works to hinder or block the inflammation, causing a reduction of the pain and inflammation in patients who are experiencing autoimmune diseases and their symptoms.

Conditions Treated

  • Certain kinds of arthritis
  • Skin disorders
  • Bowel problems

Type of Medicine

  • Biologic, TNF blockers

Side Effects

The most common side effects associated with any treatment program including Adalimumab can be any of the following, as well as any combination of two or more:

  • headaches
  • skin rashes
  • pain at the injection site
  • upper respiratory tract infections (URTIs)
  • sinus infections
  • urinary tract infections (UTIs)
  • increased creatine phosphokinase
  • nausea and abdominal pain
  • hyperlipidemia
  • high blood pressure
  • increased alkaline phosphatase
  • moderate to severe back pain
  • blood in the urine
  • vascular disorders such as systemic vasculitis and deep vein thrombosis
  • skin reactions such as cutaneous vasculitis, erythema multiforme, new cases of psoriasis, worsening cases of existing psoriasis, and alopecia
  • respiratory disorders such as interstitial lung disease, pulmonary fibrosis, and pulmonary embolism
  • nervous system disorders such as optic neuritis, and Guillain-Barre Syndrome, and cerebrovascular accident
  • benign neoplasms, malignant neoplasms, cysts or polyps, and Merkel cell carcinoma
  • immune system disorders such as sarcoidosis
  • hepatobiliary disorders like liver failure and hepatitis
  • general disorders such as fever.

In some less common situations, side effects have been reported which included allergic reactions and blood disorders such as leukopenia, thrombocytopenia, pancytopenia, and aplastic anemia.

Dosage

Patients using Adalimumab are able to self-administer the drug at home, generally using a pen device or a preloaded syringe. Adalimumab cannot be taken orally because the human digestive system would degrade or destroy its active ingredients and render it useless.

Patients who are prescribed Adalimumab generally have a long-term treatment plan which must be adhered to in order to achieve the desired results. There is considerable variation in the speed at which the analgesic and anti-inflammatory effects of Adalimumab work in different patients. While some patients may see favorable results in as little as two weeks, in other patients it may take as long as three months or more before significant improvement occurs. The important point about this variable impact is that the program treatment should not be interrupted, even if it looks as though the drug is not having any effect.

By discontinuing treatment with Adalimumab, patients are more than likely to begin experiencing all the worst symptoms of an overactive immune system in full force once again. In terms of how the drug is actually administered, Adalimumab should be injected via prefilled syringe or pen device directly into the abdomen or one of the thighs, at a site on the body where there is no bruising or tenderness, and where there are no evident patches of psoriasis.

It is not necessary for a medical professional to administer the injections because the preloaded syringes already have the proper dosage, usually either 40 mg, 20 mg, or 10 mg of medication. The strategy for Adalimumab treatment calls for an initial dosage, which is generally the largest of the entire treatment plan, and is then followed up with reinforcing doses every two weeks.

Whenever a doctor prescribes Adalimumab for a patient, the proper prefilled syringes will be issued, along with clear instructions about how they should be administered. In most cases, that initial large dosage will be administered by the physician, with all the follow-up dosages being self-administered.

In all cases, the physician will clearly demonstrate to a patient how the drug is to be self-administered so that there are no mistakes made at home, and all questions are answered right at the physician's office before the self-treatment part of the program begins. To be sure that the patient understands the process and carries it out correctly, there will generally be a practice session or two at the physician's office, to ensure proper technique.

Specific treatments and dosages for conditions treated with adalimumab are as follows:

  • Rheumatoid Arthritis - For cases of rheumatoid arthritis, Adalimumab should be used to reduce the symptoms and signs of arthritis, as well as the interruption of the progress of any structural damage. Adalimumab should provide a significant improvement of physical functionality in adults whose active rheumatoid arthritis is classified as moderate to severe. Dosage in these cases should be 40 mg of Adalimumab administered subcutaneously every two weeks, and it may be administered as a monotherapy treatment, or in combination with methotrexate or similar drugs classified as disease-modifying antirheumatic drugs. In treatment programs where Adalimumab is not being combined with methotrexate, an additional benefit may be realized by increasing the frequency of Adalimumab dosage to once every week.
  • Psoriatic Arthritis - Psoriatic arthritis can be treated with Adalimumab to reduce the signs and symptoms of the disease, and as is the case with rheumatoid arthritis, it should also inhibit the progress of any structural damage of the joints. Overall, it should improve the physical functionality of adults with active psoriatic arthritis. Similar to dosage with rheumatoid arthritis, it can be administered as a monotherapy treatment or in combination with methotrexate and other non-biologic disease-modifying antirheumatic drugs. If used in a combination program, Adalimumab should only be administered once every two weeks with a 40 mg dosage delivered subcutaneously, and as a monotherapy treatment, frequency of dosage can be increased to once weekly.
  • Juvenile Idiopathic Arthritis - For the treatment of juvenile idiopathic arthritis, Adalimumab is used for cases where the signs and symptoms need to be reduced for moderate to severe cases of active polyarticular juvenile idiopathic arthritis. It may be administered in combination with glucocorticoids, nonsteroidal anti-inflammatory drugs, analgesics, or with methotrexate. When administered to children under the age of two, less than 10 kg should be prescribed, because the safety and the effectiveness of usage has not yet been fully confirmed. For children above the age of two, the amount of Adalimumab administered subcutaneously must be carefully monitored, and explicit prescription directives must be followed. When 10 kg to 15 kg have been prescribed, only 10 mg should be administered subcutaneously every two weeks. When 15 kg to 30 kg are prescribed, only 20 mg may be administered subcutaneously every two weeks. In cases where more than 30 kg have been prescribed, the maximum subcutaneous delivery should be 40 mg.
  • Ankylosing Spondylitis - Adalimumab can be used in cases of ankylosing spondylitis for the reduction of attendant signs and symptoms, and can be delivered to the patient in a dosage not to exceed 40 mg subcutaneously every two weeks. For the treatment of ankylosing spondylitis, Adalimumab can be administered as a monotherapy, or in tandem with methotrexate or other non-biologic disease-modifying antirheumatic drugs. When Adalimumab is not prescribed in combination with methotrexate, an additional benefit may be derived in treatment by increasing the Adalimumab dosage to once every week.
  • Plaque Psoriasis - In the treatment of plaque psoriasis, Adalimumab can be used for moderate to severe cases in patients who are considered to be good candidates for either phototherapy or systemic therapy, and for whom other types of systemic therapy are not indicated. The initial dosage of Adalimumab for plaque psoriasis patients should be 80 mg delivered subcutaneously, and then a week after that initial dosage, 40 mg dosages can be delivered subcutaneously every two weeks.
  • Crohn’s Disease - For the treatment of Crohn's disease, Adalimumab is used to accomplish the reduction of symptoms associated with the disease and to accomplish the induction and maintenance of remission in patients experiencing moderate to severe Crohn's disease. Such patients should have had an unsatisfactory response to conventional therapy before switching over to treatment with Adalimumab. Other candidates for treatment with Adalimumab are those patients who have demonstrated an intolerance to infliximab, or who have developed some level of resistance to that treatment. Initial treatment calls for 160 mg of Adalimumab to be delivered subcutaneously, either as four injections of 40 mg in one day, or as two injections of 40 mg over a span of two days. Subsequent induction of Adalimumab should be 80 mg delivered subcutaneously every two weeks. After a period of four weeks have elapsed, dosage should be reduced to 40 mg every two weeks, unless patients have shown a need for weekly 40 mg dosages to manage inflammatory bowel disease.
  • Pediatric Crohn’s Disease - When treating Pediatric Crohn's Disease with Adalimumab, the goal is to reduce symptoms for the patient, and to achieve and maintain remission of the disease in those pediatric patients considered to be good candidates for treatment. In order to be identified as an appropriate candidate for treatment, patients should have demonstrated an unsatisfactory response to corticosteroids or immunomodulators such as azathioprine, methotrexate, or mercaptopurine. It should be borne in mind that the safety and effectiveness of using Adalimumab on pediatric patients below the age of six has not been fully established, and is therefore only advisable under strict medical supervision. For those children above the age of six who are prescribed between 20 kg and 40 kg of Adalimumab, there should be an initial subcutaneous delivery of Adalimumab on the first day (administered as two 40 mg injections), and two weeks later, a single 40 mg injection should be followed up. Thereafter, a maintenance program should be adhered to with 20 mg being delivered subcutaneously every two weeks. For children who are six years and above and are prescribed a dosage of greater than 40 kg, the initial dosage on day one should be 160 mg, administered as four separate injections of 40 mg, or two injections of 40 mg administered over a span of two days. Two weeks after the initial dosage delivery, an 80 mg dosage should be delivered as two separate 40 mg injections on a single day. Beginning with the fourth week, a maintenance program should be started, which calls for 40 mg of Adalimumab to be delivered subcutaneously every two weeks.
  • Ulcerative Colitis - In the treatment of ulcerative colitis, Adalimumab can be used for those patients who have demonstrated a lack of response to immunosuppressants such as corticosteroids, azathioprine, or mercaptopurine. In these cases, an initial dosage of 160 mg should be delivered subcutaneously, either as four separate injections of 40 mg apiece in a single day, or as two injections of 40 mg delivered on consecutive days. Two weeks following that initial dosage, 80 mg should be delivered subcutaneously. Beginning with the fourth week, a maintenance program should be initiated which calls for administering 40 mg subcutaneously every two weeks, and should be continued as a maintenance dosage if it becomes apparent that clinical remission is in progress within eight weeks of therapy initiation.
  • Hidradenitis Suppurativa - For the treatment of Hidradenitis Suppurativa, Adalimumab can be used when moderate to severe Hidradenitis Suppurativa is indicated in a patient, as identified by medical personnel as Hurley Stage II or Hurley Stage III disease. The initial dosage should be 160 mg of Adalimumab, delivered subcutaneously either as four separate injections of 40 mg in one day, or as two separate injections of 40 mg delivered over consecutive days. Two weeks after the initial dosage, an 80 mg dosage should be followed up with and delivered subcutaneously to the patient. Starting with the fourth week, a maintenance program should be initiated and continued, wherein 40 mg of Adalimumab are delivered to the patient subcutaneously once weekly.
  • Uveitis - In the treatment of Uveitis, Adalimumab can be used to manage noninfectious intermediate, posterior, and panuveitis in adults. Initial dosage should consist of 80 mg of Adalimumab, delivered subcutaneously one time, and a week later a program of maintenance should be initiated, which calls for the delivery of 40 mg subcutaneously every two weeks afterward.

Interactions

Doctors who prescribe Adalimumab as part of a treatment program are aware of most interactions with other drugs and will only prescribe Adalimumab in situations where there will be no severe adverse effects resulting from interactions with other medications. For that reason, it is inadvisable to make any kind of changes to the dosage of Adalimumab, or any other drug being taken without consulting a family physician beforehand.

When a patient’s reaction to taking Adalimumab with any other drug are unknown, physicians will commonly recommend doctor visits more frequently, so that any symptoms can be identified and carefully observed until they are understood. There are no known life-threatening reactions between Adalimumab and any other prescription drug, although there are mild to moderate interactions with several drugs, with interactions classified as relatively severe known to medical personnel, and these include as many as 60+ drugs on the market.

Moderate interactions of adalimumab with other drugs include all of the following:

  • influenza virus vaccine quadrivalent, recombinant
  • influenza virus vaccine trivalent, recombinant
  • maitake
  • meningococcal group B vaccine
  • mercaptopurine
  • sipuleucel-T
  • astragalus
  • belatacept
  • denosumab
  • echinacea
  • fingolimod
  • hydroxyurea

Interactions with adalimumab which are considered to be mild in nature, include the following drugs:

  • cat's claw
  • methotrexate

Warnings

There are a number of warnings and precautions which should be observed for patients who are in treatment programs including Adalimumab. The first of these is the risk of serious infection, which in the most extreme cases can result in hospitalization, or even death. In those recorded cases reaching this level of seriousness, patients were taking immunosuppressants such as methotrexate or corticosteroids in conjunction with Adalimumab.

It is known that patients aged 65 and above are at greater risk for developing these kinds of serious infections, presumably due to compromised immune systems. When any patient being treated with Adalimumab develops a serious infection or sepsis, which has no other known trigger, discontinuation of Adalimumab is indicated immediately.

Some of the types of serious infections which can develop are active tuberculosis, which may include the reactivation of latent tuberculosis. In situations like these, the reappearance of tuberculosis is often associated with extrapulmonary disease. This makes it important to test a patient for latent tuberculosis before prescribing Adalimumab, as well as throughout the period of treatment. Any latent infection should be treated and resolved before a treatment program including Adalimumab is initiated.

Another type of infection which has been reported historically is an invasive fungal infection including the following specific types: blastomycosis, pneumocystosis, aspergillosis, candidiasis, histoplasmosis, and coccidioidomycosis. These may be present with disseminated disease, as opposed to localized instances of disease. It's possible that antibody and antigen testing for histoplasmosis might yield inaccurate negative results in various patients who actually do have an active infection.

If any kind of severe systemic illness should develop, empiric antifungal therapy is indicated and should be initiated at the earliest opportunity. Other bacterial infections such as Legionella, listeria, mycobacterial infections such as tuberculosis, as well as viral infections such as hepatitis B are also part of the known history of recorded infections for Adalimumab patients.

Some kinds of malignancies including lymphoma have been reported in young patients in their teens and younger, who are being treated with medications acting as tumor necrosis factor (TNF) blockers. Some cases of chronic leukemia and acute leukemia have been identified in conjunction with post-marketing TNF blocker usage, for patients suffering from rheumatoid arthritis. Some patients with rheumatoid arthritis may be at higher risk, possibly twice as high, for contracting leukemia than is the general population.

Pharmaceutical manufacturers are required by federal law to report any such malignancies to the Food and Drug Administration (FDA), so that a thorough analysis can be performed, and so that statistics may be compiled which will indicate tendencies and patterns.

Hepatosplenic T-cell lymphoma (HSTCL) is one of the rarest and most aggressive types of T-cell lymphomas and is usually fatal when contracted. There are several recorded instances of HSTCL in teenaged patients using Adalimumab, as well as young adult patients, most of whom were being treated for either Crohn's disease or ulcerative colitis, with a program including TNF blockers.

There are also a few outlier cases such as an individual who was treated for psoriasis and two other patients who were being treated for rheumatoid arthritis, using the same program of treatment in conjunction with a prescribed dosage of Adalimumab. Most of the cases on record which involved TNF blockers have been associated with the use of azathioprine or 6-MP, and several other cases have included the usage of both these medications.

HSTCL cases are described in the Food and Drug Administration’s Adverse Event Reporting System (AERS) database, the HSTCL Cancer Survivor’s Network, and various other sources of medical literature, and these cases have included the usage of such agents as infliximab, etanercept, Adalimumab, infliximab/Adalimumab combinations, certolizumab, golimumab, azathioprine, and 6-MP.

Any patient who is known to be allergic to Adalimumab or any of the ingredients included in Adalimumab, should not be prescribed medications which include the ingredients known to be part of Adalimumab, and which could trigger an allergic reaction.

This is a serious medication which should be kept out of the reach of children at all times, which means it should be stored in a location higher than they can reach. Anyone who suspects they may have accidentally overdosed on Adalimumab should contact the Poison Control Center immediately and follow any instructions provided.

You should consider discontinuing usage of Adalimumab if hematologic disorders of the type thrombocytopenia, pancytopenia, or leukopenia should develop. Serious infections or neutropenia may develop when the drug is co-administered with interleukin blockers such as anakinra or ustekinumab. Co-usage with TNF blockers and abatacept have historically demonstrated an increased occurrence of serious infractions in clinical trials when compared with usage of TNF blockers alone.

Some serious infections such as hepatitis B virus and tuberculosis have occurred despite prophylactic treatment for tuberculosis, and reactivation of TB has also been recorded in some cases. There is an increased risk of demyelinating disorders such as multiple sclerosis, peripheral demyelinating disease, and optic neuritis with Adalimumab usage, and therapy should be discontinued immediately if any of these disorders are manifested.

There is an increased risk of lymphoma and some other types of cancers which has been reported in adolescents and young children who are on a program of Adalimumab treatment. New onset psoriasis and an increased occurrence of leukemia have been reported in some patients being treated with TNF blockers.

There is a greater risk of malignancy when Adalimumab is co-administered with either 6-MP or azathioprine. Safety surveillance and reporting requirements have been mandated by the federal government so that all malignancy data can be captured for analysis, which means all patients and physicians involved in a treatment program including Adalimumab are legally obligated to report any instance or suspicion of malignancy to FDA authorities.

Adalimumab treatment has been known to decrease the immune response to live virus vaccines, and it can also have the effect of increased infection risk with concomitant live virus vaccines. The safety level for administering live vaccines or live attenuated vaccines with infants exposed to Adalimumab in utero is not yet known or fully understood by the scientific community. Therefore, all risks and benefits should be carefully evaluated prior to the vaccination of an individual.

Whenever it is feasible, patients afflicted by juvenile idiopathic arthritis would be well advised to stay current with immunization guidelines before embarking on any program which includes Adalimumab treatment, although it is currently considered safe to receive vaccinations (other than live vaccines) while on a program of treatment with Adalimumab.

It is possible that autoimmunity may result in the generation of autoantibodies, and in some cases the development of symptoms which mimic lupus. Any patient developing these types of lupus-like symptoms during treatment with Adalimumab should immediately discontinue treatment.

Various hypersensitivity reactions have been reported, such as anaphylaxis and angioedema, although these are relatively rare. Patients taking TNF blockers have reported worsening or new onset of congestive heart failure, which means extreme caution should be exercised regarding patients who have a history of heart problems, and especially heart failure. Patients with heart failure should only use TNF alpha inhibitors when there are no other reasonable alternatives, and even so, only patients with compensated heart failure should be considered good candidates.

Adalimumab is considered appropriate in some cases for treatment of patients during pregnancy. Studies conducted on animals showed either no risk at all, or in some cases very minor risks, and clinical testing on humans has yet to demonstrate any serious risk associated with Adalimumab usage during pregnancy.

To collect all data related to pregnancy and treatment with Adalimumab, a pregnancy registry has been instituted, and all relevant data can be reported by calling phone number 1-877-311- 8972. It is known that lgG1 is actively transmitted through the placenta during the third trimester of pregnancy.

Although data is very limited in published medical literature, it is known that Adalimumab does have a presence in milk for mothers who are breastfeeding and have been treated with Adalimumab at some point in their medical history. The levels of Adalimumab which are present in such samples have been extremely low and are not considered to be any threat to an infant.

Still, it is advisable that anyone who has been previously treated with Adalimumab in their medical history and who is considering breastfeeding a newborn should consult with their family physician before proceeding.

Storage

Adalimumab must be stored in a refrigerator in its original container, and tightly sealed against possible exploration by youngsters and others. Injectable adalimumab may be stored at room temperature, not to exceed 77 degrees Fahrenheit, for up to 14 days. Beyond that point, any unused medication must be disposed of in a proper manner.

Disposal should not be by flushing it down the toilet, and should instead be discarded through a medical take-back program, so that knowledgeable persons can accomplish the disposal in the safest manner possible.

Adalimumab should never be stored in a location where children can easily access it and should not be placed in any container which lacks an open-proof safety feature.

Summary

Adalimumab is administered via subcutaneous injection and can be used alone or in conjunction with other medication to treat certain bowel conditions, particular types of arthritis, and some specific skin disorders, most of which fall into the category of autoimmune diseases.

There are a number of situations where Adalimumab would not be prescribed by a doctor, even if there were clear indications that it could be useful in reducing the pain and inflammation attendant upon typical autoimmune diseases. Before Adalimumab is prescribed, doctors prefer that all other traditional treatments have been tried first without producing favorable results, and once these other treatments have been exhausted, then Adalimumab would be considered.

A doctor will also not prescribe Adalimumab if a person's autoimmune disease is not active, or if the person has an infection now, or has had repeated severe infections in the past. Any patient who has lung fibrosis, any kind of serious heart condition, multiple sclerosis, or any type of cancer, is also not a candidate for Adalimumab treatment.

Before any treatment program including Adalimumab is begun, a patient will be subjected to chest x-rays and various tests to make sure that there has been no exposure to tuberculosis, and other tests will be conducted to make sure that there has been no exposure to hepatitis infection, since there is a potential for this to be reactivated during the treatment program.

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Last Reviewed:
December 10, 2017
Last Updated:
December 22, 2017
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