Navigating rare or autoimmune diseases is one of the if not the hardest experiences one can face. It can take years and years of suffering to even get the correct diagnosis and once that’s done- it can take even longer to find something that truly helps. With HUMIRA, many patients battling autoimmunity claim to finally have gotten their life back, here is a brief look at what HUMIRA is all about.1
Humira (adalimumab) is a drug used to manage several inflammatory conditions in patients, it belongs to the class of medications called TNF Blockers or inhibitors (Tumor necrosis factor blocker/inhibitor)
It comes in the form of an injectable pen or pre-filled injection syringes and has been approved by the FDA for use in certain conditions 2
Let’s take a brief look at diseases commonly managed by HUMIRA:
- -Crohn’s disease:
Crohn’s is an auto-immune condition wherein the body’s immune system attacks healthy tissue in the gastrointestinal tract leading to chronic inflammation3- it commonly affects the small and large intestines. Although not usually life-threatening, patients with Crohn’s have a painful experience with its symptoms such as abdominal pain, chronic diarrhea, rectal bleeding (bloody stools) infections around the anus as well as mouth ulcers etc.4 Based on its severity, Crohn’s can be mild, moderate or severe.
- -Ulcerative colitis: UC is an autoimmune related disease that causes ulcers and inflammation in the lining of the colon and rectum (parts of the large intestine) UC is usually not fatal but patients tend to undergo severe discomfort and pain. Common symptoms include abdominal cramps, pus and blood in stools, diarrhea, anemia, severe tiredness. In severe cases, the colon may have to be surgically removed too.5
- -Rheumatoid arthritis: RA is an autoimmune condition wherein the body’s immune system attacks its own tissues causing pain and swelling in the joints of the body leading to stiffness and even loss of function. It’s classification ranges from mild to severe and a number of things are factored in by the doctor to determine how severe a patient’s RA is. Patients may have low-grade fevers, and fatigue. Outside of joints, RA can cause problems in the heart, lungs, blood, nerves etcetera.6, 7
- -Plaque psoriasis: The most common kind of psoriasis- an autoimmune disorder of the skin that appears as raised, red patches of skin that are covered by silver scales. The patches usually develop in a symmetrical pattern on the body and tend to appear on the scalp, trunk, and limbs, especially the elbows and knees.8 PS can be graded mild, moderate and severe. About 15% of patients will present with arthritis of the small joints 9
- -Psoriatic arthritis: PA is a progressive inflammatory condition of the joints and the places where tendons and ligaments attach to the bone(entheses). As diseases described above, PA follows a similar course- the body’s immune system becomes overactive and creates inflammation, leading to pain and swelling. Most people who develop PA already have psoriasis of the skin that presents with itchy patches or scales on the skin, especially the knees, elbows, and scalp.10
- -Juvenile Idiopathic Arthritis: JIA is arthritis that affects 1 or more joints for at least 6 weeks in a child age 16 or younger. It is an autoimmune disease with symptoms similar to RA but unlike adult RA which is chronic (long-term), children often outgrow JIA. Nonetheless, it can affect bone development in a growing child.11
- -Ankylosing spondylitis: AS is a type of arthritis that causes inflammation in the joints and ligaments of the spine causing pain and stiffness. It may also affect peripheral joints like the knees, ankles, and hips. Disease progression can lead to severities like the bones of the spine fusing together causing inflexibility of the spine. Patients with AS may develop other inflammatory diseases like eye disease (uveitis), psoriasis, or inflammatory bowel disease. 12
- -Uveitis: Uveitis is an autoimmune inflammatory disease that affects the middle layer of the eye, called the uvea. Posterior uveitis is inflammation of the retina and choroid, while panuveitis is inflammation of the retina, choroid, and vitreous (parts of the eye). Symptoms include blurry vision, pain in the eyes, redness, and sensitivity to light. 13
- -Hidradenitis Suppurativa: HS is a long-term skin condition that causes skin abscesses and scarring. HS ranges from mild-moderate to severe in terms of symptoms, occurring near hair follicles where there are sweat glands, usually around the groin, bottom, breasts and armpits. Such lumps tend to get infected easily, hence, it is a painful condition to live with- taking care of the pus-filled lumps that often require drainage and dressings etc. 14
Let’s get into understanding HUMIRA:
Humira (Adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human Tumor Necrosis Factor (TNF) that resembles antibodies normally found in the body.
Produced by recombinant DNA technology in a mammalian cell expression system and purified by a process that includes specific viral inactivation and removal steps. 2
Who can benefit from HUMIRA and how? 15
Patients with the above-described autoimmune conditions can benefit from HUMIRA in the following cases:
- -Patients diagnosed with moderate to severe ulcerative colitis
- -Moderate to severe Crohn's disease (CD) to achieve and maintain clinical remission in adults who have not responded well to other medications.
- -Adults with Crohn’s who are unresponsive to or are unable to tolerate infliximab.
- -Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older
- -Moderate to severe hidradenitis suppurativa (HS) in adults.
- -Active moderate to severe HS in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy
- -Moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy, under the care of a doctor who will decide if other systemic therapies are less appropriate.
- -Moderate to severe rheumatoid arthritis (RA) in adults. Humira can be used as a monotherapy (alone), with methotrexate, or certain other medicines.
- -Moderate to severe juvenile idiopathic arthritis (JIA) in children 2+ years of age. Humira can be used alone, with methotrexate, or certain other medicines.
- -Adult patients diagnosed with Ankylosing Spondylitis.
- -Adult patients diagnosed with non-infectious intermediate uveitis (middle eye), posterior uveitis (back of the eye) and panuveitis (all parts of the eye).
- -When corticosteroid therapy for an autoimmune condition is no longer indicated due to multiple medical reasons.
Benefits of Humira:
- -Symptomatic relief: Although Autoimmune conditions and diseases don’t have a permanent cure, HUMIRA can provide patients with relief wherein the patient remains symptom-free for long periods of time.15
- -Halts disease progression: Monotherapy with HUMIRA or combined drug therapy including HUMIRA has proven to stop autoimmune conditions from getting worse. 15
- -Increased functionality: Patients with different types of autoimmune arthritis receiving HUMIRA showed improved functionality of the joints affected.15
- -Inducing and maintaining Clinical Remission: HUMIRA has proven to induce and maintain clinical remission in patients with UC, Crohn’s disease. 15
How HUMIRA is used:16
HUMIRA is supplied as a sterile solution of adalimumab for subcutaneous administration. It is supplied either as a single-use pen or glass syringe available as:
- -10mg and 20mg pre-filled syringes
- -40mg pre-filled syringe
- -40mg and 80mg injection pens
Drug dosages and frequency of administration are decided by the prescribing physician, the first injection is usually administered by the doctor while the patient is monitored for any side-effects and complications, remaining doses may be administered by the patient/guardian if the doctor recommends doing so, however- regular follow-ups and reporting any side-effects is crucial for safe administration. 16
Administering HUMIRA: 16
The safety and storage precautions are communicated to the patient by the prescribing doctor, the patient is expected to go through the package insert, here are a few things to keep in mind:
- -Change the injection site regularly to avoid irritation at the site.
- -Never freeze HUMIRA
- -Keep it refrigerated.
- -Let it reach room temperature before administration.
Precautions while administering HUMIRA:
- -Active infections: Patients should undergo screening for diseases—especially Tuberculosis (TB). It is recommended to be up to date with all the vaccines before the commencement of the treatment as Humira have shown to reactivate latent TB infections and hepatitis, vaccinating against these while undergoing HUMIRA administration is generally not advised and this should be taken care of before treatment. 15
- -HUMIRA should not be taken with other biologic medicines, physician must be made aware of all ongoing medications. 15
- -Any history of cancer should be communicated to the physician, to minimize the risk of malignancy. 15
Possible Side effects:
- -Increased susceptibility to infections: Since HUMIRA works by suppressing the immune system, it can predispose patients to infections. Any signs of infections such as fever or cough etc. should be reported to the healthcare provider immediately. 15
- -Allergy: Although uncommon, patients may have an allergic response to the drug or the excipients used- immediate medical attention should be given to signs of an allergic reaction such as skin rash, breathing difficulties etc.15
- -Cancer risk: People, especially adolescents have an increased risk of certain types of cancers such as lymphoma, these factors should be assessed and screened for before and during the treatment. 15
Lifestyle and autoimmunity:
Alongside medications, there are a few things that can help manage autoimmune conditions:
- -Balanced diet rich in fresh fruits, vegetables, whole grains and lean protein.
- -Avoid processed foods high in sugar and fats that can worsen inflammation.
- -Identify food sensitivities and avoid foods that can trigger an immune response.
- -Smoking is linked to the development of several autoimmune diseases and hence it is crucial to quit smoking, to manage autoimmunity. 17
- -Stress management: Stress can trigger inflammation, consistent hydration and adequate sleep are crucial in the repair of the body and regulation of stress. One may consider meditating, practising mindfulness and getting professional therapy to help counter stress.
- -Gentle exercises such as swimming that can keep joints and bones comfortably mobile without putting too much strain on the body.
Conclusion:
HUMIRA comes with a set of risks including infectious diseases as well as malignancy, it is important to work closely with your doctor to assess risks and minimize adverse reactions, apart from the risks, HUMIRA provides multiple benefits such as long-term symptomatic relief and halting disease progression leading to an improved quality of life.
Rx4U: Helping You Navigate Autoimmune Medications :
Rx4u is a platform that helps patients access rare, lifesaving medications through Named Patient Programs (NPPs). Their services include:
- Regulatory Navigation
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They source authentic medications from pharmaceutical companies and authorized distributors while managing the importation process for timely, secure delivery. Additionally, Rx4u provides patient support, offering resources and guidance throughout the journey. By bridging the gap between patients and essential treatments, Rx4u brings hope and improved health outcomes.
If you or a loved one needs critical therapy that isn’t available in India, Rx4u can be your trusted partner in accessing necessary medications.
NOTE:
The information provided is for education purpose only and is subjected to prescribing information of the drug and the guidance of your treating physician. Always consult your health care provider before making any medical decision for starting your treatment.
Reference links:
- 1. https://www2.mrc-lmb.cam.ac.uk/news-and-events/lmb-exhibitions/from-bench-to-blockbuster-the-story-of-humira-best-selling-drug-in-the-world/#:~:text=The%20patient's%20story,to%20have%20some%20energy%20again.%E2%80%9D
- 2.. https://www.drugs.com/history/humira.html
- 3. https://www.hopkinsmedicine.org/health/conditions-and-diseases/crohns-disease#:~:text=Crohn's%20disease%20is%20a%20chronic,and%20disappear%20at%20various%20times.
- 4. https://my.clevelandclinic.org/health/diseases/9357-crohns-disease
- 5. https://autoimmune.org/disease-information/ulcerative-colitis-uc/#:~:text=What%20is%20Ulcerative%20colitis%20(UC,doctors%20must%20remove%20the%20colon.
- 6. https://www.niams.nih.gov/health-topics/rheumatoid-arthritis#:~:text=Rheumatoid%20arthritis%20(RA)%20is%20a,nerves%2C%20eyes%2C%20and%20skin.
- 7.https://www.sciencedirect.com/science/article/abs/pii/S0896841114000304#:~:text=Rheumatoid%20arthritis%20(RA)%20is%20a,of%20RA%20from%20other%20pathology.
- 8. https://www.hopkinsmedicine.org/health/conditions-and-diseases/psoriasis#:~:text=Psoriasis%2C%20an%20autoimmune%20disorder%2C%20is,million%20people%20in%20the%20U.S.
- 9.https://www.ncbi.nlm.nih.gov/books/NBK430879/#:~:text=Based%20on%20the%20PASI%20score,with%20mild%20to%20moderate%20severity.
- 10. https://www.niams.nih.gov/health-topics/psoriatic-arthritis#:~:text=Psoriatic%20arthritis%20is%20a%20progressive,the%20beginning%20of%20skin%20symptoms.
- 11. https://www.hopkinsmedicine.org/health/conditions-and-diseases/arthritis/juvenile-idiopathic-arthritis
- 12.https://www.niams.nih.gov/health-topics/ankylosing-spondylitis
- 13.https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/uveitis#:~:text=What%20is%20uveitis?,away%20if%20you%20have%20symptoms.
- 14.https://www.nhs.uk/conditions/hidradenitis-suppurativa/#:~:text=Hidradenitis%20suppurativa%20(HS)%20is%20a,about%201%20in%20100%20people.
- 15. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s406lbl.pdf
- 16.https://www.humirapro.com/dosing
- 17.https://pubmed.ncbi.nlm.nih.gov/17153844/#:~:text=1%20Division%20of%20Rheumatology%2C%20Immunology,Autoimmune%20Diseases%20/%20immunology