Prescribing information and adverse event reporting can be found at the bottom of this page
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HUMIRA is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.1

HUMIRA is also indicated for the treatment of adults with severe active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.1

EAMs are considered as those conditions associated with ankylosing spondylitis which are not directly related to the locomotor system; those related to the SpA concept, such as involvement of the skin, eye and gut and those reflecting chronic inflammation.3

The prevalence of EAMs and enthesitis associated with axial SpA are frequent and unpredictable.3-5

Humira’s efficacy in EAMs and enthesitis associated with severe active AS makes it an anti-TNF prescribing option.2,6,7

The 2016 NICE guidance entitled TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis states:

Prescribing Information (PI)Humira (adalimumab) 40 mg solution for injection in pre-filled pen or pre-filled syringe or paediatric vial containing 40 mg solution for injection.Refer to Summary of Product Characteristics (SmPC) for full information.Presentation: Each single dose pre-filled pen (0.4 ml), pre-filled syringe (0.4 ml) or vial (0.8 ml) contains 40 mg of adalimumab. Indications: Rheumatoid arthritis (RA), adults: In combination with methotrexate (MTX) for moderate to severe, active RA with inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) including MTX. In combination with MTX for severe, active and progressive RA when not previously treated with MTX. Can be given as monotherapy if intolerance to or when continued treatment with MTX is inappropriate. Reduces rate of progression of joint damage on X-ray and improves physical function, in combination with MTX. Polyarticular juvenile idiopathic arthritis (pJIA), paediatrics 2 years and above: In combination with MTX, for active pJIA with inadequate response to one or more DMARDs; or monotherapy if intolerance to or when continued treatment with MTX is inappropriate. Enthesitis-related arthritis (ERA), paediatrics 6 years and above: For active ERA with inadequate response or intolerance to conventional therapy. Ankylosing spondylitis (AS), adults: For severe active AS with inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), adults: For severe nr-axSpA with objective signs of inflammation (elevated CRP and/or MRI), and an inadequate response to or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs). Psoriatic arthritis (PsA), adults: For active and progressive PsA with inadequate response to DMARDs. Reduces rate of progression of peripheral joint damage on X-ray in polyarticular symmetrical subtypes of the disease and improves physical function. Psoriasis, adults: For moderate to severe chronic plaque psoriasis who are candidates for systemic therapy. Psoriasis, paediatrics 4 years and above: For severe chronic plaque psoriasis with inadequate response, or if topical therapy and phototherapies are inappropriate. Hidradenitis suppurativa (HS), adults and adolescents from 12 years of age: For active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic HS therapy. Crohn’s disease (CD), adults: For moderately to severely active CD with inadequate response, contraindication or intolerance to corticosteroid and/or an immunosuppressant therapy. Crohn’s disease (CD), paediatrics 6 years and above: For moderately to severely active CD with inadequate response, contraindication or intolerance to conventional therapy including primary nutrition therapy and a corticosteroid, and/or an immunomodulator. Ulcerative colitis (UC), adults: For moderately to severely active UC with inadequate response, contraindication or intolerance to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA). Uveitis, adults: For the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Dosage and administration: A specialist physician experienced in diagnosis and treatment of the indicated condition, to initiate and supervise treatment. Provide patients with special alert card. Patients may self-inject after proper injection training, with physician approval and appropriate medical follow-up. Optimise other concomitant therapies. RA, adults: 40 mg dose every other week. Concomitant MTX should be continued. During monotherapy, patients may require 40 mg each week if they have experienced a decrease in clinical response. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Consider need for dose interruption, e.g. before surgery or if serious infection occurs. Reintroduction after 70 day dose interruption gave same magnitudes of clinical response and similar safety profile as before dose interruption. pJIA, paediatrics 2 years and above: Treatment beyond 12 weeks reconsidered if no clinical response in that time. pJIA, paediatrics 2-<4 years: 24 mg/m² body surface area up to 20 mg maximum single dose every other week (see vial SmPC for height/weight dosing chart). pJIA, paediatrics 4-12 years: 24 mg/m² body surface area up to 40 mg maximum single dose every other week (see vial SmPC for height/weight dosing chart). pJIA, paediatrics 13 years and above: 40 mg every other week regardless of body surface area. ERA, paediatrics 6 years and above: 24 mg/m² body surface area up to 40 mg maximum single dose every other week (see SmPC for height/weight dosing chart). AS, nr-axSpA and PsA, adults: 40 mg every other week. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Psoriasis, adults: 80 mg induction dose at week 0, 40 mg every other week from week 1. Treatment beyond 16 weeks should be reconsidered if no clinical response in that time. Beyond 16 weeks, patients with inadequate response can increase dosing frequency to 40 mg every week. If adequate response is achieved with an increased dosing frequency, the dose may subsequently be reduced to 40 mg every other week. If there is inadequate response to the increased frequency, carefully reconsider treatment. Psoriasis, paediatrics 4 years and above: 0.8 mg/kg body weight (maximum 40 mg/dose) weekly for the first 2 doses then every other week (see vial SmPC for weight dosing chart). Treatment beyond 16 weeks should be reconsidered if no response in that time. HS, adults: 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day). Two weeks later (Day 29) continue with a dose of 40 mg every week. Antibiotics may be continued if necessary. Concomitant topical antiseptic wash on HS lesions should be used on a daily basis. Treatment beyond 12 weeks should be reconsidered in a patient with no improvement in that time. Reintroduction after interruption: 40 mg every week. Evaluate periodically the benefit and risk of continued long-term treatment. HS, adolescents from 12 years of age weighing at least 30 kg: 80 mg initially at week 0 (given as two 40 mg injections on day one). 40 mg injection in week 1 followed by 40 mg every other week. In adolescent patients with inadequate response to Humira 40 mg every other week an increase in dosing frequency to 40 mg every week may be considered. Antibiotics may be continued if necessary. Concomitant topical antiseptic wash on HS lesions should be used on a daily basis. If no improvement after 12 weeks refer to SmPC for guidance. CD, adults: Induction: 80 mg Week 0 and 40 mg at Week 2. For a more rapid response: 160 mg at Week 0 (either as 4 injections in 1 day or 2 injections/day for 2 consecutive days) and 80 mg at Week 2; risk of adverse events higher during induction. Maintenance: 40 mg every other week. If decrease in clinical response, can increase dose to 40 mg weekly. Corticosteroids may be tapered in maintenance phase in accordance with clinical guidelines. Patients with no response by Week 4 may benefit from continued therapy to Week 12. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. CD, paediatrics 6 years and above < 40 kg: Induction: 40 mg Week 0, 20 mg at Week 2. For a more rapid response: 80 mg Week 0 (2 injections in 1 day), 40 mg at Week 2; risk of adverse events higher during induction. Maintenance: 20 mg every other week. If insufficient response, consider 20 mg every week. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. CD, paediatrics 6 years and above ≥ 40 kg: Induction: 80 mg Week 0, 40 mg at Week 2. For a more rapid response: 160 mg at Week 0 (4 injections in 1 day or 2 injections/day for 2 consecutive days), 80 mg at Week 2; risk of adverse events higher during induction. Maintenance: 40 mg every other week. If insufficient response, consider 40 mg every week. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. UC, adults: Induction: 160 mg at Week 0 (as 4 injections in 1 day or 2 injections/day for 2 consecutive days) and 80 mg at Week 2. Maintenance: 40 mg every other week. During maintenance, corticosteroids may be tapered in accordance with clinical guidelines. If insufficient response, consider 40 mg every week. Treatment beyond 8 weeks should be reconsidered if no clinical response in that time. Uveitis, adults: 80mg induction dose at week 0, maintenance dose; 40 mg every other week starting at week 1. Treatment can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents. Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Humira. Contraindications: Active tuberculosis (TB), severe infections (e.g. sepsis), and opportunistic infections; moderate to severe heart failure (NYHA class III/IV); hypersensitivity to adalimumab or any excipients. Warnings and precautions: Clearly record trade name and batch number of administered product to improve traceability of biological products. Infections: Patients are more susceptible to serious infections especially if impaired lung function. Monitor for infections, including TB, before, during and for 4 months after treatment. Do not initiate treatment with an active infection, until it is controlled. Consider risk/benefit prior to treatment in patients exposed to high risk of TB or endemic mycoses. Evaluate new infections during treatment and monitor closely. Stop treatment if new serious infection or sepsis, and treat appropriately. Exercise caution in patients with a history of recurring infections or who are predisposed to infections. Serious infections: Serious infections, including those with hospitalisation or death, reported in patients receiving treatment. TB: Consult SmPC for details. Reactivation and new onset TB, both pulmonary and extra-pulmonary (disseminated) reported. Screen all patients before therapy initiation for active or latent TB. If latent TB suspected, consult physician with appropriate expertise and follow local treatment recommendations for prophylaxis prior to initiation of Humira. Despite prophylaxis, TB reactivation has occurred on Humira. If active TB is diagnosed, do not initiate treatment. Other opportunistic infections: Opportunistic infections observed in patients receiving Humira. Stop treatment in patients with signs and symptoms of such infections. Consult with physician with appropriate expertise for diagnosis and administration of empiric antifungal therapy in these patients. Hepatitis B reactivation: Reactivation has occurred in chronic carriers (surface antigen positive) tested for HBV infection before initiating treatment. HBV carriers should consult a specialist physician and be closely monitored for reactivation of HBV infection throughout therapy and for several months following termination of treatment. If reactivation occurs stop treatment and initiate appropriate anti-viral and supportive treatment. Neurological events: Caution in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders. Rare association with new onset or exacerbation of symptoms and/or radiographic evidence of central and peripheral demyelinating disease. Discontinuation of treatment should be considered if any of these disorders develop. Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to initiation of treatment and regularly during treatment, to assess for existing or developing central demyelinating disorders. Allergic reactions: Reports of serious allergic reactions including anaphylaxis received. For serious allergic or anaphylactic reaction stop Humira immediately and initiate appropriate therapy. Malignancies and lymphoproliferative disorders: A possible risk of malignancy, including lymphomas and leukaemia, in all patients, including paediatric patients, treated with TNF antagonists. Examine all patients, especially those with a medical history of extensive immunosuppressant or PUVA treatment, for non-melanoma skin cancer prior to and during treatment; caution in COPD patients, and in patients with increased risk for malignancy due to heavy smoking. Consider the potential risk with the combination of AZA or 6-MP and Humira (hepatosplenic T-cell lymphoma has occurred). Risk of hepatosplenic T-cell lymphoma cannot be excluded. Caution in patients with a history of malignancy. Risk of developing dysplasia or colon cancer is unknown. Patients with UC, history of dysplasia or colon carcinoma to be screened for dysplasia before and during treatment. Haematologic reactions: Adverse events of the haematologic system reported with Humira. Patients should seek immediate medical attention if signs and symptoms of blood dyscrasias. Vaccinations: Patients may receive concurrent vaccinations, except for live vaccines. Bring paediatric patients up to date with all immunisations prior to Humira treatment. Congestive heart failure: See contraindications. Caution is advised with mild heart failure (NYHA class I/II). Discontinue treatment for new or worsening symptoms of congestive heart failure. Autoimmune processes: Autoimmune antibodies may form. Stop treatment if development of a lupus-like syndrome with positive antibodies against double-stranded DNA. Surgery: Consider the long half-life of Humira for planned surgical procedures. Monitor for infections. Small bowel obstruction: Failure to respond to treatment for CD may indicate the presence of fixed fibrotic stricture requiring surgical treatment. Elderly patients: Serious infections were higher in patients over 65 years of age, some of whom had a fatal outcome. Consider risk of infections. Interactions: Combination of adalimumab with other biologic DMARDs (e.g. anakinra and abatacept) or other TNF-antagonists is not recommended. Fertility, pregnancy and lactation: Not recommended during pregnancy. Women of childbearing age to use adequate contraception, and continue its use for at least 5 months after the last treatment. Women must not breast feed for at least 5 months after the last treatment. Side effects: Very common ≥ 1/10: Infections, leucopaenia, anaemia, lipids increased, headache, abdominal pain, nausea and vomiting, elevated liver enzymes, rash (including exfoliative rash), musculoskeletal pain, injection site reaction. Common ≥ 1/100 to < 1/10: skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm, leucocytosis, thrombocytopaenia, hypersensitivity, allergies (including seasonal allergy), hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphatemia, dehydration, mood alterations (including depression), anxiety, insomnia, paraesthesias, migraine, nerve root compression, visual impairment, conjunctivitis, blepharitis, eye swelling, vertigo, tachycardia, hypertension, flushing, haematoma, asthma, dyspnoea, cough, GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome, worsening or new onset of psoriasis (including palmoplantar pustular psoriasis), urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia, pruritus, muscle spasms (including blood creatine phosphokinase increased), renal impairment, haematuria, chest pain, oedema, pyrexia, coagulation and bleeding disorders, autoantibody test positive, blood lactate dehydrogenase increased, impaired healing. Serious, including fatal, side effects have been reported including infections/sepsis, intestinal perforation, opportunistic infections, TB, endemic mycoses, demyelinating disease, malignancies including lymphoma, (including hepatosplenic T-cell lymphoma), leukaemia and skin cancer (including melanoma and Merkel cell carcinoma), cytopenias, worsening heart failure, myocardial infarction, pulmonary embolism, pleural effusion, pulmonary fibrosis, cerebrovascular accident, interstitial lung disease, Stevens-Johnson syndrome, angioedema, anaphylaxis, sarcoidosis, hepatitis, liver failure and worsening of symptoms of dermatomyositis. Other less common and rarely reported side effects are listed in the SmPC.Basic NHS price: £704.28 (for 2 pens or 2 syringes or 2 vials). Legal category: POM. Marketing Authorisation numbers: EU/1/03/256/001, EU/1/03/256/013, EU/1/03/256/017.Further information: available from AbbVie Ltd., Maidenhead, SL6 4UB, United Kingdom. Date of revision of PI: December 2016, PI/Humira(combined)/37.
Adverse events should be reported.Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie Ltd. at:

References

  1. HUMIRA Summary of Product Characteristics. AbbVie Ltd. Available at www.medicines.org.uk
  2. National Institute for Health and Care Excellence: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis (TA383), February 2016.
  3. Mielants H and Van den Bosch F. Clin Exp Rheumatol 2009; 27(suppl.55):S56-S61.
  4. Haroon M et al. Ann Rheum Dis 2014; 0:1-6. doi:10.1136/annrheumdis-2014-205358.
  5. D’Agostino MA and Olivieri I. Best Pract Res Clin Rheumatol. 2006; 20(3):473-86.
  6. Rudwaleit M et al., Ann Rheum Dis 2009; 68(5): 696-701.
  7. Rudwaleit M et al. Poster presented at: BSR and BHPR Annual Meeting, 28 April-1 May 2009; Glasgow, Scotland. P96.

Code: AXHUR161179c(1)

Date of preparation: December 2016