Main Category: Arthritis / Rheumatology
Also Included In: Pain / Anesthetics; Bones / Orthopedics
Article Date: 24 Jun 2011 – 0:00 PDT
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MSD today announced that the National Institute for Health and Clinical Excellence (NICE) has, in its final appraisal determination (FAD), provisionally recommended ‘Simponi’® (golimumab) as an option for the treatment of severe, active ankylosing spondylitis (AS) in adults.1 Use of golimumab, the first once-monthly, self-administered, subcutaneous anti-TNF (anti-tumour necrosis factor-alpha), is recommended only if it is used in the same way as other anti-TNFs and if MSD provides the 100mg dose at the same cost as the 50mg dose. The recommendation in this FAD is expected to be published as NICE final guidance over the coming months.
NICE also issued this week its final guidance (Technology Appraisal Guidance, TAG 225), recommending the use of golimumab for the treatment of moderate to severe rheumatoid arthritis (RA), in combination with methotrexate, in eligible adults.2
Professor Peter Taylor, Head of Clinical Trials and Campus Dean, Imperial College, London said: “These two positive NICE announcements acknowledge the clinical and economic rationale for the use of golimumab in RA and AS, which can be extremely painful and debilitating conditions that can impact on every area of life. Providing patients and their health care professionals with an additional treatment choice that can help improve patients’ well-being and quality of life is to be welcomed.”
AS is a painful and progressive rheumatic disease which mainly affects the spine and pelvis causing inflammation of joints, ligaments and tendons, which can lead to severe joint and back stiffness, deformity and immobility.3 It is estimated there are 4,400 new cases per 100,000 of AS diagnosed every year in the UK.4
Golimumab is licensed for use in three rheumatology indications: RA, AS and PsA, and shows consistent efficacy, significantly reducing the signs and symptoms of disease activity in these three diseases. Additionally, golimumab has also been found to improve physical function in patients.5,6,7 Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis and rhinitis) was the most frequent adverse reaction reported in combined phase 3 trials for RA, PsA and AS.8 The once-monthly dosing schedule of golimumab offers patients greater convenience compared with other currently available anti-TNFs and also offers a lower level of injection-site reaction.8
Golimumab is licensed in the UK, having received marketing authorisation from the European Commission in late 2009. Other than in the EU, golimumab has also been approved for use in USA and Canada. The approved dose for golimumab is a 50 mg subcutaneous injection given once monthly either through the golimumab SmartJect™ auto injector or a prefilled syringe. ‘Simponi’ is a Registered Trademark owned by Centocor, Inc. and licensed to Merck and Co., Inc., Whitehouse Station, New Jersey, USA,
Golimumab is indicated for the treatment of severe, active AS in adults who have responded inadequately to conventional therapy.
Golimumab, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active RA in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy, including MTX, has been inadequate. Golimumab, in combination with MTX, is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX. Golimumab, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function in RA patients.
Alone or in combination with methotrexate, golimumab is indicated for the treatment of active and progressive PsA in adults when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.
Please refer to the Summary of Product Characteristics for full information on golimumab including contraindications, precautions, special warnings and side effect information. Available here.
About Ankylosing Spondylitis (AS)
AS is a painful and progressive rheumatic disease which mainly affects the spine and pelvis causing inflammation of joints, ligaments and tendons, which can lead to severe joint and back stiffness, deformity and immobility.3 Once the inflammation has subsided, the body, as part of its healing process, creates new bone. Movement becomes restricted where bone replaces the elastic tissue of ligaments or tendons. Repetition of this inflammatory process leads to further bone formation and the individual bones which make up your backbone, the vertebrae, can fuse together.3 It is estimated there are 4,400 new cases per 100,000 of AS diagnosed every year in the UK.4
About Rheumatoid Arthritis (RA)
RA is a chronic, debilitating inflammatory disease that causes swelling, stiffness, and loss of function in joints.9 RA is an autoimmune disease which occurs when the immune system attacks the body’s own healthy tissue and causes inflammation. RA usually affects the hands, feet and wrists, but can also spread to joints all over the body. Around 580,000 people in England have RA, with an estimated 26,000 new cases diagnosed each year.10 Onset usually begins in middle-age but the condition can also affect children and young adults.9
About Psoriatic Arthritis (PsA)
Psoriatic arthritis (PsA) is a chronic inflammatory disease of the joints and connective tissue affecting up to 30% of individuals with psoriasis (a common skin disorder).11 Onset of PsA usually occurs in middle-age and can affect one or two joints, but can also affect several joints making them tender, swollen and stiff.11
Today’s MSD is a global healthcare leader working to help the world be well. MSD is a trade name of Merck Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programmes and partnerships. For more information, visit www.msd.com or www.msd-uk.co.uk.
1. NICE Final Appraisal Determination on golimumab for the treatment of severe, active ankylosing spondylitis. June 2011.
2. NICE Technology Appraisal Guidance TA225. Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying antirheumatic drugs. June 2011.
3. A Positive Response to Ankylosing Spondylitis: Answers and practical advice. Available at http://www.nass.co.uk/about-as/just-diagnosed/. Accessed on 11th April 2011.
4. Ankylosing spondylitis data. Available at: http://www.arthritisresearchuk.org/research/data_on_arthritis/data_on_as.aspx. Accessed on 11th April 2011.
5. Keystone EC, Genovese MC, Klareskog L, et al. Golimumab, a human antibody to tumour necrosis factor a given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis 2009; 68: 789-796.
6. Kavanaugh A, McInnes I, Mease, P. et al. Golimumab, a new human tumor necrosis factor antibody,
administered every four weeks as a subcutaneous injection in psoriatic arthritis. Arthritis Rheumatism 2009; 60(4): 976-986.
7. Inman RD, Davis JC, van der Heijde D, et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis. Arthritis Rheumatism 2008; 58(11): 3402-3412.
8. Simponi Summary of Product Characteristics. June 2011. Available from: http://www.medicines.org.uk/emc/medicine/23766/SPC/simponi%2050%20mg%20solution%20for%20injection/ Accessed on 20th June 2011.
9. National Rheumatoid Arthritis Society (NRAS). What is RA? Available at: http://www.nras.org.uk/about_rheumatoid_arthritis/what_is_ra/what_is_ra.aspx. Accessed on 11th April 2011.
10. National Audit Office. Services for People with Rheumatoid Arthritis. Available from: http://www.nao.org.uk/publications/0809/services_for_people_with_rheum.aspx. Accessed on 11th April 2011.
11. National Psoriasis Foundation: Psoriatic Arthritis. Available from: http://www.psoriasis.org/NetCommunity/Document.Doc?id=912. Accessed on 11th April 2011.
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