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Adalimumab drug presentation

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Adalimumab drug presentation

  2. 2. Introduction • human monoclonal antibody against TNF-alpha • C6428H9912N1694O1987S46 • organic chemical • produced by recombinant DNA technology using mammalian cell expression system • Adalimumab is used for treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn’s disease • immune system mediated diseases
  3. 3. History • 1993 - BASF bioresearch and Cambridge Antibody • 3rd TNF inhibitor approved in United States • fully human monoclonal • initially discovered using CAT’s phage display technology and being named as D2E7 • BASF bioresearch Corporation – create • Abbott Laboratories – further manufacturing and marketing
  4. 4. • 2008 - Food and Drug Administration (FDA) approved adalimumab as treatment of arthritis and Crohn’s disease • 2012 - FDA approved for treatment of ulcerative colitis • 2014 - generic drugs of adalimumab has been launched by other companies
  5. 5. • sold under the trade name, Humira • rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease • tumor necrosis factor-alpha (TNF- α) blocker
  6. 6. How it works? • directly binding to TNF- α molecules in the blood and diseased tissue • blocks its interaction with the p55 and p75 cell surface TNF receptors • lyses surface TNF expressing cells in vitro • does not bind or inactivate lymphotoxin (TNF-beta) • Excess production of TNF-alpha - rapid growth of skin cells and damages to joint tissue • Adalimumab helps to stop the inflammatory cycle of psoriatic disease and prevent from causing the inflammation that result in psoriasis plaques.
  7. 7. Prescription, Pharmacodynamics, Pharmacokinetics • prescribed by either itself or in combination with methotrexate • given after other medications has failed in treatment • safe to take it with topical treatments or pain relievers • Adult – decrease acute inflammation, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and serum cytokines (IL-6) • maximized with the maximum serum concentration • Tmax were 4.7 ± 1.6 µg/mL and 131 ± 56 hours • linear over the dose range of 0.5 to 10.0 mg/kg following a single intravenous dose
  8. 8. efficacy of adalimumab • phase II randomized placebo-controlled trial evaluate 147 patients with psoriasis that at least 5% of their (BSA) infected and minimum 10 (PASI) • Patient had achieved the primary endpoint of PASI 75 or better as compared to 4% of the patients who received placebo. • phase II trial is to compare the efficacy of adalimumab to methotrexate (MTX) and placebo.
  9. 9. • phase III trials were performed to directly compare the therapeutic efficacy, safety and tolerability and to provide greater body of data • 80patients given adalimumab, 36% patients given methotrexate and 19% patients given placebo achieving a PASI 75 response rate at a given time • (PGA) score :73% in adalimumab, 30% in methotrexate and 11% in placebo • second phase III trials was to examine the short- and long-term efficacy of adalimumab as monotherapy against placebo • treatment with 40mg adalimumab every other week • efficacy of adalimumab is sustainable.
  10. 10. • high dose in phase II - Adverse reaction of pain with injection • headache, nausea, elevated triglycerides, cough, sinus congestion, and fatigue • no increase of serious adverse events in phase III trials • recommended dose of 40 mg every other week, and the higher dose of 40 mg weekly, either alone or in combination with methotrexate or other DMARDs • short- and long-term safety, tolerability and substantial efficacy
  11. 11. Risk • developing severe and even fatal infections • Tuberculosis may be caused by a new infection or by reactivation of a previous infection • tumor necrosis factor (TNF) blocker - develop Lymphoma and other types of cancer such as hepatosplenic T-cell lymphoma (HSTCL) • attempt a TB skin test before taking Adalimumab • positive result should begin treatment for TB • negative result should also be monitored for signs of TB while using adalimumab
  12. 12. Precautions • Should not drive - dizziness or vision changes • avoid contact with people who have colds or infections • should not do any activities that may cause bruising or injury • should not breastfeed
  13. 13. Side Effects Common side effect • back pain, headache, redness or swelling at injection site • mild stomach pain, nausea or runny nose Severe side effect • rash, itching, difficulty in breathing, swelling of lips or tongue, blood in urine, burning, numbness, chest pain, fainting, blistered, peeling skin, swelling of ankles, diarrhoea or vomit.
  14. 14. Overdose • still unclear • does not show toxic effects in clinical trials
  15. 15. Challenges • target specific drugs • specialized drug for individual • competition of new generic drugs • Amgen for patenting rights
  16. 16. Conclusion • fully human monoclonal anti-TNF antibody drug • treat inflammation and chronic skin condition • Efficacy of adalimumab is sustainable • side effect isn’t life threatening • No high toxic effect • taken by itself of accompanied by some other drug