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Biologics in Reumatoid Arthritis. Presented June 2009 Oklahoma Academy of Family Physicians Annula Meeting

Biologics in Reumatoid Arthritis. Presented June 2009 Oklahoma Academy of Family Physicians Annula Meeting

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  • More than two thirds of the patients in Study DE010 (68%) achieved an ACR-20 response in the first year of treatment with HUMIRA® (adalimumab) and methotrexate (MTX), and 30% achieved an ACR-50 response. 1 ACR-20 response rates of >60% were sustained over 5 years of treatment. The ACR‑50 response rate increased over the first 3 years of treatment from 30% to 50%, and this rate was maintained through 5 years of treatment. Similarly, the ACR-70 response rate increased from 8% after 1 year of treatment to 28% after 3 years of treatment, and this rate was maintained through the fifth year of treatment. As suggested by the high and sustained ACR-20 and ACR-50 response rates and the patient retention rate of 68% after 5 years of treatment in this trial, most patients in this study exhibited significant levels of improvement in most clinical assessments of the signs and symptoms of rheumatoid arthritis, and dramatic improvements were observed in a number of patients. For example, the mean tender joint count at baseline was 12 and the mean swollen joint count at baseline was 15. At the end of 5 years of treatment, 23% of the patients in the study had  2 tender and swollen joints, and 8% of the patients had no tender or swollen joints. The disability index scores on the Health Assessment Questionnaire (HAQ-DI) decreased from a mean of 1.4 at baseline to 1.0 after 4 years of treatment. At year 5 of the study, 23% of the patients had HAQ-DI scores of  0.5. To put this in perspective, a population-based survey of more than 1,700 subjects demonstrated that the mean HAQ-DI score for individuals at high risk for health problems was approximately 1.0 and the mean score for individuals at low risk for health problems was approximately 0.5. 2 References 1. Breedveld FC, Rau R, van Riel PLC, et al. Sustained efficacy over 5 years with adalimumab (HUMIRA) in patients with active rheumatoid arthritis . Arthritis Rheum . 2003;48(Suppl):S118 [Abstract 198]. 2. Vita AJ, Terry RB, Hubert HB, et al. Aging, health risks, and cumulative disability . N Engl J Med . 1998;338:1035-1041.
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    • 1. Challenges & Opportunities in the Treatment of RA Lawrence A Jacobs, MD June 19, 2009 Rheumatology Associates Tulsa, Oklahoma
    • 2. Why Early Diagnosis & Treatment?
    • 3. Clinical Spectrum of RA Images courtesy of J. Cush, 2002.
    • 4.  
    • 5. Joint Erosions Occur Early in RA 0 10 20 30 0 1 2 3
      • Up to 93% of patients with  2 years of RA may have radiographic abnormalities
      • Rate of progression is significantly more rapid in the first year than in the second and third years
      • Radiographic changes in the feet are important indicators of disease progression in RA
      MTP Total Hand van der Heijde DM et al. J Rheumatol . 1995;22:1792–1796; Fuchs HA et al. J Rheumatol . 1989;16:585–591; McQueen FM, et al. Ann Rheum Dis . 1998;57:350–356. Year % of Joints Affected
    • 6.  
    • 7.  
    • 8.  
    • 9. Four of Seven Criteria Required
      • Morning Stiffness lasting 1 Hour or more
      • Sort tissue swelling (Synovitis) of 3 or more joints X 6 weeks
      • Swelling of PIP, MCP or Wrist Joints X 6 weeks
      • Symmetrical arthritis X 6 Weeks
      • Subcutaneous Nodules (Vasculitis)
      • Positive Rheumatoid Factor or CCP
      • Radiographic Erosions or periarticular osteopenia
    • 10.  
    • 11.  
    • 12.  
    • 13.  
    • 14.  
    • 15.  
    • 16.  
    • 17. Biologic DMARDs Efficacy: Signs and Symptoms of Disease
    • 18.  
    • 19. Etanercept + MTX: ACR Response Rates at 24 Weeks * P   0.001; † P  0.05 Weinblatt ME, et al. N Engl J Med. 1999;340:253–259. 0 10 20 30 40 50 60 70 80 ACR-20 ACR-50 ACR-70 % of Patients * 71 27 * 39 3 † 15 0 Etanercept 25 mg + MTX Placebo + MTX
    • 20. Adalimumab + MTX (ARMADA): ACR Response Rates at 24 and 52 Weeks *P ≤ 0.001 ARMADA = Anti-TNF Research Program of the Monoclonal Antibody D2E7 [adalimumab] in Rheumatoid Arthritis Study Weinblatt ME, et al. Arthritis Rheum . 2003;48:35 – 45; Data on file; Abbott Laboratories. Placebo + MTX Adalimumab 40 mg EOW + MTX 15 8 5 * 66 * 54 * 27 0 10 20 30 40 50 60 70 ACR-20 ACR-50 ACR-70 % of Patients 70 49 25 24 Weeks (Double Blind) 52 Weeks (Open Label Extension) ACR-20 ACR-50 ACR-70
    • 21. Adalimumab + MTX : Sustained Efficacy Over 5 Years Breedveld FC, et al. Arthritis Rheum . 2003;48(Suppl):S118 [Abstract 198]. Months ACR-20 ACR-50 ACR-70 % of Patients (n = 53) (n = 36) 68 62 75 63 77 30 36 50 50 46 8 11 28 24 22 0 10 20 30 40 50 60 70 80 12 24 36 48 60
    • 22. Biologic DMARDs Efficacy: Patients With Early RA
    • 23. Etanercept in Early RA: HAQ-DI Scores at 24 Months ≥ 0.5 Improvement ≥ 1.0 Improvement % of Patients 0 10 20 30 40 50 60 37 * 55 25 29 Etanercept 25 mg MTX 20 mg Etanercept 25 mg MTX 20 mg 70 * P  0.001 Genovese MC, et al. Arthritis Rheum . 2002;46:1443 – 1450.
    • 24.  
    • 25. Safety Considerations With Biologic DMARDs
      • Serious infections
      • Opportunistic infections (TB)
      • Malignancies
      • Demyelination
      • Hematologic abnormalities
      • Administration reactions
      • Congestive heart failure
      • Autoantibodies and lupus
    • 26. TEMPO: Infections and Serious Infections Etanercept + Methotrexate (at 52 Weeks) *Fisher exact test; †No incidence of tuberculosis was noted in any treatment group. Klareskog L. Data presented at EULAR. Lisbon, Portugal, June 2003. 1.00 10 (4.3%) 10 (4.5%) 10 (4.4%) Serious infections 0.19 158 (68.4%) 134 (60.1%) 148 (64.9%) Any infection † P value* MTX + Etanercept (n = 231) Etanercept (n = 223) MTX (n = 228) Number of patients
    • 27. Infliximab: Postmarketing Reports of Tuberculosis
      • 277 cases of active TB
      • All cases were within 6 months of treatment
        • United States : 86 cases
          • 55 cases in patients with RA
          • 18 cases in patients with Crohn’s disease
          • 13 cases in patients with unspecified disease
          • 0.2 cases/1000 pt-years
        • European Union : 191 cases
          • 1.4 cases/1000 pt-years
      FDA Arthritis Advisory Committee meeting. March 4, 2003. August 2002
    • 28. Etanercept: Malignancies and Lymphomas
      • RA Clinical Trials
      • Patients 1272
      • Patient-years of follow-up 3806
      • Expected malignancies* 35
      • Observed malignancies 35
      • Malignancy SIR 1.0
      • Observed lymphomas 9
      • Lymphoma SIR 3.5
      *NCI (SEER), 2001, adjusted for age, gender distribution; SIR = standardized incidence ratio Moreland LW. Arthritis Rheum . 2002;46(suppl):S533. Abstract 427. Briefing document, FDA Arthritis Advisory Committee meeting. March 4, 2003.
    • 29.
      • Patients Patients With Disease With RA Crohn’s
      • Patients 1298 1106
      • Patient-years of follow-up 2458 1646
      • Expected non-lymphoma malignancies * 17 10
      • Malignancy SIR 0.9 2.1
      • Observed lymphomas 4 2
      • Lymphoma SIR 6.4 8.7
      Infliximab: Malignancies and Lymphomas *NCI (SEER), 2000, adjusted for age, sex distribution; SIR = standardized incidence ratio Briefing document, FDA Arthritis Advisory Committee meeting. March 4,2003.
    • 30.  
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    • 33.