Colagen

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Collagen in the treatment of rheumatic diseases

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Colagen

  1. 1. Collagen in the treatment of rheumatic diseases (Colafit  ) <ul><li>M. Stančíková, </li></ul><ul><li>National Institute of Rheumatic Diseases </li></ul><ul><li>Piešťany, Slovakia </li></ul>
  2. 2. Joint diseases <ul><li>Age is the strongest risk factor for all joint diseases, also for the most common joint disease - osteoarthritis (OA) . Over the age of 65 more then 50 % of people have rtg confirmed OA . </li></ul>
  3. 3. Osteoarthritis (OA) <ul><li>Is a disease of joints that affects all components of the joint: articular cartilage, menisci, subchondral bone, synovial membrane, joint capsule and muscle. </li></ul>
  4. 4. Healthy joint
  5. 5. OA changes in the joint
  6. 6. Osteoarthritis <ul><li>Osteoarthritis is not only a degenerativ e disease but the disease is often associated also with the inflammation , with activation of cytokines, and reactive ox y gen intermediates (superoxide, H 2 O 2 ,OH‘) , NO, de structive enzymes. </li></ul>
  7. 7. Collagens Collagens are the widespread structural components of extracellular matrices of connective tissues such as: tendons, ligaments, bones, skin and others. The common sign of collagens is the triple helix structure (  - helix) in molecule .
  8. 8. Occurrence of collagen type I  and II  in human body . Tendon  Bone  Skin  Dental mass  Ligaments  Blood vessel  Cartilage  (  only in OA ) Intervertebral discs   Vitreous humor of the eye  50% of collagen in body is present in bones
  9. 9. Collagens in the treatment of rheumatic diseases <ul><li>Native collagen type II (orally in RA, JIA , OA ) </li></ul><ul><li>Native collagen type I (orally in SSc, OA) </li></ul><ul><li>Polymeric collagen type I - collagen-polyvinylpyrolidone (subcutanly and i.m. in RA) </li></ul><ul><li>Denatured collagen - gelatine (OA) </li></ul>
  10. 10. The low doses of native collagen type II applied repeatedly to rats orally (3  g/rat) before immunization resulted in inhibit ion of collagen-induced arthritis and also adjuvant induced arthritis. Similar effects were observed by fragments of collagen II, synthetic peptides of collagen and collagen type I . Thompson,HSG,Staines,NA. Clin Exp Immunol, 1985;64:581-6 Experimental studies with collagens (animal models)
  11. 11. Clinical studies <ul><li>Clinical studies ( 8 ) with low doses of collagen (0.1 mg –10 mg) type II were performed in patients with RA. </li></ul><ul><li>Although the result s of these studies are not always statistically significant , the improve ment of disease symptoms were observed in m ost of the patients , especially in patients with JIA. </li></ul><ul><li>Trentham, DE.et al. Effects of oral administration of type II collagen on rheumatoid arthritis. Science. 1993 , 24;261(5129):1727-30. </li></ul>
  12. 12. Native collagen type II in the treatment of OA – clinical trial <ul><li>Chicken collagen, 10 mg daily in two dosages. </li></ul><ul><li>52 patients with OA of the knee. </li></ul><ul><li>26 patients treated with 10 mg of collagen type II and 26 patients treated with glucosamine HCL (1500 mg) + chondroitin sulfate (1200 mg). </li></ul><ul><li>Duration of treatment 90 days. </li></ul><ul><li>Crowley DC et al. Safety and efficacy of undenatured type II collagen in the treatment of osteoarthritis of the knee: clinical trial. Int J Med Sci, 2009, 6, 312-321. </li></ul>
  13. 13. Results of clinical trial with collagen <ul><li>Treatment with collagen reduced WOMAC score after 90 days treatment by 33 % in comparison with baseline values by 33% (p<0.005) and G+C by 14% (ns). </li></ul><ul><li>Collagen reduced VAS score by 40% ( p<0.05) and G+C by 15,4% (ns). </li></ul><ul><li>Collagen reduced Lequesne‘s functional index score by 20% (p<0.05) and G+C by 6% (ns). </li></ul>
  14. 14. Undenaturated type II collagen in the treatment of OA <ul><li>Collagen II treatment in OA of the knee was more efficaceous resulting in a significant reduction in all assesments (WOMAC index, VAS, Lequesne‘s functional index score) from baseline at 90 days. </li></ul>
  15. 15. <ul><li>COLAFIT ® </li></ul>DACOM Pharma, Kyjov, Czech Republic
  16. 16. C omposition of C olafit <ul><li>99 . 9% pure bovine crystalline atelocollagen (collagen type I) in native non-crosslinked fibrous structure. </li></ul><ul><li>less then 0 . 1 % uncollagen proteins. </li></ul><ul><li>O ne dose of Colafit contains 8 mg collagen type I. </li></ul>
  17. 17. Effect of Colafit on adjuvant arthritis in rats <ul><li>Before clinical study with Colafit (atelocollagen type I) was performed in NIRD, we had also tested it on adjuvant model of arthritis. </li></ul><ul><li>. The rats (Lewis) were administered during 2 weeks 3 x atelocollagen in dosage 5 µ g and 10 µ g, before immunization with mycobacterium in incomplete Freud‘s adjuvant. The results showed statistically significant decrease of hind paw swelling, arthritic score and serum nitrite/nitrate concentration in arthritic rats. </li></ul>
  18. 18. Open trial with Colafit in patients with osteoarthritis <ul><ul><li>Patients administered one cube of Colafit (8 mg) with cup of water after overnight fast. </li></ul></ul><ul><ul><li>Duration of treatment was 3 months </li></ul></ul><ul><ul><li>The symptoms of disease were assessed by Lequesne index. </li></ul></ul><ul><ul><li>The index was evaluated on the start of the study, after 3 months during the study and 3 months after the end of study (carry-over effect) . </li></ul></ul>
  19. 19. Open trial with Colafit 2 OA of knee III. 1 OA of knee II. 0 OA of knee I. 4 OA of hip III. 7 OA of hip II. 6 OA of hip I. 54.6 ( 39-72) Mean age 16 Number of w o men 4 Number of men 20 Number of pa t ients
  20. 20. p<0,0005 p<0,005
  21. 21. Questionnaire for Colafit Age............(years) I have joint difficulties since...... (year / month) With similar problems suffer (suffered) in family (e.g. parents, sister): ................................................................. ................................................................. I am visiting physician with my joint difficulties: Yes□ No□ Specialisation of my physician is:.................................................... Diagnosis made by physician:.......................................................... Fill your name and adress: Name and surname:....................................................... Adress:.................................................................. City and postal code:............................................................ The aim of this project is to increase the quality of life of patients suffering from osteoarthritis and other joint diseases. Thank you for your help and cooperation. 1- spine / back 2- upper extremities joints 3- hip joints 4- knee joints 5- ankles Left side Right side                  Duration of treatment: Dosage (tablets/day): Name of medication : The medication used because of pain during the last 2 months:                   Duration of treatment : Dosage (tablets/day) : Name of medication : The name of medications used because of joint difficulties during the last 2 months:
  22. 23. ( No . pac. 152)
  23. 24. ( No. of patients 167)
  24. 25. (No. of patients 177)
  25. 26. (No. of patients 197)
  26. 27. (No. of patients 121)
  27. 28. (No. of patients . 139)
  28. 29. Tenders Nails Hair Skin Joints Bones Colafit Tissues where Colafit can help:
  29. 31. Randomi z ed placebo controlled, double blinded multicentrical clinical study with c ollagen type I (Colafit) <ul><ul><li>The study was performed in National Institute of Rheumatic Diseases, Piešťany and i n Orthopedic Clinic, Banská Bystrica. </li></ul></ul><ul><ul><li>57 patients with OA of the knee. </li></ul></ul><ul><ul><li>Patients (29, 17 female, 12 male ) administered one cube of Colafit (8 mg) with cup of water after overnight fast. </li></ul></ul><ul><ul><li>Patients treated with placebo ( 28, 15 female, 12 male ) </li></ul></ul><ul><ul><li>Duration of treatment was 3 months , and one moth follow-up . </li></ul></ul><ul><ul><li>Evaluated parameters were WOMAC and VAS. </li></ul></ul>
  30. 34. Results <ul><li>Colafit - WOMAC –decrease after 3 months in comparison with basal values 38,1 % (p<001), after 4 months 37,4 % (p<0,001) </li></ul><ul><li>Placebo – WOMAC – decrease after 3 months in comparison with basal values 13,9 % (ns), after 4 month 10,2 % (ns) </li></ul><ul><li>Colafit – VAS – decrease after 3 months in comparison with basal values 41,3 % (p<0,001), after 4 months 42,6 % (p<0,001). </li></ul><ul><li>Placebo –VAS –decrease after 3 months in comparison with basal values 14,6 % (ns), after 4 months 11,8 % (ns). </li></ul>
  31. 35. Conclusion of clinical study <ul><li>Colafit in comparison with placebo significantly decreased WOMAC and VAS score. </li></ul><ul><li>Colafit produced substantial improvements in pain, stiffness and function in patients with osteoarthritis of knee. </li></ul><ul><li>No serious adverse events were noted. </li></ul><ul><li>Colafit was very well tolerated by patients </li></ul>
  32. 36. Collagen type I in patients with systemic sclerosis (SSC): <ul><li>McKown et al. (2000) </li></ul><ul><li>20 patients with SSc </li></ul><ul><li>Native bovine collagen type I </li></ul><ul><li>Dosage: 0.1mg (1m), 0.5mg (2-10 m) </li></ul><ul><li>Assessment: </li></ul><ul><li>- MRSS (modified Rodnan skin score), mHAQ </li></ul><ul><li>- IFN  , IL-10, sIL-2R </li></ul><ul><li>- lung functions (DLCo) </li></ul><ul><li>McKown, K.M., Carbone, L.D., Bustillo, J. et al:Induction od Immune Oral Tolerance to Human I Collagen in patients with Systemic Sclerosis by Oral Administration of Bovine Type I Collagen, Arthritis Rheumatism, 43, 5, 2000, pp 1054-1061 </li></ul>
  33. 37. Effects of collagen type I in patients with SSC <ul><li>The result of this study showed significant improvement of laboratory and clinical parameters in patients with SSc. </li></ul><ul><li>No adverse effect were observed. </li></ul><ul><li>McKown, K.M., Carbone, L.D., Bustillo, J. et al:Induction od Immune Oral Tolerance to Human I Collagen in patients with Systemic Sclerosis by Oral Administration of Bovine Type I Collagen, Arthritis Rheumatism, 43, 5, 2000, pp 1054-1061 </li></ul>
  34. 38. Colafit in the treatment of patients with SSc (NIRD, Piešťany, 2006) <ul><li>10 patients (limited or diffuse SSc) </li></ul><ul><li>Colafit, 8mg/day for 12 months </li></ul><ul><li>MRSS (0, 6., 12 months) </li></ul>
  35. 39. Modified Rodnan skin index
  36. 40. Colafit in OA <ul><li>The probable mechanism by which Colafit affects joint deseases is oral tolerance . </li></ul>
  37. 41. Thank you for your attention!

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