Arthrosamid

 

ARTHROSAMID® CLINICAL RESULTS

The clinical application of Arthrosamid® (iPAAG) is safe and effective.1

Stable and statistically significant change on all WOMAC subscales and WOMAC total over the 56 week observation period.2

79% response rate with the under 70-year-olds.3

Undergone over 20 years of research and development.3

Significant difference in change from baseline between Arthrosamid® and Synvisc-One® at 52 weeks.4

Statistically significant reduction in pain maintained at 3 years.5

 

Statistically significant reduction in pain maintained at 3 years.1

OBJECTIVE

The primary objective of this study was to evaluate the efficacy and safety of a single injection of 6ml intra-articular Arthrosamid® on knee symptoms in participants with moderate to severe knee OA.

METHOD

  • Prospective, multicentre study (3 sites in Denmark) where 49 patients received a single intra-articular injection of 6ml Arthrosamid®.
  • Outcomes included the transformed WOMAC pain, stiffness and function subscales and PGA** of disease impact.
  • Changes from baseline to 52 weeks, 104 weeks and 156 weeks were analysed using the mixed model for repeated measurement (MMRM).

CONCLUSION

Single injections of 6 ml intra-articular Arthrosamid® are well tolerated and continue to demonstrate clinically relevant and statistically significant effectiveness 3 years after treatment.

iPAAG: injectable polyacrylamide hydrogel

Statistically significant reduction in pain maintained at 2 years.2

OBJECTIVE

The primary objective of this study was to evaluate the efficacy and safety of a single injection of iPAAG on knee symptoms in participants with moderate to severe knee OA.

METHOD

  • Prospective, multicentre study (3 sites in Denmark) where 49 patients received a single intra-articular injection of 6ml Arthrosamid®.
  • Outcomes included the transformed pain, stiffness and function subscales and PGA** of disease impact.
  • Changes from baseline to 52 weeks and 104 weeks were analysed using the mixed model for repeated measurement (MMRM).

CONCLUSION

Single injections of 6ml intra-articular Arthrosamid® continue to be well tolerated and demonstrate clinically relevant and statistically significant effectiveness, as measured by the WOMAC† pain, stiffness and physical function subscales and PGA** at 2 years after treatment.” iPAAG: injectable polyacrylamide hydrogel.

iPAAG: injectable polyacrylamide hydrogel

After 13 weeks, 64.6% of patients were OMERACT-OARSI responders, which
was also maintained to 52 weeks.2

OBJECTIVE

The primary objective of this study was to evaluate the efficacy and safety of a single injection of iPAAG on knee symptoms in participants with moderate to severe knee OA.

METHOD

  • Open-label study in patients with symptomatic and radiographically confirmed knee OA.
  • Primary outcome was change in WOMAC† pain at 13 weeks.
  • Secondary outcomes were WOMAC subscales, PGA** and proportion of OMERACT-OARSI*** responders, follow up points were 4, 13, 26 and 52 weeks.

CONCLUSION

iPAAG can be delivered in a single injection and this non-randomised trial suggests that the good clinical effects at 13 weeks were maintained at 52 weeks in patients with moderate to severe knee OA. These encouraging results need to be confirmed in controlled studies.

iPAAG: injectable polyacrylamide hydrogel

Clinical application of iPAAG is safe and effective and can be conducted in a single injection.1

OBJECTIVE

This study evaluated the efficacy and safety of a single injection of 6ml of intra-articular iPAAG over 26 weeks.

METHOD

  • Open-label study in patients with symptomatic and radiographically confirmed knee OA. Primary outcome was change in WOMAC† pain at 13 weeks.
  • Secondary outcomes were WOMAC subscales, PGA** and proportion of OMERACT-OARSI*** responders, follow up pointswere 4, 13 and 26 weeks.

CONCLUSION

The study showed significant improvement in the WOMAC pain subscale at 4 and 13 weeks, which was sustained at 26 weeks. 2/3 of patients were OMERACT-OARSI responders. Clinical application of iPAAG is safe and effective and can be conducted in a single injection.

iPAAG: injectable polyacrylamide hydrogel

 

 

REFERENCES

References

1.Bliddal, H., et al. (2021). Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: A 6 Months Prospective Study. J Orthop Res Ther. 6(2). 1188. ISSN 2575-8241.

2.Henriksen, M., et al. (2018). Intra-articular 2.5% polyacrylamide hydrogel for the treatment of knee osteoarthritis: an observational proof-of-concept cohort study. Clin Exp Rheumatol. Nov-Dec;36(6):1082-1085. Epub 2018 Jul 18. PMID:

3. Data on file.

4. Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid in age, BMI, and Kellgren-Lawrence subgroups: A subgroup analysis of a randomised study. Osteoarthritis and Cartilage Vol.30, Supplement 1, S373-S374.

5. Henriksen, M. et al. (2023). 3-year results from a prospective study of polyacrylamide hydrogel for knee osteoarthritis. Osteoarthritis and Cartilage, Vol 31(5): P682–683. DOI:10.1016/j.joca.2023.02.023

Intra-articular 2.5% polyacrylamide hydrogel (iPAAG) for the treatment of knee OA

An observational proof-of-concept cohort 13 month study (DAISY Efficacy)1,2

1. Data on file.
2. Henriksen, M., et al. (2018). Intra-articular 2.5% polyacrylamide hydrogel for the treatment of knee osteoarthritis: an observational proof-of-concept cohort study. Clin Exp Rheumatol. Nov-Dec;36(6):1082-1085. Epub 2018 Jul 18. PMID: 30148430.

iPAAG: injectable polyacrylamide hydrogel

Polyacrylamide hydrogel (iPAAG) injection for knee osteoarthritis

A 26 week registration study (IDA 6 months)1

1. Bliddal, H., et al. (2021). Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: A 6 Months Prospective Study. J Orthop Res Ther. 6(2). 1188. ISSN 2575-8241.

A 52 week prospective study (IDA 1 year)1,2

1. Data on file.

2. Bliddal, H., et al. (2021). Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: Results of a 52 Week Prospective Study. Osteoarthritis and Cartilage Vol.29S278.

iPAAG: injectable polyacrylamide hydrogel

Results from 104 weeks after treatment (IDA 2 years)1,2

1. Data on file.

2. Bliddal, H., et al. (2022). A Prospective Study of Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: Results From 2 Years After Treatment. Osteoarthritis and Cartilage Vol.30, Supplement 1, S371-S372. DOI:10.1016/j.j.oca.2022.02.499.

Results from 156 weeks after treatment (IDA 3 years)1

1. Henriksen, M. et al. (2023). 3-year results from a prospective study of polyacrylamide hydrogel for knee osteoarthritis. Osteoarthritis and Cartilage, Vol 31(5): P682–683. DOI:10.1016/j.joca.2023.02.023

One-year performance of polyacrylamide hydrogel (iPAAG) vs. hyaluronic acid

A randomised controlled study (ROSA)1,2

1. Data on file

2. Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid: A randomised controlled study. Osteoarthritis and Cartilage. Vol 30(1): S370-71. DOI:10.1016/j.joca.2022.02.497.

Analysis of change from baseline of subgroup <70 years (ROSA)1,2

1. Data on file.

2. Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid in age, BMI, and Kellgren-Lawrence subgroups: A subgroup analysis of a randomised study. Osteoarthritis and Cartilage Vol.30, Supplement 1, S373-S374. DOI:10.1016/j.joca.2022.02.502.

iPAAG: injectable polyacrylamide hydrogel

Response rate with Arthrosamid®1,2,3

A randomised study of one-year performance of polyacrylamide hydrogel (iPAAG) vs. hyaluronic acid.2

1. Data on file.

2. Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid: A randomised controlled study. Osteoarthritis and Cartilage. Vol 30(1): S370-71. DOI:10.1016/j.joca.2022.02.497.

3. Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid in age, BMI, and Kellgren-Lawrence subgroups: A subgroup analysis of a randomised study. Osteoarthritis and Cartilage Vol.30, Supplement 1, S373-S374. DOI:10.1016/j.joca.2022.02.502.

iPAAG: injectable polyacrylamide hydrogel

A randomised study of one-year performance of polyacrylamide hydrogel vs. hyaluronic acid.1

Scatterplot of age versus change from baseline to week 52 in transformed WOMAC pain subscale for Arthrosamid®.2

1. Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid: A randomised controlled study. Osteoarthritis and Cartilage. Vol 30(1): S370-71. DOI:10.1016/j.joca.2022.02.497.

2. Date on file.

3. Henriksen, M., et al. (2018). Intra-articular 2.5% polyacrylamide hydrogel for the treatment of knee osteoarthritis: an observational proof-of-concept cohort study. Clin Exp Rheumatol.Nov-Dec;36(6):1082-1085. Epub 2018 Jul 18. PMID: 30148430.

iPAAG: injectable polyacrylamide hydrogel

The clinical application of Arthrosamid® (iPAAG) is safe and effective.1

Safety of intra-articular polyacrylamide hydrogel (iPAAG) for the treatment of knee osteoarthritis symptoms

1.Bliddal, H., et al. (2021). Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: A 6 Months Prospective Study. J Orthop Res Ther. 6(2). 1188. ISSN 2575-8241.

2. Data on file.

3. Overgaard, A., et al. (2019). Safety of intra-articular polyacrylamide hydrogel for the treatment of knee osteoarthritis symptoms: A retrospective case series. Clin Ortho Adv Res. Osteoarthritis and Cartilage Vol.30, Supplement 1, S370-S371.DOI:10.1016/j.joca.2022.02.497.

4. Bliddal, H., et al. (2021). Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: Results of a 52 Week Prospective Study. Osteoarthritis and Cartilage Vol.29 S278.

5. Bliddal, H., et al. (2022). A Prospective Study of Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: Results From 2 Years After Treatment. Osteoarthritis and Cartilage Vol.30, Supplement 1, S371-S372.DOI:10.1016/j.joca.2022.02.499.

6. Bliddal, H., et al. (2022). One-year performance of polyacrylamide hydrogel vs. hyaluronic acid: A randomised controlled study. Osteoarthritis and Cartilage. Vol 30(1): S370-71. DOI:10.1016/j.joca.2022.02.497.

iPAAG: injectable polyacrylamide hydrogel