Apligraf® real-world evidence.

Observational comparative effectiveness studies proved that Apligraf closes more VLUs and DFUs faster.1-3

*Effectiveness is the extent to which an intervention produces an overall health benefit in routine clinical practice (real-world situations). Effectiveness studies do not establish efficacy or comparative superiority. Based on data obtained from a large wound-care–specific Electronic Medical Record (EMR) database (WoundExpert®, Net Health, Pittsburgh, PA). For the Apligraf vs Oasis analyses, data are from July 2009 through July 2012. For the Apligraf vs TheraSkin analyses, data are from January 1, 2014, through March 31, 2015. For the Apligraf vs PriMatrix analyses, data are from January 2015 through January 2017. De-identified patient data released to Organogenesis were consistent with the terms and conditions of Net Health’s participating client contracts and the requirements of HIPAA. Net Health was not involved in any way in the analyses, interpretation, or reporting of the data.
  • 50% of VLU wounds closed by week 24 for Apligraf vs 41% for Oasis (P=0.01)1
  • Median time to wound closure was 24 weeks for Apligraf vs 43 weeks for Oasis (P=0.01)1
  • Apligraf closed VLUs 44% faster1
Observational comparative effectiveness study showing that by week 24, Apligraf closed 50% of VLU wounds vs 41% for Oasis

For the Apligraf vs Oasis analyses, incidence of and median time to wound closure were determined by Kaplan-Meier analysis with two-tailed log-rank test. The hazard ratio along with its 95% confidence interval (CI) and P value is based on a Cox proportional hazards regression model with one term for treatment group. Wound closure defined as an ulcer achieving an area between 0 and 0.25 cm2.

  • 65% of VLU wounds closed by week 24 for Apligraf vs 41% for TheraSkin (P=0.0002)2
  • Median time to wound closure was 15 weeks for Apligraf vs 31 weeks for TheraSkin (P=0.0002)2
  • Apligraf closed VLUs 52% faster2
Observational comparative effectiveness study showing that by week 24, Apligraf closed 65% of VLU wounds vs 41% for TheraSkin

For the Apligraf vs TheraSkin analyses, the estimated incidence of wound closure and the estimated median time to wound closure are from a Cox regression model with terms for treatment, baseline wound area, baseline wound duration, baseline wound depth, and patient age at first visit. Wound closure defined as an ulcer achieving an area between 0 and 0.25 cm2.

  • 55% of VLU wounds closed by week 24 for Apligraf vs 43% for PriMatrix (P=0.01)3
  • Median time to wound closure was 19 weeks for Apligraf vs 30 weeks for PriMatrix (P=0.01)3
  • Apligraf closed VLUs 37% faster3
Observational comparative effectiveness study showing that by week 24, Apligraf closed 55% of VLU wounds vs 43% for PriMatrix

For the Apligraf vs PriMatrix analyses, the estimated incidence of wound closure and estimated median time to wound closure are from a Cox regression model with terms for treatment, baseline wound area, baseline wound duration, baseline wound depth, patient age at first treatment, sex, and body mass index. Wound closure defined as an ulcer achieving an area between 0 and 0.25 cm2.

  • Incidence of DFU closure at week 12 was 48% vs 28% for EpiFix (P=0.01)4
  • Median time to wound closure was 13 weeks for Apligraf vs 26 weeks for EpiFix (P=0.01)4
  • Apligraf closed DFUs 49% faster4
Observational comparative effectiveness study showing that by week 12, Apligraf closed 48% of DFU wounds vs 28% for EpiFix

Estimated incidence of and median time to wound closure and P value are from a Cox regression model with terms for treatment, baseline wound area, duration, depth, and location. P=0.01. Wound closure defined as an ulcer achieving an area between 0 and 0.25 cm2. Although more patients received Apligraf treatment vs EpiFix in the database, there were no preferential exclusion/inclusion criteria applied. Additionally, the statistical methods employed ensure no bias for number of patients in either treatment group. The primary analyses were frequency of wound closure by week 12 and week 24, and median time to wound closure. As patients with healed wounds do not always follow up, wound closure was defined as an ulcer achieving area ≤0.25 cm2.

*Effectiveness is the extent to which an intervention produces an overall health benefit in routine clinical practice (real-world situations). Effectiveness studies do not establish efficacy or comparative superiority. Based on data obtained from a large wound-care–specific Electronic Medical Record (EMR) database (WoundExpert®, Net Health, Pittsburgh, PA). Data are from January 1, 2014, through December 31, 2014.

Apligraf has been proven to reduce VLU and DFU burden on patients as well as healthcare costs

Explore the economic burden of VLUs and DFUs, or contact an Organogenesis Tissue Regeneration Specialist to see how Apligraf can be cost-effective.

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REFERENCES:

  1. Marston WA, et al. Wound Repair Regen. 2014;22(3):334-340.
  2. Treadwell T, et al. Adv Wound Care. 2018;7(3):69-76.
  3. Sabolinski ML, et al. J Comp Eff Res. 2018;7(8):797-805.
  4. Kirsner RS, et al. Wound Repair Regen. 2015;23(5):737-744.