Patient Experiences With CT-P17 Suggest Strong Satisfaction and Ease of Injection – Center for Biosimilars

Report on Patient-Centered Outcomes of Biosimilar CT-P17 in Crohn Disease and Implications for Sustainable Development Goals

1.0 Introduction: Advancing SDG 3 through Patient-Centric Healthcare

In alignment with Sustainable Development Goal 3 (Good Health and Well-being), ensuring access to affordable, effective, and safe medicines is paramount. This report analyzes recent real-world data from Australia concerning the high-concentration, citrate-free adalimumab biosimilar, CT-P17 (Yuflyma). The study investigates patient-reported experiences with self-injection among individuals with Crohn disease, providing critical insights into factors that influence treatment adherence and overall well-being. By focusing on patient satisfaction and usability, this research directly supports SDG Target 3.4, which aims to reduce premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being.

2.0 Study Methodology

A cross-sectional analysis was conducted at two Australian hospitals to evaluate patient experiences with the CT-P17 autoinjector. The methodology included:

• Participants: 15 adults with Crohn disease (median age 39.9 years) with prior experience using biologic therapies and autoinjectors.
• Assessment Tool: The Self-Injection Assessment Questionnaire (SIAQ), a validated instrument, was used to measure patient experiences across several domains, including emotional response, confidence, physical discomfort, and satisfaction. Scores range from 0 (worst) to 10 (best).
• Disease Activity: The Harvey Bradshaw Index (HBI) was used to assess baseline disease activity.

3.0 Key Findings: Enhancing Quality of Life and Health Outcomes

The study’s findings indicate a highly positive patient experience with CT-P17, reinforcing its potential to contribute to the objectives of SDG 3.

1. Minimal Discomfort and High Tolerability: Participants reported minimal pain and skin reactions, with a mean SIAQ domain score of 9.2 (SD 0.9). This is attributed to the biosimilar’s citrate-free formulation, which directly improves the patient experience and supports long-term treatment adherence.
2. Ease of Use and Confidence: The autoinjector received strong ratings for ease of use (mean score 8.8) and instilled high self-confidence during administration (mean score 8.4). Such user-friendly medical technology empowers patients, promoting autonomy in managing their chronic condition.
3. High Overall Satisfaction: Overall satisfaction with the CT-P17 self-injection process was high (mean score 8.8), suggesting strong patient acceptance. This positive perception is crucial for maintaining persistence with long-term biologic therapy, a key factor in managing Crohn disease effectively.
4. Low Disease Activity: Participants exhibited low disease activity (mean HBI score 0.7), providing context on the clinical stability of the patient cohort during the assessment period.

4.0 Broader Implications for Sustainable Development Goals

The adoption of patient-centric biosimilars like CT-P17 has significant implications beyond individual health outcomes, contributing to several interconnected SDGs.

• SDG 3 (Good Health and Well-being): By improving the tolerability and usability of essential medicines, innovations like CT-P17 enhance treatment adherence, leading to better management of chronic diseases and improved quality of life. The cost-effectiveness of biosimilars also promotes progress towards universal health coverage (Target 3.8) by making advanced treatments more accessible.
• SDG 9 (Industry, Innovation, and Infrastructure): The development of a high-concentration, citrate-free formulation with an ergonomic autoinjector exemplifies sustainable industrial innovation. These advancements focus on human-centered design to solve practical healthcare challenges.
• SDG 10 (Reduced Inequalities): By providing more affordable alternatives to originator biologics, biosimilars can help reduce inequalities in access to essential healthcare, ensuring that more patients can benefit from advanced therapies regardless of their economic status.

5.0 Study Limitations

The report acknowledges the study’s limitations, which include:

• A small sample size (15 participants) from two specialized centers, which may limit the generalizability of the findings.
• A cross-sectional design that captures only a short-term snapshot of patient experience.
• Reliance on self-reported data, which carries a potential for recall bias.

6.0 Conclusion: A Step Towards Sustainable and Equitable Healthcare

The findings confirm that individuals with Crohn disease report high satisfaction and minimal discomfort with the CT-P17 biosimilar autoinjector. This evidence supports the role of patient-centered pharmaceutical design in achieving global health objectives. For health systems and managed care organizations, these insights underscore the value of adopting biosimilars that not only offer cost savings but also enhance the patient experience, thereby supporting treatment adherence and long-term well-being. Further large-scale, longitudinal research is necessary to validate these promising results and solidify the role of such innovations in building more resilient, equitable, and sustainable healthcare systems in line with the UN Sustainable Development Goals.

Analysis of Sustainable Development Goals (SDGs) in the Article

1. Which SDGs are addressed or connected to the issues highlighted in the article?

• SDG 3: Good Health and Well-being

  The entire article is centered on improving the health and quality of life for individuals with Crohn disease, a non-communicable disease. It discusses a new biosimilar treatment (CT-P17), patient satisfaction, ease of use, and adherence to long-term therapy, all of which are fundamental components of ensuring healthy lives and promoting well-being.

• SDG 9: Industry, Innovation, and Infrastructure

  The article highlights innovation within the pharmaceutical industry. The development of CT-P17 as a “citrate-free, high-concentration formulation” and the focus on “ergonomic design” of the autoinjector represent scientific research and technological advancement aimed at improving patient experience and treatment efficacy. The study itself is an example of scientific research to “address an evidence gap.”

• SDG 10: Reduced Inequalities

  The article implicitly addresses health inequality by focusing on biosimilars. It notes that these treatments have the potential for “reducing system-level costs.” By making effective biologic therapies more affordable, biosimilars can increase access for a wider population, thereby reducing inequalities in access to essential, high-quality healthcare.

2. What specific targets under those SDGs can be identified based on the article’s content?

• Under SDG 3: Good Health and Well-being

  • Target 3.4: Reduce by one-third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being.

    The article focuses on the effective management of Crohn disease, a non-communicable disease. The study’s emphasis on factors that improve treatment adherence—such as “ease of use,” “minimal pain,” and high “patient satisfaction”—directly contributes to better long-term treatment outcomes and promotes the well-being of patients. The use of the Self-Injection Assessment Questionnaire (SIAQ) measures emotional response and self-image, which are aspects of mental well-being.

  • Target 3.8: Achieve universal health coverage, including access to quality, effective, and affordable essential medicines.

    The article discusses adalimumab biosimilars, which are designed to be more affordable alternatives to reference biologic drugs. The text mentions that understanding patient-centered factors is “essential for payers and clinicians working to expand biosimilar adoption” and that the biosimilar has a “potential role in… reducing system-level costs.” This directly aligns with the goal of providing access to affordable and effective essential medicines as part of universal health coverage.

• Under SDG 9: Industry, Innovation, and Infrastructure

  • Target 9.5: Enhance scientific research, upgrade the technological capabilities of industrial sectors in all countries, including… encouraging innovation.

    The study described in the article is a form of scientific research (“cross-sectional analysis”) aimed at gathering “real-world data.” Furthermore, the development of the CT-P17 autoinjector with specific “device features such as ergonomic design, cap removal forces optimized for ease of handling, and clear injection feedback” is a clear example of technological innovation in the pharmaceutical industry designed to improve usability and patient outcomes.

3. Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

• For Target 3.4 (Promote well-being and treat NCDs):

  • Patient-Reported Outcome Measures (PROMs):

    The article explicitly mentions the use of the “Self-Injection Assessment Questionnaire (SIAQ),” a validated tool to measure patient experiences. The specific domain scores for “emotional response, confidence, physical discomfort, and satisfaction” serve as direct indicators of patient well-being. For example, the mean score for minimal pain and skin reactions was 9.2 out of 10.

  • Disease Activity Levels:

    The “Harvey Bradshaw Index (HBI)” is used to measure disease activity in patients with Crohn disease. The article reports low disease activity (average score of 0.7), which serves as an indicator of disease stability and effective management, contributing to the overall goal of treating non-communicable diseases.

• For Target 3.8 (Access to affordable medicines):

  • Rate of Biosimilar Adoption:

    The article implies this indicator by stating that its insights can “inform formulary decisions” and help “expand biosimilar adoption.” Tracking the rate at which healthcare systems and patients transition to more affordable biosimilars like CT-P17 would measure progress towards this target.

  • Reduction in Healthcare Costs:

    The article explicitly mentions the biosimilar’s potential in “reducing system-level costs.” Measuring the cost savings achieved by health systems through the adoption of biosimilars would be a direct indicator of progress towards making essential medicines more affordable.

• For Target 9.5 (Enhance scientific research and innovation):

  • Investment in Patient-Centered Research and Development:

    The existence of the study itself, which focuses on “patient-reported experiences” and “patient-centered considerations,” is an indicator of investment in this type of research. The article also highlights specific innovations like the “citrate-free, high-concentration formulation” and ergonomic autoinjector design, which are tangible outcomes of R&D efforts.

4. Summary Table of SDGs, Targets, and Indicators

Source: centerforbiosimilars.com