Early Health Outcomes Model on the Impact of Trimodulin in the Management of Patients With Severe Community-Acquired Pneumonia on Invasive Mechanical Ventilation Based on the CIGMA Phase 2 Randomized Placebo-Controlled Trial
Author(s)
Mark Lamotte, MD1, David Gomez-Ulloa, PharmD, MSc2, Thomas Häder, PhD3, Ümniye Balaban, PhD3, Mafalda Ramos, MSc1;
1Th(is)²Modeling bv, Asse, Belgium, 2Grifols, Global HEOR & RWE, Sant Cugat del Vallès, Spain, 3Biotest AG, Dreieich, Germany
1Th(is)²Modeling bv, Asse, Belgium, 2Grifols, Global HEOR & RWE, Sant Cugat del Vallès, Spain, 3Biotest AG, Dreieich, Germany
Presentation Documents
OBJECTIVES: Patients with severe community-acquired pneumonia (sCAP) often require intensive care unit (ICU) management and invasive mechanical ventilation (IMV), and have a high mortality risk. The CIGMA trial indicated a potential mortality benefit when trimodulin was added to Standard of Care (SoC) in patients with sCAP on IMV. Post-hoc analysis revealed a significant benefit in patients with C-reactive protein (CRP) levels ≥70mg/L. We developed a disease model for patients with sCAP on IMV to evaluate health outcomes of adjunctive trimodulin to SoC vs. SoC alone.
METHODS: A de novo model with short- and long-term components was developed using MS Excel. The short-term component, with a 28-day horizon, compared mortality, length of stay (LOS) in ICU and overall between treatment arms. Data from CIGMA populated the model, focusing on the overall population and a subpopulation with CRP ≥70mg/L. The starting age was 65 years. Survivors after 28 days entered a long-term analysis (20-year horizon) with two Markov health states (alive and dead) using annual cycles. US-specific long-term mortality and utilities were sourced from literature. Long-term outcomes included life expectancy (LE) and quality-adjusted life years (QALY).
RESULTS: In the overall population, trimodulin reduced mortality (-5.6%) and ICU LOS (-1.00 day), while total LOS increased (+0.50 days). Long-term, an increase in average LE (+0.80 years) and a QALY improvement (+0.65 years) were observed. In patients with CRP ≥70mg/L, trimodulin reduced mortality (-16.7%), ICU LOS (-0.47 days), and total LOS (-0.14 days). Long-term, this subgroup saw an average LE increase of 2.39 years and QALY gains of 1.93 years.
CONCLUSIONS: Adding trimodulin to SoC reduces ICU LOS and mortality, leading to improved LE and QALYs in patients with sCAP on IMV compared to SoC alone. The effects are more pronounced in patients with inflammatory disease stage, indicated by CRP levels ≥70mg/L.
METHODS: A de novo model with short- and long-term components was developed using MS Excel. The short-term component, with a 28-day horizon, compared mortality, length of stay (LOS) in ICU and overall between treatment arms. Data from CIGMA populated the model, focusing on the overall population and a subpopulation with CRP ≥70mg/L. The starting age was 65 years. Survivors after 28 days entered a long-term analysis (20-year horizon) with two Markov health states (alive and dead) using annual cycles. US-specific long-term mortality and utilities were sourced from literature. Long-term outcomes included life expectancy (LE) and quality-adjusted life years (QALY).
RESULTS: In the overall population, trimodulin reduced mortality (-5.6%) and ICU LOS (-1.00 day), while total LOS increased (+0.50 days). Long-term, an increase in average LE (+0.80 years) and a QALY improvement (+0.65 years) were observed. In patients with CRP ≥70mg/L, trimodulin reduced mortality (-16.7%), ICU LOS (-0.47 days), and total LOS (-0.14 days). Long-term, this subgroup saw an average LE increase of 2.39 years and QALY gains of 1.93 years.
CONCLUSIONS: Adding trimodulin to SoC reduces ICU LOS and mortality, leading to improved LE and QALYs in patients with sCAP on IMV compared to SoC alone. The effects are more pronounced in patients with inflammatory disease stage, indicated by CRP levels ≥70mg/L.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO135
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
SDC: Infectious Disease (non-vaccine), SDC: Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory), STA: Biologics & Biosimilars