Risk-sharing agreement based on health outcomes for the treatment of moderate-severe psoriasis with certolizumab pegol

• Published in: Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria Vol. 48; no. 2; p. 51
• Main Authors: Navarro Ruiz, Andrés, Toledo Alberola, Fernando, Aceituno, Susana
• Format: Journal Article
• Language: English; Spanish
• Published: Spain 01.03.2024
• Subjects: Adult; Biological Products - therapeutic use; Certolizumab Pegol - therapeutic use; Female; Humans; Male; Psoriasis - chemically induced; Psoriasis - drug therapy; Quality of Life; Severity of Illness Index; Treatment Outcome; Health outcomes; Effectiveness; Psoriasis; Certolizumab pegol; Resultados en salud; Acuerdos de riesgo compartido; Efectividad; Risk-sharing agreement
• ISSN: 2171-8695
• DOI: 10.1016/j.farma.2023.07.016

To provide evidence of the effectiveness of certolizumab pegol (CZP) in real clinical practice in adult patients with moderate-to-severe plaque psoriasis (PsO) in the context of a risk-sharing agreement (RSA). Retrospective observational study based on variables collected in the RSA for treatment with CZP of adult patients with moderate-severe plaque PsO. Ten Spanish hospitals where the RSA was implemented participated. The percentage of patients who achieved the target clinical response of the RSA at the follow-up visit (week 16) was evaluated: absolute Psoriasis Area and Severity Index (PASI) value ≤3 for biologic naïve population, and ≤5 in case of previous failure to a single biologic drug. In addition, the improvement in the scores of other scales included in the study was analyzed: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician's Global Assessment (PGA), and Nail Psoriasis Severity Index (NAPSI). A descriptive analysis was performed for the total population and by patient subgroups (naive vs. non-naive to biologic, male vs. female, and with vs. without discontinuation). Sixty-six patients were included, 12 men and 54 women. 90.9% achieved the target clinical response, with a mean reduction of 8 (-78.4%) absolute PASI points. Improvement was observed in BSA, PGA, NAPSI and DLQI, with a reduction of 11.3 (-80.6%), 1.9 (-65.5%), 3.3 (-30.7%) and 9.0 (-66.4%) absolute value points, respectively. Despite not achieving the therapeutic target set in the RSA in six patients (9%) (the cost of the drug was assumed by the laboratory), only two (3%) discontinued treatment. Our study shows that CZP is effective in real clinical practice in patients with moderate-severe plaque PsO, with an improvement in absolute PASI and DLQI, as well as other scales, both for the total population and in the subgroups analyzed. Nearly 91% of patients reached the therapeutic target fixed in the RSA. Implementing this type of agreement can provide a direct or indirect benefit for all the agents involved in the process, providing valuable information for decision-making.