Francesco Carubbi1,2, Rosaria Fidanza2,3, Maria Palmieri4, Alessandra Ventura4, Sara Tambone4, Paola Cipriani1, Roberto Giacomelli1, Maria Concetta Fargnoli4. 1. a Rheumatology Unit, Department of Biotechnological and Applied Clinical Science, School of Medicine , University of L'Aquila , L'Aquila , Italy. 2. b Department of Medicine , ASL1 Avezzano-Sulmona-L'Aquila , L'Aquila , Italy. 3. c San Salvatore Hospital , UOSD Dermatologia , L'Aquila , Italy. 4. d Dermatology Department, Department of Biotechnological and Applied Clinical Science, School of Medicine , University of L'Aquila , L'Aquila , Italy.
Abstract
BACKGROUND: The aim of this observational study was to assess safety and efficacy of certolizumab pegol (CZP) in a real-life cohort of patients affected by psoriasis (PsO) and psoriatic arthritis (PsA), who had an inadequate response to previous systemic immunosuppressive treatments, with a follow-up of 24 weeks. MATERIALS AND METHODS: Twelve patients with PsO and PsA, referring to our Dermatology/Rheumatology combined outpatient clinic, were enrolled. Primary endpoints were safety and efficacy of CZP, defined as statistically significant improvement of DAPSA, clinical DAPSA and PASI. Secondary endpoints validated clinical and laboratory measures and patient-reported outcomes. RESULTS: CZP injections were well-tolerated. We observed a rapid and significant improvement in all primary endpoints, in the 24-week treatment period of the study. We described positive effects of CZP in several domains, including joint and skin involvement, pain, patient and physician global assessment, physical function, and health-related quality of life. CZP was effective and safe in patients who were either naïve or previously unresponsive to other anti-TNFα. No difference was found in terms of efficacy and safety between patients treated with CZP monotherapy and patients in combination therapy with methotrexate. CONCLUSIONS: CZP was safe and effective in a real-life cohort of patients affected by PsO and PsA, who have had an inadequate response to previous systemic treatments.
BACKGROUND: The aim of this observational study was to assess safety and efficacy of certolizumab pegol (CZP) in a real-life cohort of patients affected by psoriasis (PsO) and psoriatic arthritis (PsA), who had an inadequate response to previous systemic immunosuppressive treatments, with a follow-up of 24 weeks. MATERIALS AND METHODS: Twelve patients with PsO and PsA, referring to our Dermatology/Rheumatology combined outpatient clinic, were enrolled. Primary endpoints were safety and efficacy of CZP, defined as statistically significant improvement of DAPSA, clinical DAPSA and PASI. Secondary endpoints validated clinical and laboratory measures and patient-reported outcomes. RESULTS:CZP injections were well-tolerated. We observed a rapid and significant improvement in all primary endpoints, in the 24-week treatment period of the study. We described positive effects of CZP in several domains, including joint and skin involvement, pain, patient and physician global assessment, physical function, and health-related quality of life. CZP was effective and safe in patients who were either naïve or previously unresponsive to other anti-TNFα. No difference was found in terms of efficacy and safety between patients treated with CZP monotherapy and patients in combination therapy with methotrexate. CONCLUSIONS:CZP was safe and effective in a real-life cohort of patients affected by PsO and PsA, who have had an inadequate response to previous systemic treatments.