BACKGROUND: A problem encountered when analyzing long-term efficacy is that the number of patients in follow-up decreases with time for different reasons. The method used to account for missing observations for the therapy under analysis has a great influence on the inference of efficacy. OBJECTIVE: To describe the long-term efficacy of etanercept for psoriasis in daily practice using 3 analytical approaches. METHODS: Prospective data from a cohort of patients with psoriasis treated with etanercept for at least 24 weeks were analyzed using 3 analytical approaches: as treated analysis, intention-to-treat analysis (ITT) with last observation carried forward (LOCF) and intention-to-treat analysis with modified nonresponder imputation (modified NRI). RESULTS: One hundred thirty-one patients were treated with etanercept during 134 treatment episodes with a mean treatment duration of 2.7 years. The maximum follow-up was 6.0 years. The methodological approach chosen had a great influence. Psoriasis Area and Severity Index (PASI) 75 response rates varied from 60% in the as-treated approach to 34% in LOCF and to 29% in modified NRI at week 264. LIMITATIONS: All analytical methods applied have limitations. Other outcome measures could be used to overcome the bias introduced by each method of analysis, such as drug survival. CONCLUSIONS: The methodological approach chosen to analyze long-term efficacy data has a great influence on the inferences that may be drawn regarding the degree of efficacy. Therefore we support the use of different methods to present long-term efficacy data.
BACKGROUND: A problem encountered when analyzing long-term efficacy is that the number of patients in follow-up decreases with time for different reasons. The method used to account for missing observations for the therapy under analysis has a great influence on the inference of efficacy. OBJECTIVE: To describe the long-term efficacy of etanercept for psoriasis in daily practice using 3 analytical approaches. METHODS: Prospective data from a cohort of patients with psoriasis treated with etanercept for at least 24 weeks were analyzed using 3 analytical approaches: as treated analysis, intention-to-treat analysis (ITT) with last observation carried forward (LOCF) and intention-to-treat analysis with modified nonresponder imputation (modified NRI). RESULTS: One hundred thirty-one patients were treated with etanercept during 134 treatment episodes with a mean treatment duration of 2.7 years. The maximum follow-up was 6.0 years. The methodological approach chosen had a great influence. Psoriasis Area and Severity Index (PASI) 75 response rates varied from 60% in the as-treated approach to 34% in LOCF and to 29% in modified NRI at week 264. LIMITATIONS: All analytical methods applied have limitations. Other outcome measures could be used to overcome the bias introduced by each method of analysis, such as drug survival. CONCLUSIONS: The methodological approach chosen to analyze long-term efficacy data has a great influence on the inferences that may be drawn regarding the degree of efficacy. Therefore we support the use of different methods to present long-term efficacy data.
Authors: R Prieto-Pérez; G Solano-López; T Cabaleiro; M Román; D Ochoa; M Talegón; O Baniandrés; J L López-Estebaranz; P de la Cueva; E Daudén; F Abad-Santos Journal: Pharmacogenomics J Date: 2016-09-27 Impact factor: 3.550
Authors: Marloes E Van Muijen; Sarah E Thomas; Hans M M Groenewoud; Marisol E Otero; Paul M Ossenkoppele; Marcellus D Njoo; Sharon R P Dodemont; Else N Kop; Maartje A M Berends; Marjolein I A Koetsier; Johannes M Mommers; John E M Körver; Ron A Tupker; Marjolein S De Bruin-Weller; Lizelotte J M T Weppner-Parren; Bas Peters; Marloes M Kleinpenning; Astrid L A Kuijpers; W Peter Arnold; Paula P M Van Lümig; Juul M P A Van den Reek; Elke M G J De Jong Journal: Acta Derm Venereol Date: 2022-05-16 Impact factor: 3.875
Authors: Selma Atalay; Lara S van der Schoot; Laura Vandermaesen; Lieke J van Vugt; Mascha Eilander; Juul M P A van den Reek; Elke M G J de Jong Journal: Acta Derm Venereol Date: 2021-05-25 Impact factor: 3.875
Authors: E L M Ter Haar; S E Thomas; J M P A van den Reek; M E Otero; M D Njoo; P M Ossenkoppele; E N Kop; S R P Dodemont; J E M Körver; A L A Kuijpers; R J Lindhout; R A Tupker; J M Mommers; M A M Berends; M I A Koetsier; M S de Bruin-Weller; M B Visch; W P Arnold; P P M van Lümig; M M Kleinpenning; S F K Lubeek; E M G J de Jong Journal: Drugs Aging Date: 2022-07-21 Impact factor: 4.271
Authors: Edward Keystone; Robert Landewé; Ronald van Vollenhoven; Bernard Combe; Vibeke Strand; Philip Mease; Laura Shaughnessy; Brenda VanLunen; Désirée van der Heijde Journal: Ann Rheum Dis Date: 2013-08-05 Impact factor: 19.103