Kalle J Aaltonen1, Suvi Ylikylä1, Jaana Tuulikki Joensuu1, Pia Isomäki2,3, Laura Pirilä4, Markku Kauppi3,5, Tuomas Rannio6,7, Kari Eklund8,9, Marja Blom1, Dan Nordström8,9. 1. Faculty of Pharmacy, University of Helsinki, Helsinki. 2. Department of Internal Medicine, Centre for Rheumatic Diseases, Tampere University Hospital. 3. School of Medicine, University of Tampere, Tampere. 4. Department of Rheumatology, Turku University Hospital, Turku. 5. Department of Rheumatology, Päijät-Häme Central Hospital, Lahti. 6. Department of Rheumatology, Jyväskylä Central Hospital, Jyväskylä. 7. Faculty of Health Sciences, University of Eastern Finland, Kuopio. 8. Department of Medicine, Helsinki University Central Hospital. 9. Faculty of Medicine, University of Helsinki, Helsinki, Finland.
Abstract
Objective: Efficacy of TNF inhibitors in the treatment of RA assessed in randomized controlled trials (RCTs) may not be fully comparable to routine care owing to the stringent inclusion criteria. The objective of this study was to observe the effectiveness of TNF inhibitors in real-world patients and assess the patients' potential eligibility for the RCTs. Methods: RA patients starting a TNF-inhibitor treatment between 2004 and 2014 were identified from the National Register for Biologic Treatment in Finland, which is a longitudinal observational cohort study. Effectiveness was measured using the ACR and EULAR response criteria and by studying the proportion of patients reaching DAS28 remission. The patients' baseline characteristics were compared against the inclusion criteria of 27 RCTs. Results: EULAR moderate and good treatment responses at 6 months were achieved by 69 and 40% of the users of the first TNF inhibitor, respectively. ACR20, ACR50 and ACR70 responses were reached by 48, 27 and 13%, respectively. DAS28 remission was reached by 47%. Only 7.6-44% of the patients would have been potentially eligible for the RCTs. The eligible patients had better treatment responses compared with the non-eligible patients. Different TNF inhibitors were mostly equipotent, but the usage of MTX co-therapy had a major influence on treatment response. Conclusion: Only a small proportion of patients would have been eligible for RCTs, and the efficacy of TNF inhibitors assessed in them cannot be generalized directly into Finnish routine health care.
Objective: Efficacy of TNF inhibitors in the treatment of RA assessed in randomized controlled trials (RCTs) may not be fully comparable to routine care owing to the stringent inclusion criteria. The objective of this study was to observe the effectiveness of TNF inhibitors in real-world patients and assess the patients' potential eligibility for the RCTs. Methods:RApatients starting a TNF-inhibitor treatment between 2004 and 2014 were identified from the National Register for Biologic Treatment in Finland, which is a longitudinal observational cohort study. Effectiveness was measured using the ACR and EULAR response criteria and by studying the proportion of patients reaching DAS28 remission. The patients' baseline characteristics were compared against the inclusion criteria of 27 RCTs. Results: EULAR moderate and good treatment responses at 6 months were achieved by 69 and 40% of the users of the first TNF inhibitor, respectively. ACR20, ACR50 and ACR70 responses were reached by 48, 27 and 13%, respectively. DAS28 remission was reached by 47%. Only 7.6-44% of the patients would have been potentially eligible for the RCTs. The eligible patients had better treatment responses compared with the non-eligible patients. Different TNF inhibitors were mostly equipotent, but the usage of MTX co-therapy had a major influence on treatment response. Conclusion: Only a small proportion of patients would have been eligible for RCTs, and the efficacy of TNF inhibitors assessed in them cannot be generalized directly into Finnish routine health care.
Authors: Katerina Chatzidionysiou; Merete Lund Hetland; Thomas Frisell; Daniela Di Giuseppe; Karin Hellgren; Bente Glintborg; Dan Nordström; Kalle Aaltonen; Minna Rk Törmänen; Eirik Klami Kristianslund; Tore K Kvien; Sella A Provan; Bjorn Björn Guðbjörnsson; Lene Dreyer; Lars Erik Kristensen; Tanja Schjødt Jørgensen; Lennart Jacobsson; Johan Askling Journal: RMD Open Date: 2018-04-12
Authors: Andrei A Deviatkin; Yulia A Vakulenko; Ludmila V Akhmadishina; Vadim V Tarasov; Marina I Beloukhova; Andrey A Zamyatnin; Alexander N Lukashev Journal: Biomedicines Date: 2020-01-09
Authors: Gyanendra Pokharel; Rob Deardon; Sindhu R Johnson; George Tomlinson; Pauline M Hull; Glen S Hazlewood Journal: Rheumatology (Oxford) Date: 2021-08-02 Impact factor: 7.580