H B Hammer1,2, Imj Hansen3, P Järvinen4, M Leirisalo-Repo5, M Ziegelasch6, B Agular7, L Terslev8. 1. Departmemt of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. 2. Medical Faculty, University of Oslo, Oslo, Norway. 3. Department of Rheumatology, Svendborg Hospital, Svendborg, Denmark. 4. Department of Rheumatology, Kiljava Medical Research, Hyvinkää, Finland. 5. Department of Rheumatology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. 6. Department of Rheumatology, Linköping University Hospital, Linköping, Sweden. 7. Roche A/S, Hvidovre, Denmark. 8. Department of Rheumatology, Rigshospitalet Glostrup, Copenhagen, Denmark.
Abstract
Objective: Few studies have investigated the efficacy of subcutaneous tocilizumab (TCZ-SC) on ultrasound-detected inflammation. This study aimed to explore the clinical efficacy of TCZ-SC treatment in rheumatoid arthritis (RA) patients and to evaluate the response by ultrasound compared to Composite Disease Activity Scores (CDAS).Method: This open-label, single-arm study enrolled RA patients with inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs initiating TCZ-SC 162 mg once weekly for 24 weeks, with clinical assessments at baseline, 2, 4, 8, 12, 16, 20, and 24 weeks. Ultrasound examinations [semi-quantitative score (0-3) of 36 joints and four tendons] were performed at baseline, 4, 12, and 24 weeks. CDAS and American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) response, and sum scores of ultrasound grey scale/Doppler were calculated. Changes during follow-up were explored by the Mann-Whitney test and correlations by Spearman's rho. Results: In total, 133 patients (mean ± sd age 55.9 ± 12.0 years) were assessed clinically and 110 patients were also examined with ultrasound. All clinical and ultrasound scores decreased significantly after 4 weeks (p < 0.001). At 24 weeks there was EULAR good response in 87.7% and ACR 70% response in 47.4%. Ultrasound scores had no or low correlations with patient-reported outcomes. At 24 weeks, CDAS remission was achieved in 27.4-83.5% and a sum score Doppler of 0 was found in 53.3%.Conclusions: Clinical and ultrasound scores decreased rapidly. Ultrasound scores were not associated with patient-reported variables. Half of the patients reached ultrasound remission, while there were large discrepancies in the percentage of patients reaching remission based on different CDAS.Trial registration: Study ML28691, registered 28 January 2014, ClinicalTrials.gov identifier: NCT02046616.
Objective: Few studies have investigated the efficacy of subcutaneous tocilizumab (TCZ-SC) on ultrasound-detected inflammation. This study aimed to explore the clinical efficacy of TCZ-SC treatment in rheumatoid arthritis (RA) patients and to evaluate the response by ultrasound compared to Composite Disease Activity Scores (CDAS).Method: This open-label, single-arm study enrolled RApatients with inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs initiating TCZ-SC 162 mg once weekly for 24 weeks, with clinical assessments at baseline, 2, 4, 8, 12, 16, 20, and 24 weeks. Ultrasound examinations [semi-quantitative score (0-3) of 36 joints and four tendons] were performed at baseline, 4, 12, and 24 weeks. CDAS and American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) response, and sum scores of ultrasound grey scale/Doppler were calculated. Changes during follow-up were explored by the Mann-Whitney test and correlations by Spearman's rho. Results: In total, 133 patients (mean ± sd age 55.9 ± 12.0 years) were assessed clinically and 110 patients were also examined with ultrasound. All clinical and ultrasound scores decreased significantly after 4 weeks (p < 0.001). At 24 weeks there was EULAR good response in 87.7% and ACR 70% response in 47.4%. Ultrasound scores had no or low correlations with patient-reported outcomes. At 24 weeks, CDAS remission was achieved in 27.4-83.5% and a sum score Doppler of 0 was found in 53.3%.Conclusions: Clinical and ultrasound scores decreased rapidly. Ultrasound scores were not associated with patient-reported variables. Half of the patients reached ultrasound remission, while there were large discrepancies in the percentage of patients reaching remission based on different CDAS.Trial registration: Study ML28691, registered 28 January 2014, ClinicalTrials.gov identifier: NCT02046616.
Authors: Nils Bolstad; Hilde Berner Hammer; Johanna Elin Gehin; Silje Watterdal Syversen; David John Warren; Guro Løvik Goll; Joseph Sexton Journal: RMD Open Date: 2021-12