Tocilizumab as a first-line biologic treatment in rheumatoid arthritis patients - the impact of concomitant methotrexate treatment and Rheumatic Disease Comorbidity Index on the clinical response - results from the multicenter observational ACT-POL study

Marcin Stajszczyk; Sławomir Jeka; Anna Juś; Katarzyna Pawlak-Buś

doi:10.5114/reum.2022.115986

Tocilizumab as a first-line biologic treatment in rheumatoid arthritis patients - the impact of concomitant methotrexate treatment and Rheumatic Disease Comorbidity Index on the clinical response - results from the multicenter observational ACT-POL study

Reumatologia. 2022;60(2):92-100. doi: 10.5114/reum.2022.115986. Epub 2022 May 18.

Authors

Marcin Stajszczyk¹, Sławomir Jeka², Anna Juś³, Katarzyna Pawlak-Buś⁴

Affiliations

¹ Department of Rheumatology and Autoimmune Diseases, Silesian Center for Rheumatology, Orthopedics and Rehabilitation, Ustron, Poland.
² Clinic and Department of Rheumatology and Connective Tissue Disease, University Hospital No. 2, College Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland.
³ ex. Medical Department, Roche Poland Sp. z o.o., Warsaw, Poland.
⁴ Department of Rheumatology, Rehabilitation and Internal Medicine, Poznan University of Medical Sciences, Poland.

Abstract

Objectives: According to the EULAR recommendations, remission or low disease activity (LDA) in rheumatoid arthritis should be achieved by a maximum of 6 months (M6) of treatment. Data on the use of tocilizumab (TCZ) as first-line biologic treatment in rheumatoid arthritis (RA) in routine clinical practice in Poland are lacking.

Material and methods: This multicenter, non-interventional, prospective, observational study recruited adults, presenting with moderate-to-severe RA, showing an inadequate response or intolerance to disease-modifying antirheumatic drugs, where TCZ was the first-line biologic treatment. The effectiveness of TCZ was assessed by the proportion of patients achieving remission and low disease activity following 6 months of treatment with intravenous TCZ. The impact of comorbidities on treatment outcomes was measured using the Rheumatic Disease Comorbidity Index (RDCI).

Results: Total remission rates at months 3 and 6 were 6% and 31%, respectively. Low disease activity was reported in 10% and 92% of the patients at 3 and 6 months, respectively. The response was comparable between TCZ as monotherapy and in combination with methotrexate. Mean DAS28 decreased from 6.61 at baseline to 4.27 at the scheduled time of the assessment (3 and 6 months). The Rheumatic Disease Comorbidity Index was not correlated with the number of patients achieving LDA at M3 and M6 or remission rates at M6. Remission rates correlated with RDCI at M3. A total of 114 adverse events were reported in 61 patients, among which five were considered as serious.

Conclusions: The study confirms the effectiveness and safety of TCZ in real-world settings as a first-line biologic treatment in patients with moderate-to-severe RA. Importantly, comorbidities do not affect the results of 6-month treatment with TCZ, that is, the optimal time to achieve at least LDA. Our results may improve the effects of RA therapy in Poland, especially in patients with comorbidities and those who, for various reasons, cannot receive optimal treatment with methotrexate.

Keywords: Rheumatic Disease Comorbidity Index; biologic treatment; disease-modifying antirheumatic drug; rheumatoid arthritis; tocilizumab.