Abstract:
Rheumatoid arthritis is a chronic progressive autoimmune disease that causes inflammation in joints, leading to functional disability. The annual incidence of rheumatoid arthritis varies from 5 to 50 every 100,000 population and Hong Kong has a reported prevalence of 0.35%. Tumor necrosis factor (TNF)-alpha inhibitors are recommended for moderate to high disease activity, or as adjunctive therapy in patients who have not met treatment goals despite maximally tolerated methotrexate therapy. Adalimumab is one of the TNF-alpha inhibitors available in AHNH drug formulary. Efficacy and safety of Adalimumab has been established consistently in different current studies, but data within Chinese population is limited. Hence, this study aims to provide an insight into the efficacy and safety of Adalimumab in rheumatoid arthritis treatment in Chinese patients.
Method:
It is an observational, retrospective, single-entered, and non-interventional study. Patients over 18 years old with active rheumatoid arthritis who have received Adalimumab for at least 12 weeks are included. Dispensing history of Adalimumab from 1st September 2018 to 31st August 2022 was screened and selected via Clinical Data and Analysis Reporting System (CDARS). Mean changes in 28-joint disease activity score (DAS28) and CDAI (Clinical Disease Activity Index) score from baseline to week 12 after initiation of Adalimumab were analysed and reported as the primary efficacy endpoint. The documented adverse events related to Adalimumab are analysed as the primary safety endpoint. The secondary endpoint would be proportion of patients achieving joint remission (DAS28 <2.6, CDAI<2.8) and low-disease activity (DAS28<3.2, SDAI <10) at week 12.
Inclusion criteria:
->18 years old with active rheumatoid arthritis
-received adalimumab 40mg subcutaneously every other week for 12 weeks
Primary outcome:
Mean change in 28-joint disease activity score (DAS28) from baseline to week 12.
Mean change in Clinical Disease Activity Index (CDAI) from baseline to week 12.
Secondary outcome:
Proportion of patients achieving joint remission (DAS28 <2.6, CDAI <2.8) and low-disease activity (DAS28 <3.2, CDAI <10) at week 12.
Safety: adverse and serious adverse events