Sae Ochi1,2, Kazuyoshi Saito3, Fumitaka Mizoguchi4, Shigeaki Kato5, Yoshiya Tanaka3. 1. Department of Laboratory Medicine, Jikei University School of Medicine, Nishi-shinbashi 3-25-8, Minatoku, Tokyo, 105-8461, Japan. ochisae1024@gmail.com. 2. First Department, University of Occupational and Environmental Health, Iseigaoka 1-1, Yawatanishi-ku, Kitakyushu, Fukuoka, 80708556, Japan. ochisae1024@gmail.com. 3. First Department, University of Occupational and Environmental Health, Iseigaoka 1-1, Yawatanishi-ku, Kitakyushu, Fukuoka, 80708556, Japan. 4. Department of Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Yushima 1-5-45, Bunkyo-ku, Tokyo, 113-8510, Japan. 5. Center for Regional Cooperation, Iwaki Meisei University, Chuodai Iino 5-5-1, Iwaki, Fukushima, 970-8551, Japan.
Abstract
BACKGROUND: With advancement in the treatment options of rheumatoid arthritis (RA), optimising the outcomes of difficult-to-treat patients has become increasingly important in clinical practice. In particular, insensitivity to first-line biologic disease-modifying anti-rheumatic drugs (bDMARD) is becoming a significant problem because it may decrease the treatment adherence of patients. This study aimed to compare RA patients with an insensitivity and those with a poor response to initial treatment with tumour necrosis factor inhibitors (TNFis), which are the most frequently used bDMARDs. METHODS: This is a retrospective cohort study using clinical data from the FIRST registry. bDMARD-naïve RA patients treated with tumour necrosis factor inhibitors (TNFis) from August 2003 to May 2019 were included and categorised into three groups: TNFi insensitivity, poor response to TNFis and controls. TNFi insensitivity was defined as follows: (1) discontinuation of TNFi treatment within 22 weeks due to lack of any response, or (2) an increase in the disease activity score in 28 joints-C-reactive protein (DAS28-CRP) of > 0.6 at week 22 compared with week 0. Among the remaining patients, those with a DAS28-CRP > 2.6 at week 22 were categorised in the poor response group. RESULTS: Of the included patients, 94 were classified in the insensitivity, 604 in the poor response and 915 in the control. A higher DAS28-CRP before treatment was a risk factor for a poor response but not for insensitivity. In contrast, dose escalation of infliximab decreased the risk of a poor response but not that of insensitivity. CONCLUSIONS: In future research, poor and insensitivity to bDMARDs should be assessed separately to fully elucidate the aetiology of, and risk factors for, bDMARD refractoriness.
BACKGROUND: With advancement in the treatment options of rheumatoid arthritis (RA), optimising the outcomes of difficult-to-treat patients has become increasingly important in clinical practice. In particular, insensitivity to first-line biologic disease-modifying anti-rheumatic drugs (bDMARD) is becoming a significant problem because it may decrease the treatment adherence of patients. This study aimed to compare RApatients with an insensitivity and those with a poor response to initial treatment with tumour necrosis factor inhibitors (TNFis), which are the most frequently used bDMARDs. METHODS: This is a retrospective cohort study using clinical data from the FIRST registry. bDMARD-naïve RApatients treated with tumour necrosis factor inhibitors (TNFis) from August 2003 to May 2019 were included and categorised into three groups: TNFi insensitivity, poor response to TNFis and controls. TNFi insensitivity was defined as follows: (1) discontinuation of TNFi treatment within 22 weeks due to lack of any response, or (2) an increase in the disease activity score in 28 joints-C-reactive protein (DAS28-CRP) of > 0.6 at week 22 compared with week 0. Among the remaining patients, those with a DAS28-CRP > 2.6 at week 22 were categorised in the poor response group. RESULTS: Of the included patients, 94 were classified in the insensitivity, 604 in the poor response and 915 in the control. A higher DAS28-CRP before treatment was a risk factor for a poor response but not for insensitivity. In contrast, dose escalation of infliximab decreased the risk of a poor response but not that of insensitivity. CONCLUSIONS: In future research, poor and insensitivity to bDMARDs should be assessed separately to fully elucidate the aetiology of, and risk factors for, bDMARD refractoriness.
Authors: H M Schenker; K Tascilar; L Konerth; M Sergeeva; J Prade; S Strobelt; A Kleyer; D Simon; L Mendez; M Hagen; V Schönau; A Hueber; J Roesch; A Dörfler; A Hess; G Schett; J Rech Journal: Contemp Clin Trials Commun Date: 2021-05-04