Prediction of Clinical Response After 1 Year of Infliximab Therapy in Rheumatoid Arthritis Based on Disease Activity at 3 Months: Posthoc Analysis of the RISING Study

Takeuchi, Tsutomu; Miyasaka, Nobuyuki; Inui, Takashi; Yano, Toshiro; Yoshinari, Toru; Abe, Tohru; Koike, Takao

doi:10.3899/jrheum.140572

Cited by 6 publications

(4 citation statements)

References 29 publications

(33 reference statements)

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“…Although prediction of the clinical efficacy of IFX therapy has been investigated in many studies, results have been controversial [ 10 , 11 , 30 ]. Although researchers in some studies reported that early response predicted long-term responses [ 31 , 32 ], identifying predictive factors “at baseline” would be even more worthwhile in establishing IFX treatment strategies.…”

Section: Discussionmentioning

confidence: 99%

High titers of both rheumatoid factor and anti-CCP antibodies at baseline in patients with rheumatoid arthritis are associated with increased circulating baseline TNF level, low drug levels, and reduced clinical responses: a post hoc analysis of the RISING study

et al. 2017

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BackgroundAlthough both rheumatoid factor (RF) and anticyclic citrullinated peptide antibodies (anti-CCP) are useful for diagnosing rheumatoid arthritis (RA), the impact of these autoantibodies on the efficacy of tumor necrosis factor (TNF) inhibitors has been controversial. The aim of this post hoc analysis of a randomized double-blind study (the RISING study) was to investigate the influences of RF and anti-CCP on the clinical response to infliximab in patients with RA.MethodsMethotrexate-refractory patients with RA received 3 mg/kg of infliximab from weeks 0 to 6 and then 3, 6, or 10 mg/kg every 8 weeks from weeks 14 to 46. In this post hoc analysis, patients were stratified into three classes on the basis of baseline RF/anti-CCP titers: “low/low-C” (RF < 55 IU/ml, anti-CCP < 42 U/ml), “high/high-C” (RF ≥ 160 IU/ml, anti-CCP ≥ 100 U/ml), and “middle-C” (neither low/low-C nor high/high-C). Baseline plasma TNF level, serum infliximab level, and disease activity were compared between the three classes.ResultsBaseline RF and anti-CCP titers showed significant correlations with baseline TNF and infliximab levels in weeks 2–14. Comparison of the three classes showed that baseline TNF level was lowest in the low/low-C group and highest in the high/high-C group (median 0.73 versus 1.15 pg/ml), that infliximab levels at week 14 were highest in the low/low-C group and lowest in the high/high-C group (median 1.0 versus 0.1 μg/ml), and that Disease Activity Score in 28 joints based on C-reactive protein at week 14 was lowest in the low/low-C group and highest in the high/high-C group (median 3.17 versus 3.82). A similar correlation was observed at week 54 in the 3 mg/kg dosing group, but not in the 6 or 10 mg/kg group. Significant decreases in both RF and anti-CCP were observed during infliximab treatment.ConclusionsRF/anti-CCP titers correlated with TNF level. This might explain the association of RF/anti-CCP with infliximab level and clinical response in patients with RA. Baseline RF/anti-CCP titers may serve as indices that aid infliximab treatment.Trial registrationClinicalTrials.gov, NCT00691028. Retrospectively registered on 3 June 2008.Electronic supplementary materialThe online version of this article (doi:10.1186/s13075-017-1401-2) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

High titers of both rheumatoid factor and anti-CCP antibodies at baseline in patients with rheumatoid arthritis are associated with increased circulating baseline TNF level, low drug levels, and reduced clinical responses: a post hoc analysis of the RISING study

et al. 2017

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“…The prediction of response in axial SpA and PsA patients has not been studied extensively. The majority of work in the literature has focused on prediction of response in patients with ankylosing spondylitis, PsA, RA, or psoriasis, and has focused on the use of baseline characteristics to identify patients likely to achieve a good therapeutic response (21)(22)(23)(24)(25), or else the use of early treatment response to predict those patients likely to achieve treatment targets at later time points (positive predictability) (26)(27)(28)(29)(30). These studies have consistently found that long-term clinical improvements are predicted by raised inflammatory markers (such as CRP level) at baseline, and by an early clinical response to treatment.…”

Section: Discussionmentioning

confidence: 99%

Early Disease Activity or Clinical Response as Predictors of Long‐Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis

Heijde

Deodhar

Fleischmann

et al. 2017

Arthritis Care & Research

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ObjectiveEarly identification of patients unlikely to achieve good long‐term disease control with anti–tumor necrosis factor therapy in axial spondyloarthritis (SpA) and psoriatic arthritis (PsA) is important for physicians following treat‐to‐target recommendations. Here we assess associations between disease activity or clinical response during the first 12 weeks of treatment and attainment of treatment targets at week 48 in axial SpA and PsA patients receiving certolizumab pegol.MethodsThe relationship between disease activity or clinical response during the first 12 weeks of treatment and achievement of week‐48 targets (for axial SpA: inactive disease based on Ankylosing Spondylitis Disease Activity Score [ASDAS] using the C‐reactive protein [CRP] level, or Bath Ankylosing Spondylitis Disease Activity Index <2 with normal CRP level; and for PsA: minimal disease activity) was assessed post hoc using RAPID‐axSpA and RAPID‐PsA trial data.ResultsA clear relationship between disease activity from week 2 to 12 and achievement of week‐48 treatment targets was observed in both axial SpA and PsA populations. In axial SpA, week‐48 ASDAS inactive disease was achieved by 0% of patients (0 of 21) with ASDAS very high disease activity at week 12, compared to 68% of patients (34 of 50) with week‐12 ASDAS inactive disease. For PsA, week‐48 minimal disease activity was achieved by 0% of patients (0 of 26) with Disease Activity Score in 28 joints (DAS28) using the CRP level >5.1 at week 12, compared to 73% of patients (57 of 78) with DAS28‐CRP <2.6. Similar results were observed regardless of the disease activity measure used. Clinical response at week 12 also predicted week‐48 outcomes, though to a lesser extent than disease activity.ConclusionUsing disease activity and the clinical response state during the first 12 weeks of certolizumab pegol treatment, it was possible to identify a subset of axial SpA and PsA patients unlikely to achieve long‐term treatment goals.

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“…31 Similar results have been demonstrated in rheumatoid arthritis studies in which early response to treatment predicted remission or good clinical response long term. 32– 34 Furthermore, a poor response (assessed by JIA ACR 30 and 70) to 6-month treatment with methotrexate in patients with polyarticular JIA was associated with higher disability, antinuclear antibody negativity, and longer disease duration in the PRINTO trial. 35 An analysis of the BiKeR registry demonstrated that earlier treatment with a biological agent (within 2 years of symptom onset) was associated with better disease control and drug-free remission.…”

Section: Discussionmentioning

confidence: 99%

Long-term outcomes in patients with polyarticular juvenile idiopathic arthritis receiving adalimumab with or without methotrexate

et al. 2020

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ObjectivesLong-term safety and efficacy of adalimumab among patients with juvenile idiopathic arthritis (JIA) was evaluated through 6 years of treatment.MethodsChildren aged 4–17 years with polyarticular JIA were enrolled in a phase III, randomised-withdrawal, double-blind, placebo-controlled trial consisting of a 16-week open-label lead-in period, 32-week randomised double-blind period and 360-week long-term extension. Patients were stratified by baseline methotrexate use. Adverse events (AEs) were monitored, and efficacy assessments included JIA American College of Rheumatology (JIA ACR) 30%, 50%, 70% or 90% responses and the proportions of patients achieving 27-joint Juvenile Arthritis Disease Activity Score (JADAS27) low disease activity (LDA, ≤3.8) and inactive disease (ID, ≤1).ResultsOf 171 patients enrolled, 62 (36%) completed the long-term extension. Twelve serious infections in 11 patients were reported through 592.8 patient-years of exposure. No cases of congestive heart failure-related AEs, demyelinating disease, lupus-like syndrome, malignancies, tuberculosis or deaths were reported. JIA ACR 30/50/70/90 responses and JADAS27 LDA were achieved in 66% to 96% of patients at week 104, and 63 (37%) patients achieved clinical remission (JADAS27 ID sustained for ≥6 continuous months) during the study. Attainment of JIA ACR 50 or higher and JADAS27 LDA or ID in the initial weeks were the best predictors of clinical remission. Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis).ConclusionsThrough 6 years of exposure, adalimumab was well tolerated with significant clinical response (up to clinical remission) and a relatively low retention rate.

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Prediction of Clinical Response After 1 Year of Infliximab Therapy in Rheumatoid Arthritis Based on Disease Activity at 3 Months: Posthoc Analysis of the RISING Study

Cited by 6 publications

References 29 publications

High titers of both rheumatoid factor and anti-CCP antibodies at baseline in patients with rheumatoid arthritis are associated with increased circulating baseline TNF level, low drug levels, and reduced clinical responses: a post hoc analysis of the RISING study

High titers of both rheumatoid factor and anti-CCP antibodies at baseline in patients with rheumatoid arthritis are associated with increased circulating baseline TNF level, low drug levels, and reduced clinical responses: a post hoc analysis of the RISING study

Early Disease Activity or Clinical Response as Predictors of Long‐Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis

Long-term outcomes in patients with polyarticular juvenile idiopathic arthritis receiving adalimumab with or without methotrexate

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