Introduction: One target of rheumatoid arthritis (RA) treatment is to achieve early sustained remission; over the long term, patients in sustained remission have less structural joint damage and physical disability. We evaluated Simplified Disease Activity Index (SDAI) remission with abatacept + methotrexate versus abatacept placebo + methotrexate and impact of de-escalation (DE) in anti-citrullinated protein antibody (ACPA)-positive patients with early RA.
Methods: The phase IIIb, randomized, AVERT-2 two-stage study (NCT02504268) evaluated weekly abatacept + methotrexate versus abatacept placebo + methotrexate.
Primary Endpoint: SDAI remission (≤ 3.3) at week 24. Pre-planned exploratory endpoint: maintenance of remission in patients with sustained remission (weeks 40 and 52) who, from week 56 for 48 weeks (DE period), (1) continued combination abatacept + methotrexate, (2) tapered abatacept to every other week (EOW) + methotrexate for 24 weeks with subsequent abatacept withdrawal (abatacept placebo + methotrexate), or (3) withdrew methotrexate (abatacept monotherapy).
Results: Primary study endpoint was not met: 21.3% (48/225) of patients in the combination and 16.0% (24/150) in the abatacept placebo + methotrexate arm achieved SDAI remission at week 24 (p = 0.2359). There were numerical differences favoring combination therapy in clinical assessments, patient-reported outcomes (PROs) and week 52 radiographic non-progression. After week 56, 147 patients in sustained remission with abatacept + methotrexate were randomized (combination, n = 50; DE/withdrawal, n = 50; abatacept monotherapy, n = 47) and entered DE. At DE week 48, SDAI remission (74%) and PRO improvements were mostly maintained with continued combination therapy; lower remission rates were observed with abatacept placebo + methotrexate (48.0%) and with abatacept monotherapy (57.4%). Before withdrawal, de-escalating to abatacept EOW + methotrexate preserved remission.
Conclusions: The stringent primary endpoint was not met. However, in patients achieving sustained SDAI remission, numerically more maintained remission with continued abatacept + methotrexate versus abatacept monotherapy or withdrawal.
Trial Registration: ClinicalTrials.gov identifier, NCT02504268. Video abstract (MP4 62241 KB).
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10140217 | PMC |
| http://dx.doi.org/10.1007/s40744-022-00519-9 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
The Effect of Milk-Derived Extracellular Vesicles on Intestinal Epithelial Cell Proliferation.
Int J Mol Sci
December 2024
Department of Pediatrics, Hadassah-Hebrew University Medical Center, Jerusalem 9166100, Israel.
Inflammatory bowel disease (IBD) is a chronic, relapsing inflammation disorder of the gastrointestinal tract characterized by disrupted intestinal epithelial barrier function. Despite advances in treatment, including biological agents, achieving sustained remission remains challenging for many patients with IBD. This highlights the urgent need for novel therapeutic strategies.
View Article and Find Full Text PDFContrast-enhanced ultrasound as a valuable tool to detect minimal inflammation in RA patients in sustained remission.
Front Med (Lausanne)
December 2024
Rheumatology Department, Unidade Local de Saúde de Santa Maria, Lisbon, Portugal.
Objective: The study aimed to explore the utility of contrast-enhanced ultrasound (CEUS) as a tool for detecting minimal inflammation in rheumatoid arthritis (RA) patients in sustained remission (SR) and to correlate the findings with Disease Activity Score 28 (DAS28) status scores and various ultrasound (US) scores.
Patients And Methods: Thirty RA patients in SR (minimum 6 months), 12 with active disease, and 10 healthy controls were included. Clinical evaluations and US assessments were performed, including grayscale US (GSUS), power Doppler US (PDUS), and Global OMERACT-EULAR Synovitis Score (GLOESS).
The Evolution of Treatment-Free Remission.
Blood
January 2025
South Australian Health & Medical Research Institute, Australia.
One of the most remarkable achievements of the TKI era has been the capacity to induce deep molecular remissions that are sustainable off therapy in chronic myeloid leukemia (CML) patients - treatment-free remission (TFR). TFR was first described in a handful of patients within 3-4 years of imatinib approval. In 2004 TFR was tested in a small French pilot study, followed soon after by the French STIM and Australasian TWISTER studies.
View Article and Find Full Text PDFCase report: Durable response from tegafur/gimeracil/oteracil (S-1) combined with fruquintinib and sintilimab as a third-line treatment for MSS metastatic colorectal cancer with a BRAF V600E mutation.
Front Oncol
December 2024
Department of Medical Oncology, Guangdong Provincial Hospital of Chinese Medicine, The Second Clinical Medical College, University of Guangzhou Traditional Chinese Medicine, Guangzhou, China.
Patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) who fail first- and second-line treatments face significant challenges in third-line therapy, where monotherapies often yield poor outcomes and limited survival benefits. The prognosis is particularly poor for mCRC with the unique molecular subtype of BRAF V600E mutation. This report describes sustained benefits from a third-line treatment regimen (SFS) combining tegafur/gimeracil/oteracil (S-1), fruquintinib, and sintilimab in a patient with BRAF V600E-mutated MSS mCRC.
View Article and Find Full Text PDFPonatinib and prednisolone induce sustained remission in a relapsed case of mixed-phenotype acute leukemia with fusion intolerant to dasatinib.
Int Cancer Conf J
January 2025
Department of Hematology, Uwajima City Hospital, Goten-Machi, Uwajima, Ehime 798-8510 Japan.
Mixed-phenotype acute leukemia (MPAL) with fusion is a rare leukemia subtype exhibiting both myeloid and lymphoid traits. Standard treatment involves chemotherapy with a tyrosine kinase inhibitor (TKI). However, establishing the optimal treatment strategy for elderly patients with MPAL with fusion is challenging due to their intolerance to intensive chemotherapy.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!