Change from subcutaneous to intravenous abatacept and back in patients with rheumatoid arthritis as simulation of a vacation: a prospective phase IV, open-label trial A-BREAKReport as inadecuate




Change from subcutaneous to intravenous abatacept and back in patients with rheumatoid arthritis as simulation of a vacation: a prospective phase IV, open-label trial A-BREAK - Download this document for free, or read online. Document in PDF available to download.

Arthritis Research and Therapy

, 18:88

First Online: 14 April 2016Received: 17 January 2016Accepted: 31 March 2016

Abstract

BackgroundVacation can present a major problem to patients with rheumatoid arthritis RA treated with weekly subcutaneous biologics, including subcutaneous SC abatacept. Therefore, the replacement of four SC doses of abatacept by a single dose of intravenous IV abatacept may present an acceptable alternative to cover a 4-week interval needed for vacations. In the study presented, we analyzed the efficacy and safety of this intervention followed by a switch back to SC abatacept after 4 weeks.

MethodThis open-label, prospective, single-arm, 24-week trial recruited patients with established RA in low disease activity LDA or in remission on treatment with SC abatacept for at least 3 months to receive a single dose of IV abatacept baseline followed by a break of 4 weeks and then continuation of weekly SC abatacept from day 28 on. Disease-modifying anti-rheumatic drug DMARD-inadequate or biologic-inadequate responders or both were included.

ResultsThe baseline characteristics of the 49 patients per protocol were typical for a cohort of RA patients with established disease mean disease duration of 8.31 years in LDA under treatment with synthetic DMARDs and a biologic. Two patients one flare and one patient decision dropped out of the study. The proportions of patients with disease activity score in 28 joints DAS-28 of not more than 3.2 at day 28 were 93.9 % 95 % confidence interval CI 83.5–97.9 and 93.6 % 95 % CI 82.8–97.8 at the end of the study day 168. The average DAS-28 values were 1.74 standard deviation SD ± 0.72 at baseline, 2.03 SD ± 1.03 at day 28, and 1.96 SD ± 0.92 at the end of the study day 168. Pre-exposure to IV abatacept and having failed methotrexate or anti-tumor necrosis factor anti-TNF did not influence the average DAS-28 or the proportion of patients maintaining LDA over time. The average health assessment questionnaire disability index HAQ-DI was stable throughout the study. Adverse events AEs occurred in 75 % of subjects. Four serious AEs were described during the study. None of them was related to the investigational product, and all serious AEs could be resolved during hospitalization.

ConclusionThis prospective, open-label study of abatacept shows for the first time that switching from weekly SC to IV abatacept and back after 4 weeks is an effective and safe way to bridge vacations in RA patients in LDA or remission. NCT1846975, registered April 19, 2013.

KeywordsAbatacept Intravenous Subcutaneous Switch LDA AbbreviationsAEadverse event

CIconfidence interval

DAS-28disease activity score in 28 joints

DMARDdisease-modifying anti-rheumatic drug

ESRerythrocyte sedimentation rate

HAQ-DIhealth assessment questionnaire disability index

ITTintention to treat

IVintravenous

LDAlow disease activity

MTXmethotrexate

PPper protocol

RArheumatoid arthritis

SCsubcutaneous

SDstandard deviation

TNFtumor necrosis factor

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Author: Ruediger B. Mueller - Michael Gengenbacher - Symi Richter - Jean Dudler - Burkhard Möller - Johannes von Kempis

Source: https://link.springer.com/







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