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RDF description of Abatacept in subjects who switch from intravenous to subcutaneous therapy: Results from the phase IIIb ATTUNE study - http://orbis.uaslp.mx/vivo/individual/scopus3124
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Objective: To assess safety, immunogenicity and efficacy in rheumatoid arthritis (RA) patients switched from longterm intravenous to subcutaneous (SC) abatacept. Methods: In this phase IIIb, open-label, single-arm trial, patients who completed ≥4 years of intravenous abatacept (in long-term extensions of two phase III studies) were enrolled to receive SC abatacept (125 mg/week). The primary objective was safety during the first 3 months after switching from intravenous therapy. Results: 123 patients entered the study (mean Disease Activity Score 28 (based on C reactive protein) and HAQ-DI of 3.4 and 0.94, respectively). At month 3, 120 (97.6%25) patients were continuing to receive SC abatacept; no patients discontinued due to lack of efficacy. Adverse events (AEs) were reported in 49 (39.8%25) patients through month 3. One patient (0.8%25) discontinued due to an AE and one patient (0.8%25) experienced a serious AE. Two (1.6%25) patients had SC injection site reactions (erythema, pain), both with mild intensity. Clinical efficacy was maintained throughout. Limited impact on immunogenicity was observed when switching routes of administration. Conclusion: These data demonstrate that patients can switch from long-term monthly intravenous abatacept to a weekly fixed dose of 125 mg SC abatacept with no increased safety concerns. This study further supports SC abatacept as an alternative treatment option for patients with RA.
Abatacept in subjects who switch from intravenous to subcutaneous therapy: Results from the phase IIIb ATTUNE study
abatacept; C reactive protein; corticosteroid; disease modifying antirheumatic drug; methotrexate; nonsteroid antiinflammatory agent; tumor necrosis factor inhibitor; article; brain tumor; breast cancer; bronchitis; drug efficacy; drug fatality; drug safety; drug withdrawal; erythema nodosum; gastroenteritis; human; immunogenicity; injection site erythema; injection site pain; major clinical study; musculoskeletal pain; open study; phase 3 clinical trial; pneumonia; priority journal; rheumatoid arthritis; rhinopharyngitis; sarcoidosis; sinusitis; treatment outcome; upper respiratory tract infection; urinary tract infection; uterus cancer; Adrenal Cortex Hormones; Adult; Anti-Inflammatory Agents, Non-Steroidal; Antirheumatic Agents; Arthritis, Rheumatoid; C-Reactive Protein; Drug Therapy, Combination; Follow-Up Studies; Humans; Immunoconjugates; Injections, Intravenous; Injections, Subcutaneous; Joints; T-Lymphocytes; Time; Treatment Outcome
C reactive protein, 9007-41-4; abatacept, 332348-12-6; methotrexate, 15475-56-6, 59-05-2, 7413-34-5; Adrenal Cortex Hormones; Anti-Inflammatory Agents, Non-Steroidal; Antirheumatic Agents; C-Reactive Protein, 9007-41-4; Immunoconjugates; abatacept