Abatacept in subjects who switch from intravenous to subcutaneous therapy: results from the phase IIIb ATTUNE study

Keystone, Edward; Kremer, Joel M.; Russell, Anthony S.; Box, Jane; Abud-Mendoza, Carlos; Elizondo, Mario Alberto Garza; Luo, Allison; Aranda, Richard; Delaet, Ingrid; Swanink, René; Gujrathi, Sheila; Luggen, Michael E.

doi:10.1136/annrheumdis-2011-200355

Cited by 53 publications

(58 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…This is consistent with previous clinical trial reports of SC ABA use, and further demonstrates that the frequency of SC injection-site reactions is reduced with increasing treatment time 8,9 .…”

Section: Rheumatologysupporting

confidence: 81%

“…Clinical and functional benefits were maintained longterm during the ACQUIRE study, regardless of whether patients received SC ABA throughout, or switched from IV ABA to SC ABA at the start of the LTE. These observations support findings from the ATTUNE study, which evaluated safety and efficacy in patients who switched from IV to SC ABA 9 . Together these observations suggest that patients can safely switch from a monthly ~10 mg/kg dose of IV ABA to a fixed weekly 125 mg dose of SC ABA with maintained clinical efficacy.…”

Section: Rheumatologysupporting

confidence: 80%

“…Further, immunogenicity did not appear to affect the safety or efficacy of SC ABA. Comparisons of data from this study with other ABA studies are problematic given immunogenicity has previously been evaluated using ELISA, rather than ECL 7,8,9,10,11,18 . There are a number of differences between the 2 assay types; notably, ECL has a greatly increased sensitivity compared to ELISA (12.2 ng/ml vs 275 µg/ml).…”

Section: Rheumatologymentioning

confidence: 93%

“…A subcutaneous (SC) formulation of ABA is also available. Four phase II or III trials have investigated the tolerability and clinical effectiveness of a weekly fixed dose of 125 mg SC ABA, demonstrating low immunogenicity with safety and efficacy similar to that of the IV formulation 7,8,9,10,11 .…”

mentioning

confidence: 99%

See 3 more Smart Citations

Subcutaneous Abatacept for the Treatment of Rheumatoid Arthritis: Longterm Data from the ACQUIRE Trial

Genovese

Pacheco‐Tena²,

Covarrubias³

et al. 2014

J Rheumatol

Self Cite

View full text Add to dashboard Cite

Objective.Assess longterm tolerability, safety, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate-refractory patients with rheumatoid arthritis (RA).Methods.The phase III, multinational Abatacept Comparison of Sub[QU]cutaneous Versus Intravenous in Inadequate Responders to MethotrexatE (ACQUIRE) trial comprised a 6-month, randomized, double-blind (DB) period, in which patients received intravenous (IV) or SC ABA, plus MTX, followed by an open-label, longterm extension (LTE), in which patients received SC ABA, 125 mg/week. Safety and efficacy from the LTE (∼3.5 yrs of exposure) are reported.Results.Patients who completed the DB period (1372/1385, 99.1%) entered the LTE; 1134 patients (82.7%) kept taking the treatment at time of reporting. Mean (SD) was 31.9 months (6.8); median (range) exposure was 33.0 (8–44) months. Patients entering the LTE had longstanding, moderate-to-severe disease [mean 7.6 (7.9) yrs and DAS28 (C-reactive protein) 6.2 (0.9)]. Incidence rates (events/100 patient-yrs) were reported for serious adverse events (8.76, 95% CI 7.71, 9.95), infections (44.80, 95% CI 41.76, 48.01), serious infections (1.72, 95% CI 1.30, 2.27), malignancies (1.19, 95% CI 0.86, 1.66), and autoimmune events (1.31, 95% CI 0.95, 1.79). Twenty-seven patients (2%) experienced injection-site reactions; all except 1 were mild. American College of Rheumatology 20, 50, and 70 responses achieved during the DB period were maintained through the LTE, and on Day 981 were 80.2% (95% CI 77.2, 83.2), 63.5% (95% CI 58.2, 68.9), and 39.5% (95% CI 34.0, 44.9) for patients who kept taking SC ABA, and 80.0% (95% CI 77.0, 83.0), 63.2% (95% CI 57.8, 68.7), and 39.2% (95% CI 33.7, 44.7) for those who switched from IV to SC ABA.Conclusion.These findings support SC ABA as a well-tolerated and efficacious longterm treatment for patients with RA and inadequate response to MTX (ClinicalTrials.gov identifier NCT00559585).

show abstract

Section: Rheumatologysupporting

confidence: 81%

Section: Rheumatologysupporting

confidence: 80%

Section: Rheumatologymentioning

confidence: 93%

mentioning

confidence: 99%

See 2 more Smart Citations

Subcutaneous Abatacept for the Treatment of Rheumatoid Arthritis: Longterm Data from the ACQUIRE Trial

Genovese

Pacheco‐Tena²,

Covarrubias³

et al. 2014

J Rheumatol

Self Cite

View full text Add to dashboard Cite

show abstract

“…There have been trials comparing IV and SC drug administration with most reporting on drug efficacy and safety [7][8][9][10][11][12][13][14][15][16]. In the study by Moreau et al (2011) [11], patients with relapsed multiple myeloma (MM) were randomised to receive bortezomib either by SC administration or IV infusion.…”

Section: Introductionmentioning

confidence: 99%

Intravenous versus Subcutaneous Drug Administration. Which Do Patients Prefer? A Systematic Review

Stoner

Harder

Fallowfield

et al. 2014

Patient

121

102

View full text Add to dashboard Cite

show abstract

Immunogenicity, Safety, and Efficacy of Abatacept Administered Subcutaneously With or Without Background Methotrexate in Patients With Rheumatoid Arthritis: Results From a Phase III, International, Multicenter, Parallel‐Arm, Open‐Label Study

Nash¹,

Nayiager²,

Genovese³

et al. 2013

Arthritis Care & Research

Self Cite

View full text Add to dashboard Cite

Objective. To evaluate the impact of concomitant methotrexate (MTX) on subcutaneous (SC) abatacept immunogenicity, and to assess safety and efficacy.Methods. This phase III, open-label study had a 4-month short-term (ST) period and an ongoing long-term extension (LTE) period. Rheumatoid arthritis patients were stratified to receive SC abatacept (125 mg/week) with (combination) or without MTX (monotherapy), with no intravenous loading dose; patients receiving monotherapy could add MTX in the LTE period. Immunogenicity (percentage of anti-abatacept antibody-positive patients) was assessed. ST and LTE period data are reported, including efficacy through LTE month 14 and safety through LTE month 20. Results. Ninety-six of 100 enrolled patients completed the ST period; 3.9% (combination) and 4.1% of patients (monotherapy) developed transient immunogenicity, and no patients were antibody positive at month 4. Serious adverse events (SAEs) were reported in 3.9% (combination) and 6.1% of patients (monotherapy); 5.9% (combination) and 8.2% of patients (monotherapy) experienced SC injection reactions, and all were mild in intensity. Mean 28-joint Disease Activity Score (DAS28) changes were ؊1.67 (95% confidence interval [95% CI] ؊2.06, ؊1.28; combination) and ؊1.94 (95% CI ؊2.46, ؊1.42; monotherapy) at month 4. Ninety patients entered and were treated in the LTE period; 83.3% (75 of 90) remained ongoing at month 24. One LTE-treated patient (1.1%) developed immunogenicity, 14.4% of patients experienced SAEs, and no SC injection reactions were reported. For patients entering the LTE period, mean DAS28 changes from baseline were ؊1.84 (95% CI ؊2.23, ؊1.34; combination) and ؊2.86 (95% CI ؊3.46, ؊2.27; monotherapy) at month 18. Conclusion. SC abatacept did not elicit immunogenicity associated with loss of safety or efficacy, either with or without MTX.

show abstract

Abatacept in subjects who switch from intravenous to subcutaneous therapy: results from the phase IIIb ATTUNE study

Abstract: 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.

Cited by 53 publications

References 16 publications

Subcutaneous Abatacept for the Treatment of Rheumatoid Arthritis: Longterm Data from the ACQUIRE Trial

Subcutaneous Abatacept for the Treatment of Rheumatoid Arthritis: Longterm Data from the ACQUIRE Trial

Intravenous versus Subcutaneous Drug Administration. Which Do Patients Prefer? A Systematic Review

Immunogenicity, Safety, and Efficacy of Abatacept Administered Subcutaneously With or Without Background Methotrexate in Patients With Rheumatoid Arthritis: Results From a Phase III, International, Multicenter, Parallel‐Arm, Open‐Label Study

Contact Info

Product

Resources

About