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Article: Recovery of biomethane from a submerged anaerobic membrane bioreactor treating domestic wastewater blended with semi-solid organic wastes discharged from residential establishments

Gautam, Rajneesh Kumar / Valente, Robert / Abbas, Haitham / Bui, Anh / More, Nandkishor / Gray, Stephen / Muthukumaran, Shobha / Navaratna, Dimuth

Environmental technology & innovation. 2022 June 13,

2022

Abstract: Recent research studies on the innovative concept of submerged anaerobic membrane bioreactor (SAnMBR) technology have demonstrated superior treatment and operational performance for treating a broad range of waste streams discharged from various ... ...

Abstract	Recent research studies on the innovative concept of submerged anaerobic membrane bioreactor (SAnMBR) technology have demonstrated superior treatment and operational performance for treating a broad range of waste streams discharged from various industries. This study aimed to investigate the treatment and recovery of biomethane (bio-CH₄) performance of ceramic ultrafiltration (UF) coupled with ”co-digestion based SAnMBR”, which was not previously studied by others, for treating an organic fraction of food waste (OFFW) blended with domestic wastewater (DWW) at surge organic loading rates (OLRs) disposed at modern high-rise establishments and similar residential clusters. The SAnMBR was operated in five phases (Phase 1-5), with different organic loading rates (OLRs) varying from 0.49 to 22.57 kg-COD/m³/d. All bio-CH₄, mixed liquor sludge, and treated permeate samples were analyzed using standard methods. The key parameters representing the cumulative bio-CH₄ yield during each phase were estimated using sigmoidal models, and the simulated results were validated using ANOVA. It was found that the SAnMBR produced high-quality, low-turbid reclaimed water showing an increasing trend in yield of bio-CH₄ with an increase of OLR. It was also observed that the SAnMBR demonstrated stable and superior treatment performance at shock-loads of organics. The maximum bio-CH₄ yield recorded during the study was 73.06 ± 6.48%. The findings of this study confirmed the suitability of applying this novel concept of ”co-digestion-based SAnMBR” towards sustainable and efficient waste management in modern-high rise establishments.
Keywords	anaerobic digestion ; biogas ; ceramics ; environmental technology ; food waste ; membrane bioreactors ; municipal wastewater ; sludge ; ultrafiltration ; wastewater treatment
Language	English
Dates of publication	2022-0613
Publishing place	Elsevier B.V.
Document type	Article
Note	Pre-press version
ISSN	2352-1864
DOI	10.1016/j.eti.2022.102763
Database	NAL-Catalogue (AGRICOLA)

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Article: Reductions in disease activity in the AMPLE trial: clinical response by baseline disease duration.

Schiff, Michael / Weinblatt, Michael E / Valente, Robert / Citera, Gustavo / Maldonado, Michael / Massarotti, Elena / Yazici, Yusuf / Fleischmann, Roy

RMD open

2016 Volume 2, Issue 1, Page(s) e000210

Abstract: Objectives: To evaluate clinical response by baseline disease duration using 2-year data from the AMPLE trial.: Methods: Patients were randomised to subcutaneous abatacept 125 mg weekly or adalimumab 40 mg bi-weekly, with background methotrexate. As ... ...

Abstract	Objectives: To evaluate clinical response by baseline disease duration using 2-year data from the AMPLE trial. Methods: Patients were randomised to subcutaneous abatacept 125 mg weekly or adalimumab 40 mg bi-weekly, with background methotrexate. As part of a post hoc analysis, the achievement of validated definitions of remission (Clinical Disease Activity Index (CDAI) ≤2.8, Simplified Disease Activity Index (SDAI) ≤3.3, Routine Assessment of Patient Index Data 3 (RAPID3) ≤3.0, Boolean score ≤1), low disease activity (CDAI <10, SDAI <11, RAPID3 ≤6.0), Health Assessment Questionnaire-Disability Index response and American College of Rheumatology responses were evaluated by baseline disease duration (≤6 vs >6 months). Disease Activity Score 28 (C-reactive protein) <2.6 or ≤3.2 and radiographic non-progression in patients achieving remission were also evaluated. Results: A total of 646 patients were randomised and treated (abatacept, n=318; adalimumab, n=328). In both treatment groups, comparable responses were achieved in patients with early rheumatoid arthritis (≤6 months) and in those with later disease (>6 months) across multiple clinical measures. Conclusions: Abatacept or adalimumab with background methotrexate were associated with similar onset and sustainability of response over 2 years. Patients treated early or later in the disease course achieved comparable clinical responses. Trial registration number: NCT00929864, Post-results.
Language	English
Publishing date	2016
Publishing country	England
Document type	Journal Article
ZDB-ID	2812592-7
ISSN	2056-5933
ISSN	2056-5933
DOI	10.1136/rmdopen-2015-000210
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Article: Longterm Safety and Efficacy of Subcutaneous Abatacept in Patients with Rheumatoid Arthritis: 5-year Results from a Phase IIIb Trial.

Genovese, Mark C / Pacheco-Tena, César / Covarrubias, Arturo / Leon, Gustavo / Mysler, Eduardo / Keiserman, Mauro / Valente, Robert M / Nash, Peter / Simon-Campos, J Abraham / Box, Jane / Legerton, Clarence W / Nasonov, Evgeny / Durez, Patrick / Elegbe, Ayanbola / Wong, Robert / Li, Xiaohui / Banerjee, Subhashis / Alten, Rieke

The Journal of rheumatology

2018 Volume 45, Issue 8, Page(s) 1085–1092

Abstract: Objective: To assess 5-year safety, tolerability, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate (MTX)-refractory patients with rheumatoid arthritis (RA).: Methods: The Abatacept Comparison of sub[QU]cutaneous versus intravenous in ...

Abstract	Objective: To assess 5-year safety, tolerability, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate (MTX)-refractory patients with rheumatoid arthritis (RA). Methods: The Abatacept Comparison of sub[QU]cutaneous versus intravenous in Inadequate Responders to methotrexatE (ACQUIRE) phase IIIb, randomized, double-dummy, multinational trial compared efficacy and safety of SC and intravenous (IV) ABA in patients with RA. In the initial 6-month double-blind (DB) period, patients received IV or SC ABA, plus MTX, and in the subsequent open-label longterm extension (LTE) period, all patients received SC ABA (125 mg/wk). The final 5-year safety, tolerability, and efficacy analyses are reported. Results: Of 1385 patients who completed the DB period, 1372 entered LTE and 945 (68.8%) completed ≥ 5 years of treatment. During LTE, 97 (7.1%) patients discontinued treatment because of an adverse event (AE). Incidence rate (IR; event/100 patient-yrs of exposure; based on LTE data, 95% CI) for AE of interest were the following: serious AE 7.73 (6.96-8.58), infection 38.60 (36.24-41.12), serious infection 1.68 (1.35-2.07), malignancies 1.09 (0.84-1.42), and autoimmune disorders 1.33 (1.05-1.69), and were stable over time. No association between immunogenicity and either worsening of ABA safety or loss of efficacy was noted. Efficacy in the LTE was consistent with the DB period and was maintained to the end of the study. Conclusion: These 5-year data establish that SC ABA (125 mg/wk) has a consistent safety profile and durable efficacy for longterm treatment of patients with RA who had an inadequate response to MTX.
MeSH term(s)	Abatacept/administration & dosage ; Abatacept/adverse effects ; Abatacept/therapeutic use ; Antirheumatic Agents/administration & dosage ; Antirheumatic Agents/adverse effects ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Humans ; Injections, Intravenous ; Injections, Subcutaneous ; Male ; Methotrexate/therapeutic use ; Middle Aged ; Treatment Outcome
Chemical Substances	Antirheumatic Agents ; Abatacept (7D0YB67S97) ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2018-04-15
Publishing country	Canada
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	194928-7
ISSN	1499-2752 ; 0315-162X
ISSN (online)	1499-2752
ISSN	0315-162X
DOI	10.3899/jrheum.170344
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Article ; Online: Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial.

Schiff, Michael / Weinblatt, Michael E / Valente, Robert / van der Heijde, Désirée / Citera, Gustavo / Elegbe, Ayanbola / Maldonado, Michael / Fleischmann, Roy

Annals of the rheumatic diseases

2013 Volume 73, Issue 1, Page(s) 86–94

Abstract: Objectives: To compare over 2 years the safety, efficacy and radiographic outcomes of subcutaneous abatacept versus adalimumab, in combination with methotrexate (MTX), in patients with rheumatoid arthritis (RA).: Methods: AMPLE is a phase IIIb, 2- ... ...

Abstract	Objectives: To compare over 2 years the safety, efficacy and radiographic outcomes of subcutaneous abatacept versus adalimumab, in combination with methotrexate (MTX), in patients with rheumatoid arthritis (RA). Methods: AMPLE is a phase IIIb, 2-year, randomised, investigator-blinded study with a 1-year primary endpoint. Biologic-naive patients with active RA and an inadequate response to MTX were randomised to 125 mg abatacept weekly or 40 mg adalimumab bi-weekly, both with a stable dose of MTX. Results: Of 646 patients randomised, 79.2% abatacept and 74.7% adalimumab patients completed year 2. At year 2, efficacy outcomes, including radiographic, remained comparable between groups and with year 1 results. The American College Rheumatology 20, 50 and 70 responses at year 2 were 59.7%, 44.7% and 31.1% for abatacept and 60.1%, 46.6% and 29.3% for adalimumab. There were similar rates of adverse events (AEs) and serious adverse events (SAEs). More serious infections occurred with adalimumab (3.8% vs 5.8%) including two cases of tuberculosis with adalimumab. There were fewer discontinuations due to AEs (3.8% vs 9.5%), SAEs (1.6% vs 4.9%) and serious infections (0/12 vs 9/19 patients) in the abatacept group. Injection site reactions (ISRs) occurred less frequently with abatacept (4.1% vs 10.4%). Conclusions: Through 2 years of blinded treatment in this first head-to-head study between biologic disease-modifying antirheumatic drugs in RA patients with an inadequate response to MTX, subcutaneous abatacept and adalimumab were similarly efficacious based on clinical, functional and radiographic outcomes. Overall, AE frequency was similar in both groups but there were less discontinuations due to AEs, SAEs, serious infections and fewer local ISRs with abatacept.
MeSH term(s)	Abatacept ; Adalimumab ; Adult ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antirheumatic Agents/administration & dosage ; Antirheumatic Agents/adverse effects ; Arthritis, Rheumatoid/diagnosis ; Arthritis, Rheumatoid/drug therapy ; Drug Therapy, Combination ; Female ; Humans ; Immunoconjugates/administration & dosage ; Immunoconjugates/adverse effects ; Injections, Subcutaneous ; Male ; Methotrexate/administration & dosage ; Methotrexate/adverse effects ; Middle Aged ; Treatment Outcome
Chemical Substances	Antibodies, Monoclonal, Humanized ; Antirheumatic Agents ; Immunoconjugates ; Abatacept (7D0YB67S97) ; Adalimumab (FYS6T7F842) ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2013-08-20
Publishing country	England
Document type	Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	7090-7
ISSN	1468-2060 ; 0003-4967
ISSN (online)	1468-2060
ISSN	0003-4967
DOI	10.1136/annrheumdis-2013-203843
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Article ; Online: Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study.

Weinblatt, Michael E / Schiff, Michael / Valente, Robert / van der Heijde, Désirée / Citera, Gustavo / Zhao, Cathy / Maldonado, Michael / Fleischmann, Roy

Arthritis and rheumatism

2012 Volume 65, Issue 1, Page(s) 28–38

Abstract: Objective: There is a need for comparative studies to provide evidence-based treatment guidance for biologic agents in rheumatoid arthritis (RA). Therefore, this study was undertaken as the first head-to-head comparison of subcutaneous (SC) abatacept ... ...

Abstract	Objective: There is a need for comparative studies to provide evidence-based treatment guidance for biologic agents in rheumatoid arthritis (RA). Therefore, this study was undertaken as the first head-to-head comparison of subcutaneous (SC) abatacept and SC adalimumab, both administered along with background methotrexate (MTX), for the treatment of RA. Methods: Patients with active RA who were naive to treatment with biologic agents and had an inadequate response to MTX were randomly assigned to receive 125 mg SC abatacept weekly or 40 mg SC adalimumab biweekly, both given in combination with MTX, in a 2-year study. The primary end point was treatment noninferiority, assessed according to the American College of Rheumatology 20% improvement response (ACR20) at 1 year. Results: Of the 646 patients who were randomized and treated, 86.2% receiving SC abatacept and 82% receiving SC adalimumab completed 12 months of treatment. At 1 year, 64.8% of patients in the SC abatacept group and 63.4% in the SC adalimumab group demonstrated an ACR20 response; the estimated difference between groups was 1.8% (95% confidence interval -5.6%, 9.2%), thus demonstrating the noninferiority of abatacept compared to adalimumab. All efficacy measures showed similar results and kinetics of response between treatments. The rate of radiographic nonprogression (defined as a total modified Sharp/van der Heijde score [SHS] less than or equal to the smallest detectable change) was 84.8% for SC abatacept-treated patients and 88.6% for SC adalimumab-treated patients, while the mean change from baseline in the total SHS was 0.58 and 0.38, respectively. In the SC abatacept and SC adalimumab groups, the incidence of serious adverse events (SAEs) was 10.1% and 9.1%, respectively, and the rate of serious infections was 2.2% and 2.7%, respectively. In patients treated with SC abatacept, the frequency of discontinuations due to AEs was 3.5% and discontinuations due to SAEs was 1.3%, while in patients treated with SC adalimumab, the frequencies were 6.1% and 3%, respectively. Injection site reactions occurred in 3.8% of patients receiving SC abatacept compared to 9.1% of patients receiving SC adalimumab (P=0.006). Conclusion: The results demonstrate that SC abatacept and SC adalimumab have comparable efficacy in patients with RA, as shown by similar kinetics of response and comparable inhibition of radiographic progression over 1 year of treatment. The safety was generally similar, other than the occurrence of significantly more local injection site reactions in patients treated with SC adalimumab.
MeSH term(s)	Abatacept ; Adalimumab ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Antirheumatic Agents/administration & dosage ; Antirheumatic Agents/adverse effects ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; Female ; Humans ; Immunoconjugates/administration & dosage ; Immunoconjugates/adverse effects ; Immunoconjugates/therapeutic use ; Male ; Methotrexate/administration & dosage ; Methotrexate/adverse effects ; Methotrexate/therapeutic use ; Middle Aged ; Prospective Studies ; Treatment Outcome ; Young Adult
Chemical Substances	Antibodies, Monoclonal, Humanized ; Antirheumatic Agents ; Immunoconjugates ; Abatacept (7D0YB67S97) ; Adalimumab (FYS6T7F842) ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2012-11-20
Publishing country	United States
Document type	Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	127294-9
ISSN	1529-0131 ; 0004-3591 ; 2326-5191
ISSN (online)	1529-0131
ISSN	0004-3591 ; 2326-5191
DOI	10.1002/art.37711
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Article ; Online: Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX.

Choy, Ernest / McKenna, Frank / Vencovsky, Jiri / Valente, Robert / Goel, Niti / Vanlunen, Brenda / Davies, Owen / Stahl, Hans-Detlev / Alten, Rieke

Rheumatology (Oxford, England)

2012 Volume 51, Issue 7, Page(s) 1226–1234

Abstract: Objective: Certolizumab pegol (CZP) is known to be effective as monotherapy at a dosage of 400 mg every 4 weeks in patients with active RA who have failed DMARDs. The aim of this study was to investigate every 4-week CZP in addition to continued MTX ... ...

Abstract	Objective: Certolizumab pegol (CZP) is known to be effective as monotherapy at a dosage of 400 mg every 4 weeks in patients with active RA who have failed DMARDs. The aim of this study was to investigate every 4-week CZP in addition to continued MTX therapy in patients with an inadequate response to MTX alone. Methods: Patients with active RA with inadequate response to MTX, on background MTX, were randomized to double-blind treatment with CZP 400 mg or placebo every 4 weeks for 24 weeks (NCT00544154). The primary efficacy end-point was the ACR 20% improvement criteria (ACR20) response rate at Week 24. Other end-points included ACR50 and ACR70 response rates, ACR core components, 28-joint DAS (ESR) with three variables (DAS28-3) and health-related quality-of-life outcomes in addition to safety. Results: Of 247 randomized patients, 126 received CZP and 121 received placebo, in addition to MTX. ACR20 response rates were 45.9 vs 22.9%, respectively [P < 0.001 analysed by the Cochran-Mantel-Haenszel (CMH) method], with improvements being apparent from Week 1. Statistically significant improvements over placebo were seen with CZP for ACR50, ACR core components, DAS28-3 and physical functioning. Rates of treatment-related adverse events were similar between groups (25.0 vs 27.7%), and there were no deaths or serious opportunistic infections. Conclusion: CZP 400 mg every 4 weeks plus MTX demonstrated a favourable risk-benefit profile with rapid onset of action in RA patients with an inadequate response to an earlier MTX therapy.
MeSH term(s)	Adolescent ; Adult ; Aged ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antirheumatic Agents/administration & dosage ; Arthritis, Rheumatoid/diagnosis ; Arthritis, Rheumatoid/drug therapy ; Certolizumab Pegol ; Disease Progression ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Follow-Up Studies ; Humans ; Immunoglobulin Fab Fragments/administration & dosage ; Immunologic Factors/administration & dosage ; Male ; Methotrexate/administration & dosage ; Middle Aged ; Polyethylene Glycols/administration & dosage ; Quality of Life ; Retrospective Studies ; Time Factors ; Treatment Outcome ; Young Adult
Chemical Substances	Antibodies, Monoclonal, Humanized ; Antirheumatic Agents ; Immunoglobulin Fab Fragments ; Immunologic Factors ; Polyethylene Glycols (30IQX730WE) ; Certolizumab Pegol (UMD07X179E) ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2012-07
Publishing country	England
Document type	Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1464822-2
ISSN	1462-0332 ; 1462-0324
ISSN (online)	1462-0332
ISSN	1462-0324
DOI	10.1093/rheumatology/ker519
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Conference proceedings: Clinical responses by baseline RA disease duration in the AMPLE (abatacept versus adalimumab comparison in biologic-naïve RA patients with background methotrexate) trial: 2-year results

Schiff, Michael / Weinblatt, M.E. / Valente, Robert M. / van der Heijde, Desiree / Citera, Gustavo / Maldonado, Michael / Fay, J. / Fleischmann, R.

2014 , Page(s) RA.11

Event/congress	42. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 28. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 24. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR); Düsseldorf; ; Gesellschaft für Kinder- und Jugendrheumatologie; 2014
Keywords	Medizin, Gesundheit ; abatacept ; clinical response
Publishing date	2014-09-12
Publisher	German Medical Science GMS Publishing House; Düsseldorf
Document type	Conference proceedings
DOI	10.3205/14dgrh136
Database	German Medical Science

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Article ; Online: Toll-like receptor 7 stimulates the expression of Epstein-Barr virus latent membrane protein 1.

Valente, Robert M / Ehlers, Erica / Xu, Dongsheng / Ahmad, Humera / Steadman, Andrew / Blasnitz, Laura / Zhou, You / Kastanek, Lisa / Meng, Bin / Zhang, Luwen

PloS one

2012 Volume 7, Issue 8, Page(s) e43317

Abstract: Epstein-Barr virus (EBV) is a ubiquitous human herpesvirus. Toll-like receptor 7 (TLR7) is involved in host innate immunity against pathogens, and its aberrant activation is linked to the development of systemic lupus erythematosus (SLE, also called " ... ...

Abstract	Epstein-Barr virus (EBV) is a ubiquitous human herpesvirus. Toll-like receptor 7 (TLR7) is involved in host innate immunity against pathogens, and its aberrant activation is linked to the development of systemic lupus erythematosus (SLE, also called "lupus"). Type I interferons (IFN) are apparently driving forces for lupus pathogenesis. Previously, we found that EBV latent membrane protein 1 (LMP1) primes cells for IFN production. In this report, the relationship among EBV LMP1, TLRs, and IFN production are examined. We find that TLR7 activation increases the expression of EBV LMP1, and IFN regulatory factor 7 (IRF7) is involved in the stimulation process. TLR7 activation did not induce IFNs from EBV-infected cells, but potentiates those cells for IFN production by TLR3 or TLR9 activation. In addition, we find that LMP1 and IFNs are co-expressed in the same cells in some lupus patients. Therefore, the aberrant activation of TLR7 might induce LMP1 expression and LMP1-expression cells may be producing IFNs in lupus patients. These results suggest EBV might be an exacerbating factor in some lupus patients via promoting IFN production.
MeSH term(s)	Cell Line, Tumor ; Gene Expression Regulation, Viral ; HEK293 Cells ; Herpesvirus 4, Human/metabolism ; Humans ; Immunohistochemistry/methods ; Interferon-alpha/metabolism ; Interferons/metabolism ; Leukocytes, Mononuclear/cytology ; Lupus Erythematosus, Systemic/metabolism ; Models, Biological ; Response Elements ; Sendai virus/metabolism ; Toll-Like Receptor 7/metabolism ; Transfection ; Viral Matrix Proteins/metabolism
Chemical Substances	EBV-associated membrane antigen, Epstein-Barr virus ; Interferon-alpha ; Toll-Like Receptor 7 ; Viral Matrix Proteins ; Interferons (9008-11-1)
Language	English
Publishing date	2012-08-31
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0043317
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Article: Subcutaneous abatacept for the treatment of rheumatoid arthritis: longterm data from the ACQUIRE trial.

Genovese, Mark C / Tena, César Pacheco / Covarrubias, Arturo / Leon, Gustavo / Mysler, Eduardo / Keiserman, Mauro / Valente, Robert / Nash, Peter / Simon-Campos, J Abraham / Box, Jane / Legerton, Clarence William / Nasonov, Evgeny / Durez, Patrick / Delaet, Ingrid / Teng, Julie / Alten, Rieke

The Journal of rheumatology

2014 Volume 41, Issue 4, Page(s) 629–639

Abstract: 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 ... ...

Abstract	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).
MeSH term(s)	Abatacept ; Adult ; Antirheumatic Agents/administration & dosage ; Antirheumatic Agents/adverse effects ; Arthritis, Rheumatoid/diagnosis ; Arthritis, Rheumatoid/drug therapy ; Confidence Intervals ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Follow-Up Studies ; Humans ; Immunoconjugates/administration & dosage ; Immunoconjugates/adverse effects ; Injections, Intravenous ; Injections, Subcutaneous ; Male ; Maximum Tolerated Dose ; Methotrexate/administration & dosage ; Methotrexate/adverse effects ; Middle Aged ; Pain Measurement ; Patient Safety ; Risk Assessment ; Severity of Illness Index ; Time Factors ; Treatment Outcome
Chemical Substances	Antirheumatic Agents ; Immunoconjugates ; Abatacept (7D0YB67S97) ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2014-04
Publishing country	Canada
Document type	Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	194928-7
ISSN	1499-2752 ; 0315-162X
ISSN (online)	1499-2752
ISSN	0315-162X
DOI	10.3899/jrheum.130112
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Current Therapies for Systemic Vasculitis

Valente, Robert M. / Conn, Doyt L.

Seminars in Neurology

1994 Volume 14, Issue 04, Page(s) 380–386

Language	English
Publishing date	1994-12-01
Publishing place	Stuttgart ; New York
Document type	Article
ZDB-ID	603165-1
ISSN	1098-9021 ; 0271-8235
ISSN (online)	1098-9021
ISSN	0271-8235
DOI	10.1055/s-2008-1041098
Database	Thieme publisher's database

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