azathioprine has been researched along with Neutropenia in 35 studies
Azathioprine: An immunosuppressive agent used in combination with cyclophosphamide and hydroxychloroquine in the treatment of rheumatoid arthritis. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), this substance has been listed as a known carcinogen. (Merck Index, 11th ed)
azathioprine : A thiopurine that is 6-mercaptopurine in which the mercapto hydrogen is replaced by a 1-methyl-4-nitroimidazol-5-yl group. It is a prodrug for mercaptopurine and is used as an immunosuppressant, prescribed for the treatment of inflammatory conditions and after organ transplantation and also for treatment of Crohn's didease and MS.
Neutropenia: A decrease in the number of NEUTROPHILS found in the blood.
Excerpt | Relevance | Reference |
---|---|---|
"We evaluated the clinical and hematologic response to methotrexate (MTX) in 4 women with Felty's syndrome (FS) who had had neutropenia for 1-3 years." | 7.67 | Reversal of neutropenia with methotrexate treatment in patients with Felty's syndrome. Correlation of response with neutrophil-reactive IgG. ( Fiechtner, JJ; Miller, DR; Starkebaum, G, 1989) |
"Azathioprine (AZA) was added for remission-maintenance therapy." | 5.48 | Neutropenia related to an azathioprine metabolic disorder induced by an inosine triphosphate pyrophosphohydrolase (ITPA) gene mutation in a patient with PR3-ANCA-positive microscopic polyangiitis . ( Hasegawa, T; Honda, K; Ishizuka, S; Ito, S; Kobayashi, A; Komine, K; Kubota, T; Motoi, Y; Niikura, T; Saito, Z; Sasaki, T; Yamamoto, H; Yokoo, T, 2018) |
"Azathioprine (AZA) is a thiopurine prodrug which is widely used in patients with inflammatory bowel disease (IBD)." | 5.42 | The impact of glutathione S-transferase genotype and phenotype on the adverse drug reactions to azathioprine in patients with inflammatory bowel diseases. ( Bi, H; Ding, L; Gao, X; Hu, P; Huang, M; Liu, H; Zhang, F; Zhang, Y, 2015) |
"Neutropenia was ameliorated with use of granulocyte colony-stimulating factor." | 5.37 | Infliximab- and azathioprine-related severe neutropenia and thrombocytopenia in a case with Crohn's disease. ( Alkim, C; Alkim, H; Altinkaya, E; Boğa, S; Buğdaci, MS; Köksal, AR; Özdoğan, O; Sökmen, M, 2011) |
"Azathioprine is an effective treatment for maintaining remission in inflammatory bowel disease (IBD)." | 5.31 | Is neutropenia required for effective maintenance of remission during azathioprine therapy in inflammatory bowel disease? ( Campbell, S; Ghosh, S, 2001) |
"Our work supports the strong evidence that individuals with TPMT variant homozygosity are at high risk of severe neutropenia, whereas TPMT heterozygotes are not at increased risk of ADRs at standard doses of azathioprine." | 5.15 | A pragmatic randomized controlled trial of thiopurine methyltransferase genotyping prior to azathioprine treatment: the TARGET study. ( Alder, JE; Andrews, J; Bruce, I; Elles, R; Elliott, RA; Fargher, E; Griffiths, CE; Heise, M; Houston, JB; Newman, WG; Ollier, WE; Payne, D; Payne, K; Pushpakom, S; Qasim, F; Ramsden, SC; Ray, DW; Roberts, SA; Shaffer, J; Sidgwick, GP; Tricker, K, 2011) |
" We investigated whether exposure to cyclophosphamide in patients with generalized vasculitis could be reduced by substitution of azathioprine at remission." | 5.10 | A randomized trial of maintenance therapy for vasculitis associated with antineutrophil cytoplasmic autoantibodies. ( Andrassy, K; Bacon, P; Dadoniené, J; de Groot, K; Ekstrand, A; Gaskin, G; Gregorini, G; Gross, W; Hagen, EC; Jayne, D; Mirapeix, E; Pettersson, E; Pusey, C; Rasmussen, N; Siegert, C; Sinico, A; Tervaert, JW; Tesar, V; Westman, K, 2003) |
" Detecting TPMT genetic variants before the administration of azathioprine (AZA) has the potential to prevent serious and costly adverse drug reactions (ADRs), such as neutropenia." | 4.84 | Avoiding adverse drug reactions by pharmacogenetic testing: a systematic review of the economic evidence in the case of TPMT and AZA-induced side effects. ( Bartoli, S; Buehrlen, B; Compagni, A; de Mesa, EG; Fattore, G; Ibarreta, D, 2008) |
"The aim of this research is to study the prevalence of TPMT mutation in Indian patients requiring immunomodulator therapy and its relation to the development of neutropenia on azathioprine therapy." | 3.80 | Prevalence of TPMT polymorphism in Indian patients requiring immunomodulator therapy and its clinical significance. ( Abraham, P; Ashavaid, T; Davavala, SK; Desai, DC; Gupta, T; Joshi, A, 2014) |
"The study compared the preferences of patients and health-care professionals for the key attributes of a pharmacogenetic testing service to identify a patient's risk of developing a side effect (neutropenia) from the immunosuppressant, azathioprine." | 3.77 | Valuing pharmacogenetic testing services: a comparison of patients' and health care professionals' preferences. ( Elliott, RA; Fargher, EA; Newman, WG; Payne, K; Ratcliffe, J; Roberts, SA; Tricker, K, 2011) |
" Events included eight patients with malignancies, two with pancytopenia taking methotrexate, three with septic arthritis, and two with septicaemias." | 3.71 | Monitoring and assessing the safety of disease-modifying antirheumatic drugs: a West Midlands experience. ( Bevan, J; Homer, D; Jobanputra, P; Maggs, F, 2002) |
" Azathioprine was generally well tolerated, but 11 drug-associated neutropenias were detected." | 3.70 | Identification of thiopurine methyltransferase (TPMT) polymorphisms cannot predict myelosuppression in systemic lupus erythematosus patients taking azathioprine. ( Battaglia, E; Botto, M; Naughton, MA; O'Brien, S; Walport, MJ, 1999) |
"Azathioprine, a cytostatic and immunosuppressive drug in use for some 30 years, can give rise to life-threatening neutropenia and thrombocytopenia." | 3.70 | [Bone marrow depression after azathioprine. New discoveries on an old drug]. ( Lindstedt, G; Löwhagen, GB, 2000) |
" Indications for the procedure were (1) prevention of azathioprine-induced neutropenia (n = 20); (2) Type I Gaucher disease (n = 9); and (3) cholesteryl ester storage disease, chronic myelogenous leukemia, thalassemia major, and splenic cyst in one patient each." | 3.68 | Elective subtotal splenectomy. Indications and results in 33 patients. ( Barton, N; Guzzetta, PC; Merrick, HF; Ruley, EJ; Verderese, C, 1990) |
"We evaluated the clinical and hematologic response to methotrexate (MTX) in 4 women with Felty's syndrome (FS) who had had neutropenia for 1-3 years." | 3.67 | Reversal of neutropenia with methotrexate treatment in patients with Felty's syndrome. Correlation of response with neutrophil-reactive IgG. ( Fiechtner, JJ; Miller, DR; Starkebaum, G, 1989) |
"Patients with end-stage renal disease who develop hypersplenism, patients with mild neutropenia, and those patients whose WBC fails to increase in response to cortisol administration will develop significant neutropenia following transplantation with routine doses of azathioprine." | 3.66 | Partial splenic ablation in preparation for renal transplantation in children. ( Broadman, L; Guzzetta, PC; Potter, BM; Ruley, EJ; Stolar, CH, 1983) |
" Fortunately, the absolute incidence of serious toxicity remains low, and an improved understanding of how best to minimize risk and the recognition of groups of patients at higher risk of toxicity from thiopurines means that they remain a relatively safe therapy in the majority of patients." | 2.52 | Toxicity and response to thiopurines in patients with inflammatory bowel disease. ( Goldberg, R; Irving, PM, 2015) |
"LON was not observed in minimal change disease or focal segmental glomerulosclerosis." | 1.62 | Incidence, Clinical Features, and Outcomes of Late-Onset Neutropenia From Rituximab for Autoimmune Disease. ( Cortazar, FB; Huizenga, NR; Laliberte, K; Niles, JL; Rhee, EP; Rosenthal, JM; Wallace, ZS; Zonozi, R, 2021) |
"Azathioprine (AZA) was added for remission-maintenance therapy." | 1.48 | Neutropenia related to an azathioprine metabolic disorder induced by an inosine triphosphate pyrophosphohydrolase (ITPA) gene mutation in a patient with PR3-ANCA-positive microscopic polyangiitis . ( Hasegawa, T; Honda, K; Ishizuka, S; Ito, S; Kobayashi, A; Komine, K; Kubota, T; Motoi, Y; Niikura, T; Saito, Z; Sasaki, T; Yamamoto, H; Yokoo, T, 2018) |
"Azathioprine (AZA) is a thiopurine prodrug which is widely used in patients with inflammatory bowel disease (IBD)." | 1.42 | The impact of glutathione S-transferase genotype and phenotype on the adverse drug reactions to azathioprine in patients with inflammatory bowel diseases. ( Bi, H; Ding, L; Gao, X; Hu, P; Huang, M; Liu, H; Zhang, F; Zhang, Y, 2015) |
"Neutropenia was ameliorated with use of granulocyte colony-stimulating factor." | 1.37 | Infliximab- and azathioprine-related severe neutropenia and thrombocytopenia in a case with Crohn's disease. ( Alkim, C; Alkim, H; Altinkaya, E; Boğa, S; Buğdaci, MS; Köksal, AR; Özdoğan, O; Sökmen, M, 2011) |
" Drug-induced neutropenia, especially MMF-induced neutropenia, was suspected, and the dosage of MMF was reduced." | 1.36 | Mycophenolate mofetil-induced agranulocytosis in a renal transplant recipient. ( Chikaraishi, T; Kimura, K; Matsui, K; Sasaki, H; Shibagaki, Y; Yasuda, T, 2010) |
"Azathioprine is an effective treatment for maintaining remission in inflammatory bowel disease (IBD)." | 1.31 | Is neutropenia required for effective maintenance of remission during azathioprine therapy in inflammatory bowel disease? ( Campbell, S; Ghosh, S, 2001) |
"Cyclic neutropenia is a rare hematologic disorder of unknown origin." | 1.30 | [Recurrent episodes of ulcerative gingivostomatitis associated with cyclic neutropenia]. ( Djawari, J; Sucker, C, 1999) |
" Four weeks after discontinuation of azathioprine, 1 treated cat again was given azathioprine at a lower dosage (1." | 1.28 | Systemic toxicosis associated with azathioprine administration in domestic cats. ( Altman, D; Beale, KM; Bolon, B; Clemmons, RR, 1992) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 5 (14.29) | 18.7374 |
1990's | 7 (20.00) | 18.2507 |
2000's | 12 (34.29) | 29.6817 |
2010's | 9 (25.71) | 24.3611 |
2020's | 2 (5.71) | 2.80 |
Authors | Studies |
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Chen, S | 1 |
Tan, WZ | 1 |
Sutiman, N | 1 |
Lim, C | 1 |
Lee, SS | 1 |
Leong, WF | 1 |
Tjai, M | 1 |
Wang, C | 1 |
Kong, CSC | 1 |
Chuah, SW | 1 |
Schwender, BJ | 1 |
Chan, W | 1 |
Shim, HH | 1 |
Lim, WC | 1 |
Khor, CC | 1 |
Ling, KL | 1 |
Chowbay, B | 1 |
Zonozi, R | 1 |
Wallace, ZS | 1 |
Laliberte, K | 1 |
Huizenga, NR | 1 |
Rosenthal, JM | 1 |
Rhee, EP | 1 |
Cortazar, FB | 1 |
Niles, JL | 1 |
Hon, KL | 1 |
Chang, M | 1 |
Chong, SC | 1 |
Yuen, YP | 1 |
Tsui, SKW | 1 |
Honda, K | 1 |
Kobayashi, A | 1 |
Niikura, T | 1 |
Hasegawa, T | 1 |
Saito, Z | 1 |
Ito, S | 1 |
Sasaki, T | 1 |
Komine, K | 1 |
Ishizuka, S | 1 |
Motoi, Y | 1 |
Kubota, T | 1 |
Yamamoto, H | 1 |
Yokoo, T | 1 |
Davavala, SK | 1 |
Desai, DC | 1 |
Abraham, P | 1 |
Ashavaid, T | 1 |
Joshi, A | 1 |
Gupta, T | 1 |
Goldberg, R | 1 |
Irving, PM | 1 |
Liu, H | 1 |
Ding, L | 1 |
Zhang, F | 1 |
Zhang, Y | 1 |
Gao, X | 1 |
Hu, P | 1 |
Bi, H | 1 |
Huang, M | 1 |
Compagni, A | 1 |
Bartoli, S | 1 |
Buehrlen, B | 1 |
Fattore, G | 1 |
Ibarreta, D | 1 |
de Mesa, EG | 1 |
Park, TS | 1 |
Cheong, JW | 1 |
Song, J | 1 |
Lee, KA | 1 |
Lee, SG | 1 |
Kim, J | 1 |
Yoon, S | 1 |
Choi, JR | 1 |
Park, R | 1 |
Matsui, K | 1 |
Shibagaki, Y | 1 |
Sasaki, H | 1 |
Chikaraishi, T | 1 |
Yasuda, T | 1 |
Kimura, K | 1 |
Payne, K | 2 |
Fargher, EA | 1 |
Roberts, SA | 2 |
Tricker, K | 2 |
Elliott, RA | 2 |
Ratcliffe, J | 1 |
Newman, WG | 2 |
Fargher, E | 1 |
Pushpakom, S | 1 |
Alder, JE | 1 |
Sidgwick, GP | 1 |
Payne, D | 1 |
Heise, M | 1 |
Elles, R | 1 |
Ramsden, SC | 1 |
Andrews, J | 1 |
Houston, JB | 1 |
Qasim, F | 1 |
Shaffer, J | 1 |
Griffiths, CE | 1 |
Ray, DW | 1 |
Bruce, I | 1 |
Ollier, WE | 1 |
Köksal, AR | 1 |
Alkim, C | 1 |
Altinkaya, E | 1 |
Buğdaci, MS | 1 |
Özdoğan, O | 1 |
Boğa, S | 1 |
Alkim, H | 1 |
Sökmen, M | 1 |
Evans, WE | 1 |
Schwab, M | 1 |
Schäffeler, E | 1 |
Marx, C | 1 |
Fischer, C | 1 |
Lang, T | 1 |
Behrens, C | 1 |
Gregor, M | 1 |
Eichelbaum, M | 1 |
Zanger, UM | 1 |
Kaskas, BA | 1 |
Jobanputra, P | 1 |
Maggs, F | 1 |
Homer, D | 1 |
Bevan, J | 1 |
Jayne, D | 1 |
Rasmussen, N | 1 |
Andrassy, K | 1 |
Bacon, P | 1 |
Tervaert, JW | 1 |
Dadoniené, J | 1 |
Ekstrand, A | 1 |
Gaskin, G | 1 |
Gregorini, G | 1 |
de Groot, K | 1 |
Gross, W | 1 |
Hagen, EC | 1 |
Mirapeix, E | 1 |
Pettersson, E | 1 |
Siegert, C | 1 |
Sinico, A | 1 |
Tesar, V | 1 |
Westman, K | 1 |
Pusey, C | 1 |
Reale, LD | 1 |
Besa, EC | 1 |
Richard, VS | 1 |
Al-Ismail, D | 1 |
Salamat, A | 1 |
Bastida Paz, G | 1 |
Nos Mateu, P | 1 |
Aguas Peris, M | 1 |
Beltrán Niclós, B | 1 |
Rodríguez Soler, M | 1 |
Ponce García, J | 1 |
Guzzetta, PC | 2 |
Stolar, CH | 1 |
Potter, BM | 1 |
Broadman, L | 1 |
Ruley, EJ | 2 |
Bradley, PP | 1 |
Warden, GD | 1 |
Maxwell, JG | 1 |
Rothstein, G | 1 |
Jackson, AP | 1 |
Hall, AG | 1 |
McLelland, J | 1 |
Naughton, MA | 1 |
Battaglia, E | 1 |
O'Brien, S | 1 |
Walport, MJ | 1 |
Botto, M | 1 |
Sucker, C | 1 |
Djawari, J | 1 |
Löwhagen, GB | 1 |
Lindstedt, G | 1 |
Persley, KM | 1 |
Present, DH | 1 |
Campbell, S | 1 |
Ghosh, S | 1 |
Francis, GE | 1 |
Kennedy, PG | 1 |
Hoffbrand, BI | 1 |
Berney, JJ | 1 |
Hoffbrand, AV | 1 |
Bergan, T | 1 |
Beale, KM | 1 |
Altman, D | 1 |
Clemmons, RR | 1 |
Bolon, B | 1 |
Frankel, AH | 1 |
Barker, F | 1 |
Williams, G | 1 |
Benjamin, IS | 1 |
Lechler, R | 1 |
Rees, AJ | 1 |
Merrick, HF | 1 |
Verderese, C | 1 |
Barton, N | 1 |
Mathieson, PW | 1 |
O'Neill, JH | 1 |
Durrant, ST | 1 |
Henderson, SJ | 1 |
Green, PJ | 1 |
Newsom-Davis, J | 1 |
Fiechtner, JJ | 1 |
Miller, DR | 1 |
Starkebaum, G | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Maintenance of ANCA Vasculitis Remission by Intermittent Rituximab Dosing Based on B-cell Reconstitution vs a Serologic ANCA Flare[NCT02749292] | Phase 4 | 115 participants (Actual) | Interventional | 2016-06-30 | Terminated (stopped due to Due to the coronavirus disease 2019 (COVID-19) pandemic and the deleterious impact of rituximab on vaccination efficacy, the trial was concluded before reaching the target enrollment of 200.) | ||
An International, Open Label, Randomised Controlled Trial Comparing Rituximab With Azathioprine as Maintenance Therapy in Relapsing ANCA-associated Vasculitis[NCT01697267] | Phase 3 | 188 participants (Actual) | Interventional | 2013-04-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Number of disease relapse added with the number of SAE in each group (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)
Intervention | Number of events (Number) |
---|---|
B Cell Reconstitution | 27 |
Serologic ANCA Flare | 36 |
The rituximab utilization was measured in how many times a subject received Rituximab throughout the study which was then averaged for all subjects in each treatment arm, including those who did not receive any infusion. (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)
Intervention | Infusions per subject (Mean) |
---|---|
B Cell Reconstitution | 3.6 |
Serologic ANCA Flare | 0.5 |
The Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG ) is a form with 34 predefined items grouped into 9 organ systems. The items are clinical features observed in patients with active ANCA vasculitis. Each item has a specified weight of either 3 or 1, depending on whether it reflects major or minor disease activity. The total BVAS/WG score is the weighted sum of individual manifestations that are present and believed to be due to active ANCA vasculitis. Higher scores reflect more active disease. BVAS/WG scores range from 0 to 64. (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)
Intervention | number of events (Number) |
---|---|
B Cell Reconstitution | 4 |
Serologic ANCA Flare | 7 |
Number of patients with serious adverse events (SAEs), including all episodes of late onset neutropenia (LON). SAE are defined in the Serious adverse event section. Serious adverse events were reported over the entire study period (5.5 years) (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)
Intervention | Participants (Count of Participants) |
---|---|
B Cell Reconstitution | 15 |
Serologic ANCA Flare | 14 |
Hypogammaglobulinemia defined as an IgG < 250mg/dL (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)
Intervention | Participants (Count of Participants) |
---|---|
B Cell Reconstitution | 1 |
Serologic ANCA Flare | 0 |
number of deaths throughout the study. (NCT02749292)
Timeframe: 5.5 years
Intervention | number of deaths (Number) |
---|---|
B Cell Reconstitution | 2 |
Serologic ANCA Flare | 0 |
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. (NCT02749292)
Timeframe: Assessed throughout the study period, every 6 months unless such time point was not reached or was missed by the patient. Median follow-up period is of 4.1 years (IQR, 2.5 - 5.0)
Intervention | score on a scale (Mean) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Physical functioning at 6 months | Role functioning/physical at 6 months | Role functioning/emotional at 6 months | Energy/fatigue at 6 months | Emotional well-being at 6 months | Social functioning at 6 months | Pain at 6 months | General health at 6 months | Physical functioning at 36 months | Role functioning/physical at 36 months | Role functioning/emotional at 36 months | Energy/fatigue at 36 months | Emotional well-being at 36 months | Social functioning at 36 months | Pain at 36 months | General health at 36 months | Physical functioning at 12 months | Role functioning/physical at 12 months | Role functioning/emotional at 12 months | Energy/ fatigue at 12 months | Emotional well-being at 12 months | Social functioning at 12 months | Pain at 12 months | General health at 12 months | Physical functioning at 18 months | Role functioning/physical at 18 months | Role functioning/emotional at 18 months | Energy/fatigue at 18 months | Emotional well-being at 18 months | Social functioning at 18 months | Pain at 18 months | General health at 18 months | Physical functioning at 24 months | Role functioning/physical at 24 months | Role functioning/emotional at 24 months | Energy/fatigue at 24 months | Emotional well-being at 24 months | Social functioning at 24 months | Pain at 24 months | General health at 24 months | Physical functioning at 30 months | Role functioning/physical at 30 months | Role functioning/emotional at 30 months | Energy/fatigue at 30 months | Emotional well-being at 30 months | Social functioning at 30 months | Pain at 30 months | General health at 30 months | Physical functioning at 42 months | Role functioning/physical at 42 months | Role functioning/emotional at 42 months | Energy/fatigue at 42 months | Emotional well-being at 42 months | Social functioning at 42 months | Pain at 42 months | General health at 42 months | Physical functioning at 48 months | Role functioning/physical at 48 months | Role functioning/emotional at 48 months | Energy/fatigue at 48 months | Emotional well-being at 48 months | Social functioning at 48 months | Pain at 48 months | General health at 48 months | Physical functioning at 60 months | Role functioning/physical at 60 months | Role functioning/emotional at 60 months | Energy/fatigue at 60 months | Emotional well-being at 60 months | Social functioning at 60 months | Pain at 60 months | General health at 60 months | |
Serologic ANCA Flare | 82 | 65 | 75 | 67 | 81 | 88 | 82 | 63 | 88 | 79 | 82 | 73 | 84 | 95 | 87 | 70 | 82 | 63 | 68 | 65 | 81 | 86 | 80 | 63 | 82 | 62 | 74 | 68 | 81 | 92 | 82 | 67 | 88 | 71 | 80 | 76 | 85 | 94 | 82 | 70 | 88 | 72 | 80 | 72 | 84 | 94 | 83 | 70 | 82 | 60 | 76 | 70 | 85 | 87 | 82 | 63 | 95 | 100 | 100 | 75 | 85 | 100 | 80 | 75 | 92 | 100 | 89 | 71 | 83 | 92 | 83 | 70 |
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. (NCT02749292)
Timeframe: Assessed throughout the study period, every 6 months unless such time point was not reached or was missed by the patient. Median follow-up period is of 4.1 years (IQR, 2.5 - 5.0)
Intervention | score on a scale (Mean) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Physical functioning at 6 months | Role functioning/physical at 6 months | Role functioning/emotional at 6 months | Energy/fatigue at 6 months | Emotional well-being at 6 months | Social functioning at 6 months | Pain at 6 months | General health at 6 months | Physical functioning at 36 months | Role functioning/physical at 36 months | Role functioning/emotional at 36 months | Energy/fatigue at 36 months | Emotional well-being at 36 months | Social functioning at 36 months | Pain at 36 months | General health at 36 months | Physical functioning at 12 months | Role functioning/physical at 12 months | Role functioning/emotional at 12 months | Energy/ fatigue at 12 months | Emotional well-being at 12 months | Social functioning at 12 months | Pain at 12 months | General health at 12 months | Physical functioning at 18 months | Role functioning/physical at 18 months | Role functioning/emotional at 18 months | Energy/fatigue at 18 months | Emotional well-being at 18 months | Social functioning at 18 months | Pain at 18 months | General health at 18 months | Physical functioning at 24 months | Role functioning/physical at 24 months | Role functioning/emotional at 24 months | Energy/fatigue at 24 months | Emotional well-being at 24 months | Social functioning at 24 months | Pain at 24 months | General health at 24 months | Physical functioning at 30 months | Role functioning/physical at 30 months | Role functioning/emotional at 30 months | Energy/fatigue at 30 months | Emotional well-being at 30 months | Social functioning at 30 months | Pain at 30 months | General health at 30 months | Physical functioning at 42 months | Role functioning/physical at 42 months | Role functioning/emotional at 42 months | Energy/fatigue at 42 months | Emotional well-being at 42 months | Social functioning at 42 months | Pain at 42 months | General health at 42 months | Physical functioning at 48 months | Role functioning/physical at 48 months | Role functioning/emotional at 48 months | Energy/fatigue at 48 months | Emotional well-being at 48 months | Social functioning at 48 months | Pain at 48 months | General health at 48 months | Physical functioning at 54 months | Role functioning/physical at 54 months | Role functioning/emotional at 54 months | Energy/fatigue at 54 months | Emotional well-being at 54 months | Social functioning at 54 months | Pain at 54 months | General health at 54 months | Physical functioning at 60 months | Role functioning/physical at 60 months | Role functioning/emotional at 60 months | Energy/fatigue at 60 months | Emotional well-being at 60 months | Social functioning at 60 months | Pain at 60 months | General health at 60 months | |
B Cell Reconstitution | 84 | 66 | 79 | 65 | 83 | 89 | 79 | 66 | 74 | 50 | 65 | 58 | 76 | 83 | 69 | 60 | 79 | 61 | 82 | 65 | 86 | 92 | 81 | 66 | 83 | 70 | 88 | 69 | 85 | 96 | 84 | 68 | 83 | 71 | 84 | 68 | 82 | 91 | 81 | 69 | 85 | 74 | 87 | 64 | 81 | 90 | 86 | 60 | 76 | 58 | 67 | 60 | 77 | 85 | 83 | 59 | 65 | 67 | 67 | 52 | 73 | 65 | 70 | 61 | 88 | 50 | 67 | 67 | 84 | 84 | 81 | 59 | 72 | 33 | 100 | 48 | 82 | 63 | 53 | 58 |
Number of infections mild and severe, whether they were treated or not with antibiotics (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)
Intervention | number of events (Number) | |
---|---|---|
Serious Adverse Events- Infections | Adverse Events- Infections | |
B Cell Reconstitution | 12 | 72 |
Serologic ANCA Flare | 6 | 59 |
Relapses recording period was from 6/1/2016 to 12/31/2021. The outcome was reported as the number of participants with disease relapse who had either positive ANCA titers specific for myeloperoxidase (MPO-ANCA) or proteinase 3 (PR3-ANCA). The Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG ) is a form with 34 predefined items grouped into 9 organ systems. The items are clinical features observed in patients with active ANCA vasculitis. Each item has a specified weight of either 3 or 1, depending on whether it reflects major or minor disease activity. The total BVAS/WG score is the weighted sum of individual manifestations that are present and believed to be due to active ANCA vasculitis. Higher scores reflect more active disease. BVAS/WG scores range from 0 to 64. (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)
Intervention | Participants (Count of Participants) | |
---|---|---|
PR3 | MPO | |
B Cell Reconstitution | 1 | 4 |
Serologic ANCA Flare | 7 | 7 |
The Vasculitis Damage Index (VDI) is a validated formal assessment tool in ANCA-associated vasculitis clinical trials. The VDI distinguishes vasculitis-induced chronic damage from active inflammation or persistent disease. Each item represents a disease manifestation and is given a score (of 1) if present for at least 3 months. Neither the cause of damage (vasculitis vs treatment) nor an ongoing activity are taken into consideration. The VDI includes 64 items categorized into 11 groups (by organ system) and the scored items are summed to give a total score ranging from 0 to 64. A higher score means more accrued damage. (NCT02749292)
Timeframe: 3 years starting at inclusion
Intervention | score on a scale (Mean) | |
---|---|---|
VDI at inclusion | VDI at 3 years | |
B Cell Reconstitution | 1.27 | 1.42 |
Serologic ANCA Flare | 1.07 | 1.08 |
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 12 months
Intervention | score on a scale (Mean) |
---|---|
Rituximab Maintenance | 50.8 |
Azathioprine Maintenance | 51.9 |
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 24 months
Intervention | score on a scale (Mean) |
---|---|
Rituximab Maintenance | 51.9 |
Azathioprine Maintenance | 53.5 |
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 36 months
Intervention | score on a scale (Mean) |
---|---|
Rituximab Maintenance | 52.3 |
Azathioprine Maintenance | 51.8 |
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 4 months
Intervention | score on a scale (Mean) |
---|---|
Rituximab Maintenance | 51.8 |
Azathioprine Maintenance | 51.0 |
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 48 months
Intervention | score on a scale (Mean) |
---|---|
Rituximab Maintenance | 50.9 |
Azathioprine Maintenance | 53.9 |
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 12 months
Intervention | score on a scale (Mean) |
---|---|
Rituximab Maintenance | 38.2 |
Azathioprine Maintenance | 34.6 |
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 24 months
Intervention | score on a scale (Mean) |
---|---|
Rituximab Maintenance | 36.7 |
Azathioprine Maintenance | 35.6 |
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 36 months
Intervention | score on a scale (Mean) |
---|---|
Rituximab Maintenance | 34.6 |
Azathioprine Maintenance | 33.8 |
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 4 months
Intervention | score on a scale (Mean) |
---|---|
Rituximab Maintenance | 36.7 |
Azathioprine Maintenance | 36.1 |
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. (NCT01697267)
Timeframe: 48 months
Intervention | score on a scale (Mean) |
---|---|
Rituximab Maintenance | 35.8 |
Azathioprine Maintenance | 35.0 |
Infection (treated with intravenous or oral antibiotics) rates (NCT01697267)
Timeframe: Up to 4 years
Intervention | Participants (Count of Participants) |
---|---|
Rituximab Maintenance | 54 |
Azathioprine Maintenance | 62 |
Severe adverse event (SAE) rate (NCT01697267)
Timeframe: Up to 48 months
Intervention | Participants (Count of Participants) |
---|---|
Rituximab Maintenance | 37 |
Azathioprine Maintenance | 48 |
Cumulative accrual of damage as measured by the combined damage assessment score (CDA). Each persistent or new occurrence of damage is given a score of 1. The cumulative accrual of damage is obtained by summing across the different types of damage to get an overall score (max score = 64). (NCT01697267)
Timeframe: data in Rows represent the change from randomization (month 4) to months 12, 24, 36, and 48.
Intervention | score on a scale (Mean) | |||
---|---|---|---|---|
Randomisation to month 12 | Randomisation to month 24 | Randomisation to month 36 | Randomisation to month 48 | |
Azathioprine Maintenance | 0.337 | 0.533 | 0.899 | 1.38 |
Rituximab Maintenance | 0.275 | 0.571 | 0.676 | 1.09 |
Cumulative glucocorticoid (GC) exposure during the trial. The trial had a common close out date when the final patient reached month 36 in the trial. Patients were followed until month 48 or the common close out date, whichever happened sooner. Therefore, follow up varied between 36 and 48 months. Cumulative glucocorticoid exposure is presented as a dose in mg for during the treatment period (up to month 24) and across the whole trial (until month 48 or common close out when the final patient reached month 36). (NCT01697267)
Timeframe: Up to 48 months
Intervention | mg (Mean) | |
---|---|---|
Overall (randomisation to end of trial) | Maintenance treatment period (randomisation to month 24) | |
Azathioprine Maintenance | 4780 | 2426 |
Rituximab Maintenance | 3717 | 2184 |
Proportion of patients who maintain remission at 24 and 48 months (NCT01697267)
Timeframe: 24 and 48 months
Intervention | Participants (Count of Participants) | |
---|---|---|
Month 24 | Month 48 | |
Azathioprine Maintenance | 70 | 44 |
Rituximab Maintenance | 73 | 54 |
The primary efficacy outcome measure of the trial is relapse-free survival, where a relapse is either major or minor. The primary analysis will be a Cox regression model adjusted for the stratification factors (ANCA type, relapse severity and prednisone induction regimen) for the difference in the distribution of relapse-free survival between the rituximab arm and the azathioprine (control) arm (two-sided at α-level of 5%). (NCT01697267)
Timeframe: Any patients who have not relapsed at up to a maximum of 4 years will be censored.
Intervention | participants (Number) | ||
---|---|---|---|
Total number of patients with a relapse | Total number of patients with a relapse during treatment | Total number of patients with a relapse post treatment | |
Azathioprine Maintenance | 60 | 32 | 28 |
Rituximab Maintenance | 38 | 13 | 25 |
5 reviews available for azathioprine and Neutropenia
Article | Year |
---|---|
Toxicity and response to thiopurines in patients with inflammatory bowel disease.
Topics: Azathioprine; Chemical and Drug Induced Liver Injury; Colitis, Ulcerative; Crohn Disease; Humans; Im | 2015 |
Avoiding adverse drug reactions by pharmacogenetic testing: a systematic review of the economic evidence in the case of TPMT and AZA-induced side effects.
Topics: Azathioprine; Biotransformation; Cost-Benefit Analysis; Genetic Variation; Humans; Methyltransferase | 2008 |
Acute erythroleukemia with der(1;7)(q10;p10) as a sole acquired abnormality after treatment with azathioprine.
Topics: Antineoplastic Combined Chemotherapy Protocols; Azathioprine; Bone Marrow; Chromosomes, Human, Pair | 2008 |
Rituximab in autoimmune pancytopenia: a case report and review of literature.
Topics: Adult; Anemia, Hemolytic, Autoimmune; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived | 2007 |
Neutropenia is not required for clinical remission during azathioprine therapy in inflammatory bowel disease.
Topics: Azathioprine; Female; Humans; Immunosuppressive Agents; Inflammatory Bowel Diseases; Long-Term Care; | 2001 |
2 trials available for azathioprine and Neutropenia
Article | Year |
---|---|
A pragmatic randomized controlled trial of thiopurine methyltransferase genotyping prior to azathioprine treatment: the TARGET study.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Azathioprine; Drug-Related Side Effects and Adverse | 2011 |
A randomized trial of maintenance therapy for vasculitis associated with antineutrophil cytoplasmic autoantibodies.
Topics: Adult; Aged; Antibodies, Antineutrophil Cytoplasmic; Azathioprine; Cyclophosphamide; Drug Therapy, C | 2003 |
A randomized trial of maintenance therapy for vasculitis associated with antineutrophil cytoplasmic autoantibodies.
Topics: Adult; Aged; Antibodies, Antineutrophil Cytoplasmic; Azathioprine; Cyclophosphamide; Drug Therapy, C | 2003 |
A randomized trial of maintenance therapy for vasculitis associated with antineutrophil cytoplasmic autoantibodies.
Topics: Adult; Aged; Antibodies, Antineutrophil Cytoplasmic; Azathioprine; Cyclophosphamide; Drug Therapy, C | 2003 |
A randomized trial of maintenance therapy for vasculitis associated with antineutrophil cytoplasmic autoantibodies.
Topics: Adult; Aged; Antibodies, Antineutrophil Cytoplasmic; Azathioprine; Cyclophosphamide; Drug Therapy, C | 2003 |
28 other studies available for azathioprine and Neutropenia
Article | Year |
---|---|
An intronic FTO variant rs16952570 confers protection against thiopurine-induced myelotoxicities in multiethnic Asian IBD patients.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alpha-Ketoglutarate-Dependent Dioxygenase FTO; Asian Peo | 2020 |
Incidence, Clinical Features, and Outcomes of Late-Onset Neutropenia From Rituximab for Autoimmune Disease.
Topics: Adult; Aged; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Asymptomatic Diseases; Auto | 2021 |
Adverse Effects of Azathioprine in a Child and Her Mother with Eczema.
Topics: Adolescent; Alopecia; Azathioprine; Eczema; Female; Humans; Immunosuppressive Agents; Middle Aged; N | 2018 |
Neutropenia related to an azathioprine metabolic disorder induced by an inosine triphosphate pyrophosphohydrolase (ITPA) gene mutation in a patient with PR3-ANCA-positive microscopic polyangiitis
.
Topics: Aged; Azathioprine; Humans; Male; Microscopic Polyangiitis; Mutation; Neutropenia; Pyrophosphatases; | 2018 |
Prevalence of TPMT polymorphism in Indian patients requiring immunomodulator therapy and its clinical significance.
Topics: Adult; Azathioprine; Female; Gastrointestinal Diseases; Heterozygote; Humans; Immunosuppressive Agen | 2014 |
The impact of glutathione S-transferase genotype and phenotype on the adverse drug reactions to azathioprine in patients with inflammatory bowel diseases.
Topics: Adolescent; Adult; Alleles; Analysis of Variance; Asian People; Azathioprine; Female; Genetic Predis | 2015 |
Mycophenolate mofetil-induced agranulocytosis in a renal transplant recipient.
Topics: Adult; Azathioprine; Female; Granulocyte Colony-Stimulating Factor; Humans; Immunosuppressive Agents | 2010 |
Valuing pharmacogenetic testing services: a comparison of patients' and health care professionals' preferences.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Attitude of Health Personnel; Azathioprine; Female; Gene | 2011 |
Infliximab- and azathioprine-related severe neutropenia and thrombocytopenia in a case with Crohn's disease.
Topics: Adult; Anti-Infective Agents; Anti-Inflammatory Agents; Antibodies, Monoclonal; Azathioprine; Crohn | 2011 |
Thiopurine S-methyltransferase: a genetic polymorphism that affects a small number of drugs in a big way.
Topics: Azathioprine; Colitis, Ulcerative; Crohn Disease; Genotype; Humans; Immunosuppressive Agents; Methyl | 2002 |
Azathioprine therapy and adverse drug reactions in patients with inflammatory bowel disease: impact of thiopurine S-methyltransferase polymorphism.
Topics: Adult; Aged; Azathioprine; Colitis, Ulcerative; Crohn Disease; Female; Genotype; Humans; Immunosuppr | 2002 |
Monitoring and assessing the safety of disease-modifying antirheumatic drugs: a West Midlands experience.
Topics: Antirheumatic Agents; Arthritis, Infectious; Azathioprine; Drug Monitoring; Humans; Hypokalemia; Lun | 2002 |
Should we test TPMT enzyme levels before starting azathioprine?
Topics: Aged; Arthritis, Rheumatoid; Azathioprine; Bone Marrow Diseases; Diagnostic Tests, Routine; Female; | 2007 |
[Optimization of immunomodulatory treatment with azathioprine or 6-mercaptopurine in inflammatory bowel disease].
Topics: Adolescent; Adult; Aged; Antibodies, Monoclonal; Azathioprine; Colitis, Ulcerative; Combined Modalit | 2007 |
Partial splenic ablation in preparation for renal transplantation in children.
Topics: Azathioprine; Child, Preschool; Embolization, Therapeutic; Graft Rejection; Humans; Kidney Transplan | 1983 |
Neutropenia and thrombocytopenia in renal allograft recipients treated with trimethoprim-sulfamethoxazole.
Topics: Adult; Agranulocytosis; Azathioprine; Bone Marrow; Drug Combinations; Drug Synergism; Humans; Kidney | 1980 |
Thiopurine methyltransferase levels should be measured before commencing patients on azathioprine.
Topics: Azathioprine; Biomarkers; Contraindications; Humans; Male; Methyltransferases; Middle Aged; Neutrope | 1997 |
Identification of thiopurine methyltransferase (TPMT) polymorphisms cannot predict myelosuppression in systemic lupus erythematosus patients taking azathioprine.
Topics: Azathioprine; Genotype; Humans; Immunosuppressive Agents; Inflammatory Bowel Diseases; Lupus Erythem | 1999 |
[Recurrent episodes of ulcerative gingivostomatitis associated with cyclic neutropenia].
Topics: Adrenal Cortex Hormones; Adult; Azathioprine; Dapsone; Gingivitis, Necrotizing Ulcerative; Humans; M | 1999 |
[Bone marrow depression after azathioprine. New discoveries on an old drug].
Topics: Aged; Antimetabolites, Antineoplastic; Azathioprine; Bone Marrow Cells; Female; Genotype; Hematologi | 2000 |
Is neutropenia required for effective maintenance of remission during azathioprine therapy in inflammatory bowel disease?
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Azathioprine; Cohort Studies; Female; Humans; Immunosupp | 2001 |
Response of neutropenia and anaemia to immunosuppressive therapy: report and bone marrow culture studies.
Topics: Agranulocytosis; Anemia; Azathioprine; Bone Marrow; Colony-Forming Units Assay; Colony-Stimulating F | 1979 |
Neutropenia associated with metronidazole.
Topics: Agranulocytosis; Azathioprine; Drug Therapy, Combination; Humans; Metronidazole; Neutropenia | 1979 |
Systemic toxicosis associated with azathioprine administration in domestic cats.
Topics: Animals; Azathioprine; Bone Marrow; Cat Diseases; Cats; Female; Leukocyte Count; Male; Neutropenia; | 1992 |
Neutropenic enterocolitis in a renal transplant patient.
Topics: Azathioprine; Cyclosporine; Cytomegalovirus Infections; Enterocolitis; Ganciclovir; Humans; Kidney T | 1991 |
Elective subtotal splenectomy. Indications and results in 33 patients.
Topics: Adolescent; Adult; Azathioprine; Child; Child, Preschool; Gaucher Disease; Humans; Infant; Neutropen | 1990 |
Antibody-mediated pure neutrophil aplasia, recurrent myasthenia gravis and previous thymoma: case report and literature review.
Topics: Adult; Agranulocytosis; Antibodies; Azathioprine; Bone Marrow; Female; Humans; Immunosuppression The | 1990 |
Reversal of neutropenia with methotrexate treatment in patients with Felty's syndrome. Correlation of response with neutrophil-reactive IgG.
Topics: Aged; Agranulocytosis; Azathioprine; Enzyme-Linked Immunosorbent Assay; Felty Syndrome; Female; Huma | 1989 |