azathioprine has been researched along with Duncan Disease in 48 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.
| Excerpt | Relevance | Reference |
|---|---|---|
| "The Rheumatoid Arthritis Azathioprine Registry (RAAR) was established in 1982 to examine the safety of azathioprine (AZA) and other disease modifying agents (DMARD) in the treatment of RA." | 7.68 | Occurrence of neoplasia in patients with rheumatoid arthritis enrolled in a DMARD Registry. Rheumatoid Arthritis Azathioprine Registry Steering Committee. ( Hickey, AR; Maguire, L; Matteson, EL; Tilson, HH; Urowitz, MB, 1991) |
| "Immunodeficiency-related lymphoproliferative disorders (IR-LPD) may occur in the setting of immunosuppressive therapy with methotrexate and TNF-α antagonists." | 3.77 | Transient iatrogenic immunodeficiency-related B-cell lymphoproliferative disorder of the skin in a patient with mycosis fungoides/Sézary syndrome. ( Curry, JL; Diwan, AH; Duvic, M; Jones, DM; Prieto, VG; Vega, F, 2011) |
| "We studied rejection, allograft function and side effects, such as hypertension, renal dysfunction and hypercholesterolemia, in seven patients switched from cyclosporine-based triple-drug immunosuppression to FK 506." | 3.69 | Immunosuppression switch in pediatric heart transplant recipients: cyclosporine to FK 506. ( Armitage, JM; Fricker, FJ; Swenson, JM, 1995) |
| " Four case reports are presented; 3 lymphomas and 1 multiple myeloma that developed, in heart transplant recipients receiving triple-drug immunosuppression: azathioprine, cyclosporine and prednisolone." | 3.68 | [Lymphoproliferative syndromes after cardiac transplantation and treatment with cyclosporine. Report of 4 cases]. ( Burtin, P; Guerci, AP; Lederlin, P; Mattei, S, 1992) |
| "The Rheumatoid Arthritis Azathioprine Registry (RAAR) was established in 1982 to examine the safety of azathioprine (AZA) and other disease modifying agents (DMARD) in the treatment of RA." | 3.68 | Occurrence of neoplasia in patients with rheumatoid arthritis enrolled in a DMARD Registry. Rheumatoid Arthritis Azathioprine Registry Steering Committee. ( Hickey, AR; Maguire, L; Matteson, EL; Tilson, HH; Urowitz, MB, 1991) |
| "The frequency of posttransplantation tumors is 2 to 4-fold compared to the non-transplanted population, and the distribution of tumor types is also different." | 2.44 | [Malignant tumors following renal transplantation]. ( Járay, J; Végso, G, 2007) |
| "In fact, it is expected that cancer will surpass cardiovascular complications as the leading cause of death in transplant patients within the next 2 decades." | 2.43 | Malignancy after transplantation. ( Buell, JF; Gross, TG; Woodle, ES, 2005) |
| " She went into hematological remission 6 weeks following 40 mg/day treatment with prednisolone, but the anemia relapsed frequently when the dosage was lessened." | 2.38 | [Chronic T-cell lymphoproliferative disorder associated with pure red cell aplasia]. ( Akihama, T; Chubachi, A; Endo, Y; Kuwayama, A; Miura, A; Yoshida, K, 1989) |
| "Prednisone use was associated with higher mortality [HR = 3." | 1.46 | Five-year Safety Data From ENCORE, a European Observational Safety Registry for Adults With Crohn's Disease Treated With Infliximab [Remicade®] or Conventional Therapy. ( Boice, J; Colombel, JF; Cornillie, F; D'Haens, G; Ghosh, S; Hommes, DW; Huang, Z; Huyck, S; Lindgren, S; Panes, J; Prantera, C; Reinisch, W, 2017) |
| "No significant risk for other intestinal cancers was found, especially for small bowel carcinoma." | 1.43 | Cancer in Elderly Onset Inflammatory Bowel Disease: A Population-Based Study. ( Charpentier, C; Cheddani, H; Dauchet, L; Dupas, JL; Fumery, M; Gower-Rousseau, C; Marie Bouvier, A; Pariente, B; Peyrin-Biroulet, L; Savoye, G, 2016) |
| " The aim of this analysis was to compare both the long-term patient and graft survival and the incidences of adverse effects in recipients treated with standard triple-drug therapy (TDT) alone or with an additional HDI with ATG-F." | 1.39 | High graft protection and low incidences of infections, malignancies and other adverse effects with intra-operative high dose ATG-induction: a single centre cohort study of 760 cases. ( Kaden, J; Völp, A; Wesslau, C, 2013) |
| "Eleven cases occurred in patients with Crohn's disease." | 1.38 | Excess primary intestinal lymphoproliferative disorders in patients with inflammatory bowel disease. ( Allez, M; Beaugerie, L; Brousse, N; Carrat, F; Dupas, JL; Flourié, B; Laharie, D; Lerebours, E; Maynadié, M; Peyrin-Biroulet, L; Simon, T; Sokol, H, 2012) |
| "Graft coronary disease was found in 8 patients (11%), 2 were re-transplanted and have survived 4." | 1.33 | Ten year survival after paediatric heart transplantation: a single centre experience. ( Khaghani, A; Smith, RR; Wray, J; Yacoub, M, 2005) |
| "Chronic enterocolitis is rare in infancy and accounts for less than 0." | 1.33 | Long-term outcome of intractable ulcerating enterocolitis of infancy. ( Lindley, KJ; Milla, PJ; Ramsay, AD; Shah, N; Thapar, N, 2005) |
| "His tacrolimus dosage was decreased, and azathioprine was discontinued." | 1.33 | Tumor lysis syndrome associated with reduced immunosuppression in a lung transplant recipient. ( Deel, C; Hellman, RN; Khan, BA, 2006) |
| "Four epidemiologic types of Kaposi sarcoma (KS) are known: classic KS, endemic African KS, epidemic or acquired immunodeficiency syndrome-related KS, and KS associated with immunosuppressive therapy." | 1.29 | The appearance of Kaposi sarcoma during corticosteroid therapy. ( David, M; Hodak, E; Sandbank, M; Trattner, A, 1993) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 3 (6.25) | 18.7374 |
| 1990's | 13 (27.08) | 18.2507 |
| 2000's | 14 (29.17) | 29.6817 |
| 2010's | 16 (33.33) | 24.3611 |
| 2020's | 2 (4.17) | 2.80 |
| Authors | Studies |
|---|---|
| Ritter, CG | 1 |
| de David Cruz, C | 1 |
| Zamboni, S | 1 |
| Busato, VB | 1 |
| da Silveira, RG | 1 |
| Provenzi, VO | 1 |
| Bredemeier, M | 1 |
| Sprangers, B | 1 |
| Riella, LV | 1 |
| Dierickx, D | 1 |
| Kim, JH | 1 |
| Kim, JW | 1 |
| Kaden, J | 1 |
| Völp, A | 1 |
| Wesslau, C | 1 |
| Alobaid, A | 1 |
| Torlakovic, E | 1 |
| Kongkham, P | 1 |
| Cheddani, H | 1 |
| Dauchet, L | 1 |
| Fumery, M | 1 |
| Charpentier, C | 1 |
| Marie Bouvier, A | 1 |
| Dupas, JL | 2 |
| Pariente, B | 1 |
| Peyrin-Biroulet, L | 2 |
| Savoye, G | 1 |
| Gower-Rousseau, C | 1 |
| Steele, CL | 1 |
| Doré, M | 1 |
| Ammann, S | 1 |
| Loughrey, M | 1 |
| Montero, A | 1 |
| Burns, SO | 1 |
| Morris, EC | 1 |
| Gaspar, B | 1 |
| Gilmour, K | 1 |
| Bibi, S | 1 |
| Shendi, H | 1 |
| Devlin, L | 1 |
| Speckmann, C | 1 |
| Edgar, DM | 1 |
| D'Haens, G | 1 |
| Reinisch, W | 1 |
| Colombel, JF | 1 |
| Panes, J | 1 |
| Ghosh, S | 1 |
| Prantera, C | 1 |
| Lindgren, S | 1 |
| Hommes, DW | 1 |
| Huang, Z | 1 |
| Boice, J | 1 |
| Huyck, S | 1 |
| Cornillie, F | 1 |
| Serrate, C | 1 |
| Silva-Moreno, M | 1 |
| Dartigues, P | 1 |
| Poujol-Robert, A | 1 |
| Sokol, H | 2 |
| Gorin, NC | 1 |
| Coppo, P | 1 |
| Einollahi, B | 1 |
| Lessan-Pezeshki, M | 1 |
| Nourbala, MH | 1 |
| Simforoosh, N | 1 |
| Pourfarziani, V | 1 |
| Nemati, E | 1 |
| Nafar, M | 1 |
| Basiri, A | 1 |
| Pour-Reza-Gholi, F | 1 |
| Firoozan, A | 1 |
| Ghadiani, MH | 1 |
| Makhdoomi, K | 1 |
| Ghafari, A | 1 |
| Ahmadpour, P | 1 |
| Oliaei, F | 1 |
| Ardalan, MR | 1 |
| Makhlough, A | 1 |
| Samimagham, HR | 1 |
| Azmandian, J | 1 |
| Razeghi, E | 1 |
| Shahbazian, H | 1 |
| Curry, JL | 1 |
| Prieto, VG | 1 |
| Jones, DM | 1 |
| Vega, F | 1 |
| Duvic, M | 1 |
| Diwan, AH | 1 |
| Courby, S | 1 |
| Fabre, B | 1 |
| Salameire, D | 1 |
| Gaulard, P | 1 |
| Hincky-Vitrat, V | 1 |
| Gressin, R | 1 |
| Bonaz, B | 1 |
| Epaulard, O | 1 |
| Ross, S | 1 |
| Rajwal, SK | 1 |
| Sugarman, I | 1 |
| Picton, S | 1 |
| Devlin, J | 1 |
| Davison, S | 1 |
| McClean, P | 1 |
| Adams, B | 1 |
| Lazarchick, J | 1 |
| Medina, AM | 1 |
| Willner, IR | 1 |
| Neville, B | 1 |
| Murphy, E | 1 |
| Stuart, R | 1 |
| Costa, LJ | 1 |
| Gidrewicz, D | 1 |
| Lehman, D | 1 |
| Rabizadeh, S | 1 |
| Majlessipour, F | 1 |
| Dubinsky, M | 1 |
| Kim, RD | 1 |
| Fujikawa, T | 1 |
| Mizuno, S | 1 |
| Schwartz, JJ | 1 |
| Sorensen, JB | 1 |
| Hemming, AW | 1 |
| Fujita, S | 1 |
| Presti, MA | 1 |
| Costantino, G | 1 |
| Della Torre, A | 1 |
| Belvedere, A | 1 |
| Cascio, A | 1 |
| Fries, W | 1 |
| Ye, BD | 1 |
| Beaugerie, L | 1 |
| Maynadié, M | 1 |
| Laharie, D | 1 |
| Flourié, B | 1 |
| Lerebours, E | 1 |
| Allez, M | 1 |
| Simon, T | 1 |
| Carrat, F | 1 |
| Brousse, N | 1 |
| Subramaniam, K | 1 |
| D'Rozario, J | 1 |
| Pavli, P | 1 |
| Nathanson, S | 1 |
| Debray, D | 1 |
| Delarue, A | 1 |
| Deschênes, G | 1 |
| Keogh, PV | 1 |
| Fisher, V | 1 |
| Flint, SR | 1 |
| Birkeland, SA | 1 |
| Hamilton-Dutoit, S | 1 |
| Smith, RR | 1 |
| Wray, J | 1 |
| Khaghani, A | 1 |
| Yacoub, M | 1 |
| Thapar, N | 1 |
| Shah, N | 1 |
| Ramsay, AD | 1 |
| Lindley, KJ | 1 |
| Milla, PJ | 1 |
| Buell, JF | 1 |
| Gross, TG | 1 |
| Woodle, ES | 1 |
| Au, WY | 1 |
| Pang, A | 1 |
| Wan, TS | 1 |
| Ma, ES | 1 |
| Cheng, LC | 1 |
| Kwong, YL | 1 |
| Khan, BA | 1 |
| Deel, C | 1 |
| Hellman, RN | 1 |
| Hamour, IM | 1 |
| Lyster, HS | 1 |
| Burke, MM | 1 |
| Rose, ML | 1 |
| Banner, NR | 1 |
| Végso, G | 1 |
| Járay, J | 1 |
| Swenson, JM | 1 |
| Fricker, FJ | 1 |
| Armitage, JM | 1 |
| Tzakis, AG | 1 |
| Reyes, J | 2 |
| Todo, S | 1 |
| Nour, B | 1 |
| Shapiro, R | 1 |
| Jordan, M | 1 |
| McCauley, J | 1 |
| Armitage, J | 1 |
| Fung, JJ | 1 |
| Starzl, TE | 1 |
| Malagó, M | 1 |
| Rogiers, X | 1 |
| Wadström, J | 1 |
| Burdelski, M | 1 |
| Broelsch, CE | 1 |
| Trattner, A | 1 |
| Hodak, E | 1 |
| David, M | 1 |
| Sandbank, M | 1 |
| Newell, KA | 1 |
| Alonso, EM | 1 |
| Kelly, SM | 1 |
| Rubin, CM | 1 |
| Thistlethwaite, JR | 1 |
| Whitington, PF | 1 |
| Finn, L | 1 |
| Bueno, J | 1 |
| Yunis, E | 1 |
| Pham, H | 1 |
| Lemoine, A | 1 |
| Salvucci, M | 1 |
| Azoulay, D | 1 |
| Frenoy, N | 1 |
| Samuel, D | 1 |
| Reynès, M | 1 |
| Bismuth, H | 1 |
| Debuire, B | 1 |
| Walker, RE | 1 |
| McCrindle, BW | 1 |
| Coles, JG | 1 |
| West, LJ | 1 |
| Niaudet, P | 1 |
| Hoffmeyer, F | 1 |
| Hoeper, MM | 1 |
| Spiekerkötter, E | 1 |
| Harringer, W | 1 |
| Haverich, A | 1 |
| Fabel, H | 1 |
| Niedermeyer, J | 1 |
| Bumgardner, GL | 1 |
| Hardie, I | 1 |
| Johnson, RW | 1 |
| Lin, A | 1 |
| Nashan, B | 1 |
| Pescovitz, MD | 1 |
| Ramos, E | 1 |
| Vincenti, F | 1 |
| Melosky, B | 1 |
| Karim, M | 1 |
| Chui, A | 1 |
| McBride, M | 1 |
| Cameron, EC | 1 |
| Yeung, CK | 1 |
| Landsberg, D | 1 |
| Shackleton, C | 1 |
| Keown, PA | 1 |
| Preiksaitis, JK | 1 |
| Diaz-Mitoma, F | 1 |
| Mirzayans, F | 1 |
| Roberts, S | 1 |
| Tyrrell, DL | 1 |
| Guerci, AP | 1 |
| Burtin, P | 1 |
| Mattei, S | 1 |
| Lederlin, P | 1 |
| Matteson, EL | 1 |
| Hickey, AR | 1 |
| Maguire, L | 1 |
| Tilson, HH | 1 |
| Urowitz, MB | 1 |
| Chubachi, A | 1 |
| Yoshida, K | 1 |
| Endo, Y | 1 |
| Miura, A | 1 |
| Akihama, T | 1 |
| Kuwayama, A | 1 |
| Yacoub, MH | 1 |
| Reid, CJ | 1 |
| Al-Khadimi, RH | 1 |
| Radley-Smith, R | 1 |
| Wellens, F | 1 |
| Estenne, M | 1 |
| de Francquen, P | 1 |
| Goldstein, J | 1 |
| Leclerc, JL | 1 |
| Primo, G | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Crohn's Disease European Registry. A Prospective, Observational, Postmarketing Safety Surveillance Registry of Patients Treated With Remicade® or Standard Therapy[NCT00705614] | 2,662 participants (Actual) | Observational | 2003-07-31 | Completed | |||
| Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in T and NK-Cell Lymphomas[NCT01445535] | Phase 1 | 15 participants (Actual) | Interventional | 2009-01-13 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
The number of participant fatalities was evaluated throughout the study. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Participants (Number) |
|---|---|
| Remicade | 30 |
| Standard Therapy | 14 |
| Switched to Remicade | 4 |
The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Participants (Number) |
|---|---|
| Remicade | 4 |
| Standard Therapy | 1 |
| Switched to Remicade | 0 |
The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Participants (Number) |
|---|---|
| Remicade | 50 |
| Standard Therapy | 11 |
| Switched to Remicade | 7 |
The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Participants (Number) |
|---|---|
| Remicade | 173 |
| Standard Therapy | 1 |
| Switched to Remicade | 28 |
The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Participants (Number) |
|---|---|
| Remicade | 49 |
| Standard Therapy | 21 |
| Switched to Remicade | 8 |
The number of participants with new or worsening congestive heart failure was evaluated throughout the study. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Participants (Number) |
|---|---|
| Remicade | 1 |
| Standard Therapy | 1 |
| Switched to Remicade | 0 |
The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii [PCP] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Participants (Number) |
|---|---|
| Remicade | 132 |
| Standard Therapy | 47 |
| Switched to Remicade | 18 |
The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Days (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 (Baseline; n=657,418 ,0) | Visit 2 (n=304,126, 33) | Visit 3 (n=216, 58, 35) | Visit 4 (n=151, 60, 24) | Visit 5 (n=105, 35, 34) | Visit 6 (n=107, 49, 19) | Visit 7 (n=109, 45, 25) | Visit 8 (n=98, 29, 23) | Visit 9 (n=80, 38, 17) | Visit 10 (n=85, 29, 27) | Visit 11 (n=63, 19, 18) | |
| Remicade | 12.2 | 14.4 | 14.2 | 12.6 | 11.7 | 10.8 | 10.6 | 9.5 | 12.4 | 10.1 | 11.4 |
| Standard Therapy | 10.8 | 12.0 | 9.4 | 8.5 | 9.8 | 13.7 | 10.2 | 16.3 | 6.9 | 8.0 | 8.7 |
| Switched to Remicade | NA | 13.0 | 13.5 | 9.1 | 7.1 | 18.3 | 10.0 | 14.7 | 10.7 | 9.0 | 18.1 |
The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Hospital Stays (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 (Baseline; n=1539, 1121, 0) | Visit 2 (n=1418, 920, 100) | Visit 3 (n=1334, 827, 152) | Visit 4 (n=1285, 779, 168) | Visit 5 (n=1221, 714, 188) | Visit 6 (n=1170, 665, 208) | Visit 7 (n=1111, 615, 219) | Visit 8 (n=1099, 589, 233) | Visit 9 (n=1046, 562, 229) | Visit 10 (n=1031, 535, 235) | Visit 11 (n=1006, 541, 248) | |
| Remicade | 0.7 | 0.3 | 0.3 | 0.2 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 |
| Standard Therapy | 0.5 | 0.2 | 0.1 | 0.2 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 |
| Switched to Remicade | NA | 0.5 | 0.4 | 0.2 | 0.3 | 0.1 | 0.2 | 0.1 | 0.1 | 0.1 | 0.1 |
The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Surgical Procedures (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 (Basline; n=660, 419, 0) | Visit 2 (n=304, 126, 33) | Visit 3 (n=217, 57, 36) | Visit 4 (n=153, 60, 24) | Visit 5 (n=106, 36, 34) | Visit 6 (n=108, 49, 19) | Visit 7 (n=109, 45, 25) | Visit 8 (n=98, 29, 23) | Visit 9 (n=82, 38, 17) | Visit 10 (n=85, 29, 27) | Visit 11 (n=63, 19, 18) | |
| Remicade | 171 | 135 | 121 | 68 | 50 | 49 | 48 | 43 | 38 | 38 | 34 |
| Standard Therapy | 81 | 51 | 23 | 16 | 14 | 21 | 20 | 12 | 13 | 13 | 6 |
| Switched to Remicade | NA | 7 | 12 | 8 | 14 | 11 | 6 | 7 | 8 | 8 | 8 |
The number of participants with a draining fistula was evaluated at each study visit. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 (Baseline; n=1541, 1120, 0) | Visit 2 (n=1420, 920, 100) | Visit 3 (n=1334, 827, 152) | Visit 4 (n=1285, 779, 168) | Visit 5 (n=1221, 714, 188) | Visit 6 (n=1169, 666, 208) | Visit 7 (n=1110, 615, 219) | Visit 8 (n=1097, 588, 233) | Visit 9 (n=1046, 562, 229) | Visit 10 (n=1030, 535, 235) | Visit 11 (n=1006, 541, 248) | |
| Remicade | 349 | 211 | 170 | 146 | 125 | 114 | 97 | 105 | 98 | 85 | 87 |
| Standard Therapy | 96 | 51 | 41 | 31 | 29 | 26 | 31 | 23 | 32 | 15 | 16 |
| Switched to Remicade | NA | 16 | 19 | 12 | 15 | 15 | 15 | 16 | 15 | 20 | 20 |
The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Score on a Scale (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 (Baseline; n=1526, 1116, 0) | Visit 2 (n=1344, 903, 95) | Visit 3 (n=1280, 809, 146) | Visit 4 (n=1217, 755, 162) | Visit 5 (n=1160, 704, 184) | Visit 6 (n=1110, 649, 202) | Visit 7 (n=1046, 606, 212) | Visit 8 (n=1044, 573, 221) | Visit 9 (n=999, 544, 223) | Visit 10 (n=963, 520, 227) | Visit 11 (n=956, 527, 235) | |
| Remicade | 4.3 | 3.3 | 3.2 | 3.2 | 3.1 | 3.1 | 3.1 | 3.1 | 3.1 | 3.0 | 3.0 |
| Standard Therapy | 3.9 | 3.3 | 3.1 | 3.0 | 3.1 | 3.0 | 3.0 | 3.0 | 2.9 | 2.8 | 2.8 |
| Switched to Remicade | NA | 3.9 | 3.6 | 3.5 | 3.2 | 3.4 | 3.3 | 3.2 | 3.2 | 3.1 | 3.1 |
The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Score on a Scale (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 (Baseline; n=1505, 1106, 0) | Visit 2 (n=1320, 876, 91) | Visit 3 (n=1250, 785, 143) | Visit 4 (n=1196, 742, 159) | Visit 5 (n=1127, 692, 181) | Visit 6 (n=1070, 647, 199) | Visit 7 (n=1023, 592, 209) | Visit 8 (n=1015, 562, 224) | Visit 9 (n=953, 546, 219) | Visit 10 (n=936, 526, 225) | Visit 11 (n=918, 525, 238) | |
| Remicade | 8.2 | 4.1 | 3.7 | 3.8 | 3.7 | 3.6 | 3.6 | 3.6 | 3.6 | 3.4 | 3.4 |
| Standard Therapy | 6.2 | 3.8 | 3.5 | 3.2 | 3.4 | 3.1 | 3.0 | 3.2 | 2.9 | 2.7 | 2.7 |
| Switched to Remicade | NA | 6.0 | 4.4 | 4.8 | 4.9 | 4.5 | 4.1 | 4.1 | 4.4 | 4.3 | 4.2 |
The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning. (NCT00705614)
Timeframe: Up to 5 Years
| Intervention | Score on a Scale (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 (Baseline; n=1496, 1108, 0) | Visit 2 (n=1316, 895, 94) | Visit 3 (n=1235, 797, 143) | Visit 4 (n=1192, 738, 159) | Visit 5 (n=1128, 694, 179) | Visit 6 (n=1077, 638, 201) | Visit 7 (n=1030, 601, 207) | Visit 8 (n=1025, 571, 221) | Visit 9 (n=982, 542, 222) | Visit 10 (n=934, 514, 225) | Visit 11 (n=925, 521, 235) | |
| Remicade | 5.9 | 4.2 | 3.8 | 3.6 | 3.4 | 3.3 | 3.2 | 3.3 | 3.3 | 3.1 | 3.2 |
| Standard Therapy | 4.9 | 3.7 | 3.2 | 2.9 | 3.0 | 2.7 | 2.8 | 2.7 | 2.6 | 2.4 | 2.4 |
| Switched to Remicade | NA | 5.5 | 4.8 | 4.3 | 4.0 | 3.9 | 3.6 | 3.5 | 3.5 | 3.6 | 3.6 |
A classic 3+3 dose-escalation design was used to assess the MTD of siplizumab in combination with dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). If 2 of 6 patients experienced a dose-limiting toxicity (DLT) at a particular dose level, the MTD has been exceeded. The preceding dose level will be the MTD, provided 6 patients have been entered at this level and no more than one has experienced a DLT. DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an Epstein Barr Virus (EBV)-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted EPOCH-R and grade 3 laboratory adverse events (AEs) were not considered to be DLTs. (NCT01445535)
Timeframe: First 30 days after treatment initiation.
| Intervention | mg/kg (Number) |
|---|---|
| All Participants | 15 |
DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an EBV-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) and grade 3 laboratory AEs were not considered to be DLTs. (NCT01445535)
Timeframe: First 30 days after treatment initiation.
| Intervention | Dose Limiting Toxicities (Number) |
|---|---|
| Cohort 1 - 3.4 mg/kg | 0 |
| Cohort 2 - 4.8 mg/kg | 0 |
| Cohort 3 - 8.5 mg/kg | 0 |
| Cohort 4 - 15 mg/kg | 0 |
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01445535)
Timeframe: Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
| Intervention | Participants (Count of Participants) |
|---|---|
| Cohort 1 - 3.4 mg/kg | 3 |
| Cohort 2 - 4.8 mg/kg | 3 |
| Cohort 3 - 8.5 mg/kg | 3 |
| Cohort 4 - 15 mg/kg | 5 |
Progression was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Progression is defined as ≥50% increase from nadir in the sum of the products of the perpendicular diameters (SPD) of any previously identified abnormal nodes for Partial Response's or non-responders. Progression-free survival (PFS) was determined from the on-study date until date of progression or last follow-up. The probability of PFS as a function of time was estimated by the Kaplan-Meier method. (NCT01445535)
Timeframe: On-study date until date of progression or last follow up, approximately 7 months.
| Intervention | Months (Median) |
|---|---|
| All Participants | 6.8 |
Overall survival was determined from the on-study date until date of progression or last follow up. The probability of OS as a function of time was estimated by the Kaplan-Meier method. (NCT01445535)
Timeframe: On study date until date of death or last follow up, approximately 12 months.
| Intervention | Months (Median) |
|---|---|
| All Participants | 12.1 |
Response was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete Remission was defined as the disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (for example lactate dehydrogenase (LDH)) definitely assignable to the lymphoma. Complete response unconfirmed was defined as a residual node greater than 1.5 cm, with a decrease by greater than 75 percent in the sum of the products of the perpendicular diameters (SPD) of all measured lymph nodes. Partial Response was defined as a ≥ 50% decreased in SPD of 6 largest dominant nodes or nodal masses. Relapsed disease was defined as the appearance of any new lesion or increase by ≥50% in the size of the previously identified sites. Progressive disease was defined as a ≥50% increase from nadir in the SPD. (NCT01445535)
Timeframe: Response assessments were performed after the fourth and sixth cycle of therapy, at therapy completion, and every 3 months for year 1, four months for year 2, 6 months for years 3-5, and annually thereafter, up to 5 years.
| Intervention | Participants (Count of Participants) | ||||||
|---|---|---|---|---|---|---|---|
| Complete Remission | Complete Response Unconfirmed | Partial Response | Relapsed Disease | Progressive Disease | Stable Disease | Not Evaluable | |
| Cohort 1 - 3.4 mg/kg | 1 | 0 | 1 | 0 | 1 | 0 | 0 |
| Cohort 2 - 4.8 mg/kg | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| Cohort 3 - 8.5 mg/kg | 1 | 0 | 1 | 0 | 1 | 0 | 0 |
| Cohort 4 - 15 mg/kg | 4 | 0 | 0 | 0 | 0 | 0 | 2 |
9 reviews available for azathioprine and Duncan Disease
| Article | Year |
|---|---|
Posttransplant Lymphoproliferative Disorder Following Kidney Transplantation: A Review.
Topics: Alleles; Antilymphocyte Serum; Antineoplastic Combined Chemotherapy Protocols; Azathioprine; Calcine | 2021 |
[Effect of Immunomodulators and Biologic Agents on Malignancy in Patients with Inflammatory Bowel Disease].
Topics: Adalimumab; Azathioprine; Biological Factors; Female; Humans; Immunosuppressive Agents; Inflammatory | 2017 |
[Inflammatory bowel disease and lymphoproliferative disorders].
Topics: Anti-Inflammatory Agents; Antibodies, Monoclonal; Azathioprine; Humans; Immunosuppressive Agents; In | 2011 |
Lymphoma and other lymphoproliferative disorders in inflammatory bowel disease: a review.
Topics: Age Factors; Azathioprine; Epstein-Barr Virus Infections; Humans; Immunosuppressive Agents; Inflamma | 2013 |
Resolution of oral non-Hodgkin's lymphoma by reduction of immunosuppressive therapy in a renal allograft recipient: a case report and review of the literature.
Topics: Azathioprine; Diabetes Mellitus, Type 1; Diagnosis, Differential; Female; Gingival Neoplasms; Humans | 2002 |
Malignancy after transplantation.
Topics: Azathioprine; Calcineurin Inhibitors; Carcinoma, Hepatocellular; Cyclosporine; Hepatitis, Viral, Hum | 2005 |
[Malignant tumors following renal transplantation].
Topics: Adrenal Cortex Hormones; Azathioprine; Calcineurin Inhibitors; Cyclosporine; Humans; Immunosuppressi | 2007 |
Lymphoproliferative disorders after renal transplantation in patients receiving triple or quadruple immunosuppression.
Topics: Actuarial Analysis; Antilymphocyte Serum; Azathioprine; Carcinoma; Cyclosporine; Graft Survival; Her | 1992 |
[Chronic T-cell lymphoproliferative disorder associated with pure red cell aplasia].
Topics: Adult; Azathioprine; Combined Modality Therapy; Cyclophosphamide; Female; Humans; Lymphoproliferativ | 1989 |
4 trials available for azathioprine and Duncan Disease
| Article | Year |
|---|---|
Two-year experience with FK 506 in pediatric patients.
Topics: Adolescent; Azathioprine; Child; Child, Preschool; Cyclosporine; Follow-Up Studies; Graft Survival; | 1993 |
Occurrence of gammopathies and lymphoproliferative disorders in liver transplant recipients randomized to tacrolimus (FK506)- or cyclosporine-based immunosuppression.
Topics: Adrenal Cortex Hormones; Adult; Azathioprine; Cyclosporine; Female; Humans; Liver Transplantation; L | 1998 |
Azathioprine withdrawal in stable lung and heart/lung recipients receiving cyclosporine-based immunosuppression.
Topics: Acute Disease; Adult; Azathioprine; Bronchiolitis Obliterans; Cyclosporine; Cytomegalovirus Infectio | 2000 |
Results of 3-year phase III clinical trials with daclizumab prophylaxis for prevention of acute rejection after renal transplantation.
Topics: Acute Disease; Adrenal Cortex Hormones; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; A | 2001 |
35 other studies available for azathioprine and Duncan Disease
| Article | Year |
|---|---|
EBV-positive mucocutaneous ulcer in a patient with systemic lupus erythematosus.
Topics: Azathioprine; Conservative Treatment; Deprescriptions; Epstein-Barr Virus Infections; Facial Dermato | 2020 |
High graft protection and low incidences of infections, malignancies and other adverse effects with intra-operative high dose ATG-induction: a single centre cohort study of 760 cases.
Topics: Adult; Antilymphocyte Serum; Azathioprine; Cohort Studies; Cyclosporine; Cytomegalovirus Infections; | 2013 |
Primary Central Nervous System Immunomodulatory Therapy-Induced Lymphoproliferative Disorder in a Patient with Ulcerative Colitis: A Case Report and Review of the Literature.
Topics: Anti-Inflammatory Agents; Azathioprine; Colitis, Ulcerative; Female; Humans; Immunologic Deficiency | 2015 |
Cancer in Elderly Onset Inflammatory Bowel Disease: A Population-Based Study.
Topics: Adrenal Cortex Hormones; Age of Onset; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroi | 2016 |
X-linked Inhibitor of Apoptosis Complicated by Granulomatous Lymphocytic Interstitial Lung Disease (GLILD) and Granulomatous Hepatitis.
Topics: Azathioprine; Biomarkers; Biopsy; Bone Marrow; Child, Preschool; Female; Genetic Diseases, X-Linked; | 2016 |
Five-year Safety Data From ENCORE, a European Observational Safety Registry for Adults With Crohn's Disease Treated With Infliximab [Remicade®] or Conventional Therapy.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Anti-Inflammatory Agents; Azathio | 2017 |
Epstein-Barr virus-associated lymphoproliferation awareness in hemophagocytic syndrome complicating thiopurine treatment for Crohn's disease.
Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Azathioprine; Crohn Disease; Drug Th | 2009 |
Posttransplant lymphoproliferative disorders in kidney transplant recipients: an Iranian multicenter experience.
Topics: Adolescent; Adult; Aged; Azathioprine; Child; Cohort Studies; Female; Humans; Immunosuppressive Agen | 2008 |
Transient iatrogenic immunodeficiency-related B-cell lymphoproliferative disorder of the skin in a patient with mycosis fungoides/Sézary syndrome.
Topics: Aged; Azathioprine; B-Lymphocytes; Epstein-Barr Virus Infections; Humans; Immunocompromised Host; Im | 2011 |
Multifocal polyclonal Epstein-Barr virus-associated B-cell lymphoproliferative disorder secondary to azathioprine therapy successfully treated with rituximab.
Topics: Adult; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Agents; Azathi | 2010 |
Epstein-Barr virus-associated lymphoproliferative disorder in Crohn disease treated with azathioprine.
Topics: Azathioprine; B-Lymphocytes; Child; Crohn Disease; Herpesvirus 4, Human; Humans; Immunosuppressive A | 2010 |
Iatrogenic immunodeficiency-associated lymphoproliferative disease of the Hodgkin lymphoma-like variant in a patient treated with mycophenolate mofetil for autoimmune hepatitis.
Topics: Adult; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Azathioprine; Diagnosis, Diff | 2010 |
Primary EBV infection resulting in lymphoproliferative disease in a teenager with Crohn disease.
Topics: Adolescent; Anti-Inflammatory Agents; Antibodies, Monoclonal; Azathioprine; Crohn Disease; Epstein-B | 2011 |
Adult post-transplant lymphoproliferative disease in the liver graft in patients with recurrent hepatitis C.
Topics: Adolescent; Aged; Antibodies, Viral; Azathioprine; Cohort Studies; Cyclosporine; Drug Therapy, Combi | 2011 |
Severe CMV-related pneumonia complicated by the hemophagocytic lymphohistiocytic (HLH) syndrome in quiescent Crohn's colitis: harmful cure?
Topics: Azathioprine; Crohn Disease; Epstein-Barr Virus Infections; Female; Herpesvirus 4, Human; Humans; Im | 2011 |
Excess primary intestinal lymphoproliferative disorders in patients with inflammatory bowel disease.
Topics: Adult; Aged; Aged, 80 and over; Azathioprine; Case-Control Studies; Child; Colitis, Ulcerative; Croh | 2012 |
Long-term survival after post-transplant lymphoproliferative disease in children.
Topics: Adolescent; Azathioprine; Child; Child, Preschool; Female; Follow-Up Studies; Humans; Immunosuppress | 2002 |
Is posttransplant lymphoproliferative disorder (PTLD) caused by any specific immunosuppressive drug or by the transplantation per se?
Topics: Azathioprine; Humans; Immunosuppressive Agents; Incidence; Lymphoproliferative Disorders; Muromonab- | 2003 |
Ten year survival after paediatric heart transplantation: a single centre experience.
Topics: Azathioprine; Cardiomyopathies; Child; Child, Preschool; Coronary Angiography; Coronary Disease; Cyc | 2005 |
Long-term outcome of intractable ulcerating enterocolitis of infancy.
Topics: Adolescent; Adult; Azathioprine; Child; Child, Preschool; Chronic Disease; Colectomy; Colitis, Ulcer | 2005 |
Concomitant post-transplantation lymphoproliferative disease and therapy-related myelodysplastic syndrome after lung transplantation.
Topics: Adult; Azathioprine; B-Lymphocytes; Biopsy; Bone Marrow; Causality; Female; Humans; Immunosuppressiv | 2006 |
Tumor lysis syndrome associated with reduced immunosuppression in a lung transplant recipient.
Topics: Aged; Azathioprine; Fatal Outcome; Humans; Immunosuppressive Agents; Liver Transplantation; Lymphopr | 2006 |
Mycophenolate mofetil may allow cyclosporine and steroid sparing in de novo heart transplant patients.
Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aged; Azathioprine; Cyclosporine; Female; Heart Transpla | 2007 |
Immunosuppression switch in pediatric heart transplant recipients: cyclosporine to FK 506.
Topics: Adolescent; Adult; Antihypertensive Agents; Azathioprine; Cardiac Catheterization; Child; Cyclospori | 1995 |
Optimal clinical regimens for living related liver transplantation.
Topics: Azathioprine; Bacterial Infections; Child; Child, Preschool; Cyclosporine; Drug Administration Sched | 1994 |
The appearance of Kaposi sarcoma during corticosteroid therapy.
Topics: Adult; Aged; Autoimmune Diseases; Azathioprine; Betamethasone; Female; Humans; Lymphoproliferative D | 1993 |
Association between liver transplantation for Langerhans cell histiocytosis, rejection, and development of posttransplant lymphoproliferative disease in children.
Topics: Adolescent; Age Factors; Antiviral Agents; Azathioprine; Child; Child, Preschool; Cyclosporine; Foll | 1997 |
Epstein-Barr virus infections in children after transplantation of the small intestine.
Topics: Adolescent; Azathioprine; Child; Child, Preschool; Cyclophosphamide; Female; Graft Rejection; Herpes | 1998 |
Clinical outcomes associated with conversion to tacrolimus-based immunosuppression in pediatric cardiac transplantation.
Topics: Adolescent; Azathioprine; Child; Child, Preschool; Cyclosporine; Drug Therapy, Combination; Female; | 1998 |
Postransplant lymphoproliferative disease following renal transplantation: a multicenter retrospective study of 41 cases observed between 1992 and 1996. French Speaking Transplantation Workshop.
Topics: Azathioprine; Cyclosporine; Drug Therapy, Combination; Humans; Immunophenotyping; Immunosuppression | 1998 |
Quantitative oropharyngeal Epstein-Barr virus shedding in renal and cardiac transplant recipients: relationship to immunosuppressive therapy, serologic responses, and the risk of posttransplant lymphoproliferative disorder.
Topics: Adolescent; Adult; Antilymphocyte Serum; Azathioprine; Cyclosporine; DNA, Viral; Female; Follow-Up S | 1992 |
[Lymphoproliferative syndromes after cardiac transplantation and treatment with cyclosporine. Report of 4 cases].
Topics: Adult; Azathioprine; Cyclosporine; Drug Therapy, Combination; Heart Transplantation; Humans; Immunos | 1992 |
Occurrence of neoplasia in patients with rheumatoid arthritis enrolled in a DMARD Registry. Rheumatoid Arthritis Azathioprine Registry Steering Committee.
Topics: Adult; Aged; Aged, 80 and over; Arthritis, Rheumatoid; Azathioprine; Female; Humans; Incidence; Lymp | 1991 |
Cardiac transplantation--the London experience.
Topics: Adolescent; Adrenal Cortex Hormones; Adult; Azathioprine; Child; Cyclosporins; Drug Therapy, Combina | 1985 |
Combined heart-lung transplantation for terminal pulmonary lymphangioleiomyomatosis.
Topics: Adult; Azathioprine; Bronchial Diseases; Cyclosporins; Female; Heart Transplantation; Heart-Lung Tra | 1985 |