mesalamine has been researched along with Lymphoproliferative Disorders in 2 studies
Mesalamine: An anti-inflammatory agent, structurally related to the SALICYLATES, which is active in INFLAMMATORY BOWEL DISEASE. It is considered to be the active moiety of SULPHASALAZINE. (From Martindale, The Extra Pharmacopoeia, 30th ed)
mesalamine : A monohydroxybenzoic acid that is salicylic acid substituted by an amino group at the 5-position.
Lymphoproliferative Disorders: Disorders characterized by proliferation of lymphoid tissue, general or unspecified.
| Excerpt | Relevance | Reference |
|---|---|---|
| "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) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 2 (100.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Cheddani, H | 1 |
| Dauchet, L | 1 |
| Fumery, M | 1 |
| Charpentier, C | 1 |
| Marie Bouvier, A | 1 |
| Dupas, JL | 1 |
| Pariente, B | 1 |
| Peyrin-Biroulet, L | 1 |
| Savoye, G | 1 |
| Gower-Rousseau, C | 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 |
| 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 | |||
| [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 |
2 other studies available for mesalamine and Lymphoproliferative Disorders
| Article | Year |
|---|---|
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 |
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 |