TABLE 6.
Reported Malignancies Through 1 Year (Excluding NMSC)
| Malignacy (PT) | Age/ Sex | IBD Duration (years) | Relevant Risk Factors | Smoking Status | Study Treatment | Last Study Agent Dose (study day) | Malignancy Diagnosis (study day) | Prior IBD Therapy |
|---|---|---|---|---|---|---|---|---|
| Ulcerative colitis | ||||||||
| Prostate Cancer | 61/M | 1 | Family history of prostate cancer | Yes-Past smoker | Ustekinumab 130 mg IV; 1 dose of 90 mg SC | 56 | 69 | Steroids, IFX, 6-MP |
| Rectal adenocarcinoma | 32/M | 6 | Ulcerative colitis | No | Ustekinumab 130 mg IV; 1 dose of 90 mg SC | 56 | 159 | Steroids, ADA, IFX, GOL, 6-MP |
| Colon cancer | 48/F | 28 | None | No | Ustekinumab 6 mg/kg IV; 1 dose of 90 mg SC | 58 | 59 | IFX, steroids |
| Papillary renal cell carcinoma | 70/M | 33 | hypertension, diuretic use | Yes-Past smoker | Ustekinumab 130 mg IV; 1 dose of 90 mg SC | 56 | 92 | Steroids |
| Testis cancer | 26/M | 1 | None | No | Placebo | 285 | 302 | Steroids |
| Crohn’s disease | ||||||||
| Adenocarcinoma of small intestine & incidental carcinoid tumor | 68/M | 4 | Family history of cancer | Yes, Past smoker | Placebo, ustekinumab 130 mg IV, 2 doses of 90 mg | 196 | 255 | IFX, steroids |
| Plasma cell myeloma (multiple myeloma) | 57/M | 34 | Monoclonal IgG kappa gammopathy of undetermined significance | No | Ustekinumab 6 mg/ kg IV | 1 | 199 | IFX, ADA, steroids, IMMa |
| Prostate cancer | 53/M | 30 | Elevated prostate-specific antigen levels before randomization | Not reported | Ustekinumab induction IV 4.3 mg/kg | 1 | 64 | steroids, 5-ASA |
Abbreviations: 5-ASA, 5-aminosalicylates; 6-MP, 6-mercaptopurine; ADA, adalimumab; F, female; GOL, golimumab; IFX, infliximab; IV, intravenous; NMSC, non-melanoma skin cancer; PT, preferred term Y, yes; M, male; N, no.
aIMM is azathioprine and/or 6-MP and/or methotrexate