TABLE 6.

Reported Malignancies Through 1 Year (Excluding NMSC)

Malignacy (PT)Age/ SexIBD Duration (years)Relevant Risk FactorsSmoking Status Study TreatmentLast Study Agent Dose (study day)Malignancy Diagnosis (study day)Prior IBD Therapy
Ulcerative colitis
Prostate Cancer61/M1Family history of prostate cancerYes-Past smokerUstekinumab 130 mg IV; 1 dose of 90 mg SC56 69Steroids, IFX, 6-MP
Rectal adenocarcinoma32/M6 Ulcerative colitis NoUstekinumab 130 mg IV; 1 dose of 90 mg SC56 159Steroids, ADA, IFX, GOL, 6-MP
Colon cancer48/F28 None NoUstekinumab 6 mg/kg IV; 1 dose of 90 mg SC58 59IFX, steroids
Papillary renal cell carcinoma70/M33 hypertension, diuretic use Yes-Past smokerUstekinumab 130 mg IV; 1 dose of 90 mg SC56 92Steroids
Testis cancer26/M 1 None NoPlacebo285 302Steroids
Crohn’s disease
Adenocarcinoma of small intestine & incidental carcinoid tumor68/M4Family history of cancerYes, Past smokerPlacebo, ustekinumab 130 mg IV, 2 doses of 90 mg196 255IFX, steroids
Plasma cell myeloma (multiple myeloma)57/M34Monoclonal IgG kappa gammopathy of undetermined significance NoUstekinumab 6 mg/ kg IV1 199IFX, ADA, steroids, IMMa
Prostate cancer53/M30Elevated prostate-specific antigen levels before randomizationNot reportedUstekinumab induction IV 4.3 mg/kg 1 64steroids, 5-ASA
Malignacy (PT)Age/ SexIBD Duration (years)Relevant Risk FactorsSmoking Status Study TreatmentLast Study Agent Dose (study day)Malignancy Diagnosis (study day)Prior IBD Therapy
Ulcerative colitis
Prostate Cancer61/M1Family history of prostate cancerYes-Past smokerUstekinumab 130 mg IV; 1 dose of 90 mg SC56 69Steroids, IFX, 6-MP
Rectal adenocarcinoma32/M6 Ulcerative colitis NoUstekinumab 130 mg IV; 1 dose of 90 mg SC56 159Steroids, ADA, IFX, GOL, 6-MP
Colon cancer48/F28 None NoUstekinumab 6 mg/kg IV; 1 dose of 90 mg SC58 59IFX, steroids
Papillary renal cell carcinoma70/M33 hypertension, diuretic use Yes-Past smokerUstekinumab 130 mg IV; 1 dose of 90 mg SC56 92Steroids
Testis cancer26/M 1 None NoPlacebo285 302Steroids
Crohn’s disease
Adenocarcinoma of small intestine & incidental carcinoid tumor68/M4Family history of cancerYes, Past smokerPlacebo, ustekinumab 130 mg IV, 2 doses of 90 mg196 255IFX, steroids
Plasma cell myeloma (multiple myeloma)57/M34Monoclonal IgG kappa gammopathy of undetermined significance NoUstekinumab 6 mg/ kg IV1 199IFX, ADA, steroids, IMMa
Prostate cancer53/M30Elevated prostate-specific antigen levels before randomizationNot reportedUstekinumab induction IV 4.3 mg/kg 1 64steroids, 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

TABLE 6.

Reported Malignancies Through 1 Year (Excluding NMSC)

Malignacy (PT)Age/ SexIBD Duration (years)Relevant Risk FactorsSmoking Status Study TreatmentLast Study Agent Dose (study day)Malignancy Diagnosis (study day)Prior IBD Therapy
Ulcerative colitis
Prostate Cancer61/M1Family history of prostate cancerYes-Past smokerUstekinumab 130 mg IV; 1 dose of 90 mg SC56 69Steroids, IFX, 6-MP
Rectal adenocarcinoma32/M6 Ulcerative colitis NoUstekinumab 130 mg IV; 1 dose of 90 mg SC56 159Steroids, ADA, IFX, GOL, 6-MP
Colon cancer48/F28 None NoUstekinumab 6 mg/kg IV; 1 dose of 90 mg SC58 59IFX, steroids
Papillary renal cell carcinoma70/M33 hypertension, diuretic use Yes-Past smokerUstekinumab 130 mg IV; 1 dose of 90 mg SC56 92Steroids
Testis cancer26/M 1 None NoPlacebo285 302Steroids
Crohn’s disease
Adenocarcinoma of small intestine & incidental carcinoid tumor68/M4Family history of cancerYes, Past smokerPlacebo, ustekinumab 130 mg IV, 2 doses of 90 mg196 255IFX, steroids
Plasma cell myeloma (multiple myeloma)57/M34Monoclonal IgG kappa gammopathy of undetermined significance NoUstekinumab 6 mg/ kg IV1 199IFX, ADA, steroids, IMMa
Prostate cancer53/M30Elevated prostate-specific antigen levels before randomizationNot reportedUstekinumab induction IV 4.3 mg/kg 1 64steroids, 5-ASA
Malignacy (PT)Age/ SexIBD Duration (years)Relevant Risk FactorsSmoking Status Study TreatmentLast Study Agent Dose (study day)Malignancy Diagnosis (study day)Prior IBD Therapy
Ulcerative colitis
Prostate Cancer61/M1Family history of prostate cancerYes-Past smokerUstekinumab 130 mg IV; 1 dose of 90 mg SC56 69Steroids, IFX, 6-MP
Rectal adenocarcinoma32/M6 Ulcerative colitis NoUstekinumab 130 mg IV; 1 dose of 90 mg SC56 159Steroids, ADA, IFX, GOL, 6-MP
Colon cancer48/F28 None NoUstekinumab 6 mg/kg IV; 1 dose of 90 mg SC58 59IFX, steroids
Papillary renal cell carcinoma70/M33 hypertension, diuretic use Yes-Past smokerUstekinumab 130 mg IV; 1 dose of 90 mg SC56 92Steroids
Testis cancer26/M 1 None NoPlacebo285 302Steroids
Crohn’s disease
Adenocarcinoma of small intestine & incidental carcinoid tumor68/M4Family history of cancerYes, Past smokerPlacebo, ustekinumab 130 mg IV, 2 doses of 90 mg196 255IFX, steroids
Plasma cell myeloma (multiple myeloma)57/M34Monoclonal IgG kappa gammopathy of undetermined significance NoUstekinumab 6 mg/ kg IV1 199IFX, ADA, steroids, IMMa
Prostate cancer53/M30Elevated prostate-specific antigen levels before randomizationNot reportedUstekinumab induction IV 4.3 mg/kg 1 64steroids, 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

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