Increased Risk of Cancer with Humira Combination Therapy, Compared to Monotherapy, for Crohn's Disease.

[kiny]

http://www.ncbi.nlm.nih.gov/pubmed/24361468

2013 Dec

Increased Risk of Malignancy with Adalimumab Combination Therapy, Compared to Monotherapy, for Crohn's Disease.

Osterman MT1, Sandborn WJ2, Colombel JF3, Robinson AM4, Lau W4, Huang B4, Pollack PF4, Thakkar RB4, Lewis JD5.

BACKGROUND & AIMS:

Few studies have assessed the risk of malignancy from anti-tumor necrosis factor monotherapy or combination therapy for Crohn's disease (CD). We determined the relative risk of malignancy in patients with CD who received adalimumab monotherapy, compared with the general population. We also compared the risk of malignancy associated with combination adalimumab and immunomodulator therapy to that of adalimumab monotherapy.

METHODS:

We performed a pooled analysis of data from 1594 patients with CD who participated in clinical trials of adalimumab (CLASSIC I and II, CHARM, GAIN, EXTEND, and ADHERE studies; 3050 patient-years of exposure). We calculated rates of malignancy among patients; expected rates of malignancy, based on the general population, were derived from the Surveillance, Epidemiology, and End Results registry and National Cancer Institute survey.

RESULTS:

Compared to the general population, patients receiving adalimumab monotherapy did not have a greater than expected incidence of non-melanoma skin cancer (NMSC) or other cancers, whereas those receiving combination therapy had a greater than expected incidence of malignancies other than NMSC (standardized incidence ratio, 3.04; 95% confidence interval [CI], 1.66-5.10) and of NMSC (standardized incidence ratio, 4.59; 95% CI, 2.51-7.70). Compared to patients receiving adalimumab monotherapy, those receiving combination therapy had an increased risk of malignancy other than NMSC (relative risk, 2.82; 95% CI, 1.07-7.44) and of NMSC (relative risk, 3.46; 95% CI, 1.08-11.06).

CONCLUSIONS:

In patients with CD, the incidence of malignancy with adalimumab monotherapy was not greater than that of the general population. Co-administration of immunomodulator therapy and adalimumab was associated with an increased risk of NMSC and other cancers.

 

[kiny]

People who don't understand "combination therapy", they're referring to imuran, 6mp, etc.

Not steroids or antibiotics or 5-ASA.

 

[VeganOstomy]

I can't find the full text for this study, but I'd like to know how long they tracked these patients. It's already known that imuran increases cancer risks, even in its own, but humira is new, and the actual risks may not be known for another 15 years. Even in smokers it could take 20-40 years for cancer to show up.

 

[kiny]

Yah, it's been known since a while that imuran increases skin cancer rates for people who spend a lot of time in the sun. They showed it in transplant patients.

That combination therapy increases risks substantially has been shown with infliximab too.

 

[rollinstone]

Do you know how long this takes? Or is it increased simply after initial exposure to combination therapy? I've only had 4 infusions of inflixmab but iv been on imuran for about a year now, maybe just over, alrdy flared since initially getting good results with the first few infusions, so i'm about to give anti-map a try.