Stelara Cancer Risk

[newdiagnosis]

I've been on stelara for over 2 years. Does anyone know if Stelara has an increased cancer risk compared to other biologics. And if so, is it worth switching to an anti tnf. Stelara is the only drug I tried.

 

[kiny]

In animals blocking those interleukins results in cancers. But these results are (currently) not see in humans.

Why is anyone's guess, different immune pathways, studies that are limited in scope due to it being a recent biologic, often side effects of medication is only discovered much later.


''Ustekinumab: new drug. Suspicion of carcinogenicity: too great a risk for psoriasis patients.

In animal studies, interleukin 12 and 23 inhibitors cause cancer. There is therefore a high risk of cancer developing during prolonged treatment with ustekinumab.

In summary, for symptomatic relief of patients whose psoriasis poses major problems despite treatment with methotrexate or ciclosporin, in the absence of a better alternative, it is better to use a TNF alpha antagonist and to avoid exposing patients to the risks associated with ustekinumab, particularly its carcinogenic risk. ''

https://www.ncbi.nlm.nih.gov/pubmed/19882785/

 

[kiny]

It should also not be understated how much pressure there was to get Stelara on the market. Stelara is made by Janssens, Jansses holds the patents on Infliximab, which they have lost in the last couple of years, which saw the rise of biosimilars. This put enormous pressure on Janssens to come up with a new drug to avoid the financial losses from patents expiring on infliximab.

As a result, Stelara was moved through trials and studies as fast as possible to avoid billions in financial losses. So those early studies on Stelara in human subjects are simply inconclusive since they are limited in scope.

 

[my little penguin]

Malignancies
Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy. Some patients who received STELARA in clinical studies developed cutaneous and non-cutaneous malignancies (see section 4.8).
No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving STELARA. Thus, caution should be exercised when considering the use of STELARA in these patients.
All patients, in particular those greater than 60 years of age, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of non-melanoma skin cancer (see section 4.8).

Malignancies
In the placebo-controlled period of the psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 0.11 per 100 patient-years of follow-up for ustekinumab-treated patients (1 patient in 929 patient-years of follow-up) compared with 0.23 for placebo-treated patients (1 patient in 434 patient-years of follow-up). The incidence of non-melanoma skin cancer was 0.43 per 100 patient-years of follow-up for ustekinumab-treated patients (4 patients in 929 patient-years of follow-up) compared to 0.46 for placebo-treated patients (2 patients in 433 patient-years of follow-up).
In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis clinical studies, representing 11,561 patient-years of exposure in 6,709 patients, the
7

median follow-up was 1.0 years; 1.1 years for psoriatic disease studies, 0.6 year for Crohn’s disease studies and 1.0 years for ulcerative colitis studies. Malignancies excluding non-melanoma skin cancers were reported in 62 patients in 11,561 patient-years of follow-up (incidence of 0.54 per 100 patient- years of follow-up for ustekinumab-treated patients). The incidence of malignancies reported in ustekinumab-treated patients was comparable to the incidence expected in the general population (standardised incidence ratio = 0.93 [95% confidence interval: 0.71, 1.20], adjusted for age, gender and race). The most frequently observed malignancies, other than non-melanoma skin cancer, were prostate, colorectal, melanoma and breast cancers. The incidence of non-melanoma skin cancer was 0.49 per 100 patient-years of follow-up for ustekinumab-treated patients (56 patients in
11,545 patient-years of follow-up). The ratio of patients with basal versus squamous cell skin cancers (3:1) is comparable with the ratio expected in the general population (see section 4.4).

from

https://www.ema.europa.eu/en/documents/product-information/stelara-epar-product-information_en.pdf

Extremely low risk when used in ibd
Which is different than those with psoriasis
Animal studies are not the same as human studies