Autologous therapies may negate disease risks but a bigger concern is that of malignancy development.
A positive PET scan was defined as a report that included any of the following statements: concern or suggestion of malignancy, findings that described increased 18F-fluorodeoxyglucose uptake or hypermetabolic activity, or an SUV ≥ 2.5.
Safety is an especially important concern because the FDA has placed a box warning on the DMARDs that target tumor necrosis factor alpha (TNF-α) (e.g., etanercept, infliximab, adalimumab), because of concerns about increased risk of malignancy.
Data concerning numbers and types of malignancy cases were not available in the SSc group.
There is also concern about increased rates of malignancy, although results have been conflicting.
However, concerns about induction of malignancies from iPSCs persist and are being cautiously tackled with refinements in induction methods that include virus-free and transgene-free reprogramming and xeno-free approaches [30].
Safety concerns exist regarding lymphopenia, risk of malignancy, elevations in low and high-density lipoproteins and creatinine [ 53, 54].
In addition, 2 of 84 AIP patients developed pancreatic carcinoma 6 and 10 years after diagnosis, raising further concerns for an elevated risk of malignancy in AIP.
A recent meta-analysis of randomized clinical trials reported by Bongartz and coworkers raised concerns about an increased rate of malignancy and serious infection in rheumatoid arthritis patients treated with anti-tumour necrosis factor monoclonal antibodies.
Maintenance CY therapy may prevent relapse, however, recognition of a variety of toxicities, particularly concerns about the long-term risk of malignancy and gonadal toxicity, often lead clinicians to consider less toxic alternative medications whenever possible (Csuka et al, 1986; Hoffman et al, 1992).
