Eight patients (median age years old) were identified. At the time of flare-up the median duration of pregnancy was weeks of gestation (range 4-25). Seven patients had pancolitis. All patients had more than 3 commonly used clinical and biological severity criteria. Three patients had severe endoscopic lesions and 5 patients had not. All patients received intravenous corticosteroids for at least 7 days before introduction of cyclosporine. Two patients received azathioprine during treatment with cyclosporine. No severe infections or other complications due to treatment were observed. Treatment was effective in 7/8 patients. One patient received infliximab due to cyclosporine therapy failure with a good outcome. No colectomy was performed during pregnancy. Seven pregnancies were conducted to term, but 1 in utero death occurred due to maternal absence of S-protein. Two newborns were premature, including 1 case of hypotrophy. No malformations were observed.
The ULTRA-2 study did not reveal any new safety concerns. There were no significant differences between ADA vs. Placebo for any AE’s: malignancy, injection reaction, opportunistic infection, CHF, demyelination or Lupus-like reactions. Two patients experienced malignancy and were in the ADA group (one squamous cell carcinoma and one gastric cancer). There were no cases of tuberculosis, lymphoma, or demyelinating disease reported in this study.
Sub-analysis of ULTRA-2, provides some additional insights about ADA treatment of moderate to severe UC failing conventional therapy. Trough ADA concentrations were obtained periodically though out the study. A trough cut off value of ADA concentration > 10 was seen for UC remitters, see Table 3 .