Kane, Sunanda V.

The development and utilization of monoclonal antibodies (mAbs) have been of great interest in all fields of medicine. A substantial increase in the production and development of mAbs has occurred because these biologic agents are proving to be effective and less toxic given their targeted mechanism of action. However, data are limited on coadministration of two or more mAbs. With the increasing availability of mAbs and the comorbidities of some patients, assessment is needed of the ability to safely use multiple mAbs for an individual patient. Although the efficacy of coadministered mAbs may be inferred from their specific targets, we could find no literature reporting such a finding. Herein, we report our experience using two different classes of mAbs to treat hypereosinophilic syndrome and ulcerative colitis in a single patient.

Crohn's disease is a chronic inflammatory bowel disease commonly diagnosed during the reproductive years. Disease management involves advocating conception during periods of stable clinical remission and continuing safe medications throughout pregnancy to achieve optimal maternal and fetal outcomes.

SummaryBackgroundCertolizumab pegol (CZP) is Food and Drug Administration (FDA)‐approved to treat Crohn's disease (CD). However, the efficacy and safety of CZP outside clinical trials are not well established.AimTo report the efficacy, safety and predictors of response to CZP in CD patients treated during a 6‐year period since FDA‐approval at a tertiary care centre.MethodsAll CD patients who received CZP at our institution between 2008 and 2013 were evaluated through retrospective medical record‐based review of steroid‐free complete response (SCR), loss of response and safety.ResultsA total of 358 patients were included. One hundred twelve patients (31.3%) and 189 (52.8%) received CZP as their second and third biological agent, respectively. The probability of SCR at 26 week was 19.9% (95% CI, 15.9–24.5). The probability of survival free of loss of response at 2 year was 45.7% (95% CI, 32.5–59.5). A predictor of SCR was age at CD diagnosis of >40 years old (hazard ratio, HR relative to those <17, 4.69; 95% CI, 1.75–12.61). Negative predictors included present perianal fistula (HR, 0.39; 95% CI, 0.16–0.98) and prior primary nonresponse to adalimumab (ADA; HR relative to secondary loss of response, 0.18; 95% CI, 0.04–0.76). Twenty‐three patients (6.4%) experienced serious adverse events and 19 patients (5.3%) discontinued CZP due to adverse events.ConclusionsCertolizumab pegol was both effective and well tolerated for the treatment of Crohn's disease in this large tertiary care centre enriched with biologics‐exposed patients. It may be more effective in patients without early‐aged Crohn's disease diagnosis, prior primary nonresponse to adalimumab and present perianal fistula.

SummaryBackgroundPast studies with ulcerative colitis (UC) patients indicate that disease activity strongly predicts health‐related quality of life (HRQL).AimTo examine the degree to which daily treatment with MMX mesalazine predicts improved HRQL for patients with active UC and with stable HRQL for patients with quiescent UC.MethodsData from two phases of a multicentre open‐label trial were examined. In the acute phase, 132 patients with mild‐to‐moderate active UC received MMX mesalazine 2.4–4.8 g/day for 8 weeks, while 206 patients with quiescent UC received MMX mesalazine 2.4 g/day for a 12‐month maintenance phase. Disease‐specific HRQL was measured at baseline and endpoint of each phase using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Repeated‐measures anova models examined baseline‐endpoint changes in SIBDQ, stool frequency (SF), and rectal bleeding severity (RBS). Correlations assessed the associations between SIBDQ and SF/RBS scores, while ancova techniques tested the sensitivity of SIBDQ to disease recurrence.ResultsSIBDQ scores significantly increased for active mild‐to‐moderate UC patients following 8 weeks of treatment, while SIBDQ scores remained stable for quiescent UC patients following 12 months of treatment. Changes in SIBDQ scores correlated significantly with changes in SF and RBS scores. Patients with recurrent UC at maintenance phase endpoint had significantly lower SIBDQ scores than nonrecurrent patients.ConclusionsDaily MMX mesalazine therapy was associated with significant improvement in disease‐specific HRQL for patients with mild‐to‐moderate active UC and with the maintenance of HRQL for patients with quiescent UC. In both patient groups, HRQL was significantly associated with disease activity.