Clinical trial: the effects of certolizumab pegol therapy on work productivity in patients with moderate‐to‐severe Crohn’s disease in the PRECiSE 2 study

Aliment Pharmacol Ther 31 , 1276–1285

Summary

Background The effect of certolizumab pegol on employment status and work productivity has not been previously assessed. Aim To assess the impact of treatment with certolizumab pegol, the only PEGylated, Fab′ TNF antagonist, on work productivity in patients with active Crohn’s disease (CD) from the PRECiSE 2 study. Methods Patients (n = 668) with active disease [CD activity index (CDAI) score of 220–450] were treated with open‐label subcutaneous certolizumab pegol 400 mg (week 0, 2, 4). Responders (n = 425) (≥100‐point decrease in CDAI from baseline) were randomized to receive certolizumab pegol 400 mg or placebo every 4 weeks until week 24, with final evaluation at week 26. Patients completed the Work Productivity and Activity Impairment for CD questionnaire (WPAI:CD) and the Inflammatory Bowel Disease Questionnaire (IBDQ) at weeks 0, 6, 16 and 26 and at the withdrawal visit. Results Work productivity improved following induction with certolizumab pegol. Between week 6 and 26, certolizumab pegol‐treated patients experienced significant improvement in work productivity compared with placebo recipients (11% and 10% overall improvement in work and activity impairment, respectively). During the maintenance phase, impairments in productivity and activities due to CD were significantly less in the certolizumab pegol group than in the placebo group. Conclusion Induction and maintenance therapy with certolizumab pegol significantly improved the work productivity of patients with active CD compared with those in the placebo group.     

EFFECTS OF TWO DIFFERING HALOTHANE CONCENTRATIONS ON THE METABOLIC AND ENDOCRINE RESPONSES TO SURGERY

The effects of two differing concentrations of halothane, 2.1MAC or 1.2 MAC, on the metabolic and endocrine responses toabdominal hysterectomy were investigated. The changes in bloodglucose and lactate values, and plasma glycerol, cortisol, insulinand catecholamine concentrations were similar in both groups.We conclude that high concentrations of halothane do not suppressthe responses to pelvic surgery, and that accurate quantificationof the dose of halothane, within the concentration range of1.2 to 2.1 MAC, is not essential in studies of metabolic changesassociated with surgery.     

CD30 expression in non-Hodgkin''s lymphoma

The CD30 antigen has been reported as the immunophenotypic hallmark of a recently described category of non-Hodgkin's lymphoma, termed anaplastic large cell lymphoma. From a series of approximately 500 lymphomas, 17 cases showing typical anaplastic features have been identified. They were strongly labelled by monoclonal antibodies recognizing CD30 (Ki-1 or BerH2). However, 36 other lymphomas, mainly high-grade, of non-anaplastic cytology also expressed CD30, either diffusely or focally, with a staining pattern identical to that seen in anaplastic large cell lymphomas. This clearly suggests that such lymphomas cannot be identified solely on the basis of being high-grade non-Hodgkin's lymphomas showing CD30 positivity. From the present results, the distinction between the anaplastic and non-anaplastic types would be better made with antibodies to epithelial membrane antigen than to CD30. Clinical data, available for 48 of the patients (16 with anaplastic large cell lymphomas and 32 with non-anaplastic) revealed no significant differences with regard to age at presentation, sex or clinical signs. A short-term follow-up study of 25 patients revealed that for the first 2 years after diagnosis there were no significant differences in patient survival between anaplastic large cell lymphoma, other CD30+ high-grade lymphomas and all high-grade non-Hodgkin's lymphomas considered together. These findings, which must be confirmed by larger studies, suggest that in a general lymphoma clinic there is probably little justification for differentiating anaplastic large cell lymphomas or CD30+ lymphomas from other high-grade non-Hodgkin's lymphomas.     

The Role of a Third and Possible Fourth Coronary Angioplasty for Recurrent Stenosis

From 1980 to 1985, 1,179 patients underwent percutaneous transluminal coronary angioplasty (PTCA) for the first time. Of these, 92 (7.8%) underwent a second PTCA, 25 (2.1%) a third, and 5 (0.4%) a fourth PTCA of the same vessel and site of the initial stenosis. Success rates for these groups were 78%, 87%, 88%, and 100%, respectively. The left anterior descending coronary artery (LAD) was involved in 14 (56%), the right coronary artery (RCA) in 9 (36%), and the circumflex coronary artery (CX) in 2 (8%). There were no deaths or emergency surgery due to the third and fourth PTCA. Follow-up after the last PTCA indicated symptomatic relief and an improvement in Canadian Cardiovascular Society functional class (CAHA) along with an increase in the exercise time on a standard Bruce stress test. We conclude that a third or fourth PTCA provides a safe and effective therapy for recurrent stenosis.     

The significance of anti-c alloimmunization in pregnancy

Summary. In an 8-year period, 177 of 280 000 pregnancies were complicated by maternal anti-c alloimmunization. Although there was one neonatal death associated with anti-c haemolytic disease of the newborn, only two infants were severely anaemic at birth. A total of 11 babies required exchange transfusion, but nine of these developed hyperbilirubinaemia alone. The remaining c positive infants were either unaffected or only mildly affected by erythroblastosisfetalis. A strategy for management of these pregnancies is outlined, and proposed methods of prevention and serological control are discussed.