Moore, Gregory

SummaryBackgroundObesity may affect efficacy and safety of biologic treatments for ulcerative colitis (UC). Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of UC.AimsTo assess efficacy and safety of tofacitinib in patients with UC, by baseline body mass index (BMI).MethodsThis post hoc analysis evaluated patients with UC receiving placebo or tofacitinib from the 8‐week OCTAVE Induction 1 and 2 (NCT01465763, NCT01458951) and 52‐week OCTAVE Sustain (NCT01458574) studies. Patients were stratified by BMI at OCTAVE Induction 1 and 2 baseline (<25, 25 to <30 and ≥30 kg/m2). Outcomes included remission, endoscopic improvement, clinical response, sustained steroid‐free remission, Inflammatory Bowel Disease Questionnaire total score and Short Form‐36 Health Survey scores. Adverse events were evaluated.ResultsAt Week 8 of OCTAVE Induction 1 and 2, and Week 52 of OCTAVE Sustain, higher proportions of patients receiving tofacitinib 5 or 10 mg twice daily (b.d.) achieved clinical response vs placebo, regardless of baseline BMI subgroup (all P < 0.05). Proportions of patients achieving efficacy endpoints were generally similar across BMI subgroups; in univariate and multivariate regression analyses, BMI was not a significant predictor (all P ≥ 0.05; univariate BMI [continuous] odds ratio for remission: 0.98 [95% confidence interval 0.95, 1.02]). There was no consistent trend between BMI and adverse events. Among patients receiving tofacitinib 10 mg b.d. in OCTAVE Induction 1 and 2, serious infections were numerically greater in the BMI ≥30 subgroup (3.2%) vs other subgroups (0.4%). Limitations included small patient numbers in the BMI ≥30 subgroup.ConclusionsEfficacy and safety of tofacitinib were similar in patients with UC regardless of baseline BMI.

This article presents three medical-legal cases that define a physician’s duty to warn and include caveats on medical practice within the scope of the law. Some physicians may not recognize that these legal and liability requirements extend not only to physical danger, but also to infectious diseases, medical illness, and drug effects.

In this article we present a case of a patient who received reversal of anticoagulation therapy with factor IX in violation of hospital guidelines. As a direct result, myocardial infarction and ischemic stroke occurred, leaving the patient neurologically debilitated. Factor IX is indicated in the setting of warfarin-induced, life-threatening bleeding. The patient’s care was provided by an intern with attending physician supervision. Delayed charting and questionable shared decision-making were present in the care. We discuss usage of factor IX, liability for supervision of physicians in training, and factors that can lead to plaintiff awards.