Safety and efficacy of long-term tofacitinib treatment in East Asian patients with ulcerative colitis in OCTAVE Open.

BACKGROUND AND AIM: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We present safety and efficacy data from patients from East Asia (Japan, Korea, and Taiwan) in OCTAVE Open, an open-label, long-term extension study. METHODS: Patients in remission at OCTAVE Open baseline received tofacitinib 5 mg twice daily (BID); all others received tofacitinib 10 mg BID. Proportions and IRs (unique patients with events/100 patient-years) were calculated for adverse events (AEs) of special interest. Efficacy endpoints were evaluated up to 36 months. RESULTS: In OCTAVE Open, 105/944 patients were from East Asia (tofacitinib 5 mg BID, n = 22; tofacitinib 10 mg BID, n = 83). Overall, 87.6% and 24.8% of patients had AEs and serious AEs, respectively; IRs (95% CI) for AEs of special interest were herpes zoster (HZ; non-serious and serious), 6.07 (3.40-10.02); serious infections, 1.47 (0.40-3.76); opportunistic infections, 1.91 (0.62-4.45); major cardiovascular adverse events, 0.37 (0.01-2.04); malignancies (excluding non-melanoma skin cancer [NMSC]), 0.37 (0.01-2.04); and NMSC, 0.00 (0.00-1.35). No deaths, venous thromboembolic events, or gastrointestinal perforations occurred. At month 36, 68.2% and 54.2% of patients had a clinical response, 68.2% and 53.0% had endoscopic improvement, and 63.6% and 49.4% were in remission with tofacitinib 5 and 10 mg BID, respectively. CONCLUSIONS: The HZ IR in East Asian patients was numerically higher versus the global study population; excluding HZ, tofacitinib safety and efficacy were consistent with the global study population.

Treatment for postoperative wound pain in gynecologic laparoscopic surgery: topical lidocaine patches.

BACKGROUND: This article reports our early experience with the use of lidocaine patches for pain control in the immediate postoperative period after laparoscopic gynecologic surgery. SUBJECTS AND METHODS: A prospective, double-blind, placebo-controlled clinical trial was conducted on 40 patients undergoing a gynecologic laparoscopy who were randomized to receive either topical patches of 700 mg of lidocaine (n=20) or placebo patches (n=20). The patch was divided evenly into four smaller patches, which were applied at the four port sites and changed every 12 hours for 36 hours after surgery. Postoperative pain was evaluated using the visual analog scale (VAS) score and the Prince Henry and 5-point verbal rating pain scale (VRS), and the analgesic requirement was also evaluated at 1, 6, 12, 24, and 36 hours after surgery. RESULTS: The VAS score for wound pain was lower in the lidocaine patch group at 1 and 6 hours after surgery than the control group (P=.005 and <.0005, respectively). The VAS scores for postoperative pain were lower in the lidocaine patch group at rest 1 hour after surgery (P=.045). The 5-point VRS score for postoperative pain was lower in the lidocaine patch group at 6 and 12 hours after surgery (P=.015 and .035, respectively) than in the control group. CONCLUSIONS: Topical lidocaine patches at the laparoscopic port sites reduced postoperative pain, particularly postoperative wound pain after gynecological laparoscopic procedures.