Immunogenicity of an adalimumab biosimilar, FKB327, and its reference product in patients with rheumatoid arthritis.

Aim: This study, FKB327-003, is a phase 3, open-label extension (OLE) study comparing the long-term immunogenicity of an adalimumab biosimilar, FKB327 (F), with the reference product (RP).

Methods: In the OLE, patients completing 24 weeks of an initial randomized, double-blind (DB) study (Period 1) with clinical response and no safety concerns were rerandomized to F or RP, so that two-thirds of patients remained on the same treatment and one-third switched to the alternate treatment for weeks 24 through 54 (OLE weeks 0-30; Period 2), then all received F through week 100 (OLE week 76; Period 3). Treatment sequences were F-F-F (no switch), RP-F-F and RP-RP-F (single switch), and F-RP-F (double switch).

Enhanced luminescence of europium-doped layered double hydroxides intercalated by sensitiser anions.

Four sensitising anions naphthalene-1,5-disulfonate (15-NDS), naphthalene-2,6-dicarboxylate (26-NDC), benzoate (BA) and terephthalate (TA) were intercalated into a Eu(3+)-doped Zn/Al layered double hydroxide. The carboxylate anions enhanced the red luminescence of Eu(3+) much more strongly than the sulfonate, in the descending order TA > 26-NDC > BA > 15-NDS.

Comparison of the single-dose pharmacokinetics and tolerability of modafinil and dextroamphetamine administered alone or in combination in healthy male volunteers.

An open-label, randomized, crossover study was performed in healthy male volunteers to evaluate the potential pharmacokinetic and pharmacodynamic interactions and tolerability of single oral doses of modafinil (200 mg) and dextroamphetamine (10 mg). Blood samples were collected for determination of plasma levels of modafinil, the acid and sulfone metabolites of modafinil, and dextroamphetamine at intervals through 48 hours after administration for each treatment. Vital signs (blood pressure and pulse rate) were measured through 48 hours, and electrocardiograms were measured through 24 hours after administration.

Primary atherosclerotic aneurysm of the profunda femoris artery associated with distal embolization.

A rare case of an isolated atherosclerotic aneurysm of the profunda femoris artery associated with emboli to the distal leg and foot is reported. A mechanism for such distal embolization is proposed and the management of the condition discussed.

The role of computed tomography in assessing the operability of oesophageal carcinoma.

The reliability of CT scanning in assessing resectability in carcinoma of the oesophagus was investigated prospectively by direct comparison with the operative findings. Over 11 months, 38 patients judged potentially operable following conventional investigation underwent CT scanning from the thoracic inlet to the level of the adrenal glands. These patients were then explored surgically with a view to resection.