Grand-averaged waveforms of the onset and change-related responses.

Grand-averaged waveforms of the onset responses (A) and change-related responses (B) for each condition. Red arrowheads indicate the sound (A) and change (B) onsets.</p

Amplitude and latency for LDAEP and the change-related response.

LDAEP and the change-related response are shown aligned. On the right are the P50/N100 and N100/P200 amplitudes corresponding to sound pressure and sound pressure changes, respectively, and on the left are the P50, N100, and P200 latencies corresponding to sound pressure and sound pressure changes.</p

Waveforms of a representative subject.

Both the onset and abrupt sound pressure increase evoked a triphasic response with peaks at approximately 50 (P50), 100 (N100), and 200 (P200) ms, with peak amplitudes measured in the time windows of 30–80, 80–150, and 150–280 ms, respectively. The EOG does not affect evoked potentials for either LDAEP or change-related responses. LDAEP, loudness-dependent auditory evoked potentials; ISI, interstimulus interval.</p

Sex differences in LDAEP and the change-related response in P50/N100 and N100/P200.

Differences in correlation coefficients between LDAEP and the change-related response by are shown for the P50/N100 and N100/P200 components. (TIF)</p

Efficacy and safety of baricitinib in Japanese patients with rheumatoid arthritis: Subgroup analyses of four multinational phase 3 randomized trials

<p><b>Objectives:</b> To evaluate efficacy/safety of baricitinib for rheumatoid arthritis (RA) in Japanese subpopulations from four phase 3 studies, and assess whether results in these subpopulations are consistent with the overall study populations.</p> <p><b>Methods:</b> Subgroup analyses (394 patients) of four phase 3 randomized controlled trials: RA-BEGIN [no or limited treatment with disease-modifying antirheumatic drugs (DMARDs)], RA-BEAM [inadequate response (IR) to methotrexate], RA-BUILD [IR to conventional synthetic DMARDs (csDMARDs)], and RA-BEACON (IR to tumor necrosis factor inhibitors receiving csDMARDs).</p> <p><b>Results:</b> For American College of Rheumatology 20% improvement (ACR20) response rate, Japanese patients receiving baricitinib 4-mg showed similar improvement compared to methotrexate at Week 24 (72 versus 69%; RA-BEGIN), and greater improvement compared with placebo at Week 12 (67 versus 34%; RA-BEAM). Japanese patients receiving baricitinib 4-mg also showed greater improvement compared with placebo at Week 12 in RA-BUILD and RA-BEACON. Across all studies, baricitinib was well-tolerated, with no deaths and one malignancy. In RA-BEGIN and RA-BEAM, herpes zoster rates were higher for Japanese patients than for overall populations; all events were mild/moderate.</p> <p><b>Conclusion:</b> Data for baricitinib, with/without methotrexate, in Japanese subpopulations across all stages of the RA treatment continuum accord with the efficacy/safety profile in overall study populations. Baricitinib appears to be similarly effective in Japanese patients.</p