Physical activity according to sit-to-stand, standing, and stand-to-sit abilities in subacute stroke with walking difficulty: a cross-sectional study.

OBJECTIVE: This study investigated the characteristics of physical activity according to sit-to-stand, standing, and stand-to-sit abilities in subacute stroke with walking difficulty. METHODS: In this study, 29 participants with subacute stroke and walking difficulty were enrolled and classified into two groups: participants who successfully completed three items (i.e., sit-to-stand, standing, and stand-to-sit) of the Functional Balance Scale (independent group, n = 13) and those who showed incomplete scores on any of the three items (dependent group, n = 16). Light-intensity physical activity (LIPA) and moderate-to-vigorous physical activity (MVPA) were measured using an accelerometer at three periods (i.e. daytime, therapy time, and non-therapy time) for a week. RESULTS: Two-way analysis of variance (groups × physical activity intensity) demonstrated a significant interaction in each period. Post-hoc tests showed significantly more LIPAs and MVPAs in the independent group in all periods, except for MVPA in the non-therapy time. Particularly, LIPA showed significant between-group differences in each period. CONCLUSIONS: Among individuals with subacute stroke and walking difficulty, those who could completely perform sit-to-stand, standing, and stand-to-sit could perform more LIPAs. Increasing sit-to-stand, standing, and stand-to-sit abilities could be an important factor in increasing the opportunity to perform LIPAs.

Number needed to treat and cost per remitter for biologic treatments of Crohn's disease in Japan.

Aims: Adalimumab, infliximab, and ustekinumab have been approved for patients with moderate-to-severe Crohn's disease in Japan. This study compared the relative efficacy and cost-effectiveness of adalimumab, infliximab, and ustekinumab in patients with Crohn's disease based on data from randomized controlled trials.Methods: Data were extracted from four phase 3 clinical trials: CHARM, NCT00445432, ACCENT I, and IM-UNITI. A network meta-analysis (NMA) compared 1-year clinical remission rates in patients who responded to treatment during an induction phase. Remission was defined as a Crohn's Disease Activity Index score <150. The number needed to treat (NNT) was defined as the inverse of the risk reduction (compared with placebo) estimated from the NMA among initial responders. Cost per incremental remitter was calculated based on the projected per patient drug cost (2018 Japanese Yen [¥]) and the NNT.Results: Among initial responders, the remission rates were 45.2%, 31.9%, 27.4%, 24.1%, and 15.6% for adalimumab 40 mg every other week (EOW), infliximab 5 mg/kg every 8 weeks, ustekinumab 90 mg every 8 weeks, ustekinumab 90 mg every 12 weeks, and placebo, respectively. The NNT was the lowest for adalimumab 40 mg EOW. Compared with adalimumab, the incremental cost per remitter was numerically higher for infliximab (¥5,375,470) and statistically higher for ustekinumab 90 mg every 8 weeks and ustekinumab 90 mg every 12 weeks (¥42,788,597 and ¥41,495,543, respectively).Limitations: Indirect comparisons are limited by the availability of suitable clinical evidence and there may be residual heterogeneity that could not be adjusted for.Conclusion: Adalimumab was associated with a numerically lower cost per remitter compared with infliximab and a statistically lower cost per remitter compared with ustekinumab in patients with moderate-to-severe Crohn's disease in Japan.

Pregnancy Outcomes of Patients Exposed to Adalimumab in Japan.

BACKGROUND: This is the first retrospective report of pregnancy outcomes after exposure to adalimumab treatment in Japan. METHODS: Using the AbbVie safety database, we analyzed pregnancy outcome data from patients who received adalimumab treatment from April 16, 2008, to May 15, 2017. RESULTS: Data were extracted retrospectively for 74 pregnancies in 73 patients. More than half of the patients included in the study received adalimumab for the treatment of Crohn's disease (37.8%) or ulcerative colitis (20.3%), while 9.5% received adalimumab for rheumatoid arthritis. Of the 53 pregnancies with available outcome data, 45 newborns (45/53 [84.9%]) were delivered. Of these births, 30 were full-term, 2 were preterm, and 13 were unknown. Apgar scores were available for 11 of the 16 newborns whose mothers were exposed to adalimumab in the third trimester; all scores were within the normal range. Low birth weight was observed in 5 infants out of the 30 full-term deliveries. There were also 5 miscarriages (5/53 [9.4%]), 2 induced abortions (2/53 [3.8%]), and 1 stillbirth (1/53 [1.9%]). Eight maternal adverse events were observed in 5 pregnancies; no serious adverse events occurred. CONCLUSION: Although safety concerns were inconclusive, these data do not report additional risk to pregnancy outcomes with adalimumab exposure.