Risk Factors for Alcohol Consumption after Starting Assisted Reproductive Technology Treatment among Japanese Women: Japan-Female Employment and Mental Health in Assisted Reproductive Technology (J-FEMA) Study.

AIMS: To determine the association between drinking habits and social factors among women undergoing assisted reproductive technology (ART) treatment in Japan. METHODS: The study participants who provided answers for the questionnaire concerning alcohol consumption were 1017 female patients undergoing ART treatment were enrolled in the Japan-Female Employment and Mental Health in assisted reproductive technology (J-FEMA) study between August and December 2018. Patient characteristics, including demographic, clinical, and socioeconomic status, were assessed using a self-administered questionnaire which was distributed only once during the period, regardless of their first or follow-up examination. We defined current drinkers who drank ≥46 g of ethanol per week as the habitual drinking group. The risk factors for habitual drinking were analyzed using multivariable-adjusted logistic regression. RESULTS: The proportion of habitual drinkers was 15.5% in this study population. The multivariable-adjusted odds ratios (95% confidence interval) for habitual drinking were 2.27 (0.99-5.21) for women aged ≥35 years versus those <35 years, 4.26 (1.98-9.16) for women having partners who currently drink compared to those with partners without current drinking, 1.84 (1.08-3.12) for women without a history of childbirth versus those with, and 1.77 (1.00-3.14) for working women compared with those not working. CONCLUSIONS: In our study, habitual drinking among women undergoing ART treatment was significantly associated with older age, no history of childbirth, partner's current drinking status, and working.

Early-Phase Partial Mayo Score following Golimumab Treatment Is Associated with Endoscopic Improvement at 1 Year in Ulcerative Colitis: A post hoc Analysis of PURSUIT-J Randomized Controlled Trial.

Introduction: Golimumab (GLM) is an anti-tumor necrosis factor-alpha antibody therapy for moderately to severely active ulcerative colitis (UC). Endoscopic improvement is considered one of UC treatment's main goals, and earlier prediction of future endoscopic improvement has clinical implications. We retrospectively analyzed data from the PURSUIT-J, a phase III randomized controlled trial evaluating the efficacy of GLM in the maintenance phase, to find predictors for endoscopic improvement after 60 weeks of GLM treatment. Methods: Ninety-two patients who had completed the maintenance phase of the PURSUIT-J were divided into two groups: those with mucosal healing (MH: Mayo endoscopic subscore of 0 or 1) and those without MH at week 60 (non-MHs). Multivariate logistic regression analysis was conducted using baseline data in the induction phase to determine predictive factors for MHs compared to non-MHs. Results: Twenty-nine patients were classified as MHs and 63 as non-MHs. The multivariate logistic regression analysis showed that the odds ratio for partial Mayo (pMayo) score was highest in MHs (1.87 [95% CI: 1.18-2.98]) at baseline in the induction phase. The receiver operating characteristic analysis to determine the timing of predictions of MHs using pMayo showed that an area under the curve reached 0.8 at week 14 after the first GLM administration. Discussion/Conclusion: pMayo scores at week 14 of GLM treatment are associated with MH at week 60. These results suggest the timing when a clinical decision to continue GLM based on the patient-reported outcomes and the physician's general assessment could be considered.

Synthesis of Water-Soluble Planar Cobalt(II), Nickel(II), and Copper(II) Hydroxo Clusters Using a (1,4,7-Triazacyclononane)cobalt(III) Complex as a Hydrolysis-Terminating Group.

We report on a group of planar cobalt(II), nickel(II), and copper(II) hydroxo clusters that have a definite composition and are water-soluble: [{Co(tacn)(OH)2}6Co7(OH)12](NO3)2(CF3SO3)6·10H2O (1), [{Co(tacn)(OH)2}6Ni7(OH)12](NO3)2(CF3SO3)6·10H2O (2a), [{Co(tacn)(OH)2}6Ni7(OH)12](BNPP)8·6CH3NO2·8H2O [2b; BNPP = bis(p-nitrophenyl)phosphate], [{Co(tacn)(OH)2}12Ni16(OH)26(OH2)2](SO4)4(CF3SO3)10·30H2O (3a), [{Co(tacn)(OH)2}12Ni16(OH)26(OH2)2](SO4)8(CF3SO3)2·44H2O (3b), [{Co(tacn)(OH)2}2Co2(OH)2(OH2)4](SO4)(CF3SO3)2·4H2O (4), [{Co(tacn)(OH)2}2Ni2(OH)2(OH2)4](SO4)(CF3SO3)2·4H2O (5), and [{Co(tacn)(OH)2}4Cu4(OH)6](ClO4)6·5H2O (6), where tacn is 1,4,7-triazacyclononane. The peripheral of each metal hydroxo cluster plane is chemically protected by the coordination of {CoIII(tacn)(OH)2}+ groups to prevent further hydrolysis. These clusters were synthesized by the reaction of an equimolar amount of [Co(tacn)(OH2)3]3+ and cobalt, nickel, or copper salt at pH values in the range of 6.0-12.0. The structure of the cation in compounds 1, 2a or 2b, 4, and 5 is relevant to the surface structure of the cobalt phosphate and nickel borate oxygen-evolution catalysts; in particular, the Co7(OH)12 core in 1. Moreover, the arrangement of M7(OH)12 in 1 and 2a or 2b and Cu4(OH)6 in 6 represents the solid-state structures of the (111) face of the cubic CoO or NiO and the (002) plane of Cu(OH)2, respectively. Extended X-ray absorption fine structure spectra of an aqueous solution of 1, 2a, 4, and 5 exhibit well-resolved peaks at the first and second coordination spheres due to the M-O and M···M distances, respectively; the solution-state bond distances were estimated, and they agreed well with the bond distances in the solid-state structures.

Risk factors for infertility treatment-associated harassment among working women: a Japan-Female Employment and Mental health in assisted reproductive technology (J-FEMA) study.

PURPOSE: This study aims to elucidate the risk factors of infertility treatment-associated harassment (I-harassment) among Japanese working women. METHODS: The study participants were 1103 female patients who enrolled in the Japan-Female Employment and Mental Health in artificial reproductive technology (J-FEMA) study. Of the 1727 female patients, 1103 female patients were working during the initiation of infertility treatment and were still working during the survey. Risk factors for I-harassment were analyzed using a multivariable logistic regression model. RESULTS: In this study, 82 female patients (7.4%) experienced I-harassment. The risk was significantly higher in those who had more in vitro fertilization (IVF) cycles than those who had fewer IVF cycles (OR, 1.06; 95% CI, 1.01-1.10). Similarly, those who disclosed their infertility treatment to their workplace were at significantly higher risk for I-harassment than those who did not (OR, 1.80; 95% CI, 1.03-3.15). CONCLUSION: This study found that 7.4% of female patients experienced I-harassment after infertility treatment initiation. Those female patients who "experienced more IVF cycles," and "disclosed their infertility treatment in their workplace" should be carefully followed up by healthcare professionals to prevent I-harassment.

Selective Formation of Intramolecular Hydrogen-Bonding Palladium(II) Complexes with Nucleosides Using Unsymmetrical Tridentate Ligands.

Three palladium(II) complexes with amino-amidato-phenolato-type tridentate ligands were synthesized and characterized by 1H NMR spectroscopy and X-ray crystallography. The strategic arrangement of a hydrogen-bond donor and acceptor adjacent to the substitution site of the PdII complex allowed the selective coordination of nucleosides. Among two pyrimidine-nucleosides, cytidine and 5-methyluridine, cytidine was successfully coordinated to the PdII complex while 5-methyluridne was not. On the other hand, both purine-nucleosides, adenosine and guanosine, were coordinated to the PdII complex. As purines have several coordination sites, adenosine afforded three kinds of coordination isomers expected from the three different donors. However, guanosine afforded a sole product according to the ligand design such that the formation of double intramolecular hydrogen-bond strongly induced the specific coordination by N1-position of guanine moiety. Furthermore, the preference of the nucleosides was evaluated by scrambling reactions. It was found that the preference of guanosine is nearly twice as high as adenosine and cytidine, owing to the three-point interaction of a coordination bond and two hydrogen bonds. These results show that the combination of a coordination and hydrogen bonds, which is reminiscent of the Watson-Crick base pairing, is an effective tool for the precise recognition of nucleosides.

Depressive and anxiety symptoms among Japanese cancer survivors: Japan cancer survivorship research project.

BACKGROUND: This study aimed to clarify predictors of depressive symptoms and anxiety symptoms after cancer diagnosis among Japanese cancer survivors (CSs). METHODS: As part of a Japanese cancer survivorship research project commissioned by the Ministry of Health, Labour and Welfare (MHLW) of Japan, we conducted a web-based nationwide survey of CSs in 2018. We analyzed the risk factors for depressive and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale Japanese version (HADS). RESULTS: Of 1,234 Japanese CSs, mean score of HADS-depression and HADS-anxiety were 4.08 and 4.78, respectively. At the time of the study, the number of CSs with symptoms of depression and anxiety were 111 (9.0%) and 269 (21.8%), respectively. After multivariable analysis, CSs ≥ 60 years old (reference: ≤ 39 years old, odds ratios (OR): 0.39, 95%CI: 0.17-0.90) and those ≥ 10 years from cancer diagnosis (reference: 0-4 years, OR: 0.55, 95%CI: 0.32-0.96) had lower odds for depressive symptoms. And CSs ≥ 60 years old (reference: ≤ 39 years old, OR: 0.27, 95%CI: 0.15-0.49) and those ≥ 10 years from cancer diagnosis (reference: 0-4 years, OR: 0.62, 95%CI: 0.42-0.90) also had lower odds for anxiety symptoms. CSs who received chemotherapy (OR: 1.56, 95%CI: 1.10-2.20) had higher odds for anxiety symptoms. CONCLUSIONS: Based on manifestation of symptoms, CSs who were younger, closer to the time of cancer diagnosis, had advanced-staged cancer, or received chemotherapy may be at higher risk for depressive or anxiety symptoms. Those CSs who have higher risk for depression and anxiety symptoms, should be followed-up more carefully for better cancer survivorship, by medical professionals, companies, and society.

Real-world data for golimumab treatment in patients with ulcerative colitis in Japan: interim analysis in post-marketing surveillance.

BACKGROUND/AIMS: Golimumab (GLM) is an anti-tumor necrosis factor-α drug approved for treating moderate-to-severe active ulcerative colitis (UC). A 52-week post-marketing surveillance (PMS) was initiated to evaluate its safety and effectiveness in patients with UC in Japan. We present an interim report of the ongoing PMS. METHODS: Patients received 200 mg of subcutaneous GLM at week 0, 100 mg at week 2, and 100 mg 4 weekly thereafter. The safety analysis set included 392 patients with UC, and the effectiveness analysis set 387 patients. Safety and effectiveness were assessed at week 6. RESULTS: Adverse drug reactions (ADRs) were reported in 8.2% (32/392) and serious ADRs in 4.6% (18/392). The most frequent ADRs were infection and infestation (3.3%), with herpes zoster being the most common. ADRs were significantly higher in patients with concomitant corticosteroid use (odds ratio [OR], 3.45; 95% confidence interval [CI], 1.40-9.68). No significant difference in ADR incidence was observed between patients aged ≥65 and <65 years (OR, 1.23; 95% CI, 0.35-3.47). Six-week effectiveness of GLM was confirmed by a decrease in the partial Mayo score (-2.3; 95% CI, -2.6 to -2.1) and C-reactive protein levels (-0.64; 95% CI, -0.92 to -0.36), including in the biologics-experienced population. CONCLUSIONS: The safety and effectiveness of GLM at week 6 in a real-world setting were demonstrated in patients with UC in Japan. ADR patterns were consistent with previous reports with no new safety signals. Concomitant corticosteroid use may be associated with increased ADR incidence. The final results of the ongoing PMS are necessary for further evaluation.

Predictors of resignation and sick leave after cancer diagnosis among Japanese breast cancer survivors: a cross-sectional study.

BACKGROUND: In Japan, 55.5% of breast cancer survivors (BCSs) are of working age, so various perspectives regarding return to work (RTW) after cancer diagnosis need to be considered. Therefore, this study aimed to clarify the risk factors for resignation and taking sick leave (SL) among BCSs in continued employment at the time of diagnosis. METHODS: A web-based retrospective cross-sectional survey was conducted on BCSs using data from a 2018 Japanese national research project (Endo-Han) commissioned by the Ministry of Health, Labour and Welfare of Japan. The subjects were women aged 18-69 years who had been diagnosed with breast cancer for the first time at least 1 year previously. The risk factors for resignation and taking SL after breast cancer diagnosis, including age at diagnosis, education level, cancer stage, surgery, chemotherapy, radiotherapy, employment status, and occupational type, were then analyzed using a logistic regression model. RESULTS: In total, 40 (14.9%) of 269 BCSs quit their jobs at least 1 year after being diagnosed with breast cancer. The results of the multivariable analysis indicated that lower education level (odds ratio [OR]: 3.802; 95% confidence interval [CI]: 1.233-11.729), taking SL (OR: 2.514; 95%CI: 1.202-5.261), and younger age at diagnosis (OR: 0.470; 95%CI: 0.221-0.998) were predictors of resignation. Of 229 patients who continued working, SL was taken by 72 (31.4%). In addition, undergoing surgery was found to be a predictor of taking SL (OR: 8.311; 95%CI: 1.007-68.621). CONCLUSIONS: In total, 40 (14.9%) of 269 BCSs quit their jobs at least 1 year after being diagnosed with breast cancer. The results of this study indicated that younger age, lower education level, and taking SL were predictors of resignation after breast cancer diagnosis.

Analysis of severe psychological stressors in women during fertility treatment: Japan-Female Employment and Mental health in Assisted reproductive technology (J-FEMA) study.

PURPOSE: To identify risk factors for severe psychological stress in women undergoing fertility treatment. METHODS: This cross-sectional, multi-center study was conducted from August to December 2018. We recruited 1672 subjects who completed an anonymous, self-reported questionnaire regarding fertility treatment, conditions at work and home, and psychological stress using K6 score, which estimates psychological distress during the previous 30 days. We further focused our analysis on 1335 subjects who were working when starting fertility treatment. RESULTS: Of 1672 women, mean K6 score (range 0-24) was 4.8 ± 4.4, including 103 women (6.2%) with K6 score ≥ 13 (high K6), and classified as probable severe psychological distress. Multivariate logistic regression analysis showed that high K6 was strongly associated with low annual family income of ≤ USD55,700 (JPY6 million) (odds ratio [OR] 1.89, 95% confidence interval [CI] 1.04-3.42), infertility duration of ≥ 2 years (OR 1.87, 95% CI 1.08-3.25), and no experience of childbirth (OR 2.04, 95% CI 1.05-3.97). Focusing on 1335 working women, 266 (19.9%) experienced resignation from work. High K6 was strongly associated with low family income (OR 2.83, 95% CI 1.52-5.28), cessation of professional duties (OR 2.08, 95% CI 1.05-4.14), infertility-related harassment in the workplace (OR 2.07, 95% CI 1.08-3.98), and perceived difficulties to continue working during fertility treatment (OR 2.94, 95% CI 1.15-7.50). CONCLUSION: Severe psychological stressors in women during fertility treatment included low family income, long infertility duration, childlessness, infertility-related harassment, and perceived difficulty in working conditions or cessation from work. Establishment of mental health care support systems is urgently required in this population.

Risk factors for resignation from work after starting infertility treatment among Japanese women: Japan-Female Employment and Mental health in Assisted reproductive technology (J-FEMA) study.

OBJECTIVE: To elucidate the risk factors associated with resignation from work of Japanese women undergoing infertility treatment. METHODS: A total of 1727 female patients who attended a private fertility clinic in Japan participated in the Japan-Female Employment and Mental health in Assisted reproductive technology study. Questions related to demographic, clinical and socioeconomic characteristics were employed in the questionnaire. Out of the 1727 patients, 1075 patients who were working at the time of initiating infertility treatment and felt infertility treatment incompatible with work were included in the analysis. Risk factors for resignation were assessed by using multivariable logistic regression models. RESULTS: Among 1075 working women who started infertility treatment, 179 (16.7%) subsequently resigned. Multivariable-adjusted ORs for resignation in those with lower educational background and infertility for ≥2 years were 1.58 (95% CI: 1.07 to 2.34) and 1.82 (95% CI: 1.15 to 2.89), respectively. The OR for resignation in non-permanent workers undergoing infertility treatment was 2.65 (95% CI: 1.61 to 4.37). While experiencing harassment in the workplace approached significance, lack of support from the company was significantly associated with resignation after starting infertility treatment, with ORs of 1.71 (95% CI: 0.98 to 2.99) and 1.91 (95% CI: 1.28 to 2.86), respectively. CONCLUSION: One-sixth of women resigned after starting infertility treatments. It was found that factors related to education, infertility duration and work environment were significantly associated with resignation. Reducing the physical and psychological burden endured by women, for example, by increasing employer-provided support, is vitally important in balancing infertility treatment with maintenance of work life.

Predictors of post-cancer diagnosis resignation among Japanese cancer survivors.

PURPOSE: In Japan, due to the increased incidence of cancer among the working population, it has become more important to support employees to achieve a balance between cancer treatment and work. This study aimed to clarify the predictors of resigning from employment after being diagnosed with cancer (post-cancer diagnosis [PCD] resignation) among Japanese employees. METHODS: As part of a Japanese national research project (Endo-Han), the investigators conducted a web-based survey of cancer survivors (CSs) in 2017. The investigators analyzed the risk factors for PCD resignation using a logistic regression model, including age at diagnosis, sex, cancer type, cancer stage, year of diagnosis, whether the patient held a managerial role, type of employment, and company size. RESULTS: Of 750 employed Japanese CSs, 93 (12.4%) resigned from their jobs. The non-managers resigned more often (14.6%) than the managers (7.6%) (p = 0.007). The temporary workers exhibited the highest PCD resignation rates (22.2%), while the PCD resignation rates of the self-employed workers and permanent workers were 15.2% and 7.6%, respectively (p < 0.001). As the result of multivariate analysis, being female (odds ratio [OR], 3.67; 95%CI, 1.71-7.87), having hematological cancer (OR, 4.23; 95%CI, 1.37-13.04), having advanced cancer (OR, 2.48; 95%CI, 1.52-4.03), and being a temporary worker (OR, 2.51; 95%CI, 1.40-4.50) were identified as predictors of PCD resignation. CONCLUSIONS: In total, 12.4% of Japanese employees quit their jobs after being diagnosed with cancer. Being female or a temporary worker and having advanced cancer were identified as predictors of PCD resignation. Regarding cancer type, hematological cancer was most strongly associated with PCD resignation. IMPLICATION OF CANCER SURVIVORS: CSs who are females and temporary workers and have advanced cancer should be followed-up more carefully after cancer diagnosis for their work sustainability, by medical professionals, companies, and society.

Recurrent sick leave and resignation rates among female cancer survivors after return to work: the Japan sickness absence and return to work (J-SAR) study.

BACKGROUND: To date, there have not been any workforce-based Japanese cohort studies investigating work sustainability after return to work (RTW). The objective of this study was to investigate the post-RTW cumulative recurrent sick leave rate and cumulative resignation rate among female cancer survivors. METHODS: Among Japanese employees who were registered in the Japan sickness absence and return to work (J-SAR) study, the subjects were those female employees who returned to work after sick leave due to newly clinically diagnosed cancer (C01-C99; ICD-10), based on a physician's certificate, between 2000 and 2011. The last day of the follow-up period was December 31, 2012. The recurrent sickness leave rate and resignation rate were calculated using competing risk survival analysis. RESULTS: Of 223 cancer survivors, 61 took further physician-certified sick leave after their RTW. The median duration of the post-RTW work period among all cancer survivors was 10.6 years. The work continuance rates of the female cancer survivors were 83.2 and 60.4% at 1 and 5 years after they returned to work, respectively. There was a steep reduction in the work continuance rate during the first post-RTW year. There were considerable differences in the work continuance rate according to the primary cancer site. Cumulative recurrent sick leave rates of 11.8 and 28.9% were seen at 1 and 5 years after the subjects returned to work. The cumulative resignation rate was 5.0 and 10.7% at 1 and 5 years after the subjects returned to work. Most recurrent sick leave occurred in the first year after the subjects returned to work, followed by the second year. CONCLUSIONS: Sixty percent of female cancer survivors were still working at 5 years after returning to work, although the work continuance rates for different types of cancer varied significantly.

Characteristics of lower leg and foot muscle thicknesses in sprinters: Does greater foot muscles contribute to sprint performance?

The present study aimed to determine the differences in thicknesses of the lower leg and foot muscles between sprinters and non-sprinters and to examine the relationship between these muscle thicknesses and sprint performance in sprinters. Twenty-six well-trained sprinters and 26 body size-matched non-sprinters participated in this study. Total 9 muscle thicknesses of bilateral lower leg and foot muscles in participants were measured using ultrasonography. Regarding the lower leg muscles, thicknesses of the tibialis anterior, gastrocnemius medial, and gastrocnemius lateral were measured. Regarding the foot muscles, thicknesses of the flexor digitorum longus, flexor hallucis longus, peroneal longus and brevis, abductor hallucis, flexor digitorum brevis, and flexor hallucis brevis were measured. Most muscle thicknesses were significantly larger in sprinters than in non-sprinters. The differences in mean thicknesses of both legs between the two groups were greater in the foot muscles, where it ranged from 10.2% to 17.1%, than in the lower leg muscles, where it ranged from -0.9% to 9.4%. Among foot muscles, the thickness of only the abductor hallucis was positively correlated with the personal best 100-m sprint time in sprinters (r = 0.419, P = 0.033), indicating that a greater abductor hallucis may be a negative factor for superior sprint performance. These findings suggest that although the foot muscles in addition to the lower leg muscles are more developed in sprinters than in non-sprinters, these muscle sizes may not contribute to achieve superior sprint performance.

Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies.

BACKGROUND/AIMS: Efficacy and safety of ustekinumab were evaluated in a Japanese subpopulation with moderately to severely active Crohn's disease (CD) in UNITI-1, UNITI-2 and IM-UNITI studies and results were compared with the overall population. METHODS: Overall, patients in UNITI-1 (Japan, n=56; failed response to tumor necrosis factor antagonist) and UNITI-2 (Japan, n=26; failed response to prior conventional therapy) were randomized to placebo or ustekinumab intravenous induction (130 mg or ~6 mg/kg) at week 0. Responders to ustekinumab induction therapy (Japan, n=21) were randomized to placebo or ustekinumab (90 mg, subcutaneous) maintenance (every 12 weeks [q12w] or 8 weeks [q8w]) in IM-UNITI. The primary endpoint was clinical response at week 6 for induction studies and clinical remission at week 44 for maintenance study. RESULTS: Percentage of patients achieving clinical response at week 6 was greater in ustekinumab 130 mg and ~6 mg/kg groups than in the placebo group (UNITI-1: 36.8% and 31.6% vs. 27.8%, respectively, for Japanese; 34.3% and 33.7% vs. 21.5%, respectively, for overall; UNITI-2: 37.5% and 55.6% vs. 11.1%, respectively, for Japanese; 51.7% and 55.5% vs. 28.7%, respectively, for overall). Clinical remission rate at week 44 during maintenance was greater in the ustekinumab 90 mg SC q12w and q8w groups than in the placebo group (50.0% and 55.6% vs. 25.0%, respectively, for Japanese; 48.8% and 53.1% vs. 35.9%, respectively, for overall). Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population. CONCLUSIONS: Ustekinumab could be considered as a new therapeutic option for moderately to severely active CD in Japanese patients. Both ustekinumab induction and maintenance treatments were generally well tolerated (Clinical Trial Registration: NCT01369329, NCT01369342, NCT01369355).

Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study).

BACKGROUND: The global phase 3 studies of golimumab [PURSUIT-SC and PURSUIT-maintenance (M)], an anti-tumor necrosis factor-α (anti-TNFα) antibody, have demonstrated clinical efficacy and safety as induction and maintenance therapies in patients with moderate to severely active ulcerative colitis (UC). This study aimed to evaluate the efficacy and safety of golimumab as maintenance therapy in the Japanese population. METHODS: In this phase 3, double-blind (DB), placebo-controlled, parallel group, randomized withdrawal study, 144 Japanese patients with moderately to severely active UC received golimumab doses of 200 mg (at week 0) and 100 mg (at week 2) subcutaneously during the 6-week open-label induction phase. Patients who responded to golimumab induction therapy entered the DB maintenance (M) phase and were randomized (1:1) to receive 100 mg of golimumab subcutaneous injection (SC) or placebo every 4 weeks for 52 weeks. The primary endpoint was clinical response through M-week 54; secondary endpoints included clinical remission and mucosal healing at M-week 30 and 54. RESULTS: Among induction responders, more patients on golimumab treatment (56.3%) maintained clinical response through M-week 54 versus the placebo group (19.4%). At both M-week 30 and 54, 50% golimumab-treated patients achieved clinical remission versus the placebo group (6.5%) and a higher proportion of patients on golimumab (59.4%) experienced mucosal healing than the placebo group (16.1%). Incidence of treatment-emergent adverse events was 96.9% in the golimumab group and 71% in the placebo group. Overall, the efficacy and safety results in this study were comparable with those observed in global studies. CONCLUSIONS: Golimumab SC treatment maintained clinical efficacy through week 54 among induction responders, and no new safety signals were observed in the patients with moderate to severely active UC. CLINICAL TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov NCT01863771.