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Patients who have had inadequate response to tumour necrosis factor inhibitors have fewer treatment options and are generally more treatment refractory to subsequent therapeutic interventions than previously untreated patients. We report the efficacy and safety of ixekizumab, a monoclonal antibody that selectively targets interleukin-17A, in patients with active psoriatic arthritis and previous inadequate response to tumour necrosis factor inhibitors. In this double-blind, multicentre, randomised, placebo-controlled, phase 3 study (SPIRIT-P2), patients were recruited from 109 centres across ten countries in Asia, Australia, Europe, and North America. Patients were aged 18 years or older, had a confirmed diagnosis of psoriatic arthritis for at least 6 months, and had a previous inadequate response, distinguished by being refractory to therapy or had loss of efficacy, or were intolerant to tumour necrosis factor inhibitors. Patients were randomly assigned (1:1:1) by a computer-generated random sequence to receive a subcutaneous injection of 80 mg ixekizumab every 4 weeks or every 2 weeks after a 160 mg starting dose or placebo. The primary endpoint was the proportion of patients who attained at least 20% improvement in the American College of Rheumatology response criteria (ACR-20) at week 24. This study is registered with ClinicalTrials.gov, number NCT02349295. Between March 3, 2015, to March 22, 2016, 363 patients were randomly assigned to placebo (n=118), ixekizumab every 4 weeks (n=122), or ixekizumab every 2 weeks (n=123). At week 24, a higher proportion of patients attained ACR-20 with ixekizumab every 4 weeks (65 [53%] patients; effect size vs placebo 33·8% [95% CI 22·4–45·2]; p<0·0001) and ixekizumab every 2 weeks (59 [48%] patients; 28.5% [17·1–39.8]; p<0·0001) than did patients with placebo (23 [20%] patients). Up to week 24, serious adverse events were reported in three (3%) patients with ixekizumab every 4 weeks, eight (7%) with ixekizumab every 2 weeks, and four (3%) with placebo; no deaths were reported. Infections were reported in 47 (39%) patients with ixekizumab every 4 weeks, 47 (38%) with ixekizumab every 2 weeks, and 35 (30%) with placebo. Three (2%) serious infections, all in patients in the ixekizumab every 2 weeks group, were reported. Both the 2-week and 4-week ixekizumab dosing regimens improved the signs and symptoms of patients with active psoriatic arthritis and who had previously inadequate response to tumour necrosis factor inhibitors, with a safety profile consistent with previous studies investigating ixekizumab. Eli Lilly and Company.

Background People with HIV (PWH) experience high levels of mental health or substance use disorders (MSDs) which may compromise HIV treatment outcomes. Differences in the relationship between MSDs and HIV treatment outcomes by gender remain understudied. Methods We conducted interviews with 426 PWH aged  ≥  21 years initiating HIV care in Cameroon between June 2019 and March 2020. Clinic data and laboratory results were used to ascertain loss to clinic and viral non-suppression six months after HIV care initiation. We used log binomial regression models to assess the relationship between symptoms of depression (PHQ-9 scores > 9), anxiety (GAD-7 scores > 9), post-traumatic stress disorder (PTSD; PCL-5 scores > 30), and harmful alcohol use (AUDIT scores > 15) at HIV care initiation and 6-month loss to clinic and viral non-suppression in the study population overall, and among men and women, separately. Results Nearly 25% of individuals ( N  = 100) were lost to clinic at 6 months. Among the 326 individuals retained in care at their original clinic at 6 months, 234 had a measured viral load, of whom 28% were virally non-suppressed ( N  = 65). Among men, the risk of disengagement was greater among those who reported PTSD symptoms at care initiation compared to those who did not. Viral non-suppression was significantly higher among those reporting symptoms of anxiety at care initiation in the population retained overall and among men. Conclusions Men initiating HIV care with poor mental health may be particularly vulnerable to unstable care engagement and viral non-suppression. Interventions are needed for men specifically to foster improved mental health.

Psychiatric comorbidity, the presence of two or more mental health disorders, has been associated with suboptimal HIV treatment outcomes. Little is known about the prevalence of psychiatric comorbidity among people with HIV (PWH) in sub-Saharan Africa. We conducted interviews with PWH initiating HIV care in Cameroon between June 2019 and March 2020. Depression, anxiety, post-traumatic stress disorder (PTSD), and harmful drinking were dichotomized to represent those with and without symptoms of each. Psychiatric comorbidity was defined as having symptoms of two or more disorders assessed. Moderate or severe household hunger, high anticipatory HIV-related stigma, low social support, and high number of potentially traumatic events were hypothesized as correlates of psychiatric comorbidity. Bivariable log binomial regression models were used to estimate unadjusted associations between psychosocial stressors and psychiatric comorbidity. Among 424 participants interviewed, the prevalence of psychiatric comorbidity was 16%. Among those with symptoms of at least one mental health or substance use disorder (n = 161), the prevalence of psychiatric comorbidity was 42%. The prevalence of psychiatric comorbidity was 33%, 67%, 76%, and 81% among those with symptoms of harmful drinking, depression, anxiety, and PTSD, respectively. Among individuals with symptoms of a mental health or substance use disorder, a high number of potentially traumatic events (prevalence ratio (PR) 1.71 [95% CI 1.21, 2.42]) and high anticipatory HIV-related stigma (PR 1.45 [95% CI 1.01, 2.09]) were associated with greater prevalence of psychiatric comorbidity. Psychiatric comorbidity was common among this group of PWH in Cameroon. The effectiveness and implementation of transdiagnostic or multi-focus mental health treatment approaches in HIV care settings should be examined.

ObjectivesTo compare efficacy and safety of ixekizumab (IXE) to adalimumab (ADA) in biological disease-modifying antirheumatic drug-naïve patients with both active psoriatic arthritis (PsA) and skin disease and inadequate response to conventional synthetic disease-modifying antirheumatic drug (csDMARDs).MethodsPatients with active PsA were randomised (1:1) to approved dosing of IXE or ADA in an open-label, head-to-head, blinded assessor clinical trial. The primary objective was to evaluate whether IXE was superior to ADA at week 24 for simultaneous achievement of a ≥50% improvement from baseline in the American College of Rheumatology criteria (ACR50) and a 100% improvement from baseline in the Psoriasis Area and Severity Index (PASI100). Major secondary objectives, also at week 24, were to evaluate whether IXE was: (1) non-inferior to ADA for achievement of ACR50 and (2) superior to ADA for PASI100 response. Additional PsA, skin, treat-to-target and quality-of-life outcome measures were assessed at week 24.ResultsThe primary efficacy endpoint was met (IXE: 36%, ADA: 28%; p=0.036). IXE was non-inferior for ACR50 response (IXE: 51%, ADA: 47%; treatment difference: 3.9%) and superior for PASI100 response (IXE: 60%, ADA: 47%; p=0.001). IXE had greater response versus ADA in additional PsA, skin, nail, treat-to-target and quality-of-life outcomes. Serious adverse events were reported in 8.5% (ADA) and 3.5% (IXE) of patients.ConclusionsIXE was superior to ADA in achievement of simultaneous improvement of joint and skin disease (ACR50 and PASI100) in patients with PsA and inadequate response to csDMARDs. Safety and tolerability for both biologicals were aligned with established safety profiles.

Background Mental disorders are common among people with HIV (PWH) and are associated with poor HIV outcomes. Despite high unmet mental health needs among PWH, use of evidence-based mental health screening and treatment protocols remains limited at HIV treatment facilities across low-resource settings. Integrating mental health services into HIV care can reduce this gap. This study’s objective was to explore factors that influence integration of mental health screening and treatment into HIV clinics in Cameroon. Methods We analyzed 14 in-depth interviews with clinic staff supporting PWH at three urban HIV treatment clinics in Cameroon. Interviews focused on current processes, barriers and facilitators, and types of support needed to integrate mental health care into HIV care. Interviews were recorded and transcribed. French transcripts were translated into English. We used thematic analysis to identify factors that influence integration of mental health screening and treatment into HIV care in these settings. Ethical review boards in the United States and Cameroon approved this study. Results Respondents discussed a lack of standardized mental health screening processes in HIV treatment facilities and generally felt ill-equipped to conduct mental health screening. Low community awareness about mental disorders, mental health-related stigma, limited physical space, and high clinic volume affected providers’ ability to screen clients for mental disorders. Providers indicated that better coordination and communication were needed to support client referral to mental health care. Despite these barriers, providers were motivated to screen clients for mental disorders and believed that mental health service provision could improve quality of HIV care and treatment outcomes. All providers interviewed said they would feel more confident screening for mental disorders with additional training and resources. Providers recommended community sensitization, training or hiring additional staff, improved coordination to manage referrals, and leadership buy-in at multiple levels of the health system to support sustainable integration of mental health screening and treatment into HIV clinics in Cameroon. Conclusions Providers reported enthusiasm to integrate mental health services into HIV care but need more support and training to do so in an effective and sustainable manner.

Background This study explored the relationship between specific types of potentially traumatic events (PTEs) and symptoms of mental health disorders among people with HIV (PWH) in Cameroon. Methods We conducted a cross-sectional study with 426 PWH in Cameroon between 2019–2020. Multivariable log binominal regression was used to estimate the association between exposure (yes/no) to six distinct types of PTE and symptoms of depression (Patient Health Questionnaire-9 score > 9), PTSD (PTSD Checklist for DSM-5 score > 30), anxiety (Generalized Anxiety Disorder-7 scale score > 9), and hazardous alcohol use (Alcohol Use Disorders Identification Test score > 7 for men; > 6 for women). Results A majority of study participants (96%) reported exposure to at least one PTE, with a median of 4 PTEs (interquartile range: 2–5). The most commonly reported PTEs were seeing someone seriously injured or killed (45%), family members hitting or harming one another as a child (43%), physical assault or abuse from an intimate partner (42%) and witnessing physical assault or abuse (41%). In multivariable analyses, the prevalence of PTSD symptoms was significantly higher among those who reported experiencing PTEs during childhood, violent PTEs during adulthood, and the death of a child. The prevalence of anxiety symptoms was significantly higher among those who reported experiencing both PTEs during childhood and violent PTEs during adulthood. No significant positive associations were observed between specific PTEs explored and symptoms of depression or hazardous alcohol use after adjustment. Conclusions PTEs were common among this sample of PWH in Cameroon and associated with PTSD and anxiety symptoms. Research is needed to foster primary prevention of PTEs and to address the mental health sequelae of PTEs among PWH.

Mental health and substance use disorders (MSDs) increase the risk of poor human immunodeficiency virus (HIV) care outcomes among people living with HIV (PLWH). Receipt of mental health care may improve these adverse outcomes. We aimed to identify correlates of prior mental health help-seeking among PLWH with symptoms of an MSD in Cameroon. We characterize prior mental health help-seeking from formal (mental health specialist/general medical provider) and informal (traditional healer/religious leader) sources among 161 people with symptoms of depression (Patient Health Questionnaire-9 scores> 9), anxiety (General Anxiety Disorder-7 scores> 9), probable post-traumatic stress disorder (PTSD Checklist for DSM-5 scores> 30), or possible alcohol use disorder (Alcohol Use Disorders Identification Test scores≥16) who were newly entering HIV care at three healthcare facilities in Cameroon between June 2019 and March 2020. Help-seeking was defined as ever speaking to a formal or informal source about emotional problems, sadness, or the way they were feeling or behaving. We estimated the association between sociodemographic and psychosocial measures and lifetime mental health help-seeking from each type of source using log-binomial regression. Overall, 55.3% of 161 PLWH with MSD symptoms reported prior mental health help-seeking, with 24.2% and 46.0% seeking help from formal and informal sources, respectively. Religious leaders were the most common source of help (40.4%), followed by general medical professionals (22.4%), traditional healers (16.8%), and mental health specialists (7.4%). Individuals with higher depressive, anxiety, and trauma symptom severity scores were more likely to have sought help than those with lower scores. Individuals with possible alcohol use disorder were the least likely to have sought help. Prior help-seeking was more common among those reporting a higher number of lifetime traumatic events (prevalence ratio [PR]: 1.06; 95% confidence interval [CI]: 1.01, 1.11) and those with a history of emotional intimate partner violence (PR: 1.34; 95% CI: 1.01, 1.80). Prior mental health help-seeking was associated with psychosocial stressors. Help-seeking from informal networks was more common than formal help-seeking. Training in the provision of evidence-based mental health support for informal networks could improve access to mental health care for PLWH with MSDs in Cameroon.