Long-term safety profile of ixekizumab in patients with moderate-to-severe plaque psoriasis: an integrated analysis from 11 clinical trials.

BACKGROUND: Psoriasis in many patients is a chronic and recalcitrant disease that requires long-term treatment, reinforcing the importance of long-term safety data. Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A, is approved for treating patients with moderate-to-severe plaque psoriasis. OBJECTIVE: To determine long-term safety of ixekizumab in psoriasis. METHODS: Integrated safety data are presented from 12-week induction period, 12-60-week maintenance period, and from all ixekizumab-treated patients from 11 clinical studies. Exposure-adjusted incidence rates (IRs) per 100 patient-years are reported. RESULTS: Overall, 5689 patients accounted for 12 061.5 patient-years of ixekizumab exposure from 11 studies. Over 156 weeks, a total of 83.9% (n = 4775) of patients reported treatment-emergent adverse events (AEs). Most opportunistic infections (IR [95% confidence interval; CI] 1.8 [1.6, 2.1]) reported were mucocutaneous candidiasis. The IR (95% CI) for oral Candida infection was 0.9 (0.8, 1.1). There was no trend of increase in IR of AEs of special interest. Serious AEs were reported in 11.8% of patients; death occurred in 0.4% (n = 23) of patients. CONCLUSION: The 3-year, long-term maintenance treatment with ixekizumab did not show any new safety signals in patients with moderate-to-severe plaque psoriasis.

Efficacy and safety of continuous every-2-week dosing of ixekizumab over 52 weeks in patients with moderate-to-severe plaque psoriasis in a randomized phase III trial (IXORA-P).

BACKGROUND: Ixekizumab is an interleukin-17A antagonist approved for treatment of moderate-to-severe plaque psoriasis with a recommended 160-mg starting dose, then 80 mg every 2 weeks (Q2W) to week 12, and every 4 weeks (Q4W) thereafter. OBJECTIVE: To evaluate continuous Q2W dosing over 52 weeks. METHODS: In this phase III, multicentre, double-blinded, parallel-group trial, three ixekizumab dosing regimens were assessed for efficacy and safety at week 52 in patients with moderate-to-severe plaque psoriasis randomized at a 2 : 1 : 1 ratio to continuous Q2W (n = 611), continuous Q4W (n = 310) or dose adjustment per protocol (Q4W/Q2W, n = 306), each with a 160-mg starting dose. Dose adjustment was determined by predefined criteria to which investigators were blinded; 72 (23?5%) patients in the Q4W/Q2W group adjusted dose. Efficacy outcomes were evaluated using logistic regression. RESULTS: Co-primary end points were met at week 52: Psoriasis Area and Severity Index 75 responses for Q2W and Q4W dose groups were 85·9% and 79·0%, respectively (P = 0·006), and static patient global assessment 0/1 responses for Q2W and Q4W dose groups were 78·6% and 70·6%, respectively (P = 0·005). Treatment-emergent and serious adverse events were comparable across dose groups. CONCLUSIONS: Ixekizumab Q2W had higher efficacy at week 52 than ixekizumab Q4W, with no increase in safety events.

Diabetes care in Nigeria: time for a paradigm shift.

Diabetes mellitus is becoming a major public health problem in Africa and its burden is expected to increase. Persons with diabetes mellitus require continuing medical care and self-management education to prevent complications. In both developed and some resource-poor countries, the management of persons with diabetes has been undergoing rapid changes in order to improve standards of care, through restructuring of clinics or through the establishment of diabetes centres with a multidisciplinary team approach to care. There has been a progressive increase in the prevalence of diabetes mellitus in Nigeria and the burden is expected to increase even further. In view of the looming burden of diabetes in Nigeria, there is an urgent need to examine existing healthcare structures, revise the delivery process of healthcare programmes for persons with diabetes and effectively implement a process that facilitates accessibility to such programmes. Well-structured community-based care, appropriate to the local situation and resources, would provide for this, making it more accessible and realistic to the needs of persons with diabetes living in urban and rural areas of Nigeria. Various models have been adopted for the delivery of diabetes care. This article aims to highlight some of these various models of diabetes care. It concludes with a proposed model for the care of persons with diabetes mellitus in Nigeria.

Microalbuminuria and clinical correlates in black African patients with type 2 diabetes.

BACKGROUND: Diabetes mellitus is a major cause of morbidity and mortality as a result of its complications. Long-term complications of diabetes mellitus have been linked to poor glycemic control. Diabetic nephropathy is the leading cause of end stage renal disease in the developed world and third leading cause in Nigeria. Various independent risk factors have been identified as predictors of diabetic nephropathy. One of such factors is urinary albumin excretion. OBJECTIVE: This study set out to determine the prevalence of microalbuminuria (MA), glycemic control and the relationship between urinary albumin excretion (UAE) and other known predictors of diabetic nephropathy in type 2 diabetic patients with disease duration greater than 5 years. STUDY DESIGN: Fifty non-proteinuric patients were selected consecutively for this cross-sectional study. Urinary albumin concentration was determined in a timed overnight urine sample by immunoturbidimetry and glycated haemoglobin was determined using boronate affinity method. Comparison was made between the patients with microalbuminuria and those with normal albumin excretion and the most likely predictors of urinary albumin excretion were determined. RESULTS: Fifty-two percent of the patients studied had good glycaemic control (HbA1c < 7%) while 83% had microalbuminuria (UAE 20-200 mg/min). There was no significant correlation between the UAE and the HbA1c. UAE however correlated significantly with the age and diastolic blood pressure (DBP) of the patients. CONCLUSION: Almost half of the patient population had suboptimal glycemic control. There was a high prevalence of microalbuminuria amongst the patients studied. Significant predictors of UAE in this study were the age of the patients and DBP but not HbA1c.