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 ixekizumab in a randomized, double-blinded, placebo-controlled phase IIIb study of patients with moderate-to-severe genital psoriasis.

BACKGROUND: Genital psoriasis (GenPs) is a common, debilitating and difficult-to-treat manifestation of plaque psoriasis. However, few controlled, interventional studies of GenPs exist. OBJECTIVES: To determine the efficacy of ixekizumab vs. placebo in patients with moderate-to-severe GenPs with ≥ 1% involved body surface area (BSA). METHODS: Patients with moderate-to-severe GenPs, defined as a baseline static Physician's Global Assessment of Genitalia (sPGA-G) score of ≥ 3, with BSA ≥ 1% were randomized 1 : 1 to receive placebo (n = 74) or the recommended dosing of ixekizumab (n = 75). Major outcomes included the percentage of patients achieving 0 or 1 scores on the sPGA-G (primary end point), overall sPGA, GenPs Sexual Frequency Questionnaire (GenPs-SFQ) item 2, and ≥ 3-point improvement from baseline on the GenPs itch numerical rating scale. RESULTS: At week 12, ixekizumab was superior to placebo for sPGA-G 0/1 (73% vs. 8%, P < 0·001), overall sPGA 0/1 (73% vs. 3%, P < 0·001), GenPs-SFQ item 2 score of 0 or 1 (78% vs. 21%, P < 0·001) and genital itch (60% vs. 8%, P < 0·001). No candidiasis was reported, no deaths occurred and one (1%) serious adverse event was reported in a patient receiving placebo. CONCLUSIONS: Ixekizumab was superior to placebo for the treatment of moderate-to-severe GenPs with BSA ≥ 1%. The safety profile of ixekizumab was consistent with previous studies in moderate-to-severe plaque psoriasis.

Tear break-up time in eyes with pterygia and pingueculae in Ibadan.

BACKGROUND: Ultraviolet (UV) rays and chronic irritation to dust have been implicated in the pathogenesis of degenerative conditions of the cornea and conjunctiva like pterygium and pinguecula. It has been postulated that exposure to these environmental factors cause corneal and conjunctival drying by disruption of the tear film. While some researchers have found tear film dysfunction in eyes with pterygia and pingueculae, others have found no such abnormalities. The differences in findings may be due to different methods of investigation, or differences based on geography and climate. STUDY DESIGN: The tear film has been studied using tear break-up time (TBUT) in adults with pterygia and pingueculae disorders, TBUT was measured in 73 eyes with pterygia and 74 eyes with pinguecula and were compared to TBUT in 74 eyes of age and sex matched normal controls. Abnormal TBUT was defined as TBUT less than 15 secs. Unstable tear film was defined as TBUT less than 10 secs. RESULTS: The mean TBUT was lower in eyes with pterygia (17.90 secs) than in control eyes (19.86 secs), although the mean difference was not statistically significant. Abnormal TBUT, defined as TBUT less than 15 secs, was found in 29 eyes out of 73 eyes with pterygia (39.7%), compared with 13 eyes out of 74 eyes with pingueculae (17.6%) and in 17(23.0%) of 74 control eyes (X2 = 10.01, df = 2, P = 0.0006). A TBUT of less than 15 secs was more significantly associated with eyes with pterygia compared to control eyes. Unstable tear film (TBUT less than 10 secs) was found in 12(16.4%) eyes with pterygia, compared to 4(5.4%) eyes with pingueculae and 4(5.4%) control eyes. Unstable tear film was significantly associated with eyes with pterygia (P = 0.027). CONCLUSION: Tear film abnormalities are associated with pterygium but not with pinguecula in the subjects studied. TBHT may vary in different populations.

Ocular morbidity survey in an opthalmically underserved rural area of Nigeria.

This paper describes in some detail a prevalence of blindness study conducted in a rural area of South-Western Nigeria, which is served by a peripheral eye clinic. By a stratified random cluster-sampling procedure, 1975 people in ten villages were selected for ocular examination. Community prevalence rate of ocular morbidity was 3.3% with the highest prevalence in the 51-60 years age group. There was a male-female ratio of 4:3 and the prevalence of ocular morbidity in the 31-50 years age group was most significant, but people in this age group seldom reported at the peripheral eye clinic serving the survey areas. Age-related macular degeneration was found to be prevalent in the community, while few cases were reported at the peripheral eye centre. The information gathered in the survey is being used to plan and improve eye care services from the peripheral eye clinic. Case finding in persons aged 31-50 years and those at risk for age-related macular degeneration has been recommended as part of the programme of the peripheral eye clinic.

Age-related eye disease in the elderly members of rural African community.

The results of eye examination of the elderly persons (above age sixty years) in a rural population in south-western Nigeria are presented. The group comprised only 8.4% of the total population of the village studied, but its members constituted 37% of the persons with blindness and low vision and 27.9% of the persons with ocular abnormalities. Cataract was the commonest cause of blindness and low vision. Age-related macular degeneration (ARMD) and glaucoma were also important causes. Seven of the 208 members of the community aged above sixty years had demonstrable ARMD. This incidence is much higher than found in hospital studies performed earlier. The study demonstrates clearly the fact that blindness prevalence increases with age and highlights the causes of blindness and low vision in this population. An early, well-structured approach to age-related eye diseases is suggested, to prevent it from being a serious problem.

Eye care outreach to an underserved rural population in Oyo State.

This paper is essentially an initial assessment of work done through a rural community outreach programme based in the ophthalmology department of a large teaching hospital. It evaluates the accessibility, acceptability, and initial effectiveness of the programme by presenting information on selected variables. The evaluation is used to assess the initial achievements of the programme against the planned objectives.

Effect of etomidate on intra-ocular pressure.

Etomidate, a new short-acting non-barbiturate hypnotic, was administered to 40 patients between the ages of 12 years and 65 years. Intra-ocular pressure was measured before and after etomidate injection using a Schiotz tonometer. A significant reduction of intra-ocular pressure was found to follow etomidate injection in spite of the often associated myoclonic movements. The mechanism of reduction of intra-ocular pressure has not been determined in this study. It is suggested that etomidate will be a useful intravenous induction agent where elevation of intra-ocular pressure is undesirable.