The Journal of dermatology
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Multicenter Study
Twenty-four-week interim analysis from a phase 3 open-label trial of adalimumab in Japanese patients with moderate to severe hidradenitis suppurativa.
Hidradenitis suppurativa (HS) is a chronic skin disease characterized by recurrent painful inflamed nodules/abscesses and draining fistulas that negatively impact quality of life. Adalimumab, a monoclonal antibody against tumor necrosis factor-α, has been approved in the EU, USA and Japan for the treatment of moderate to severe HS. This is an interim analysis of an ongoing phase 3, multicenter, open-label, single-arm study of the safety and efficacy of adalimumab weekly dosing in Japanese patients with moderate to severe HS. ⋯ At week 12, 86.7% of patients achieved clinical response, with improvements at week 12 across the primary and secondary end points generally sustained through week 24. Adalimumab weekly dosing was generally safe and well tolerated with no new safety findings through week 24. These results suggest that adalimumab is effective and well tolerated in Japanese patients with moderate to severe HS.
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Randomized Controlled Trial
Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial.
Risankizumab, a humanized immunoglobulin G1 monoclonal antibody, selectively inhibits interleukin-23, a key cytokine in the pathogenesis of psoriasis, by binding to its p19 subunit. In SustaIMM (ClinicalTrials.gov/NCT03000075), a phase 2/3, double-blinded, placebo-controlled study, Japanese patients with moderate to severe plaque psoriasis (n = 171) were stratified by bodyweight and concomitant psoriatic arthritis and randomized 2:2:1:1 to 75 mg risankizumab, 150 mg risankizumab, placebo with cross-over to 75 mg risankizumab and placebo with cross-over to 150 mg risankizumab. Dosing was at weeks 0, 4, 16, 28 and 40, with placebo cross-over to risankizumab at week 16. ⋯ Through week 52, PASI and sPGA responses increased or were maintained and treatment-emergent adverse events were comparable across treatment groups. Both doses of risankizumab were superior to placebo in treating patients with moderate to severe plaque psoriasis. The safety profile was consistent with previous risankizumab trials, with no new or unexpected safety findings.
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Randomized Controlled Trial
Nemolizumab in moderate to severe atopic dermatitis: An exploratory analysis of work productivity and activity impairment in a randomized phase II study.
Atopic dermatitis negatively impacts work productivity. This study investigated the impact of nemolizumab on work productivity and activity impairment in adults with moderate to severe atopic dermatitis inadequately controlled by topical treatments in a two-part, phase II, randomized control trial. The Work Productivity and Activity Impairment - Atopic Dermatitis questionnaire was an exploratory end-point. ⋯ At week 12, patients receiving nemolizumab every 4 weeks showed greater mean (standard error) Work Productivity and Activity Impairment - Atopic Dermatitis improvement (score reduction) from baseline versus placebo: Percent Work Time Missed (0.1, 0.5 or 2.0 mg/kg vs placebo): -4.0% (3.9%), -1.7% (4.2%) and -1.6% (4.2%) versus 4.9% (4.5%); Percent Impairment While Working, -15.8% (6.0%), -24.1% (6.5%) and -34.3% (6.4%) versus -16.5% (7.1%); Percent Overall Work Impairment, -16.3% (6.0%), -23.1% (6.5%) and -34.5% (6.3%) versus -16.6% (7.1%); and Percent Activity Impairment, -13.4% (5.3%), -23.5% (5.3%) and -41.9% (5.5%) versus -10.9% (5.7%). Improvements were sustained through week 64. Nemolizumab-treated patients with moderate to severe atopic dermatitis reported improvements in Work Productivity and Activity Impairment through week 64.
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Melanoma is one of the most serious form of skin cancer. Nowadays, ipilimumab is used for advanced melanoma refractory to first-line anti-programmed death 1 (PD-1) antibodies. Thirty patients (male : female ratio, 18:12; median age, 60.5 years) sequentially treated with ipilimumab after anti-PD-1 antibody (nivolumab or pembrolizumab), while 58 (male : female ratio, 27:31; median age, 66.5 years) with anti-PD-1 antibody only. ⋯ Prior to first-line PD-1 blockade, these parameters were not associated with OS. The other factors (i.e. age, sex, number of doses, absolute neutrophil counts, neutrophil : lymphocyte ratio, lactate dehydrogenase and C-reactive protein) were not associated with OS. [Correction added on 17 April 2019, after first online publication: 'not related to OS' has been amended to 'not associated with OS'.] Ipilimumab as sequential therapy did not appear to improve OS and was associated with more severe irAE than PD-1 blockade monotherapy. We need to carefully consider treating patients with poor PS and low ALC.