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#自身免疫

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Oct 15Thu
  1. N Engl J Med77

    Phase 2 Trial of Icotrokinra for Patients with Ulcerative Colitis.

    Once-daily oral icotrokinra, a peptide that blocks the interleukin-23 receptor, beat placebo for clinical response at week 12 in adults with moderately to severely active ulcerative colitis: 63% at 400 mg, 58% at 200 mg and 55% at 100 mg versus 27% on placebo (P<0.001 for all). The 400-mg group also showed more clinical remission (30% vs. 11%), symptomatic remission (46% vs. 19%) and endoscopic improvement (37% vs. 14%). It offers an oral alternative to injected interleukin-23-targeted antibodies.

    Why it matters: An oral interleukin-23 receptor blocker matched injected antibodies' mechanism with positive phase 2 results.

Oct 6Tue
  1. N Engl J Med84

    Obexelimab for the Treatment of IgG4-Related Disease.

    Weekly subcutaneous obexelimab, 250 mg for 52 weeks, cut the risk of IgG4-related disease flare requiring rescue therapy by more than half in a phase 3 trial of 194 patients (hazard ratio 0.44; flares in 26.8% vs. 54.6% with placebo). Complete remission at week 52 was reached by 37.1% versus 19.6%, and cumulative glucocorticoid rescue dose was 329.5 mg versus 929.8 mg. The results position this non-depleting anti-CD19/FcγRIIb antibody as an alternative to glucocorticoid-dependent management.

    Why it matters: Phase 3 evidence that a non-depleting B-cell-targeted antibody reduces flares and steroid exposure in IgG4-related disease.

Sep 13Sun
  1. N Engl J Med63

    Obinutuzumab or Tacrolimus in Primary Membranous Nephropathy.

    Obinutuzumab outperformed tacrolimus for inducing complete remission in primary membranous nephropathy in a phase 3 trial of 142 adults. At week 104, complete remission occurred in 26 of 71 patients given obinutuzumab versus 4 of 70 given tacrolimus (37% vs. 6%; adjusted difference, 31 percentage points; P<0.001). Grade 3 or higher adverse events were similar, at 22% and 19%. The finding positions obinutuzumab as an effective alternative to tacrolimus in this disease.

    Why it matters: Phase 3 data show obinutuzumab superior to tacrolimus for complete remission in primary membranous nephropathy.

Sep 5Sat
  1. Nat Med61

    Inhaled siRNA therapy targeting RAGE for pulmonary inflammation: a first-in-human randomized trial.

    Inhaled ARO-RAGE, a lung-epithelium-targeted siRNA against pulmonary RAGE mRNA, was safe and well tolerated in a first-in-human randomized trial in 58 healthy volunteers and 19 patients with asthma. Plasma levels were low, consistent with drug retention in the lung, and prolonged dose-responsive decreases in serum and bronchoalveolar lavage sRAGE indicated effective pulmonary target engagement. The results support continued clinical development of inhaled therapeutic siRNA for pulmonary inflammation.

    Why it matters: First-in-human data show an inhaled siRNA can safely engage a lung target with minimal systemic exposure.

Sep 1Tue
  1. Lancet60

    Rezpegaldesleukin treatment of moderate-to-severe atopic dermatitis (REZOLVE-AD): final results from the 16-week induction period of an international, double-blind, placebo-controlled, randomised phase 2b study.

    Rezpegaldesleukin, an interleukin-2 receptor agonist that expands regulatory T cells, met its primary endpoint in adults with moderate-to-severe atopic dermatitis naive to biological treatment. At week 16, mean percentage change in EASI was -61% for 24 μg/kg every 2 weeks, -58% for 18 μg/kg every 2 weeks and -53% for 24 μg/kg every 4 weeks, versus -31% for placebo, with treatment differences of -30, -27 and -22 percentage points respectively (p<0·0001, p<0·0001, p=0·0002). Injection-site reactions occurred in 70% of rezpegaldesleukin-treated patients but were nearly all mild to moderate and resolved, with no deaths reported.

    Why it matters: Phase 2b data support a Treg-enhancing mechanism as a new biological approach in moderate-to-severe atopic dermatitis.

Aug 28Fri
  1. Lancet70

    Efficacy and safety of upadacitinib in adults and adolescents for treatment of non-segmental vitiligo (Viti-Up): results of two phase 3 randomised controlled studies.

    Upadacitinib 15 mg once daily produced clinically meaningful repigmentation in non-segmental vitiligo, a disease with no approved systemic therapies. In two phase 3 placebo-controlled trials, T-VASI 50 at week 48 was reached by 19% and 21% of patients on upadacitinib versus 6% on placebo in each study, and F-VASI 75 by 25% and 23% versus 6% and 7%; both coprimary endpoints met p<0·001. Safety was consistent with the known upadacitinib profile, with no new signals.

    Why it matters: First phase 3 data supporting a systemic therapy for non-segmental vitiligo, an approved-therapy gap.

Aug 27Thu
  1. Nat Med50

    CD19 CAR T cell therapy for treatment-refractory seropositive rheumatoid arthritis: a phase 1 trial.

    A single infusion of mivocabtagene autoleucel, a fully human CD19 CAR T cell therapy, depleted CD19+ B cells in blood and tissue of six patients with severe, treatment-refractory, ACPA-positive rheumatoid arthritis after lymphodepletion. CRS occurred in all six but was limited to grade 1 and 2, with no ICANS or serious adverse events. Disease activity improved in all patients off immunosuppression, with a median 34% DAS28-CRP reduction, DAS28-CRP remission and ACR70 response in 3 of 6, and ACPA seroconversion in 4 of 6. The primary safety endpoint was met, allowing advancement to phase 2.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org