Abstract
Levilimab is anti-interleukin-6 receptor (IL6R) monoclonal antibody. The article presents data obtained during 24 weeks of the SOLAR phase III study.Objective: to confirm efficacy and safety of levilimab in combination with methotrexate (MTX) in patients with methotrexate resistant active rheumatoid arthritis (RA).Patients and methods. 154 adult patients, aged ≥18 years with the diagnosis of RA (ACR/EULAR 2010) and confirmed disease activity at screening despite treatment with MTX for at least 12 weeks (in a stable dose 15-25 mg/week). Patients were randomized 2:1 in levilimab (162 mg once a week, subcutaneously) + MTX (n=102) or placebo + MTX (n=52) group.The hypothesis of superiority of levilimab over placebo was tested for two co-primary efficacy endpoints: proportion of subjects who achieved ACR20 at week 12 and proportion of subjects who achieved low disease activity (LDA) of RA (DAS28-CRP <3.2) at week 24. Safety was assessed through monitoring of adverse events (AEs).Results and discussion. Seventy (68.6%) subjects who received levilimab and 20 (38.5%) who received placebo achieved ACR20 response at week 12. Fifty three (52%) subjects who received levilimab and 3 (5,8%) subjects who received placebo achieved LDA at week 24. The most common adverse events (reported in ≥5% of subjects) in levilimab and placebo arms, respectively were (by decreasing frequency): blood c holesterol increase (24% vs 12%), alanine aminotransferase elevation (11% vs 8%), lymphocyte count decrease (9% vs 8%), blood total bilirubin increase (11% vs 0%), blood triglycerides increase (10% vs 2%), aspartate aminotransferase elevation (7% vs 4%), positive interferon-gamma release assay (IGRA) with M.tuberculosis antigen blood test (5% vs 6%), absolute neutrophil count decrease (8% vs 0%). No deaths were occurred.Conclusion. The study confirmed superior efficacy of levilimab + MTX over placebo + MTX in subjects with MTX resistant active RA. Levilimab showed favorable safety profile and low immunogenicity. No new important safety risks were detected.
Highlights
Левилимаб – моноклональное антитело к рецептору интерлейкина 6
Рандомизация проводилась в соотношении 2:1 в группу левилимаба (162 мг, 1 раз в неделю, подкожно) в комбинации с МТ (n=102) или плацебо в комбинации с МТ (n=52)
Результаты исследования подтвердили, что у пациентов с ревматоидным артритом (РА), устойчивых к монотерапии МТ, левилимаб в комбинации с МТ превосходит по эффективности плацебо с МТ
Summary
Повышение уровня холестерина в крови имелось у 24 (23,5%) пациентов группы левилимаба и 6 (11,5%) группы плацебо. Увеличение уровня холестерина 3–4-й степени регистрировалось в единичных случаях у пациентов группы левилимаба По результатам скрининга на туберкулез на 24-й неделе исследования различий между группами по частоте получения положительных результатов не выявлено: тест на высвобождение ИФНγ с антигеном M. tuberculosis был позитивным у 8 (7,8%) пациентов группы левилимаба и у 5 (9,6%) группы плацебо. У 5 (4,9%) больных группы левилимаба и 3 (5,8%) группы плацебо положительный результат анализа на высвобождение ИФНγ был получен на фоне отсутствия признаков туберкулеза в ходе рентгенологического исследования органов грудной клетки. Досрочно прекративших участие в исследовании в связи с развитием НЯ/СНЯ, в том числе: реакция в месте инъекции (2-й степени) рак почки (3-й степени)
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