Abstract

Background: the list expansion of genetically engineered biological drugs (GEBD) used for the treatment of ankylosing spondylitis (AS) determines the relevance of studies aimed at comparing them and determining their place in this disease treatment. Real clinical practice studies are the preferred source of this data type. Aim: to evaluate the efficacy of various GEBD in patients with AS according to the Moscow Unified Arthritis Registry (MUAR). Material and methods: the analysis of the MUAR data was carried out. These included clinical cases with GEBD, for which there were data of a completed visit after 6 months or more after the treatment initiation. Parameters values achieved during treatment with various drugs were analyzed. The comparison was conducted during a multivariate analysis with adjustments for the identified confounders. Non-clinical parameters that were reliably and independently associated with the achieved BASDAI index (CRP) values were considered as confounders. Results: the study included 363 treatment episodes with GEBP in 361 patients. As mutually independent significant predictors of the achieved ASDAS (confounders) values, GEBD treatment duration were established until the evaluation of indicators (p<0.001) and the age of the patient (p=0.006). Significant association between the established values of the studied parameters and the used GEBD were found for the achieved ASDAS (p=0.033) and ESR (p=0.007) values. In a pairwise drug comparison using the conservative Šidák correction, the achieved values of ASDAS and ESR during infliximab and adalimumab administration were significantly less than during certolizumab pegol administration. Conclusion: infliximab, adalimumab, etanercept, certolizumab pegol, golimumab, secukinumab in real clinical practice demonstrate generally similar clinical efficacy in the treatment of AS. The effect of golimumab and secukinumab, recently introduced into clinical practice, does not significantly differ from the effect produced by long-term TNF-α inhibitors. Certain disease activity preservation in a significant part of patients gives grounds to continue the search for new treatment methods. KEYWORDS: ankylosing spondylitis, genetically engineered biological drugs, tumor necrosis factor inhibitors, C-reactive protein, confounders, registry. FOR CITATION: Rosochkina E.A., Lukina G.V., Koltsova E.N. et al. Comparative efficacy of genetically engineered biological drugs in real clinical practice according to the Moscow Unified Arthritis Registry (MUAR) data. Russian Medical Inquiry. 2021;5(2):58–63. DOI: 10.32364/2587-6821-2021-5-2-58-63.

Highlights

  • Background: the list expansion of genetically engineered biological drugs (GEBD) used for the treatment of ankylosing spondylitis (AS) determines the relevance of studies aimed at comparing them and determining their place in this disease treatment

  • Aim: to evaluate the efficacy of various GEBD in patients with AS according to the Moscow Unified Arthritis Registry (MUAR)

  • Non-clinical parameters that were reliably and independently associated with the achieved BASDAI index (CRP) values were considered as confounders

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Summary

Материал и методы

Проведен анализ данных пациентов с АС, которые вклю­ чены в МЕРА и получали терапию ГИБП не менее 6 мес. На всех пациентов при включении и на каждом после­ дующем визите заполнялись опросники, характеризую­ щие качество жизни: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), BASFI (Bath Ankylosing Spondylitis Functional Index), HAQ (Health Assessment Questionnaire); оценивалась общая активность заболевания пациентом по ВАШ; регистрировались результаты лабораторных те­ стов (СОЭ и С-реактивный белок, СРБ); врачом оценива­. Эффективность препаратов оценивали по достигнутым значениям индексов активности заболевания и его проявле­ ний (ASDAS (СРБ) и BASDAI, показатель ВАШ общей оценки активности заболевания пациентом, LEI, MASES) и показате­ лей функциональной способности пациентов (BASFI, HAQ) на последнем завершающем визите на фоне лечения препа­ ратом, но не ранее 6 мес.

Результаты исследования
Курение Smoking
Findings
Доля завершенных эпизодов лечения Percentage of completed treatment episodes
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