Evaluation of adalimumab biosimilar candidate (HS016) in Chinese patients with active ankylosing spondylitis based on a health survey: sub-analysis of a phase 3 study

Jinmei Su,Jianhua Xu,Xiaoxia Zuo,Huaxiang Wu,Huaxiang Liu,Wei Wei,Lindi Jiang,Weiguo Wan,Mengtao Li,Zhuoli Zhang,Cibo Huang,Yu Lei ,Xin Lü ,Yi Tao,Ai Huang ,Dongyi He,Lingli Dong,Yi Liu,Haiying Chen,Xiaofeng Li,Tianwang Li,Yanyan Wang,Dongbao Zhao,Fen Li,Xiumei Liu,Jingyang Li,Zhiyi Zhang,Lan He,Jian Xu,Xiaofeng Zeng

doi:10.1007/s10067-021-05943-w

Abstract

ObjectiveThe equivalence of the biosimilar HS016 to adalimumab (Humira) for the treatment of active ankylosing spondylitis (AS) patients has been previously validated. The aim was to compare the efficacy of HS016 and adalimumab in stratified subgroups at different time points using Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) and short form 36 (SF-36) questionnaires.MethodsWe carried out a multicenter, randomized, double-blind, parallel, positive control, phase 3 trial of patients with active AS. They were selected randomly to be subcutaneously administered 40 mg HS016 or adalimumab every 2 weeks for a total treatment period of 24 weeks in a 2:1 ratio. A health surveys were used to assess mental and physical improvements of patients as well as other factors.ResultsHAQ-S revealed that changes in scores from baseline in both groups were time dependent until 14 weeks and that during the first 4 weeks of treatment the changes declined rapidly. The SF-36 health survey revealed that both HS016 and adalimumab produced rapid beneficial effects against AS during the first 2 weeks of therapy, which gradually declined between 2 and 12 weeks and flattened out after 12 weeks until 24 weeks.ConclusionThis trial demonstrated that both HS016 and adalimumab produced rapid improvements in symptoms during the first 2 weeks of treatment. These findings suggest that HS016 is an alternative economical treatment for Chinese AS patients producing a rapid amelioration of symptoms, aiding them to recover their lifestyle satisfaction.Trial registrationhttp://www.chictr.org.cn/enindex.aspx, ChiCTR1900022520, retrospectively registered.Key points• HS016 and adalimumab produced rapid AS symptom improvements during the first 2 weeks followed by a slowdown of improvements until week 4 with afterwards few improvements evaluated by HAQ-S• The improvements according to the short form of the 36 (SF-36) questionnaires revealed similar trends as for HAQ-S• There was no significant difference in HAQ-S and SF-36 scores between HS016 and adalimumab

Highlights

Ankylosing spondylitis (AS) is an inflammatory disease affecting spinal joints, causing back pain and stiffness
After 24 weeks treatment, the Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) score was improved to 54.4% of baseline in HS016 group and 54.1% of baseline in the adalimumab group
AS patients exhibit the most difficulty in carrying out regular activity (71 (17.1%) in HS016-treated patients and 56 (24.1%) in the adalimumab group)

Summary

Introduction

Ankylosing spondylitis (AS) is an inflammatory disease affecting spinal joints, causing back pain and stiffness. Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) is often used to evaluate of the functions and health status of AS patients [7]. One contained 5 dimensions of health outcomes and the other one was a short HAQ, which included the HAQ disability index (HAQ-DI) and the visual analog scales (VAS) of pain and stiffness [9]. Liu et al [10] reported (2017) that the Chinese version of HAQ-S was suitable to assess Chinese-speaking AS patients, because the Chinese version correlated well with the Bath AS Functional Index (BASFI), and only moderately with the Bath AS Disease Activity Index (BASDAI) and Bath AS Metrology Index (BASMI)

Methods

Results

Conclusion