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.

OBJECTIVE: The 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. METHODS: We 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. RESULTS: HAQ-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. CONCLUSION: This 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 REGISTRATION: http://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.

Leukocytapheresis Therapy for Rheumatoid Arthritis: Results Compared with Control Trial.

CONTEXT: Rheumatoid arthritis (RA) is a chronic multisystem autoimmune disease, mainly characterized by synovitis and with symmetrical joint involvement. LCAP therapy for RA patients has been shown to be safe and efficacious in some developed countries for over a decade. OBJECTIVE: The study intended to evaluate the efficacy and safety of leukocytopheresis (LCAP) for treatment of rheumatoid arthritis (RA) and to study the influence of treatment on the levels of various serum cytokines. DESIGN: The study was a nonblinded, nonrandomized, controlled trial. SETTING: The study took place in the Department of Rheumatology and Immunology at Beijing Hospital at the National Center of Gerontology in Beijing, China. PARTICIPANTS: Participants were 51 patients with RA at the hospital with a 28-joint disease activity score (DAS28) exceeding the 3.20 needed to fulfill the classification criteria of the American College of Rheumatology (ACR). INTERVENTION: Participants were divided into 2 groups. One group (intervention group) received LCAP therapy (n = 20), while the control group (n = 31) received disease-modifying antirheumatic drugs (DMARDs). Patients receiving the LCAP therapy were treated using a Cellsorba column every 5 days for a total of 5 treatments. OUTCOME MEASURES: Clinical assessment of participants' symptoms included: (1) a tender-joint count, (2) a swollen-joint count, (3) erythrocyte sedimentation rates (ESR), (4) C-reactive protein levels (CRP), (5) a visual analog scale (VAS) for pain, (6) the DAS28 C-reactive protein (DAS28-CRP) scores, and the Health Assessment Questionnaire Disability Index (HAQ-DI). The study also evaluated participants' scores for the American College of Rheumatology (ACR) Core Data Set. Serum collected before and after therapy from both groups was analyzed for the levels of bradykinin, serotonin, heat shock protein 70, human CXC-chemokine ligand 16 (CXCL16), prostaglandin E2, and macrophage inflammation protein 1α. RESULTS: At week 4 for participants receiving the LCAP therapy, ACR20, ACR50, and ACR70 were observed in 55%, 30%, and 20% of patients, respectively, compared to 19.4%, 3.2%, and 0% for patients in the control group (P < .05). Also, at week 24 of LCAP therapy, ACR20, ACR50, and ACR70 were observed in 70%, 50%, and 30% of patients, respectively, which was significantly higher than the 25.8%, 12.9%, and 3.2% of patients in the control group (P < .05). The serum levels of CXCL16 and serotonin were significantly reduced in the LCAP group compared with control group. CONCLUSIONS: This study indicated that LCAP therapy can significantly decrease RA disease activity and is a safe and effective alternative therapy. LCAP therapy significantly reduced serum CXCL16 and serotonin levels, offering a putative mechanism by which it improves the articular symptoms of RA.