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Objective To compare the safety and efficacy of switching from reference adalimumab to adalimumab biosimilar CT-P17 with continuing reference adalimumab/CT-P17 in active RA. Methods This double-blind, phase III study randomized (1:1) subjects with active RA to receive 40 mg (100 mg/ml) CT-P17 or European Union-sourced reference adalimumab subcutaneously every 2 weeks (Q2W) until week (W) 24 [treatment period (TP) 1]. Thereafter, subjects receiving reference adalimumab were randomized (1:1) to continue reference adalimumab or switch to CT-P17 from W26 (both Q2W until W48; TP2). Subjects receiving CT-P17 in TP1 continued CT-P17. W0–W24 results were previously reported; we present W26–W52 findings. End points were efficacy (including joint damage progression), pharmacokinetics, safety and immunogenicity. Results Of 607 subjects who initiated TP2 treatment, 303 continued CT-P17, 153 continued reference adalimumab and 151 switched to CT-P17. Efficacy improvements up to W24 were maintained during TP2; efficacy was comparable among groups. At W52, 20% improvement in ACR response rates were 80.5% (continued CT-P17), 77.8% (continued reference adalimumab) and 82.2% (switched to CT-P17). Joint damage progression was minimal. Mean trough serum adalimumab concentrations were similar among groups. CT-P17 and reference adalimumab safety profiles were numerically similar and switching did not affect immunogenicity. At W52, 28.4% (continued CT-P17), 27.0% (continued reference adalimumab) and 28.3% (switched to CT-P17) of subjects were anti-drug antibody-positive. Conclusion Efficacy, pharmacokinetics, safety and immunogenicity of CT-P17 and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to CT-P17. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov , NCT03789292. [ABSTRACT FROM AUTHOR]

Objective To assess non-inferiority of s.c. to i.v. CT-P13 in RA. Methods Patients with active RA and inadequate response to MTX participated in this phase I/III double-blind study at 76 sites. Patients received CT-P13 i.v. 3 mg/kg [week (W) 0 and W2] before randomization (1:1) at W6 to CT-P13 s.c. via pre-filled syringe (PFS) 120 mg biweekly until W28, or CT-P13 i.v. 3 mg/kg every 8 weeks until W22. Randomization was stratified by country, W2 serum CRP and W6 body weight. From W30, all patients received CT-P13 s.c. In a usability sub-study, patients received CT-P13 s.c. via auto-injector (W46–54) then PFS (W56–64). The primary endpoint was change (decrease) from baseline in disease activity score in 28 joints (DAS28)-CRP at W22 (non-inferiority margin: −0.6). Results Of 357 patients enrolled, 343 were randomized to CT-P13 s.c. (n  = 167) or CT-P13 i.v. (n  = 176) at W6. The least-squares mean change (decrease) from baseline (standard error) in DAS28-CRP at W22 was 2.21 (0.22) for CT-P13 s.c. (n  = 162) and 1.94 (0.21) for CT-P13 i.v. [ n  = 168; difference 0.27 (95% CI: 0.02, 0.52)], establishing non-inferiority. Efficacy findings were similar between arms at W54. Safety was similar between arms throughout: 92 (54.8%; CT-P13 s.c.) and 117 (66.9%; CT-P13 i.v.) patients experienced treatment-emergent adverse events (from W6). There were no treatment-related deaths or new safety findings. Usability was similar for CT-P13 s.c. via auto-injector or PFS. Conclusion CT-P13 s.c. was non-inferior to CT-P13 i.v. in active RA. The convenience of s.c. administration could benefit patients. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT03147248. [ABSTRACT FROM AUTHOR]

In our previous paper we have presented recent advances in the knowledge of the genetic risk factors predisposing to rheumatoid arthritis development. In contrast to the progress that has been made in identification of genes responsible for susceptibility to RA, there is still little known about genetic risk factors of the more aggressive and (or) refractory RA. In this part of our review we present a detailed knowledge of the role of genetic factors in severity of RA. Gene polymorphisms of the TNF-alpha gene (-238G/A, -308G/A, +489G/ A), IL-1beta gene (-11C/T, +3953C/T), IL-4 gene (-590C/T), MMP genes (-1607 ins1G/del2G, -1612 ins/del A) and TRAF1/C5 genes region (rs 10818488) are among the most intensively investigated HLA independent genetic risk factors of the severe course of RA.

Cyclophosphamide has been used in the therapy of rheumatoid arthritis (RA) for nearly fifty years. An experience gathered throughout that time helped to identify indications, profits, restrictions and side effects related to its use. As a result of the progress in RA therapy in the recent years, including introduction of anti - TNF alpha therapy, the importance of cyclophosphamide significantly decreased. However, despite all restrictions related to its use, there are still RA patients for whom cyclophosphamide can be considered as a first choice drug. In this article we review the current knowledge on the issue.

Rheumatoid arthritis (RA) is a chronic, inflammatory, autoimmune disease leading to severe disability. A secondary amyloidosis (AA amyloidosis) affecting RA patient is a life threatening clinical complication of the illness. The most common symptoms of secondary amyloidosis include: proteinuria, erythrocyturia, abdominal pain and chronic diarrhoea. It is essential to carry out regular screening tests, especially abdominal fat tissue biopsy, to early diagnose and properly manage patients with the condition. Effective anti-inflammatory therapy of RA and eradication of coexisting infections seem to be the best way to decrease the risk of development and prevent progression of the secondary amyloidosis.