scholarly journals Results of studying the clinical efficacy and safety of tofacitinib in the treatment of psoriatic arthritis

2019 ◽  
Vol 13 (2) ◽  
pp. 112-118 ◽  
Author(s):  
T. V. Korotaeva ◽  
E. Yu. Loginova
Keyword(s):  
Psoriatic Arthritis ◽  
Clinical Efficacy ◽  
Signal Transmission ◽  
Current Data ◽  
Life Questionnaire ◽  
Inadequate Response ◽  
Medical Monitoring ◽  
Efficacy And Safety ◽  
Tnf Α ◽  
Wide Range

The paper reviews of the data available in the literature on the clinical efficacy and safety of tofacitinib (TOFA) in the treatment of psoriatic arthritis (PsA). It considers the mechanism of action of TOFA, which is mainly in the selective inhibition of signal transmission due to its effect on the activity of JAK3 and/or JAK1, the enzymes that ensure the function of turning on and turning off the signals transmitted by cytokines. TOFA is noted to directly or indirectly act on a wide range of a number of molecules that play an important role in the pathogenesis of PsA.The paper analyzes the current data on the clinical efficacy of TOFA in treating PsA, which have been obtained in the 12-month OPAL Broaden study including patients with PsA and an inadequate response to synthetic disease-modifying anti-rheumatic drugs and in the 6-month OPAL Beyond study enrolling those with PsA and an inadequate response to tumor necrosis factor-α (TNF-α) inhibitors. It is noted that the results of these studies confirmed the efficacy of the drug in treating PsA not only according to the data of objective (medical) monitoring, but also to the subjective characteristics of pain, to the global assessment of disease activity, fatigue, as well as the mental and physical components of the SF-36 quality of life questionnaire.It is concluded that the current findings allow JAK inhibitors to be recommended as a new pathogenetically sound approach to treating PsA and suggest that TOFA has benefits in managing patients unresponsive to therapy with TNF-α inhibitors. 

scholarly journals Ixekizumab is efficacious when used alone or when added to conventional synthetic disease-modifying antirheumatic drugs (cDMARDs) in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor inhibitors

RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000692 ◽  
Author(s):  
Peter Nash ◽  
Frank Behrens ◽  
Ana-Maria Orbai ◽  
Suchitrita S Rathmann ◽  
David H Adams ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Short Form ◽  
Joint Disease ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Disease Modifying ◽  
Necrosis Factor

ObjectiveTo conduct subset analyses of SPIRIT-P2 (NCT02349295) to investigate the efficacy and safety of ixekizumab versus placebo in three subgroups of patients with active psoriatic arthritis (PsA) according to the concomitant conventional synthetic disease-modifying antirheumatic drug (cDMARD) received: any background cDMARDs (including methotrexate), background methotrexate only, or none.MethodsPatients were randomised to receive placebo, ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W). Efficacy and safety were assessed when patients were subdivided according to cDMARD use at baseline. Efficacy was evaluated versus placebo at week 24 by the American College of Rheumatology criteria (ACR20/50), achievement of minimal disease activity (MDA) state, Disease Activity Index for PsA (DAPSA), 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP), Health Assessment Questionnaire-Disability Index and the 36-item Short-Form health survey physical functioning domain.ResultsRegardless of background cDMARD status, ACR20, ACR50 and MDA response rates were significantly higher than placebo with IXEQ4W or IXEQ2W treatment. Similarly, significant improvements were observed relative to placebo for DAS28-CRP and DAPSA across subgroups. Physical function also significantly improved relative to placebo with IXEQ4W treatment regardless of background cDMARD status and with IXEQ2W alone. Percentages of reported treatment-emergent adverse events (AEs), serious AEs (including serious infections) and discontinuations due to AEs in each subgroup were comparable to the overall SPIRIT-P2 population.ConclusionIxekizumab was efficacious in patients with active PsA and previous tumour necrosis factor inhibitor (TNFi) inadequate response or TNFi intolerance treated with ixekizumab alone or when added to cDMARDs with subgroup safety profiles that were consistent with that observed in the overall SPIRIT-P2 population.

scholarly journals Efficacy and safety of netakimab in patients with psoriatic arthritis: results of the phase III PATERA clinical study

2020 ◽  
Vol 58 (5) ◽  
pp. 480-488
Author(s):  
T. V. Korotaeva ◽  
V. I. Mazurov ◽  
A. M. Lila ◽  
I. Z. Gaydukova ◽  
A. L. Bakulev ◽  
...  
Keyword(s):  
Placebo Group ◽  
Psoriatic Arthritis ◽  
Safety Profile ◽  
Phase Iii ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acr20 Response ◽  
American College Of Rheumatology ◽  
Blinded Manner

Netakimab (NTK) is a humanized anti-interleukin-17А (IL-17A) monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Here, we present the results of the 24-weeks double blind period of the PATERA study.Objective. The objective of the study was to evaluate the efficacy and safety of NTK compared to placebo in patients with psoriatic arthritis (PsA).Patients and methods. 194 patients with active PsA with an inadequate response to previous therapy with nonsteroidal anti-inflammatory drugs, conventional or biologic disease-modifying antirheumatic drugs, were randomized in a 1:1 ratio to receive subcutaneous 120 mg NTK or placebo at weeks 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. At week 16 ACR20 (20% improvement in the American College of Rheumatology response criteria) non-responders in placebo group were reassigned to NTK in a blinded manner. The primary endpoint was the proportion of patients achieved ACR20 response at week 24.Results. 82,5% of patients in the NTK group and 9.3% of patients in the placebo group achieved ACR20 at week 24 with the 95% CI [0,63; 0,84] (p < 0,0001). Skin manifestations and axial disease significantly improved with NTK. The safety profile of NTK was comparable to placebo. The most frequent treatment-related AEs were expected and common for all other IL-17 inhibitors: increased alanine aminotransferase (ALT), infections, lymphopenia.Conclusion. NTK in the dose of 120 mg has superior efficacy over placebo in patients with active psoriatic arthritis. The safety profile is consistent with other IL-17 inhibitors.

scholarly journals Tackling Cancer Resistance by Immunotherapy: Updated Clinical Impact and Safety of PD-1/PD-L1 Inhibitors

Cancers ◽  
2018 ◽  
Vol 10 (2) ◽  
pp. 32 ◽  
Author(s):  
Shifaa Abdin ◽  
Dana Zaher ◽  
El-Shaimaa Arafa ◽  
Hany Omar
Keyword(s):  
Clinical Efficacy ◽  
Death Receptor ◽  
Clinical Applications ◽  
Special Focus ◽  
Cancer Resistance ◽  
Efficacy And Safety ◽  
Anticancer Effect ◽  
Checkpoint Protein ◽  
Programmed Death ◽  
Wide Range

Cancer therapy has been constantly evolving with the hope of finding the most effective agents with the least toxic effects to eradicate tumors. Cancer immunotherapy is currently among the most promising options, fulfilling this hope in a wide range of tumors. Immunotherapy aims to activate immunity to fight cancer in a very specific and targeted manner; however, some abnormal immune reactions known as immune-related adverse events (IRAEs) might occur. Therefore, many researchers are aiming to define the most proper protocols for managing these complications without interfering with the anticancer effect. One of these targeted approaches is the inhibition of the interaction between the checkpoint protein, programmed death-receptor 1 (PD-1), and its ligand, programmed death-ligand 1 (PD-L1), via a class of antibodies known as PD-1/PD-L1 inhibitors. These antibodies achieved prodigious success in a wide range of malignancies, including those where optimal treatment is not yet fully identified. In this review, we have critically explored and discussed the outcome of the latest PD-1 and PD-L1 inhibitor studies in different malignancies compared to standard chemotherapeutic alternatives with a special focus on the clinical efficacy and safety. The approval of the clinical applications of nivolumab, pembrolizumab, atezolizumab, avelumab, and durvalumab in the last few years clearly highlights the hopeful future of PD-1/PD-L1 inhibitors for cancer patients. These promising results of PD-1/PD-L1 inhibitors have encouraged many ongoing preclinical and clinical trials to explore the extent of antitumor activity, clinical efficacy and safety as well as to extend their applications.

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