Publications
View and download slide summaries of the latest original articles focusing on cytokine signalling therapies within rheumatoid arthritis. All materials produced by the CSF team are subsequently reviewed and approved by individual Steering Committee members.
The Incidence of Opportunistic Infections in Patients with Psoriatic Arthritis Treated with Biologic and Targeted Synthetic Agents: A Systematic Review and Meta-analysis
Front Pharmacol 2022;13:992713 doi: 10.3389/fphar.2022.992713
This is the largest meta-analysis to date, assessing the risk of OIs (Opportunistic infection) in patients with PsA. In coming to this conclusion, a systematic review and meta-analysis was undertaken to estimate the incidence of OIs following treatment with b- and tsDMARDs.
Olokizumab versus Placebo or Adalimumab in Rheumatoid Arthritis
N Engl J Med. 2022;387(8):715–726. doi: 10.1056/NEJMoa2201302
Phase 3 trial of olokizumab, a direct inhibitor of the IL-6 ligand, demonstrates superiority to placebo with respect to an ACR20 response at week 12 and noninferiority to adalimumab (all combined with methotrexate), in patients with RA.
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Two Phase 3 Trials of Baricitinib for Alopecia Areata
N Engl J Med. 2022. Epub ahead of print doi: 10.1056/NEJMoa2110343
Phase 3 trials in patients with severe alopecia areata show that baricitinib is superior to placebo with respect to hair regrowth at 36 weeks.
Alopecia areata is characterised by nonscarring hair loss that can affect any hair-bearing site. Although mild cases of this emotionally- and psychosocially-distressing autoimmune disease may resolve within 12 months, more severe forms of the disease are unlikely to remit without treatment.
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Trial of UPA or Abatacept in Rheumatoid Arthritis
N Engl J Med 2020;383:1511–21 DOI: 10.1056/NEJMoa2008250
In patients with refractory RA to bDMARDs, upadacitinib was found to be superior to abatacept in DAS28-CRP change from baseline and the achievement of remission at week 12.612 bDMARD-IR patients were randomised 1:1 to UPA 15 mg QD or ABA, each in combination with stable synthetic DMARDs. At Week 12, patients with <20% decrease in TJC and Swollen joint count (SJC) had background medication adjusted or added. All patients completing Week 24 were eligible to remain in an open-label, long-term exten...
Filgotinib, a JAK1 Inhibitor, Modulates Disease Related Biomarkers in Rheumatoid Arthritis: Results from Two Randomized, Controlled Phase 2b Trials
Rheumatol Ther. 2020 DOI: 10.1007/s40744-019-00192-5
In this study examining the effect of FIL on a panel of biomarkers, FIL down-modulated several key inflammatory mediators of signalling pathways in RA - independent of MTX background therapy. This confirmed the strong network effects of the JAK1 node in autoimmunity, matrix and cartilage degradation, angiogenesis, and leukocyte adhesion and recruitment. Biomarkers key to RA pathophysiology were measured at baseline, Wk4 and Wk12 in FIL 100 mg, FIL 200 mg or PBO treatment groups from two phase 2b...
Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis
N Engl J Med 2017; 377:1537-50. DOI: 10.1056/NEJMoa1615975
In the Phase 3 OPAL Broaden trial of patients with active psoriatic arthritis (PsA) with inadequate response to ≥1 csDMARD, superior efficacy was observed in patients treated with tofacitinib (TOF) compared with those given placebo. Patients were randomised to: 5 mg TOF BID, 10 mg TOF BID, 40 mg adalimumab administered subcutaneously q2W, or placebo with a switch to 5 mg TOF at Month 3. Adalimumab was used as an active control in the study. A variety of primary and secondary endpoints were used ...
Treatment Persistence and Healthcare Costs Among Patients with Rheumatoid Arthritis Changing Biologics in the USA
Adv Ther. 2017 Nov;34(11):2422-2435. doi: 10.1007/s12325-017-0617-5
Updated treatment guidelines recommend the use of different mechanism of action (MOA) therapies earlier in the treatment course. Clinical studies have revealed that this approach may be better than TNFi cycling, and may be more cost effective.This study of Commercial and Medicare Advantage claims data showed that patients who switched MOA had higher treatment persistence and lower healthcare costs than TNFi cyclers.After the first TNFi claim, patients either cycled to another TNFi (n=935) or swi...
Treatment Persistence and Clinical Outcomes of Tumor Necrosis Factor Inhibitor Cycling or Switching to a New Mechanism of Action Therapy: Real-world Observational Study of Rheumatoid Arthritis Patients in the United States with Prior Tumor Necrosis Factor Inhibitor Therapy
Adv Ther. 2017 Aug;34(8):1936-1952. doi: 10.1007/s12325-017-0578-8
This retrospective, observational study used a real-world US clinical database to demonstrate greater effectiveness of switching to a therapy with an alternative mechanism of action (MOA) vs cycling between TNF inhibitors (TNFis) in patients in which TNFi therapy has failed.Between 1 April 2010 and 31 March 2015, a total of 613 of the observed patients failed a TNFi therapy and then either cycled to another TNFi therapy (54.2%) or switched to a therapy with an alternative MOA (45.8%). The most c...
Outcomes of Tumor Necrosis Factor Inhibitor Cycling versus Switching to a Disease-modifying Anti-rheumatic Drug with a New Mechanism of Action Among Patients with Rheumatoid Arthritis
J Med Econ 2017;20:464–73
This retrospective study looked at claims-based datasets to establish whether it is preferable to switch to another TNF inhibitor (TNFi) or to a therapy with a different mechanism of action (MOA) when RA treatment failure occurs with an initial TNFi, due to inadequate response or lack of tolerability.Administrative claims data from a large US database were used to compare treatment patterns, treatment effectiveness (based on fulfillment of six criteria) and costs in in the 12 months after RA pat...
Extended-release once-daily formulation of tofacitinib: evaluation of pharmacokinetics compared with immediate-release tofacitinib and impact of food
J Clin Pharmacol. 2016 Mar 11. doi: 10.1002/jcph.734. [Epub ahead of print]
PK profile of TOF is rapid absorption and elimination with time to max concentration 0.5-1 hour and terminal half-life at 3 hours. It is currently approved for immediate release (IR) 5 mg BID, 10 mg total; however, decreasing the dosage to QD dosing may help increase compliance. This study performed in 24 healthy males compared the PK of XR and IR TOF under both single and multiple dose conditions and evaluated the effect of a high-fat meal on the PK of XR TOF. There were no clinically important...