April 2024

Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks from 2 Phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2)

J Am Acad Dermatol 2018;79:302–14. doi: 10.1016/j.jaad.2018.04.012

Treatment of moderate-to-severe chronic plaque PsO with either CZP 400 mg or 200 mg Q2W was associated with significant, clinically meaningful improvements in efficacy and quality of life that were maintained over time compared with placebo. Safety findings were in line with those expected of the therapy.

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Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a Phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT)

J Am Acad Dermatol 2018;79:266–76. doi: 10.1016/j.jaad.2018.04.013

In this phase 3 study, both 200mg and 400mg certolizumab pegol doses improved psoriasis symptoms at Week 12 measured via PASI 75. Improvement was maintained, after rerandomisation, through Week 48, with a safety profile consistent with its drug class. This Phase 3 CIMPACT trial by Lebwohl et al., assessed the safety and efficacy of certolizumab pegol for the treatment of moderate-to-severe chronic plaque psoriasis.

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Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltiMMa-1 and UltiMMa-2): Results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled Phase 3 trials

Lancet. 2018;392:650–61. doi: 10.1016/S0140-6736(18)31713-6

Here, the authors reported risankizumab to be both efficacious when compared to both placebo and ustekinumab in the treatment of moderate to severe plaque PsO. This publication aimed to describe two Phase 3 replicate studies, UltiMMa-1 and UltiMMa-2, which assessed the efficacy and safety of risankizumab compared with placebo or ustekinumab in patients with moderate-to-severe chronic plaque PsO.

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December 2018

Professor Iain McInnes Reviews the Most Notable Papers from 2018

Please click the links below to go to the CSF review of each paper

2018 brought a wealth of new data in cytokine signalling and IL-6 that helps inform current clinical practice and brings the promise of new options in the future. There was good data on the use of sub cutaneous tocilizumab as well as strategies in early RA and for methotrexate tapering. For the currently marketed JAK inhibitors, tofacitinib and baricitinib, continuous long-term efficacy and safety data further support its current use and applications. On the development side, the outcomes of the...

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Evaluation of the Short-, Mid-, and Long-term Effects of Tofacitinib on Lymphocytes in Patients with Rheumatoid Arthritis

Arthritis Rheumatol 2018 DOI: 10. 1002/art.40780

Tofacitinib (TOF) treatment is associated with short-term transient increases in absolute lymphocyte counts (ALC), followed by a gradual decline to reach steady state by ~48 months. Changes in both ALC and lymphocyte subset counts (LSC) were reversible upon TOF discontinuation. Low ALC but not LSC were associated with an increased risk of serious infective episodes (SIEs) and herpes zoster (HZ). This data supported the treatment recommendations on ALC counts for starting and continuing therapy w...

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November 2018

Safety and Efficacy of Baricitinib in Patients Receiving Conventional Synthetic Disease-Modifying Antirheumatic Drugs or Corticosteroids

Rheumatol Ther 2018 Dec;5(2):525-536. DOI 10.1007/s40744-018-0128-0

Baricitinib (BARI) in combination with MTX and concomitant csDMARDs was shown to be efficacious, regardless of corticosteroid use in RA patients. MTX is prescribed to most RA patients but concomitant csDMARDs and/or corticosteroids can be added. This study assessed the efficacy and safety of BARI in two arms; with/without corticosteroids and; with MTX only/MTX plus csDMARD/csDMARDs only. Baseline characteristics and adverse reactions were also compared. Data were pooled from two phase 3 studies ...

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Herpes zoster in Tofacitinib: Risk is Further Increased with Glucocorticoids but not Methotrexate

Arthritis Care Res 2018 DOI 10.1002/acr.23769

The rate of Herpes Zoster (HZ) in tofacitinib (TOF) users with concomitant glucocorticoids (GC) was approximately double that of other TOF combination therapies.TOF is an effective treatment for RA. Increased HZ risk has been observed with the use of JAK inhibitors, whereas the HZ risk with biologics and targeted RA therapies are comparable. This study evaluated the HZ risk in TOF users according to concomitant GC, MTX, both, or neither. MarketScan and Medicare data were used to identify 8030 rh...

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Efficacy and Safety of Filgotinib, a Selective Janus Kinase 1 Inhibitor, in Patients with Active Ankylosing Spondylitis (TORTUGA): Results from a Randomized, Placebo-controlled, Phase 2 Trial

Lancet 2018 Dec 1;392(10162):2378-2387. DOI 10.1016/S0140-6736(18)32463-2

In this first clinical trial of filgotinib in patients with active AS, filgotinib significantly reduced disease activity, and the signs and symptoms of AS compared with placebo. The TORTUGA trial was a randomized, double-blind, placebo-controlled, Phase 2 trial, that enrolled 263 adult patients from 30 sites in seven countries. Patients with active AS and an inadequate response or intolerance to two or more NSAIDs were assigned 1:1 to receive filgotinib 200 mg or placebo once daily for 12 weeks....

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Efficacy and Safety of Filgotinib, a Selective Janus Kinase 1 Inhibitor, in Patients with Active Psoriatic Arthritis (EQUATOR): Results from a Randomised, Placebo-controlled, Phase 2 Trial

Lancet. 2018 Dec 1;392(10162):2367-2377. DOI 10.1016/ S0140-6736(18)32483-8

In this first clinical trial of filgotinib in patients with PsA, filgotinib was effective in treating the signs and symptoms of active PsA across various disease manifestations.The EQUATOR trial was a randomized, double-blind, placebo-controlled, Phase 2 trial, that enrolled 191 adult patients from 25 sites in seven countries. Patients with active moderate-to-severe PsA and an insufficient response or intolerance to at least one csDMARD were assigned 1:1 to receive filgotinib 200 mg or placebo o...

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October 2018

A Network Meta-Analysis Comparing Efficacy and Safety of Tofacitinib and Baricitinib

Z Rheumatol. 2018 Sep 6. DOI 10.1007/s00393-018-0531-5

Tofacitinib (TOF) 10mg and baricitinib (BARI) 4mg, in combination with methotrexate (MTX), were the most efficacious treatments in RA patients with an inadequate response to DMARDs or biologics. Both combination treatments presented acceptable safety profiles and were not associated with a significant risk of serious adverse events.This study employed a Bayesian approach to Meta-Analysis; combining the available evidence across a network of Randomised Controlled trials (RCTs).Twelve RCTs contai...

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