August 2018

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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Two Years of Sarilumab in Patients with Rheumatoid Arthritis and an Inadequate Response to MTX: Safety, Efficacy and Radiographic Outcomes

Rheumatology 2018;57:1423–1431 DOI: 10.1093/rheumatology/key121

Two-year treatment of active, moderate-to-severe RA with sarilumab, along with dose reduction in the event of laboratory abnormalities, resulted in durable efficacy outcomes and a safety profile consistent with previous reports involving IL-6R inhibition. Durable long-term safety and efficacy, reduced joint damage progression, and conserving health-related quality of life and work productivity are important goals of therapy in RA.1 Sarilumab significantly reduced disease activity, improved physi...

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Adverse Events, Clinical Considerations and Management Recommendations in Rheumatoid Arthritis Patients Treated with JAK Inhibitors

Exp Rev Clin Immunol 2018 Nov;14(11):945-956. DOI: 10.1080/1744666X.2018.1504678

Janus kinase (JAK) inhibitors are efficacious in patients with moderate-to-severe RA and have a favourable safety profile. However adverse events (AE), in particular infections, are associated with the use of JAK inhibitors. This paper reviews the mechanism behind JAK inhibitors, the AEs associated with them, and provides consideration in the management of AEs in clinical practice. Data on two RA approved JAK inhibitors – tofacitinib (TOF) and baricitinib (BARI) – was obtained using PubMed, Medl...

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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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July 2018

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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Sarilumab for Previously-Treated Moderate or Severe Rheumatoid Arthritis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

Pharmacoeconomics. 2018 Dec;36(12):1427-1437. doi: 10.1007/s40273-018-0677-7

In this National Institute for Health and Care (NICE) single technology appraisal of sarilumab (SAR) monotherapy and combination therapy with methotrexate (MTX), SAR was considered to have similar efficacy to other bDMARDs for treating moderate-to-severe RA with inadequate response to cDMARDs or TNFis. SAR was also considered a cost-effective use of National Health Service (NHS) resources versus some or all of its comparators in most considered populations.NICE is an independent organisation res...

Safety and Efficacy of Upadacitinib in Patients with Active Rheumatoid Arthritis Refractory To Biologic Disease-Modifying Anti-Rheumatic Drugs (SELECT-BEYOND): a Double-Blind, Randomised Controlled Phase 3 Trial

Lancet 2018;391:2513–24

Upadacitinib (UPA) extended release formulation was effective in treating patients with moderate-to-severe RA with an inadequate response to bDMARDs.Phase 2 study data has shown that UPA is an efficacious and safe treatment for active RA.1,2 SELECT-BEYOND was a double-blind, long-term extension, Phase 3 study to assess the efficacy of UPA in patients with RA who were bDMARD-IR. The first 12-weeks of SELECT-BEYOND were placebo-controlled, with a double-blind period followed by an ongoing double-b...

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Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (SELECT-NEXT): a Randomised, Double-Blind, Placebo-Controlled Phase 3 Trial

Lancet 2018;391:2503–12

Patients with moderate-to-severe active RA had significant improvements in clinical signs and symptoms with upadacitinib (UPA) compared with placebo.In Phase 2 studies, UPA showed favourable efficacy when administered twice daily as an immediate-release formulation at doses of 6–12 mg in patients with active RA who had TNFi-IR.1,2 An extended-release formulation allowing once-daily (QD) administration was developed for Phase 3 studies. SELECT-NEXT was a double-blind, multicentre, Phase 3 study t...

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June 2018

Patient Characteristics Influence the Choice of Biological Drug in RA, and will make non-TNFi Biologics appear more Harmful than TNFi Biologics

Ann Rheum Dis 2018; 77:650–57 DOI: 10.1136/annrheumdis-2017-212395

Analysis of patient characteristics revealed that older and less healthy patients with RA were more likely to receive non-TNFi bDMARDs as a first bDMARD compared to other treatments.This study aimed to describe patient characteristics at initiation of bDMARD treatment at two-time points: first bDMARD initiation and switch to second bDMARD after TNFi treatment. The second aim of the study was to estimate the potential of treatment channelling to confound results in comparative treatment studies i...

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Effects of Baricitinib on Radiographic Progression of Structural Joint Damage at 1 year in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Synthetic Disease-modifying Antirheumatic Drugs

RMD Open. 2018 May 8;4(1):e000662. DOI: 10.1136/rmdopen-2018-000662

Once daily baricitinib (BARI) inhibited radiographic progression of structural joint damage in patients with an inadequate response or intolerance to csDMARDs over 48 weeks.Current treatment goals aim to use DMARDs to inhibit structural joint damage and prevent long-term functional disability. In RA-BUILD¹, BARI was shown to significantly reduce radiographic joint damage progression in patients with active RA, with an intolerance or inadequate response to csDMARDs. Here, the authors report the l...

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