Publications

Bimekizumab versus adalimumab in plaque psoriasis

N Engl J Med 2021; 385:130–41. doi: 10.1056/NEJMoa2102388

Warren RB,

Blauvelt A,

Bagel J,

Papp KA,

Yamauchi P,

Armstrong A,

Langley RG,

Vanvoorden V,

De Cuyper D,

Cioffi C,

Peterson L,

Cross N,

Reich K

Bimekizumab was noninferior and superior to adalimumab with respect to PASI 90 response and IGA score at Week 16. Bimekizumab is a promising IL-17A/F inhibitor that has shown clinical improvement in PsO patients compared to placebo and other IL inhibitors. Warren et al. compared the safety and efficacy of bimekizumab with adalimumab in a 56-week double-blind trial.

Keywords:

• Bimekizumab,
• Efficacy,
• Phase 3,
• Safety,
• Skin

Highlights of 2021

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

McInnes IB

I’m sure we’d all hoped that this year would be a return to normal but, in the midst of the challenges we’ve faced with COVID-19, the rheumatology community has continued to deliver excellent publications, and we’ve covered many of these on the CSF. Here are my highlights from 2021's publications: Points to Consider for the Treatment of Immune-Mediated Inflammatory Diseases With Janus Kinase Inhibitors: A Co...

Keywords:

• Review

Incidence and risk factors for herpes zoster in patients with rheumatoid arthritis receiving upadacitinib: a pooled analysis of six phase III clinical trials

Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-220822.

Winthrop KL,

Nash P,

Yamaoka K,

Mysler E,

Khan N,

Camp HS,

Song Y,

Suboticki JL,

Curtis JR

JAKinibs have been linked with an increased risk of HZ in patients with RA. To this end, Winthrop, et al. evaluated data from six Phase III clinical trials to determine the incidence of HZ in the upadacitinib (UPA)-treated patients with RA and identify potential risk factors for the development of HZ in these patients.Analysis of data provides further support for the need for continued vigilance and monitoring for signs of herpes zoster (HZ) in patients receiving UPA, particularly in Asian popul...

Keywords:

• JAK,
• Updacitinib,
• Phase 3,
• Safety,
• Meta Analysis,
• Infections

Median Time to Pain Improvement and the Impact of Baseline Pain Severity on Pain Response in Patients with Psoriatic Arthritis Treated with Tofacitinib

RMD Open. 2021;7(2):e001609.

de Vlam K,

Ogdie A,

Bushmakin AG,

Cappelleri JC,

Fleischmann R,

Taylor PC,

Azevedo V,

Fallon L,

Woolcott J,

Mease PJ.

Tofacitinib 5 mg twice daily provides clinically meaningful improvements in pain for patients with PsA.Reducing pain is a primary treatment concern for patients with PsA. As such, de Vlam, et al. set out to evaluate the time to pain improvement and the impact of baseline pain severity on pain response in patients with PsA receiving tofacitinib.Using data from the OPAL Broaden and OPAL Beyond trials, they discovered that clinically important improvements in pain were experienced by more patients,...

Keywords:

• JAK,
• Tofacitinib,
• PRO / QoL,
• Pain

Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis

N Engl J Med. 2021;384(13):1227-1239.

McInnes IB,

Anderson JK,

Magrey M,

Merola JF,

Liu Y,

Kishimoto M,

Jeka S,

Pacheco- Tena C,

Wang X,

Chen L,

Zueger P,

Liu J,

Pangan AL,

Behrens F.

Upadacitinib efficacy proves to be greater than placebo, and non-inferior to adalimumab, in treating patients with psoriatic arthritis (PsA). Already approved for the treatment of rheumatoid arthritis, McInnes, et al. studied oral upadacitinib at a dose of 15 mg or 30 mg, alongside placebo or adalimumab, in this 24-week, Phase III trial, in over 1700 patients with PsA. At the primary endpoint (Week 12), ACR20 response was greater with upadacitinib than placebo, and non-inferior to adalimumab; wi...

Keywords:

• JAK,
• Updacitinib,
• Review

Upadacitinib in Rheumatoid Arthritis: A Benefit–Risk Assessment Across a Phase III Program

Drug Saf. 2021 Feb 2. DOI: 10.1007/s40264-020-01036-w

Conaghan PG,

Mysler E,

Tanaka Y,

Da Silva-Tillmann B,

Shaw T,

Liu J,

Ferguson R,

Enejosa JV,

Cohen S,

Nash P,

Rigby W,

Burmester G

Upadacitinib 15 mg has a favourable benefit–risk profile according to an assessment of data from the phase III SELECT clinical trial programme.In this review of data for the once-daily, oral JAK inhibitor, Conaghan PG, et al. provided insights into the benefit–risk profile of upadacitinib in approximately 4400 patients with RA. Based on pooled data from five pivotal studies, benefits and risks were assessed up to the time of regulatory submission, and additional long-term integrated safety revie...

Keywords:

• JAK,
• Updacitinib,
• Phase 3,
• Review

Filgotinib Versus Placebo or Adalimumab in Patients with Rheumatoid Arthritis and Inadequate Response to Methotrexate: A Phase III Randomised Clinical Trial

Ann Rheum Dis. 2021 Jan 27:annrheumdis-2020-219214

Combe B,

Kivitz A,

Tanaka Y,

van der Heijde D,

Simon JA,

Baraf HSB,

Kumar U,

Matzkies F,

Bartok B,

Ye L,

Guo Y,

Tasset C,

Sundy JS,

Jahreis A,

Genovese MC,

Mozaffarian M,

Landewé RBM,

Bae S-C,

Keystone EC,

Nash P

Filgotinib improved RA signs and symptoms, physical function, and inhibited radiographic progression. FIL 200mg plus MTX, but not FIL 100mg plus MTX showed non-inferiority to ADA plus MTX, based on DAS28(CRP) low disease activity. FIL was also well tolerated in RA patients with inadequate response to MTX.This 52-week, phase 3 randomised clinical trial (FINCH 1) evaluated the efficacy and safety of FIL in patients with RA randomised to FIL 200 or 100mg, ADA 40mg, or placebo, all with background M...

Keywords:

• JAK,
• Fenebrutinib,
• Phase 3

Tofacitinib in psoriatic arthritis patients: skin signs and symptoms and health-related quality of life from two randomized Phase 3 studies

J Eur Acad Dermatol Venereol 2020;34:2809–2820.

Merola JF,

Papp KA,

Nash P,

Gratacós J,

Boehncke W-H,

Thaçi D,

Graham D,

Hsu M-A,

Wang C,

Wu J,

Young P

Considering the multi-domain nature of PsA, effective treatments must demonstrate efficacy across a range of clinical and patient-reported outcomes. Dermatologic symptoms often precede rheumatic manifestations in people with PsA, typically by 10 years. Tofacitinib demonstrated significant improvements across a range of outcomes including burdensome dermatologic symptoms. This post hoc analysis included data from two double-blind, Phase 3 studies in patients with active PsA and an inadequate resp...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• PRO / QoL,
• Skin