Publications

Ozanimod as induction therapy and maintenance therapy for ulcerative colitis

N Engl J Med 2021;385:1280–91 doi: 10.1056/NEJMoa2033617

Sandborn WJ,

Feagan BG,

D’Haens G,

Wolf DC,

Jovanovic I,

Hanauer SB,

Ghosh S,

Petersen A,

Hua SY,

Lee JH,

Charles L,

Chitkara D,

Usiskin K,

Colombel JF,

Laine L,

Danese S,

True North Study Group

Patients receiving ozanimod displayed a significant improvement in clinical response and all secondary endpoints during both the 10-week induction and 52-week maintenance study periods. Percentage of patients achieving clinical remission at Weeks 10 and 52 was the primary endpoint.

Keywords:

• Efficacy,
• GI,
• Phase 3,
• Safety

Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): Efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled Phase 3 trial

Lancet 2021;397:487–98. doi: 10.1016/S0140-6736(21)00125-2

Reich K,

Papp KA,

Blauvelt A,

Langley RG,

Armstrong A,

Warren RB,

Gordon KB,

Merola JF,

Okubo Y,

Madden C,

Wang M,

Cioffi C,

Vanvoorden V,

Lebwohl M

Bimekizumab was more efficacious than ustekinumab and placebo in the treatment of moderate to severe plaque psoriasis. Previous bimekizumab Phase 2 clinical studies have shown both rapid and durable clinical improvements in skin clearance, as well as a safety profile in line with expectations from this MoA. This study aimed to evaluate the efficacy and safety of bimekizumab in moderate to severe plaque PsO over 1 year compared with both placebo and ustekinumab.

Keywords:

• Bimekizumab,
• Phase 3,
• Skin,
• Ustekinumab

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,
• Upadacitinib,
• Phase 3,
• Safety,
• Meta analysis,
• Infections

A review of JAK-STAT signalling in the pathogenesis of spondyloarthritis and the role of JAK inhibition

Rheumatology (Oxford). 2021. Epub ahead of print. doi: 10.1093/rheumatology/keab740.

McInnes IB,

Szekanecz Z,

McGonagle D,

Maksymowych WP,

Pfeil A,

Lippe R,

Song IH,

Lertratanakul A,

Sornasse T,

Biljan A,

Deodhar A

JAK inhibitors are likely to become an important part of the overall treatment paradigm for spondyloarthritis (SpA).Although not fully understood, the pathogenesis of SpA is complex and thought to involve both environmental and genetic factors that together elicit a chronic inflammatory response involving the innate and adaptive immune systems. Several different cytokines, TNF, IL-17A, IL-12/23 and IL-23, which are directly/indirectly affected by JAK molecules, are involved in the pathogenesis o...

Keywords:

• JAK,
• Basic Science,
• Review

Efficacy and safety of tofacitinib versus baricitinib in patients with rheumatoid arthritis in real clinical practice: analyses with propensity score-based inverse probability of treatment weighting

Ann Rheum Dis. 2021;80(9):1130-1136

Miyazaki Y,

Nakano K,

Nakayamada S,

Kubo S,

Inoue Y,

Fujino Y,

Tanaka Y.

Propensity score-based inverse probability of treatment weighting shows that efficacy may differ between tofacitinib and baricitinib. Miyazaki, et al. compared the efficacy and safety of the two JAK inhibitors in real-world clinical practice, after reduction to a minimum of the selection bias, using propensity score-based inverse probability of treatment weighting, and adjustment for confounding patient characteristics. They found that tofacitinib may be less effective in patients resistant to m...

Keywords:

• JAK,
• Baricitinib,
• Efficacy,
• Safety,
• Real-World

バリシチニブの関節性肺疾患に対するリスク: 治験症例の報告

Rheumatol Ther. 2021 Jun 28. DOI: 10.1007/s40744-021-00332-w

Salvarani C,

Sebastiani M,

Dieude P,

Garcia M,

Deberdt W,

Rogai V,

de la Torre I,

Inciarte-Mundo J,

Balsa A

Findings from a descriptive clinical case report from clinical trials show that patients with RA, treated with baricitinib, are at low risk to developing non-infectious interstitial lung disease (ILD) during treatment.Salvarani, et al. used a descriptive, multicentric, retrospective cohort study of eight randomised trials and one long-term extension study to estimate the number of incident ILD cases reported. Their findings showed that the risk of developing non-infectious ILD during baricitinib...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• Lung / ILD

ウパダシチニブ単剤治療は関節リウマチにおける患者報告アウトカムを改善する: SELECT-EARLY 試験および SELECT-MONOTHERAPY 試験結果

Rheumatology (Oxford). 2021;60(7):3209–21

Strand V,

Tundia N,

Wells A,

Buch MH,

Radominski SC,

Camp HS,

Friedman A,

Suboticki JL,

Dunlap K,

Goldschmidt D,

Bergman M.

Upadacitinib treatment results in statistically significant and clinically meaningful improvements in health-related quality of life.Strand, et al. evaluated the effect of upadacitinib monotherapy versus methotrexate (MTX) on patient-reported outcomes (PRO) in MTX-naïve and MTX-inadequate responder patients with moderately-to-severely active RA. Their research from the SELECT-EARLY and SELECT-MONOTHERAPY randomised controlled trials found that upadacitinib monotherapy resulted in clinically mean...

Keywords:

• JAK,
• Upadacitinib,
• Phase 3,
• PRO / QoL

乾癬性関節炎患者におけｒトファシチニブ治療による疼痛改善までの時間とベースライン時の疼痛重症度が反応性におよぼす影響

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