Publications

Two Phase 3 Trials of Baricitinib for Alopecia Areata

N Engl J Med. 2022. Epub ahead of print doi: 10.1056/NEJMoa2110343

King B,

Ohyama M,

Kwon O,

Zlotogorski A,

Ko J,

Mesinkovska NA,

Hordinsky M,

Dutronc Y,

Wu WS,

McCollam J,

Chiasserini C,

Yu G,

Stanley S,

Holzwarth K,

DeLozier AM,

Sinclair R,

BRAVE-AA Investigators

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.

Keywords:

• JAK,
• Baricitinib,
• Phase 3

A Retrospective Study of the Efficacy of JAK Inhibitors or Abatacept on Rheumatoid Arthritis-Interstitial Lung Disease

Inflammopharmacology. 2022. Epub ahead of print doi: 10.1007/s10787-022-00936-w

Tardella M,

 Di Carlo M,

 Carotti M,

 Ceccarelli L,

 Giovagnoni A,

 Salaffi F.

This study of the effectiveness of JAKinibs or abatacept in patients with RA-interstitial lung disease (RA-ILD) shows that treatment is related to stability or improvement of RA-ILD in over 80% of patients.

Keywords:

• JAK,
• Safety,
• Lung / ILD,
• Review

Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment

Rheumatol Ther. 2021. Epub ahead of print. doi: 10.1007/s40744-021-00390-0

Winthrop KL,

Curtis JR,

Yamaoka K,

Lee EB,

Hirose T,

Rivas JL,

Kwok K,

Burmester GR

This post hoc analysis provides the first detailed description of the management and outcomes of HZ events in tofacitinib RA and PsA clinical studies.While prior studies have characterised the increased HZ risk with JAKinibs, the clinical management of these events has not been detailed.To this end, Winthrop, et al. analysed data from 21 RA and 3 PsA clinical studies to evaluate how HZ events and their sequelae were clinically managed during the RA and PsA tofacitinib clinical development progra...

Keywords:

• JAK,
• Tildrakizumab,
• Safety,
• Infections

Incidence Rates of Interstitial Lung Disease Events in Tofacitinib-Treated Rheumatoid Arthritis Patients

J Clin Rheumatol. 2021;27(8):e482–e490

Citera G,

Mysler E,

Madariaga H,

Cardiel MH,

Castañeda O,

Fischer A,

Richette P,

Chartrand S,

Park JK,

Strengholt S,

Rivas JL,

Thorat AV,

Girard T,

Kwok K,

Wang L,

Ponce de Leon D

This post hoc analysis of pooled data from 21 clinical trials in the tofacitinib clinical trial programme highlights the importance of identifying known risk factors of RA-interstitial lung disease (ILD) in clinical practice.Citera, et al. investigated incidence rates of ILD – an extra-articular manifestation of RA – in patients with RA, receiving tofacitinib 5 or 10 mg BID and sort to identify potential risk factors for ILD in these patients....

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Lung / ILD

Tofacitinib in juvenile idiopathic arthritis: a double-blind, placebo-controlled, withdrawal phase 3 randomised trial

Lancet. 2021;398(10315):1984–96

Ruperto N,

Brunner HI,

Synoverska O,

Ting TV,

Mendoza CA,

Spindler A,

et al.

Pivotal trial data show that tofacitinib is an effective treatment in patients with polyarticular course juvenile idiopathic arthritis (pJIA).New oral therapies are particularly relevant for children and adolescents, who might prefer to avoid injections. To this end, Ruperto, et al. assessed the efficacy and safety of tofacitinib versus placebo in patients with pJIA (N=225). They observed a JIA flare rate at Week 44 of 29% and 53% for tofacitinib and placebo, respectively. Safety results were si...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3

Baricitinib and the Risk of Incident Interstitial Lung Disease: A Descriptive Clinical Case Report from Clinical Trials

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

Post-Approval Comparative Safety Study of Tofacitinib and Biological Disease-Modifying Antirheumatic Drugs: 5-Year Results from a United States–Based Rheumatoid Arthritis Registry

ACR Open Rheumatol. 2021 Feb 11.

Kremer JM,

Bingham CO 3rd,

Cappelli LC,

Greenberg JD,

Madsen AM,

Geier J,

Rivas JL,

Onofrei AM,

Barr CJ,

Pappas DA,

Litman HJ,

Dandreo KJ,

Shapiro AB,

Connell CA,

Kavanaugh A

Analysis from the US Corrona RA registry has provided the longest-term real-world safety data for a JAK inhibitor to date. The analysis showed that the cohorts had similar adverse events, except for higher herpes zoster rates for tofacitinib initiators vs bDMARDs.Kremer JM, et al. analysed adult patients with RA newly initiating tofacitinib, or a bDMARD, to compare incidence rates of MACE, SIEs, HZ, malignancies and death. VTE data were also collected prospectively and assessed descriptively thr...

Keywords:

• JAK,
• Tildrakizumab,
• Real-World

Baricitinib Inhibits Structural Joint Damage Progression in Patients with Rheumatoid Arthritis – A Comprehensive Review

Arthritis Res Ther 2021;23(1):3.

Emery P,

Durez P,

Hueber AJ,

Ide la Torre I,

Larsson E,

Holzkämper T,

Tanaka Y

MRI studies have shown that BARI reduces joint inflammation and damage in patients with moderate-to-severe active RA. This review summarises the effects of BARI on structural joint damage progression and the mechanisms underlying these effects, using MRI data from across the clinical trial program. Early preclinical animal models showed a significant reduction in joint inflammation, ankle width, and bone resorption. Efficacy and safety of BARI have been confirmed in an extensive programme, inclu...

Keywords:

• JAK,
• Baricitinib,
• Radiographic,
• Review

Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal Phase 3 trial

Lancet 2021;397:475–86 doi: 10.1016/S0140-6736(21)00126-4

Gordon KB,

Foley P,

Krueger JG,

Pinter A,

Reich K,

Vender R,

Vanvoorden V,

Madden C,

White K,

Cioffi C,

Blauvelt A

Bimekizumab therapy was associated with a rapid and sustained improvement in PASI response and IGA score in patients with moderate to severe plaque psoriasis. Dual inhibition of IL-17A/F with bimekizumab can affect a more durable response in PsO patients than sole IL-17A inhibition. Gordon et al. compared the safety and efficacy of two different maintenance dosing schedules, in addition to the effects of treatment withdrawal in the 52-week BE READY trial.

Keywords:

• Bimekizumab,
• Efficacy,
• IL-17,
• Phase 3,
• Safety

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