Publications

Efficacy of Pharmacological Interventions: A Systematic Review Informing the 2023 EULAR Recommendations for the Management of Fatigue in People with Inflammatory Rheumatic and Musculoskeletal Diseases

RMD Open 2023;9(4):e003349 doi 10.1136/rmdopen-2023-003349

Farisogullari B,

Santos EJF,

Dures E,

Geenen R,

Machado PM

Adalimumab demonstrated superiority over placebo in reducing fatigue in RA at 12 and 52 weeks. Other interventions, which included golimumab, baricitinib, sarilumab, tocilizumab, and tofacitinib, also proved effective in reducing fatigue in patients with RA. Secukinumab also reduced fatigue by Week 52 in patients with SpA.

Keywords:

• Baricitinib,
• Efficacy,
• Fatigue,
• Golilumab,
• Safety,
• Secukinumab

Anti-gm-csf Otilimab versus Sarilumab or Placebo in Patients with Rheumatoid Arthritis and Inadequate Response to Targeted Therapies: A Phase III Randomised Trial (contRAst 3)

Ann Rheum Dis. 2023;82(12):1527–1537 doi 10.1136/ard-2023-224449

Taylor PC,

Weinblatt ME,

McInnes IB,

Atsumi T,

Strand V,

Takeuchi T,

Bracher M,

Brooks D,

Davies J,

Goode C,

Gupta A,

Makherjee S,

O’Shea C,

Saurigny D,

Schifano LA,

Shelton C,

Smith JE,

Wang M,

Watts S,

Fleischmann R

The ContRAst 3 study investigated otilimab, in RA patients with inadequate responses to multiple treatments. Otilimab did not significantly improve ACR20 versus placebo at Weeks 12 or 24. In addition, there we no significant improvements in secondary endpoints, including disease activity, disability, and pain.

Keywords:

• Sarilumab,
• Phase 3

Magnetic resonance imaging characteristics in patients with spondyloarthritis and clinical diagnosis of heel enthesitis: post hoc analysis from the phase 3 ACHILLES trial

Arthritis Res Ther. 2022 doi: 10.1186/s13075-022-02797-8

Baraliakos X,

Sewerin P,

de Miguel E,

Pournara E,

Kleinmond C,

Shekhawat A,

Jentzsch C,

Wiedon A,

Behrens F; ACHILLES study group

Enthesitis is a hallmark feature of SpA, including PsA and axSpA, and is proposed as the primary lesion in spondyloarthropathies. This study aimed to investigate the imaging characteristics of heel enthesitis in SpA in a post hoc analysis using the HEMRIS in blinded and centrally read MRI data from the ACHILLES trial..

Keywords:

• IL-17,
• Sarilumab,
• Efficacy,
• Imaging

Efficacy of Monotherapy with Biologics and JAK inhibitors for the Treatment of Rheumatoid Arthritis: A Systematic Review

ADV Ther 2018; 35(10):1525–63 DOI: 10.1007/s12325-018-0757-2

Emery P,

Pope JE,

Kruger K,

Lippe R,

DeMasi R,

Lula S,

Kola B

The b/tsDMARDs evaluated in this systematic literature review (SLR) were shown to be efficacious as monotherapies, although combination therapies usually achieved better treatment outcomes.Current treatment guidelines recommend combining b/tsDMARDs with MTX in the treatment of RA; however, up to a third of patients are treated with monotherapy. While previous SLRs1–3 have compared the efficacy of b/tsDMARD mono- versus MTX combination therapy they covered a limited number of randomised controlle...

Keywords:

• JAK,
• Review

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

Genovese MC,

van Adelsberg J,

Fan C,

Graham NMH,

van Hoogstraten H,

Parrino J,

Mangan EK,

Spindler A,

Huizinga TWJ,

van der Heijde D,

for the EXTEND study investigators

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...

Keywords:

• IL-6,
• Sarilumab,
• Phase 3,
• Safety,
• Radiographic

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

Bermejo I,

Ren S,

Simpson E,

Clowes M,

Scott DL,

Young A,

Stevenson M

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...

Sarilumab improves Patient-reported Outcomes in Rheumatoid Arthritis Patients with Inadequate Response/Intolerance to Tumour Necrosis Factor Inhibitors

RMD Open 2017;3:e000416. DOI:10.1136/rmdopen-2016-000416

Strand V,

Reaney M,

Chen C-I,

Proudfoot CWJ,

Guillonneau S,

Bauer D,

Mangan E,

Graham NMH,

van Hoogstraten H,

Lin Y,

Pacheco-Tena C,

Fleischmann R

Evidence is presented that treatment with sarilumab demonstrates patient-reported benefits in TNF-IR patients with moderate to severe RA. These improvements complement the clinical efficacy previously reported for sarilumab, and are consistent with those seen in the MOBILITY trial (MTX-IR patients)1, yet in a more difficult-to-treat population.Data were analysed from the 24-week Phase 3 TARGET randomised controlled trial in adult patients with active RA and previous inadequate response or intole...

Keywords:

• IL-6,
• Sarilumab,
• PRO / QoL

Sarilumab and Non-biologic Disease-Modifying Antirheumatic Drugs in Patients with Active RA and Inadequate Response or Intolerance to TNF Inhibitors

Arthritis Rheumatol 2016. DOI:10.1002/art.39944.

Fleischmann R,

van Adelsberg J,

Lin Y,

da Rocha,

Castelar-Pinheiro G,

Brzezicki J,

Hrycaj P,

Graham NMH,

van Hoogstraten H,

Bauer D,

Burmester GR

In this Phase 3 study (TARGET) of TNF-IR patients, sarilumab plus csDMARD(s) demonstrated clinical efficacy and improvements in physical function versus placebo plus csDMARD(s).Patients (N=546) were randomised 1:1:1 to sarilumab 150 mg, 200 mg Q2W or placebo (all plus csDMARD[s]). Two co-primary endpoints versus placebo were investigated: ACR20 response rate at Week 24, and HAQ-DI change from baseline at Week 12.As well as improvements in ACR20 responses (33.7% vs 55.8 and 60.9%, for placebo, sa...

Keywords:

• IL-6,
• Sarilumab,
• Phase 3

Efficacy and Safety of Sarilumab Monotherapy versus Adalimumab Monotherapy for the Treatment of Patients with Active Rheumatoid Arthritis (MONARCH): a Randomised, Double-blind, Parallel-group Phase III Trial

Ann Rheum Dis 2016. DOI 10.1136/annrheumdis-2016-210310

Burmester GR,

Lin Y,

Patel R,

van Adelsberg J,

Mangan EK,

Graham NMH,

van Hoogstraten H,

Bauer D,

Vargas JI,

Lee E-B

In this Phase 3 superiority study (MONARCH) of patients with active RA who should not continue treatment with MTX because of intolerance or inadequate response, sarilumab monotherapy demonstrated superior efficacy to adalimumab (ADA) monotherapy. Patients receiving sarilumab versus ADA also reported greater improvement in health status, including a trend towards greater improvement in fatigue.In this randomised, multicentre study, patients received sarilumab 200 mg Q2W plus placebo (n=184) or AD...

Keywords:

• IL-6,
• Sarilumab,
• Phase 3

Sarilumab plus Methotrexate Improves Patient-reported Outcomes in Patients with Active Rheumatoid Arthritis and Inadequate Responses to Methotrexate: Results of a Phase III Trial

Arthritis Res Ther 2016; 18:198. DOI.10.1186/s13075-016-9

Strand V,

Kosinski M,

Chen C-I,

Joseph G,

Rendas-Baum R,

Graham NMH,

van Hoogstraten H,

Bayliss M,

Fan C,

Huizinga T,

Genovese MC

Evidence is presented that treatment with sarilumab improves patient-reported outcomes (PROs). These improvements complement the clinical efficacy previously reported for sarilumab.Data were analysed from the 52-week Phase 3 MOBILITY randomised controlled trial in adult patients with active RA and previous inadequate response to MTX. Patients received subcutaneous placebo or sarilumab 150 mg or 200 mg every 2 weeks in combination with MTX, for 52 weeks.PROs assessed were: Patient Global Assessme...

Keywords:

• IL-6,
• Sarilumab,
• Phase 3