A Phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-α) in patients with systemic lupus erythematosus (ROSE)

Kalunian, Kenneth C.; Merrill, Joan T.; Maciuca, Romeo; McBride, Jacqueline; Townsend, Michael J.; Wei, Xiaohui; Davis, John C.; Kennedy, William P.

doi:10.1136/annrheumdis-2014-206090

Cited by 303 publications

(190 citation statements)

References 36 publications

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“…This group also had higher trough concentrations of rontalizumab, suggesting that the inefficacy in the IFN signature high group may have been due to under-dosing. However, this was not reflected in attenuation of ISG expression, which was similar in both groups (120). Other strategies directly targeted pDCs, the main source of IFN-I.…”

Section: Rheumatoid Arthritismentioning

confidence: 99%

Type I interferon–mediated autoimmune diseases: pathogenesis, diagnosis and targeted therapy

2017

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Section: Rheumatoid Arthritismentioning

confidence: 99%

Type I interferon–mediated autoimmune diseases: pathogenesis, diagnosis and targeted therapy

2017

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“…There is no clear explanation for this finding, which may require confirmation by other studies. One possibility is that patients with low ISM may be less refractory to treatment than patients with high ISM [97].…”

Section: Rontalizumabmentioning

confidence: 97%

Update on Biologic Therapies for Systemic Lupus Erythematosus

et al. 2016

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Systemic lupus erythematosus (SLE) is a chronic multisystemic autoimmune disease driven by genetic, hormonal, and environmental factors. Despite the advances in diagnostic and therapeutic approaches in the last decades, SLE still leads to significant morbidity and increased mortality. Although a cure for SLE is still unknown, treatment is required to control acute disease exacerbation episodes (flares), decrease the frequency and severity of subsequent lupus flares, address comorbidities, and prevent end-organ damage. While conventional SLE pharmacotherapy may exhibit suboptimal efficacy and substantial toxicity, a growing knowledge of the disease pathogenesis enabled the research on novel therapeutic agents directed at specific disease-related targets. In this paper, we review the recent progress in the clinical investigation of biologic agents targeting B cells, T cells, cytokines, innate immunity, and other immunologic or inflammatory pathways. Although many investigational agents exhibited insufficient efficacy or inadequate safety in clinical trials, one of them, belimumab, fulfilled the efficacy and safety regulatory requirements and was approved for the treatment of SLE in Europe and the USA, which confirms that, despite all difficulties, advances in this field are possible.

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“…The primary endpoint was not achieved in the phase-II trial of the anti-IFNα mAb, rontalizumab [79], whereas the primary endpoint (assessed at week 52) was achieved in the phase-IIb trial of a different anti-IFNα mAb, sifalimumab. In this latter trial, the absolute percentage difference in clinical response between patients treated with the highest dose of sifalimumab and those treated with placebo was 14% [80], similar to the absolute percentage differences observed in the successful trial with belimumab or tabalumab.…”

Section: ) Targeting Of Baff Receptors Rather Than Of Baffmentioning

confidence: 97%

The Future of B-cell Activating Factor Antagonists in the Treatment of Systemic Lupus Erythematosus

Stohl

2017

J Rheum Dis

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s personal library were searched. BAFF-antagonist therapy in SLE has a checkered past, with four late-stage clinical trials meeting their primary endpoints and four failing to do so. Additional late-stage clinical trials are enrolling subjects to address some of the remaining unresolved questions, and novel approaches are proposed to improve results. The BAFF-centric pathway is a proven therapeutic target in SLE. As the only pathway in the past 50+ years to have yielded an United States Food and Drug Administration-approved drug for SLE, it occupies a unique place in the armamentarium of the practicing rheumatologist. The challenges facing clinicians and investigators are how to better tweak the BAFF-centric pathway and improve on the successes realized. (J Rheum Dis 2017;24:65-73)

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A Phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-α) in patients with systemic lupus erythematosus (ROSE)

Abstract: NCT00962832.

Cited by 303 publications

References 36 publications

Type I interferon–mediated autoimmune diseases: pathogenesis, diagnosis and targeted therapy

Type I interferon–mediated autoimmune diseases: pathogenesis, diagnosis and targeted therapy

Update on Biologic Therapies for Systemic Lupus Erythematosus

The Future of B-cell Activating Factor Antagonists in the Treatment of Systemic Lupus Erythematosus

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