Primary (Month-6) Outcomes of the STOP-Uveitis Study: Evaluating the Safety, Tolerability, and Efficacy of Tocilizumab in Patients With Noninfectious Uveitis

Sepah, Yasir J.; Sadiq, Mohammad Ali; Chu, David; Dacey, Mark; Gallemore, Ron P.; Dayani, Pouya N.; Hanout, Mostafa; Hassan, Muhammad; Afridi, Rubbia; Agarwal, Aniruddha; Halim, Muhammad Sohail; Diana, V.; Nguyen, Quan Dong

doi:10.1016/j.ajo.2017.08.019

Cited by 127 publications

(80 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…95 A randomised, controlled, multicentre clinical trial is currently underway, known as the STOP-Uveitis Study, assessing two different dosage groups, and primary 6-month outcomes have recently been published. 96 Preliminary results show that visual acuity and CME improved in both the groups, confirming that monthly i.v. tocilizumab infusions significantly improved the visual, anatomic and inflammatory outcomes in patients with noninfectious intermediate, posterior and panuveitis, including those that were treatment naive.…”

Section: Il Blockers Tocilizumabsupporting

confidence: 58%

See 1 more Smart Citation

The use of biologic agents in the management of uveitis

Trivedi

Katelaris

2019

Internal Medicine Journal

View full text Add to dashboard Cite

The uveitides are a heterogenous group of ocular inflammatory disorders that account for the third highest cause of blindness worldwide, responsible for 5–10% of visual impairment globally. Up to 35% of patients with uveitis can suffer significant vision loss. To prevent irreversible structural damage and blindness, it is important that the diagnosis and commencement of appropriate therapy occurs promptly. Management includes topical and systemic corticosteroid therapy and conventional immunomodulatory agents, including methotrexate, azathioprine, mycophenolate mofetil and cyclosporin. Significant progress has been made in the past decade in our understanding of the immunopathological pathways that drive intraocular inflammation, allowing the development of targeted therapy with biologic agents. These include TNF‐α inhibitors, such as infliximab, adalimumab and etanercept; interleukin blockers, such as tocilizumab and daclizumab; and other targeted therapies, such as rituximab and abatacept. The efficacy of these agents has been studied in cases of severe uveitis that are refractory to conventional immunomodulatory agents and provide exciting results that have revolutionised uveitis management. Though the biologic era has provided a large armamentarium to treat uveitis, ongoing challenges and cases of recalcitrant uveitis remain, posing a challenge to internal medicine physicians. This comprehensive review aims to construct an updated summary on the existing evidence pertaining to the use of biologic agents in the treatment of uveitis. Methods include a systematic search for studies between 2000 and 2018 using PubMed, EMBASE, Ovid MEDLINE and Cochrane libraries.

show abstract

Section: Il Blockers Tocilizumabsupporting

confidence: 58%

“…A randomised, controlled, multicentre clinical trial is currently underway, known as the STOP‐Uveitis Study, assessing two different dosage groups, and primary 6‐month outcomes have recently been published . Preliminary results show that visual acuity and CME improved in both the groups, confirming that monthly i.v.…”

Section: Il Blockersmentioning

confidence: 88%

The use of biologic agents in the management of uveitis

Trivedi

Katelaris

2019

Internal Medicine Journal

View full text Add to dashboard Cite

show abstract

“…Recently, STOP-Uveitis, which was a phase 2, multicentre, open-label study comparing the safety and efficacy of two doses of tocilizumab (4 and 8 mg/kg given monthly), demonstrated the efficacy of tocilizumab in patients with NIU at the primary endpoint of month 6. 115 The mean improvement in the visual acuity was 8.2 letters (10.9 letters: 4 mg/kg and 5.5 letters; P < .01) at a dose of 8 mg/kg. Forty-three percent of the patients with a potential of two-step improvement demonstrated a two-step improvement in vitreous haze score.…”

Section: Tocilizumab and Sarilumabmentioning

confidence: 85%

“…Fifty percent of the eyes demonstrated improvement in the visual acuity where the effect was sustained through to approximately 8 months in 25%. Recently, STOP‐Uveitis, which was a phase 2, multicentre, open‐label study comparing the safety and efficacy of two doses of tocilizumab (4 and 8 mg/kg given monthly), demonstrated the efficacy of tocilizumab in patients with NIU at the primary endpoint of month 6 . The mean improvement in the visual acuity was 8.2 letters (10.9 letters: 4 mg/kg and 5.5 letters; P < .01) at a dose of 8 mg/kg.…”

Section: Emerging and Adopted Therapiesmentioning

confidence: 99%

New therapies in development for the management of non‐infectious uveitis: A review

Hassan

Karkhur

Bae

et al. 2019

Clinical Exper Ophthalmology

Self Cite

View full text Add to dashboard Cite

Uveitis is a spectrum of inflammatory disorders characterized by ocular inflammation and is one of the leading causes of preventable visual loss. The main aim of the treatment of uveitis is to control the inflammation, prevent recurrences of the disease and preserve vision while minimizing the adverse effects associated with the therapeutic agents. Initial management of uveitis relies heavily on the use of corticosteroids. However, monotherapy with high‐dose corticosteroids is associated with side effects and cannot be maintained long term. Therefore, steroid‐sparing agents are needed to decrease the burden of steroid therapy. Currently, the therapeutic approach for non‐infectious uveitis (NIU) consists of a step‐ladder strategy with the first‐line option being corticosteroids in various formulations followed by the use of first‐, second‐ and third‐line agents in cases with suboptimal steroid response. Unfortunately, the agents currently at our disposal have limitations such as having a narrow therapeutic window along with their own individual potential side‐effect profiles. Therefore, research has been targeted to identify newer drugs as well as new uses for older drugs that target specific pathways in the inflammatory response. Such efforts are made in order to provide targeted and safer therapy with reduced side effects and greater efficacy. Several specially designed molecular antibodies are currently in various phases of investigations that can potentially halt the inflammation in patients with NIU. In the review, we have provided a comprehensive overview of the current and upcoming therapeutic options for patients with NIU.

show abstract

“…Other biologics that are being used in patients with non‐infectious uveitis include IL–6 receptor inhibitors such as tocilizumab. In the phase 1/2 STOP‐Uveitis randomized clinical trial (n = 37), patients receiving 4 or 8 mg/kg intravenous tocilizumab for 6 months showed improvements in visual acuity and a reduction in vitreous haze; tocilizumab was well tolerated . Additionally, a multi‐center, randomized controlled study using filgotinib, a small molecule selective Janus‐activated kinase 1 inhibitor, to treat patients with non‐infectious uveitis, is ongoing at present.…”

Section: Impact Of Biologics On Uveitis Therapymentioning

confidence: 99%