Adalimumab therapy for refractory uveitis: Results of a multicentre, open-label, prospective trial

Eric Suhler, Careen Y. Lowder, Debra A. Goldstein, Tracy Giles, Andreas (Andy) Lauer, Paul A. Kurz, Sirichai Pasadhika, Shelly T. Lee, Alexandre De Saint Sardos, Nicholas J. Butler, Howard H. Tessler, Justine R. Smith, James (Jim) Rosenbaum

Research output: Contribution to journalArticle

76 Citations (Scopus)

Abstract

Objective: Tumour necrosis factor (TNF) blockers have been demonstrated to be effective in the treatment of systemic and ocular inflammatory diseases. We conducted a prospective, multicentre, open-label Phase II clinical trial to assess the effectiveness and safety of adalimumab, a fully human anti-TNF monoclonal antibody, in treating refractory uveitis. Methods: Subjects with non-infectious uveitis refractory to corticosteroids and at least one other immunosuppressive medication were enrolled. Treatment outcome was ascertained by a composite endpoint comprised of visual acuity, intraocular inflammation, ability to taper immunosuppressives, and posterior segment imaging. Clinical response was defined by improvement in at least one parameter, worsening in none, and well controlled intraocular inflammation. Week 10 responders were permitted to continue receiving adalimumab for the study duration of 50 weeks. Results: Twenty-one of 31 patients (68%) were characterised as clinical responders at 10 weeks, of whom 12 patients (39%) exhibited durable response after 50 weeks. The most common reason for study termination was primary or secondary inefficacy. No patients experienced treatment-limiting toxicity clearly related to study therapy. Conclusions: Adalimumab was safe and effective in 68% of refractory uveitis patients 10 weeks after study enrolment, and maintained in 39% after 1 year. Ongoing study is required to determine the place of adalimumab and other TNF blockers in the treatment of uveitis.

Original languageEnglish (US)
Pages (from-to)481-486
Number of pages6
JournalBritish Journal of Ophthalmology
Volume97
Issue number4
DOIs
StatePublished - Apr 2013

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Uveitis
Immunosuppressive Agents
Tumor Necrosis Factor-alpha
Inflammation
Phase II Clinical Trials
Aptitude
Eye Diseases
Therapeutics
Visual Acuity
Adrenal Cortex Hormones
Monoclonal Antibodies
Safety
Adalimumab

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience

Cite this

Adalimumab therapy for refractory uveitis : Results of a multicentre, open-label, prospective trial. / Suhler, Eric; Lowder, Careen Y.; Goldstein, Debra A.; Giles, Tracy; Lauer, Andreas (Andy); Kurz, Paul A.; Pasadhika, Sirichai; Lee, Shelly T.; De Saint Sardos, Alexandre; Butler, Nicholas J.; Tessler, Howard H.; Smith, Justine R.; Rosenbaum, James (Jim).

In: British Journal of Ophthalmology, Vol. 97, No. 4, 04.2013, p. 481-486.

Research output: Contribution to journalArticle

Suhler, E, Lowder, CY, Goldstein, DA, Giles, T, Lauer, AA, Kurz, PA, Pasadhika, S, Lee, ST, De Saint Sardos, A, Butler, NJ, Tessler, HH, Smith, JR & Rosenbaum, JJ 2013, 'Adalimumab therapy for refractory uveitis: Results of a multicentre, open-label, prospective trial', British Journal of Ophthalmology, vol. 97, no. 4, pp. 481-486. https://doi.org/10.1136/bjophthalmol-2012-302292
Suhler, Eric ; Lowder, Careen Y. ; Goldstein, Debra A. ; Giles, Tracy ; Lauer, Andreas (Andy) ; Kurz, Paul A. ; Pasadhika, Sirichai ; Lee, Shelly T. ; De Saint Sardos, Alexandre ; Butler, Nicholas J. ; Tessler, Howard H. ; Smith, Justine R. ; Rosenbaum, James (Jim). / Adalimumab therapy for refractory uveitis : Results of a multicentre, open-label, prospective trial. In: British Journal of Ophthalmology. 2013 ; Vol. 97, No. 4. pp. 481-486.
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