A double-blind, randomized, placebo-controlled trial of adalimumab in the treatment of cutaneous sarcoidosis

Pariser, Robert J.; Paul, Joan; Hirano, Stefanie A.; Torosky, Cyndi; Smith, Michael L.

doi:10.1016/j.jaad.2012.10.056

Cited by 123 publications

(61 citation statements)

References 22 publications

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“…The lack of efficacy of these two active drugs may provide insight into the immunopathogenesis and treatment of sarcoidosis. It is somewhat surprising that golimumab did not demonstrate a benefit versus placebo in this trial, as other TNF-a antagonists have shown favourable results for the treatment of sarcoidosis, including in randomised, double-blind, placebo-controlled trials [1,14,36,40]. Furthermore, the entry criteria for the lung group in this trial matched that of a subgroup in a previous positive trial involving infliximab for pulmonary sarcoidosis that had a more robust response [1].…”

Section: Discussionmentioning

confidence: 89%

Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis

et al. 2014

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Sarcoidosis is characterised by non-caseating granulomas that secrete pro-inflammatory cytokines, including interleukin (IL)-12, IL-23, and tumour necrosis factor (TNF)-a. Ustekinumab and golimumab are monoclonal antibodies that specifically inhibit IL-12/IL-23 and TNF-a, respectively.Patients with chronic pulmonary sarcoidosis (lung group) and/or skin sarcoidosis (skin group) received either 180 mg ustekinumab at week 0 followed by 90 mg every 8 weeks, 200 mg golimumab at week 0 followed by 100 mg every 4 weeks, or placebo. Patients underwent corticosteroid tapering between weeks 16 and 28. The primary end-point was week 16 change in percentage predicted forced vital capacity (DFVC % pred) in the lung group. Major secondary end-points were: week 28 for DFVC % pred, 6-min walking distance, St George's Respiratory Questionnaire (lung group), and Skin Physician Global Assessment response (skin group).At week 16, no significant differences were observed in DFVC % pred with ustekinumab (-0.15, p50.13) or golimumab (1.15, p50.54) compared with placebo (2.02). At week 28, there were no significant improvements in the major secondary end-points, although a nonsignificant numerically greater Skin Physician Global Assessment response was observed following golimumab treatment (53%) when compared with the placebo (30%). Serious adverse events were similar in all treatment groups.Although treatment was well tolerated, neither ustekinumab nor golimumab demonstrated efficacy in pulmonary sarcoidosis. However, trends towards improvement were observed with golimumab in some dermatological end-points. @ERSpublicationsNeither ustekinumab nor golimumab demonstrated efficacy for the treatment of patients with pulmonary sarcoidosis

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Section: Discussionmentioning

confidence: 89%

Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis

et al. 2014

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“…Improvement in signs of disease was also observed in a case series of 26 patients with sarcoidosis patients with refractory chronic noninfectious posterior uveitis who were treated with 40 mg adalimumab once a week and followed up for 1 year [34]. In a Phase 2 study, adalimumab or placebo was administered to 10 and 6 patients with cutaneous sarcoidosis, respectively, in double-blind, randomized manner for 12 weeks, followed by open-label treatment for an additional 12 and 8 weeks of no treatment [35]. Compared to the placebo recipients, those administered adalimumab showed improvement in the target lesion area (P = 0.0203) at the end of the double-blind phase, and, relative to baseline, significant improvements in the target lesion area (P = 0.0063) and the target lesion volume (P = 0.0225), and DLQI score (P = 0.0034) were observed at the end of the open-label phase [35].…”

Section: Early-stage Clinical Studies In Sarcoidosismentioning

confidence: 77%

Adalimumab (Humira®)

Reichert¹

2014

Handbook of Therapeutic Antibodies

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“…Other anti-TNFα medications have been studied in sarcoidosis [29,30]. Adalimumab, a recombinant human monoclonal antibody against TNF, was used in a small randomized controlled trial including 16 patients with cutaneous sarcoidosis.…”

Section: Biological Agentsmentioning

confidence: 99%

“…Adalimumab, a recombinant human monoclonal antibody against TNF, was used in a small randomized controlled trial including 16 patients with cutaneous sarcoidosis. The improvement of the skin lesions in the adalimumab group was significant compared to placebo, which makes it a viable option for this condition [29]. Most experts believe that adalimumab dosing should be aggressive, similar to that used for inflammatory bowel disease, and that the time to effect is slower than for infliximab.…”

Section: Biological Agentsmentioning

confidence: 99%