Drug-induced morphea: Report of a case induced by balicatib and review of the literature

Peroni, Anna; Zini, Antonio; Braga, V.; Colato, Chiara; Adami, Silvano; Girolomoni, Giampiero

doi:10.1016/j.jaad.2008.03.009

Cited by 104 publications

(61 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Most TEAEs were either mild or moderate in severity, with no evidence of a dose-response relationship. Another cathepsin K inhibitor, balicatib, has been reported to have an increased risk of skin-related AEs, (12,31) mainly pruritus. Although ONO-5334 has a similar mode of action, there were no trends to indicate any safety concerns in skin AEs in this study.…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of the cathepsin K inhibitor ONO-5334 in postmenopausal osteoporosis: The OCEAN study

Eastell

Nagase

Ohyama

et al. 2011

Journal of Bone and Mineral Research

119

122

View full text Add to dashboard Cite

Osteoporosis occurs when there is an imbalance between resorption and formation of bone, with resorption predominating. Inhibitors of cathepsin K may rebalance this condition. This is the first efficacy study of a new cathepsin K inhibitor, ONO-5334. The objective of the study was to investigate the efficacy and safety of ONO-5334 in postmenopausal osteoporosis. This was a 12-month, randomized, double-blind, placebo-and active-controlled parallel-group study conducted in 13 centers in 6 European countries. Subjects included 285 postmenopausal women aged 55 to 75 years with osteoporosis. Subjects were randomized into one of five treatment arms: placebo; 50 mg twice daily, 100 mg once daily, or 300 mg once daily of ONO-5334; or alendronate 70 mg once weekly. Lumbar spine, total hip, and femoral neck BMD values were obtained along with biochemical markers of bone turnover and standard safety assessments. All ONO-5334 doses and alendronate showed a significant increase in BMD for lumbar spine, total hip (except 100 mg once daily), and femoral neck BMD. There was little or no suppression of ONO-5334 on bone-formation markers compared with alendronate, although the suppressive effects on bone-resorption markers were similar. There were no clinically relevant safety concerns. With a significant increase in BMD, ONO-5334 also demonstrated a new mode of action as a potential agent for treating osteoporosis. Further clinical studies are warranted to investigate long-term efficacy as well as safety of

show abstract

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of the cathepsin K inhibitor ONO-5334 in postmenopausal osteoporosis: The OCEAN study

Eastell

Nagase

Ohyama

et al. 2011

Journal of Bone and Mineral Research

119

122

View full text Add to dashboard Cite

show abstract

“…The primary safety analysis focused on AEs, with special attention to skin disorders, based on reports with another catK inhibitor. (3,15) AEs were summarized by number (%) of patients within treatment groups for the 1-year extension period (from year 2 to year 3). Percentages of patients with at least one laboratory value outside the predefined limits of change during the 1-year extension period were summarized by treatment group and analyte.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

“…(2)(3)(4)(5)11,12) Some early catK inhibitors proved to have crossreactivity with other cathepsins, (5,13,14) and cutaneous adverse events were reported for one. (3,15) A highly selective catK inhibitor that affects osteoclast bone resorption activity without effects on other cell types, including osteoblasts, would be attractive as a treatment for osteoporosis.…”

Section: Introductionmentioning

confidence: 99%

Odanacatib in the treatment of postmenopausal women with low bone mineral density: Three-year continued therapy and resolution of effect

Eisman

Bone²,

Hosking

et al. 2010

Journal of Bone and Mineral Research

229

147

View full text Add to dashboard Cite

The selective cathepsin K inhibitor odanacatib (ODN) progressively increased bone mineral density (BMD) and decreased boneresorption markers during 2 years of treatment in postmenopausal women with low BMD. A 1-year extension study further assessed ODN efficacy and safety and the effects of discontinuing therapy. In the base study, postmenopausal women with BMD T-scores between À2.0 and À3.5 at the lumbar spine or femur received placebo or ODN 3, 10, 25, or 50 mg weekly. After 2 years, patients (n ¼ 189) were rerandomized to ODN 50 mg weekly or placebo for an additional year. Endpoints included BMD at the lumbar spine (primary), total hip, and hip subregions; levels of bone turnover markers; and safety assessments. Continued treatment with 50 mg of ODN for 3 years produced significant increases from baseline and from year 2 in BMD at the spine (7.9% and 2.3%) and total hip (5.8% and 2.4%). Urine cross-linked N-telopeptide of type I collagen (NTx) remained suppressed at year 3 (À50.5%), but bone-specific alkaline phosphatase (BSAP) was relatively unchanged from baseline. Treatment discontinuation resulted in bone loss at all sites, but BMD remained at or above baseline. After ODN discontinuation at month 24, bone turnover markers increased transiently above baseline, but this increase largely resolved by month 36. There were similar overall adverse-event rates in both treatment groups. It is concluded that 3 years of ODN treatment resulted in progressive increases in BMD and was generally well tolerated. Bone-resorption markers remained suppressed, whereas bone-formation markers returned to near baseline. ODN effects were reversible: bone resorption increased transiently and BMD decreased following treatment discontinuation. ß

show abstract

“…Since an attempt for the use of hydroxychloroquine and ultraviolet A1 in particular was made in the treatment of morphea, the unexpected onset of lesions was interesting. 5 Drug-induced morphea is only rarely reported, [6][7][8] however, non-steroidal antiinflammatory drugs-induced morphea has not been reported in the literature. Lesions of superficial circumscribed morphea often undergo gradual spontaneous resolution over a three to five-year period.…”

Section: Discussionmentioning

confidence: 99%

Coexistence of Ankylosing Spondylitis With Morphea: A Case Report

Gümüşsu¹

2014

Arch Rheumatol

View full text Add to dashboard Cite

Morphea, also known as localized scleroderma, is a chronic cutaneous disorder caused by excessive collagen deposition, and characterized by fat tissue atrophy and by thickening and hardening of the skin.1 Morphea can be seen in different shapes on the body and extremities, from small plaques to large lesions causing cosmetic problems. 1 Raynaud's phenomenon, joint involvement, sclerodactyly, and constitutional symptoms found in scleroderma are not present in morphea. Morphea is usually asymptomatic, and the development of lesions is typically insidious. Extracutaneous involvement is present in 20% of patients. Although known to be an autoimmune-based disorder, the pathogenesis of morphea is still unclear. Radiation therapy, chimerism, infection or vaccination, drugs, trauma, hormones and genetic factors are implicated in the etiology. It may be also associated with the use of drugs such as bleomycin, D-penicillamine, vitamin K1, and L-5-hydroxytryptophane plus carbidopa, and is occasionally found in association with other autoimmune diseases. 3,4 We present herein a case of ankylosing spondylitis (AS) who developed morphea and was followed up in our rheumatology outpatient clinic. CASE REPORTA 60-year-old woman was followed up in our outpatient clinic due to human leukocyte antigen (HLA) B27 + AS with axial involvement. Although she had back pain for 30 years, she was first diagnosed two years ago when admitted with Morphea, which is also known as localized scleroderma, is a disorder caused by excessive collagen deposition and characterized by the thickening and hardening of the skin. Unlike systemic sclerosis, morphea lacks features such as Raynaud phenomenon, joint involvement, sclerodactyly, and constitutional symptoms. It may be associated with drug use and is occasionally found together with other autoimmune diseases. In this article, we report a 60-year-old woman who was admitted to our outpatient clinic due to HLA B27 + ankylosing spondylitis with axial involvement and morphea. Her disease was able to be managed with exercise and non-steroidal antiinflammatory drugs, however, a 10¥7 cm diameter atrophic lesion of medium hardness was identified on her left shoulder. The histopathology of the lesion was compatible with morphea, and improved with topical steroid treatment. Although the concomitance of autoimmune diseases is frequent, there is no coexistence of morphea with ankylosing spondylitis in the literature, except a case who was considered to be associated with the adalimumab use. Despite limited data, however, common autoimmune pathogenesis may be seen in association with ankylosing spondylitis and morphea.

show abstract

Drug-induced morphea: Report of a case induced by balicatib and review of the literature

Cited by 104 publications

References 31 publications

Safety and efficacy of the cathepsin K inhibitor ONO-5334 in postmenopausal osteoporosis: The OCEAN study

Safety and efficacy of the cathepsin K inhibitor ONO-5334 in postmenopausal osteoporosis: The OCEAN study

Odanacatib in the treatment of postmenopausal women with low bone mineral density: Three-year continued therapy and resolution of effect

Coexistence of Ankylosing Spondylitis With Morphea: A Case Report

Contact Info

Product

Resources

About