Risk of Malignancies in Patients With Rheumatoid Arthritis Treated With Biologic Therapy

López-Olivo, María A.; Tayar, Jean; Martínez-López, Juan Antonio; Pollono, Eduardo N.; Cueto, Jose Polo; Gonzales-Crespo, M. Rosa; Fulton, Stephanie; Suarez‐Almazor, María E.

doi:10.1001/2012.jama.10857

Cited by 280 publications

(170 citation statements)

References 103 publications

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“…According to a recent systematic review, these longerterm adverse events that have been reported in the literature occurred in individuals who had received other immunosuppressive medications before rituximab and in nonrenal patients. 40 Finally, most recent reports, including the present trial, have included only white patients, and further studies of patients from different ethnic groups are needed.…”

Section: Discussionmentioning

confidence: 97%

Rituximab in Children with Steroid-Dependent Nephrotic Syndrome

Ravani

Rossi

Bonanni

et al. 2015

Journal of the American Society of Nephrology

161

142

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Steroid-dependent nephrotic syndrome (SDNS) carries a high risk of toxicity from steroids or steroid-sparing agents. This open-label, noninferiority, randomized controlled trial at four sites in Italy tested whether rituximab is noninferior to steroids in maintaining remission in juvenile SDNS. We enrolled children age 1-16 years who had developed SDNS in the previous 6-12 months and were maintained in remission with high prednisone doses ($0.7 mg/kg per day). We randomly assigned participants to continue prednisone alone for 1 month (control) or to add a single intravenous infusion of rituximab (375 mg/m 2 ; intervention). Prednisone was tapered in both groups after 1 month. For noninferiority, rituximab had to permit steroid withdrawal and maintain 3-month proteinuria (mg/m 2 per day) within a prespecified noninferiority margin of three times the levels among controls (primary outcome). We followed participants for $1 year to compare risk of relapse (secondary outcome). Fifteen children per group (21 boys; mean age, 7 years [range, 2.6-13.5 years]) were enrolled and followed for #60 months (median, 22 months). Three-month proteinuria was 42% lower in the rituximab group (geometric mean ratio, 0.58; 95% confidence interval, 0.18 to 1.95 [i.e., within the noninferiority margin of three times the levels in controls]). All but one child in the control group relapsed within 6 months; median time to relapse in the rituximab group was 18 months (95% confidence interval, 9 to 32 months). In the rituximab group, nausea and skin rash during infusion were common; transient acute arthritis occurred in one child. In conclusion, rituximab was noninferior to steroids for the treatment of juvenile SDNS.

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Section: Discussionmentioning

confidence: 97%

Rituximab in Children with Steroid-Dependent Nephrotic Syndrome

Ravani

Rossi

Bonanni

et al. 2015

Journal of the American Society of Nephrology

161

142

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“…Rare adverse effects, such as progressive multifocal leukoencephalopathy, may occur, especially with rituximab. 7 Biologics do not seem to be associated with an increased risk of cancer overall among patients with rheumatoid arthritis, 8,9 although there may be a slight increase in the risk of skin cancers. 10,11 Whether biologic use increases the risk of lymphoma beyond that associated with rheumatoid arthritis is controversial; 5,11,12 major limitations of the current data are lack of long-term follow-up and the need for very large samples because of the rarity of this event.…”

Section: What Adverse Effects Can Occur With Biologics?mentioning

confidence: 98%

Use of biologics in a patient with rheumatoid arthritis refractory to methotrexate

Singh

2013

CMAJ

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“…Özellikle RA hastalar›nda yap›lan baz› çal›flmalar anti-TNF-α tedavisi alan hastalarda malignite s›kl›¤›nda art›fl bildirmifl ancak bu durum kesin olarak do¤rulanamam›fl-t›r. [1,6,20,[28][29][30] Buna karfl›n ço¤u çal›flma melanoma d›fl› cilt kanserlerinin bu ilaçlar› kullanan hastalarda artt›¤› konusunda hemfikirdir. [30][31][32][33] Bizim çal›flmam›zda 2 hastada malignite gözlendi.…”

Section: Tart›flmaunclassified

“…Öte yandan bu sitokinlerin konak savunmas›nda görev almas› baflta infeksiyon ve olas› lenfoproliferatif hastal›k geliflimi gibi istenmeyen yan etkilerin ortaya ç›kmas›na yol açabil-mektedir. [1,2] Güvenlik kayg›lar›n›n yan›s›ra biyolojik ajanlar flu an için oldukça maliyetli tedavilerdir. Bu nedenle bu ilaçlar›n kullan›m› ülkemizde de oldu¤u üzere belli koflullara tabiidir.…”

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The analysis of ankylosing spondylitis patients receiving biological therapies: data from TURKBIO registry

Güllüoğlu¹

2014

RAED Derg

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Risk of Malignancies in Patients With Rheumatoid Arthritis Treated With Biologic Therapy

Cited by 280 publications

References 103 publications

Rituximab in Children with Steroid-Dependent Nephrotic Syndrome

Rituximab in Children with Steroid-Dependent Nephrotic Syndrome

Use of biologics in a patient with rheumatoid arthritis refractory to methotrexate

The analysis of ankylosing spondylitis patients receiving biological therapies: data from TURKBIO registry

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