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Role of biologics in intractable urticaria.

Cooke A, Bulkhi A, Casale TB - Biologics (2015)

Bottom Line: Of these, the anti-IgE monoclonal antibody omalizumab is the best studied, and has recently been approved for the management of CU.Other agents, such as interleukin-1 inhibitors, have proved beneficial for Schnitzler syndrome and cryopyrin-associated periodic syndromes (CAPS), diseases associated with urticaria.This review summarizes the relevant data regarding the efficacy of biologics in antihistamine-refractory CU.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Division of Allergy and Immunology, University of South Florida, Tampa, FL, USA.

ABSTRACT
Chronic urticaria (CU) is a common condition faced by many clinicians. CU has been estimated to affect approximately 0.5%-1% of the population, with nearly 20% of sufferers remaining symptomatic 20 years after onset. Antihistamines are the first-line therapy for CU. Unfortunately, nearly half of these patients will fail this first-line therapy and require other medication, including immune response modifiers or biologics. Recent advances in our understanding of urticarial disorders have led to more targeted therapeutic options for CU and other urticarial diseases. The specific biologic agents most investigated for antihistamine-refractory CU are omalizumab, rituximab, and intravenous immunoglobulin (IVIG). Of these, the anti-IgE monoclonal antibody omalizumab is the best studied, and has recently been approved for the management of CU. Other agents, such as interleukin-1 inhibitors, have proved beneficial for Schnitzler syndrome and cryopyrin-associated periodic syndromes (CAPS), diseases associated with urticaria. This review summarizes the relevant data regarding the efficacy of biologics in antihistamine-refractory CU.

No MeSH data available.


Related in: MedlinePlus

Percentage reduction from baseline to week 12 in DLQI score.Note: Significant treatment differences in change from baseline to week 12 in DLQI score were observed with omalizumab 300 mg versus placebo in the pool ASTERIA I/II and GLACIAL studies. *Treatment difference in least squares means (LSM) relative to placebo. Data from Bernstein JA, Saini SS, Maurer M, et al. Efficacy of omalizumab in patients with chronic idiopathic/spontaneous urticaria with different background therapy: post hoc analysis of ASTERIA I, ASTERIA II, and GLACIAL studies. J Allergy Clin Immunol. 2014;133(2 Suppl):AB117.34Abbreviations: CI, confidence interval; DLQI, Dermatology Life Quality Index.
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f3-btt-9-025: Percentage reduction from baseline to week 12 in DLQI score.Note: Significant treatment differences in change from baseline to week 12 in DLQI score were observed with omalizumab 300 mg versus placebo in the pool ASTERIA I/II and GLACIAL studies. *Treatment difference in least squares means (LSM) relative to placebo. Data from Bernstein JA, Saini SS, Maurer M, et al. Efficacy of omalizumab in patients with chronic idiopathic/spontaneous urticaria with different background therapy: post hoc analysis of ASTERIA I, ASTERIA II, and GLACIAL studies. J Allergy Clin Immunol. 2014;133(2 Suppl):AB117.34Abbreviations: CI, confidence interval; DLQI, Dermatology Life Quality Index.

Mentions: The results of ASTERIA I, a 24-week randomized, double-blinded, placebo-controlled study evaluating both the efficacy and safety of omalizumab as an add-on therapy, was published in July 2014.27 The design of ASTERIA I was similar to ASTERIA II, except that the treatment period was 24 weeks, instead of 12 weeks. Three hundred and nineteen subjects were randomized to either 24 weeks of 75 mg, 150 mg, or 300 mg omalizumab or placebo. By week 12, all omalizumab arms experienced a significant improvement in weekly pruritus score over baseline, while the placebo arm did not, with the 300 mg omalizumab arm demonstrating the greatest improvement. Additionally, over four times as many subjects in the omalizumab 300 mg arm achieved complete remission than in the placebo arm. Subjects in the omalizumab 300 mg arm showed sustained benefit through week 24 while in the active phase of the trial. Once again, the urticarial activity increased to values similar to placebo upon follow-up. The safety profile of this study showed 5% of subjects in the placebo arm experienced a drug-related adverse event; in the omalizumab arms, these were slightly higher, with 8.6% in the 75 mg arm, 10.3% in the 150 mg arm, and 17.3% in the 300 mg arm. A recent analysis pooled the data of these three large trials and showed that the efficacy of omalizumab was consistent in patients with CU with different underlying therapy, as shown in Figures 1–3.34


Role of biologics in intractable urticaria.

Cooke A, Bulkhi A, Casale TB - Biologics (2015)

Percentage reduction from baseline to week 12 in DLQI score.Note: Significant treatment differences in change from baseline to week 12 in DLQI score were observed with omalizumab 300 mg versus placebo in the pool ASTERIA I/II and GLACIAL studies. *Treatment difference in least squares means (LSM) relative to placebo. Data from Bernstein JA, Saini SS, Maurer M, et al. Efficacy of omalizumab in patients with chronic idiopathic/spontaneous urticaria with different background therapy: post hoc analysis of ASTERIA I, ASTERIA II, and GLACIAL studies. J Allergy Clin Immunol. 2014;133(2 Suppl):AB117.34Abbreviations: CI, confidence interval; DLQI, Dermatology Life Quality Index.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4403603&req=5

f3-btt-9-025: Percentage reduction from baseline to week 12 in DLQI score.Note: Significant treatment differences in change from baseline to week 12 in DLQI score were observed with omalizumab 300 mg versus placebo in the pool ASTERIA I/II and GLACIAL studies. *Treatment difference in least squares means (LSM) relative to placebo. Data from Bernstein JA, Saini SS, Maurer M, et al. Efficacy of omalizumab in patients with chronic idiopathic/spontaneous urticaria with different background therapy: post hoc analysis of ASTERIA I, ASTERIA II, and GLACIAL studies. J Allergy Clin Immunol. 2014;133(2 Suppl):AB117.34Abbreviations: CI, confidence interval; DLQI, Dermatology Life Quality Index.
Mentions: The results of ASTERIA I, a 24-week randomized, double-blinded, placebo-controlled study evaluating both the efficacy and safety of omalizumab as an add-on therapy, was published in July 2014.27 The design of ASTERIA I was similar to ASTERIA II, except that the treatment period was 24 weeks, instead of 12 weeks. Three hundred and nineteen subjects were randomized to either 24 weeks of 75 mg, 150 mg, or 300 mg omalizumab or placebo. By week 12, all omalizumab arms experienced a significant improvement in weekly pruritus score over baseline, while the placebo arm did not, with the 300 mg omalizumab arm demonstrating the greatest improvement. Additionally, over four times as many subjects in the omalizumab 300 mg arm achieved complete remission than in the placebo arm. Subjects in the omalizumab 300 mg arm showed sustained benefit through week 24 while in the active phase of the trial. Once again, the urticarial activity increased to values similar to placebo upon follow-up. The safety profile of this study showed 5% of subjects in the placebo arm experienced a drug-related adverse event; in the omalizumab arms, these were slightly higher, with 8.6% in the 75 mg arm, 10.3% in the 150 mg arm, and 17.3% in the 300 mg arm. A recent analysis pooled the data of these three large trials and showed that the efficacy of omalizumab was consistent in patients with CU with different underlying therapy, as shown in Figures 1–3.34

Bottom Line: Of these, the anti-IgE monoclonal antibody omalizumab is the best studied, and has recently been approved for the management of CU.Other agents, such as interleukin-1 inhibitors, have proved beneficial for Schnitzler syndrome and cryopyrin-associated periodic syndromes (CAPS), diseases associated with urticaria.This review summarizes the relevant data regarding the efficacy of biologics in antihistamine-refractory CU.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Division of Allergy and Immunology, University of South Florida, Tampa, FL, USA.

ABSTRACT
Chronic urticaria (CU) is a common condition faced by many clinicians. CU has been estimated to affect approximately 0.5%-1% of the population, with nearly 20% of sufferers remaining symptomatic 20 years after onset. Antihistamines are the first-line therapy for CU. Unfortunately, nearly half of these patients will fail this first-line therapy and require other medication, including immune response modifiers or biologics. Recent advances in our understanding of urticarial disorders have led to more targeted therapeutic options for CU and other urticarial diseases. The specific biologic agents most investigated for antihistamine-refractory CU are omalizumab, rituximab, and intravenous immunoglobulin (IVIG). Of these, the anti-IgE monoclonal antibody omalizumab is the best studied, and has recently been approved for the management of CU. Other agents, such as interleukin-1 inhibitors, have proved beneficial for Schnitzler syndrome and cryopyrin-associated periodic syndromes (CAPS), diseases associated with urticaria. This review summarizes the relevant data regarding the efficacy of biologics in antihistamine-refractory CU.

No MeSH data available.


Related in: MedlinePlus