Efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenia patients with moderate thrombocytopenia.

Abstract

The practical usefulness of Helicobacter pylori eradication for immune thrombocytopenia (ITP) patients is still controversial. However, some ITP patients respond to H. pylori eradication. We conducted a multi-center, open label, prospective phase II study to define the efficacy and toxicities of H. pylori eradication as the first line treatment for persistent or chronic ITP patients with moderate thrombocytopenia. Patients with persistent or chronic ITP showing moderate thrombocytopenia (30 × 10(9)/L ≤ platelet count ≤ 70 × 10(9)/L) and positive C(13)-urea breath test (UBT) were selected. Medication consisted of lansoprazole 30 mg, amoxicillin 1000 mg, and clarithromycin 500 mg orally twice daily for a week. Complete response (CR) rate at 4 weeks, 3 months, 6 months, 12 months, and maximal response was 19.2, 50.0, 50.0, 26.9, and 65.4%, respectively. Overall response rate (ORR) at 4 weeks, 3 months, 6 months, 12 months, and maximal response was 19.2, 57.7, 65.4, 30.8, and 69.2%, respectively. Median maximal platelet count during the first 3 months was 110 × 10(9)/L (range, 40-274). Median time to CR was 8 weeks (95% CI = 5.429-10.571). Median time to ORR was 4 weeks (95% CI = 1.228-6.772). Only per-protocol population was a response predictor for ORR at 3 months (70.0%, p = 0.054) and maximal ORR (80.0%, p = 0.051), but not for CR at 3 months (60.0%, p = 0.160). Therefore, eradication of H. pylori is an effective and durable first line treatment for persistent or chronic ITP with moderate thrombocytopenia with high ORR and rapid onset in this study.

• Authors: Hawk Kim, Won-Sik Lee, Kyoo-Hyung Lee, Sung Hwa Bae, Min Kyoung Kim, Young-Don Joo, Dae Young Zang, Jae-Cheol Jo, Sang Min Lee, Je-Hwan Lee, Jung-Hee Lee, Dae-Young Kim, Hun-Mo Ryoo, Myung Soo Hyun, Hyo Jung Kim, CoOperative Study Group A for Hematology (COSAH)
• Journal: Annals of hematology (Ann Hematol) Vol. 94 Issue 5 Pg. 739-46 (May 2015) ISSN: 1432-0584 [Electronic] Germany
• PMID: 25501820 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Lansoprazole
• Amoxicillin
• Clarithromycin

Topics

• Adult
• Amoxicillin (therapeutic use)
• Anti-Bacterial Agents (therapeutic use)
• Clarithromycin (therapeutic use)
• Female
• Helicobacter Infections (drug therapy)
• Helicobacter pylori (pathogenicity)
• Humans
• Lansoprazole (therapeutic use)
• Male
• Middle Aged
• Purpura, Thrombocytopenic, Idiopathic (drug therapy)
• Thrombocytopenia (drug therapy)
• Treatment Outcome
• Young Adult