Clinical and Diagnostic Value of Ribosomal p2 Autoantibodies in Systemic Lupus Erythematosus
Study Details
Study Description
Brief Summary
Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder characterized by production of autoantibodies directed against nuclear and cytoplasmic antigens. Clinically, this disorder is characterized by periods of remission and relapse (1). The early and accurate diagnosis of SLE is challenging (2).
The SLE pathogenesis involves multiple cellular components of the innate and immune systems, presence of autoantibodies and immune complexes, engagement of the complement system and cytokine dysregulation (3). About 180 autoantibodies have been identified in SLE patients, 102 of which are reported to have an organ-specific correlation with SLE disease identified in SLE patients, with SLE disease activity (4). However, with the exception of autoantibodies such as antinuclear antibody (ANA), anti double stranded DNA (dsDNA), anti-smith and antiphospholipid antibodies, currently proposed by the American college of rheumatology (ACR) (5)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
systemic lupus international collaborating clinics (SLICC) (6) for the diagnosis of SLE, most of these autoantibodies lack sufficient sensitivity and/or specificity for use in clinical diagnosis. Discovery of additional autoantibodies with high sensitivity and specificity is important for early diagnosis and assessment of the prognosis of SLE (7).
Anti-ribosomal P(Anti-Rib-P) antibody, routinely tested in SLE, targets a homologous 22-amino acid C-terminal (C-22) sequence shared by three ribosomal phosphoproteins known as P0, P1, and P2 (8).
The prevalence of anti-Rib-P antibody is about 15-40% in SLE patients and varies with the ethnicity, disease activity and detection method (9). Studies have disclosed that anti-P antibodies react with activated T cells but not with B cells, suggesting possible direct effects of anti-P antibodies on immune regulation (10).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| SLE patients group The study will include 50 patients suffering from SLE, all patients with SLE should fulfill 2012 SLICC criteria |
Diagnostic Test: Ribosomal p2 Autoantibodies as a Serum marker
Using serum marker
|
| Healthy control group Control group of 40 healthy volunteers with age and gender-matched with SLE patients. |
Diagnostic Test: Ribosomal p2 Autoantibodies as a Serum marker
Using serum marker
|
Outcome Measures
Primary Outcome Measures
- a. Primary (main): Assessment of diagnostic value (sensitivity and specificity) of serum ribosomal p2 autoantibody level in SLE patients in comparison to healthy controls [Baseline]
The importance of Ribosomal p2 autoantibodies in diagnosis of SLE
Secondary Outcome Measures
- b. Secondary (subsidiary): correlation between serum ribosomal p2 autoantibody level and SLE clinical, laboratory data, disease activity and severity. [Baseline]
The relation between rib p2 level in serum and determination of disease severity and prognosis
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients who fulfilled the 2012 SLICC criteria (6).
-
SLE Patients >= 18 years old.
Exclusion Criteria:
- 1-SLE Patients < 18 years old. 2- Patients with other autoimmune diseases or malignancy.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
- Study Director: Samar Hassanein goma, MD, Assiut university Egypt
- Study Director: Maha Sayed ibrahim, MD, Assiut university Egypt
Study Documents (Full-Text)
None provided.More Information
Publications
- Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrøm K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirják L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumánovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rúa-Figueroa Fernández Í, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dörner T, Johnson SR. 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Ann Rheum Dis. 2019 Sep;78(9):1151-1159. doi: 10.1136/annrheumdis-2018-214819. Epub 2019 Aug 5. Review.
- Fava A, Petri M. Systemic lupus erythematosus: Diagnosis and clinical management. J Autoimmun. 2019 Jan;96:1-13. doi: 10.1016/j.jaut.2018.11.001. Epub 2018 Nov 16. Review.
- Fortuna G, Brennan MT. Systemic lupus erythematosus: epidemiology, pathophysiology, manifestations, and management. Dent Clin North Am. 2013 Oct;57(4):631-55. doi: 10.1016/j.cden.2013.06.003. Review.
- Gladman DD, Ibañez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
- Ling HZ, Xu SZ, Leng RX, Wu J, Pan HF, Fan YG, Wang B, Xia YR, Huang Q, Shuai ZW, Ye DQ. Discovery of new serum biomarker panels for systemic lupus erythematosus diagnosis. Rheumatology (Oxford). 2020 Jun 1;59(6):1416-1425. doi: 10.1093/rheumatology/kez634.
- Mahler M, Kessenbrock K, Raats J, Fritzler MJ. Technical and clinical evaluation of anti-ribosomal P protein immunoassays. J Clin Lab Anal. 2004;18(4):215-23.
- Mahler M, Kessenbrock K, Raats J, Williams R, Fritzler MJ, Blüthner M. Characterization of the human autoimmune response to the major C-terminal epitope of the ribosomal P proteins. J Mol Med (Berl). 2003 Mar;81(3):194-204. Epub 2003 Mar 14.
- Nagai T, Arinuma Y, Yanagida T, Yamamoto K, Hirohata S. Anti-ribosomal P protein antibody in human systemic lupus erythematosus up-regulates the expression of proinflammatory cytokines by human peripheral blood monocytes. Arthritis Rheum. 2005 Mar;52(3):847-55.
- Petri M, Orbai AM, Alarcón GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sánchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.
- Stoll T, Seifert B, Isenberg DA. SLICC/ACR Damage Index is valid, and renal and pulmonary organ scores are predictors of severe outcome in patients with systemic lupus erythematosus. Br J Rheumatol. 1996 Mar;35(3):248-54.
- Thong B, Olsen NJ. Systemic lupus erythematosus diagnosis and management. Rheumatology (Oxford). 2017 Apr 1;56(suppl_1):i3-i13. doi: 10.1093/rheumatology/kew401. Review.
- Yaniv G, Twig G, Shor DB, Furer A, Sherer Y, Mozes O, Komisar O, Slonimsky E, Klang E, Lotan E, Welt M, Marai I, Shina A, Amital H, Shoenfeld Y. A volcanic explosion of autoantibodies in systemic lupus erythematosus: a diversity of 180 different antibodies found in SLE patients. Autoimmun Rev. 2015 Jan;14(1):75-9. Review.
- Rib P2 antibodies in sle pts