Method for determining severity of extraskeletal manifestations of axial spondyloarthritis

Abstract

FIELD: rheumatology.SUBSTANCE: used to determine the severity of extraskeletal manifestations of axial spondyloarthritis (axSpA). A set of indicators is determined: the sum of extraskeletal manifestations, the number of uveitis exacerbations per year, glaucoma, macular edema, aortic / mitral insufficiency, atrioventricular block, erythrocyturia, the frequency of loose stools per day, the total area of psoriatic lesions of the body (Body Surface Area (BSA)), glomerular filtration rate (GFR). Based on the data obtained, the extraskeletal index of axial spondyloarthritis severity (ESIaxSpA) is determined using the formula: ESIaxSpA = 2.955×X1 + 1.057×X2 + 0.43×X3 + 0.838×X4 + 0.847×X5 + 0.672×X6 + 1.183×X7 + 1.408×X8 + 1.191×X9 + 1.007×X10. If the resulting sum exceeds the value of 4.518, a high degree of severity of extraskeletal manifestations of axial spondyloarthritis is determined; if the sum is equal to or less than 4.518, a low degree of severity of extraskeletal manifestations of axial spondyloarthritis is determined.EFFECT: comprehensive assessment of the severity of axSpA taking into account the extraskeletal manifestations, allowing for adequate patient monitoring and the prescription of the correct treatment.1 cl, 1 dwg, 2 tbl, 4 ex

Description

[0001] The invention relates to the field of medicine, namely to rheumatology, and can be used to optimize the assessment of the severity and choice of therapy for axial spondyloarthritis (axSpA).

[0002] Axial spondyloarthritis is a chronic inflammatory rheumatic disease that predominantly affects the axial skeleton: the spine (spondylitis) and sacroiliac joints (sacroiliitis), with frequent involvement of peripheral joints and entheses (sites of attachment of tendons / ligaments to bone) [Erdes Sh.F., Rebrov A.P., Dubinina T.V., Badokin V.V., Bochkova A.G. et al. Spondyloarthritis: modern terminology and definitions. Therapeutic archive. 2019;91(5):84-88. doi: 10.26442 / 00403660.2019.05.000208; Ramiro S, Nikiphorou E, Sepriano A, Ortolan A, Webers C, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023 Jan;82(1):19-34. doi:10.1136 / ard-2022-223296].

[0003] AxSpA includes both the variant with radiographic signs of sacroiliitis – radiographic axSpA (r-axSpA) or ankylosing spondylitis (AS), and the variant without reliable radiographic signs of sacroiliitis – non-radiographic axSpA (nr-axSpA).

[0004] In addition to musculoskeletal damage, up to 50% of patients with axSpA have extraskeletal manifestations (ESM): damage to the eyes (uveitis), heart (inflammation of the aortic root and valves, conduction system disorder), skin (psoriasis), kidneys (nephritis), inflammatory bowel disease (IBD) [Godzenko AA, Bochkova AG, Rumyantseva OA et al. Frequency and severity of extraskeletal manifestations of ankylosing spondylitis. Scientific and practical rheumatology. 2017, 55 (2): 169-176].

[0005] EPs are an important component of axSpA, significantly influencing the prognosis and choice of therapy. It has been shown that EPs significantly aggravate the course of AS due to decreased vision in patients with uveitis, progression of structural changes in the aorta and heart valves, the possibility of severe psoriasis, IBD, and impaired renal function, which is observed in almost / 1 / 3 of patients [Godzenko AA, Bochkova AG, Rumyantseva OA et al. Frequency and severity of extraskeletal manifestations of ankylosing spondylitis. Scientific and practical rheumatology. 2017, 55 (2): 169-176].

[0006] In some cases, uveitis is a decisive factor in determining the treatment tactics for axSpA. According to the Russian guidelines for the management of axSpA, recurrent or chronic uveitis that does not respond to standard therapy is an independent indication for the use of genetically engineered biological therapy (GEBT), regardless of the activity of inflammation of the spine and joints [Gaidukova IZ, Rebrov AP, Lapshina SA et al. Use of non-steroidal anti-inflammatory drugs and genetically engineered biological agents for the treatment of axial spondyloarthritis. Recommendations of the Expert Group for the Study of Spondyloarthritis at the All-Russian Public Organization "Association of Rheumatologists of Russia". Scientific and Practical Rheumatology. 2017; 55 (5): 474-484].

[0007] Aortic and heart valve damage in axSpA, which tends to progress in 60% of cases, also requires active anti-inflammatory therapy, including the use of biological therapy [Godzenko A.A., Korsakova Yu.O., Rumyantseva O.A. Progression of aortic and heart valve pathology in patients with ankylosing spondylitis. Scientific and practical rheumatology 2017,55 (5): 509-513].

[0008] Other CP (IBD, nephritis, psoriasis) are also associated with severe disease parameters: peripheral arthritis, fever, anemia, amyloidosis development, and the need for genetically engineered biological drugs (GEBD) or systemic glucocorticoids (SG). [Godzenko A.A. Extraskeletal manifestations of ankylosing spondylitis: clinical presentation, course, prognosis. Abstract of the doctor of medical sciences. Moscow, 2019].

[0009] Patients with psoriasis have worse functional status and quality of life, higher levels of C-reactive protein (CRP), total cholesterol and triglycerides, and high cardiovascular risk [Braun J, Rudwaleit M, Kary S, Kron Wong RL, Kupper H. Clinical manifestations and responsiveness to adalimumab are similar in patients with ankylosing spondylitis with and without concomitant psoriasis. Rheumatology (Oxford). 2010 Aug; 49(8):1578-89. doi: 10.1093 / rheumatology / keq129. Epub 2010 May 6].

[0010] IBD in patients with axSpA is one of the factors characterizing the category of “difficult-to-treat” patients (D2T). [Philippoteaux C, Delepine T, Cailliau E, Philippe P, Taisne N, Pascart T, Cortet B, Paccou J, Flipo RM, Letarouilly JG. Characteristics of difficult-to-treat axial spondyloarthritis: Results of a real-world multicentric study. Joint Bone Spine. 2024 Mar;91(2):105670. doi: 10.1016 / j.jbspin.2023.105670. Epub 2023 Nov 29. PMID: 38036061].

[0011] Thus, the characteristics of EP, along with standard indicators of inflammatory activity, must be taken into account in the overall assessment of the severity of axSpA.

[0012] Currently, the assessment of axSpA consists of determining the inflammatory activity and functional capacity. To assess the inflammatory activity of axSpA, two indices are used: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and ASDAS (Ankylosing Spondylitis Disease Activity Score) [Dubinina TV, Gaidukova IZ, Godzenko AA, et al. Recommendations for assessing disease activity and the functional state of patients with ankylosing spondylitis in clinical practice. Scientific and practical rheumatology. 2017; 55 (4): 344-350. Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R, et al. Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis 2009;68(Suppl II):ii1-ii44. doi:10.1136 / ard.2008.104018].

[0013] The BASDAI index is based on a self-administered questionnaire consisting of six questions regarding pain in the spine, joints, and entheses. Responses are expressed as numbers corresponding to the visual analog scale (VAS) or numeric rating scale (NRS). The BASDAI index is calculated using the following formula:

[0014]

[0015] Inflammatory activity is considered high when the BASDAI value is ≥ 4.0.

[0016] The ASDAS index assesses both the patient's subjective perceptions and laboratory indicators of inflammation (Westergren's ESR or CRP). Two index versions are used, depending on the laboratory parameter used:

[0017] ASDAS СРБ = 0.121 x Back pain x 0.110 patient's OOAZ + 0.073 x peripheral joint pain / swelling + 0.558 x ln (CRP + 1)

[0018] ASDAS СОЭ= 0.113 x patient's OOAZ + 0.293 x √ESR + 0.0856 x peripheral joint pain / swelling + 0.069 x duration of morning stiffness + 0.079 back pain

[0019] √ESR – square root of the erythrocyte sedimentation rate (mm / h)

[0020] Ln(CRP+1) – natural logarithm of CRP (mg / l)+1.

[0021] Back pain intensity assessment, patient's overall assessment of disease activity, peripheral joint pain / swelling, patient's assessment of fatigue / tiredness are assessed using VAS or NRS (0-10).

[0022] Activity grading according to the ASDAS index: < 1.3 – inactive disease, 1.3 ≤ ASDAS < 2.1 – low activity, 2.1 ≤ ASDAS < 3.5 – high activity, ≥ 3.5 – very high activity.

[0023] To determine functional capacity, the BASFI (Bath Ankylosing Spondylitis Functional Index) index is used, as well as an assessment of spinal mobility using metrological measurements.

[0024] BASFI contains 10 questions reflecting functional status, which the patient answers using the VAS or NRS, after which the arithmetic mean of the 10 values ​​is calculated. Functional impairment is considered severe if the BASFI score is ≥ 4.0.

[0025] Spinal mobility is assessed using the Bath Ankylosing Spondylitis Metrology Index (BASMI), which includes five measurements: lumbar lateral flexion, tragus-to-wall distance, lumbar flexion (modified Schober test), maximum inter-ankle distance, and cervical rotation. The measurement results are converted into points, which are summed to obtain the BASMI score.

[0026] In addition to the BASMI index, the excursion of the thoracic spine is measured to determine the mobility of the thoracic spine, and the cervical spine – the distance from the tragus to the wall [Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R, et al. Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis 2009;68(Suppl II):ii1–ii44. doi:10.1136 / ard.2008.104018].

[0027] In addition, the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) index, which examines 13 enthesis points, and an assessment of 44 peripheral joints are used to assess enthesitis in axSpA [Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R, et al. Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis 2009;68(Suppl II):ii1–ii44. doi:10.1136 / ard.2008.1040].

[0028] All of the above methods are designed to assess changes in the musculoskeletal system and do not take into account VP. A method similar to the proposed one is currently unknown. The novelty of the proposed method lies in the development of an original axSpA severity index that takes into account the severity of each VP in points, allowing for a comprehensive understanding of all disease manifestations and the determination of treatment strategies.

[0029] The technical problem to be solved is the quantitative determination of the severity of extraskeletal manifestations of axSpA.

[0030] The technical result achieved is a comprehensive assessment of the severity of axSpA taking into account the VP, which allows for adequate monitoring of the patient and the prescription of the correct treatment.

[0031] The stated problem is solved by taking into account a set of characteristics characterizing the clinical manifestations and complications of CAP. To this end, severity criteria for CAP were developed with a scoring system for assessing the significance of each parameter. A multivariate analysis was performed using a stepwise discriminant method with the construction of a ROC curve. A formula for calculating the extraskeletal index of axSpA severity was derived.

[0032] Implementation of the invention

[0033] A statistical analysis of clinical data was performed to identify reliable indicators associated with the need for active anti-inflammatory therapy using biologic agents and / or systemic glucocorticoids. For this purpose, 256 patients diagnosed with axSpA who had CP were examined.

[0034] A severity scale for EP was developed, according to which each EP was assessed in all patients (Table 1).

[0035] [Godzenko AA, Bochkova AG, Rumyantseva OA et al. Frequency and severity of extraskeletal manifestations of ankylosing spondylitis. Scientific and practical rheumatology. 2017, 55 (2): 169-176; Kucharzik T, Taylor S, Allocca M, Burisch J, Ellul P, et al. ECCO-ESGAR-ESP-IBUS Guideline on Diagnostics and Monitoring of Patients with Inflammatory Bowel Disease: Part 1. J Crohns Colitis. 2025 Jul 3;19(7):jjaf106. doi: 10.1093 / ecco-jcc / jjaf106. PMID: 40741688.; Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016 / j.ajo.2005.03.057; Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980 Mar 8;1(8167):514. doi: 10.1016 / s0140-6736(80)92767-1. PMID: 6102236.; Chronic kidney disease (CKD). Clinical guidelines National Association of Nephrologists. 2024. https: / / cr.minzdrav.gov.ru / ; Arthropathic psoriasis. Psoriatic arthritis. Clinical guidelines of the Association of Rheumatologists of Russia, All-Russian public organization "Russian Society of Dermatovenerologists and Cosmetologists." 2024. https: / / cr.minzdrav.gov.ru / ].

[0036]

[0037]

[0038]

[0039]

[0040]

[0041] According to this scale, the total score for each patient was calculated. The category "total score ≥ 10" was defined as a separate parameter of EP severity.

[0042] The signs that best characterize the severity of uveitis and are associated with the prescription of biological agents / GCs were: the sum of uveitis points ≥ 10, the number of uveitis exacerbations per year, glaucoma, macular edema, aortic / mitral insufficiency, AV block, erythrocyturia, SCF, frequency of loose stools per day, BSA.

[0043] In order to determine the overall severity of CP and the need for the appointment of GIBT / GC, a multifactorial stepwise discriminant analysis was performed and a discriminant rule was obtained:

[0044] 2.955*(sum of EP points ≥ 10) + 1.057*number of uveitis attacks per year + 0.43*glaucoma + 0.838*macular edema + 0.847*aortic / mitral insufficiency + 0.672*AV block / ECS + 1.183*erythrocyturia + 1.408*frequency of loose stools per day + 1.191*BSA + 1.007*SCF.

[0045] If ​​the discriminant function value is more than 4.518, a severe course of CP is determined, which necessitates the appointment of active anti-inflammatory therapy using GIBP / GC.

[0046] The extraskeletal index of severity of axSpA (ESIAS) is calculated using a specially developed formula, where each feature corresponds to a specific coefficient (Table 2).

[0047] Prognostic indicator coefficients

[0048] Table 2

[0049] Indicator Designation of the indicator Coefficient Total VP score ≥ 10 X1 ( =1, no-0) 2,955 Number of uveitis exacerbations per year X2 ( = 1-3, no uveitis -0) 1,057 Glaucoma X3 (=2, no-0) 0,43 Macular edema X4 (= 3, no-0) 0,838 Aortic / mitral regurgitation X5 (= 2-3, no-0) 0,847 A / V block / ECS X6 (= 2-3, no-0) 0,672 Erythrocyturia X7 (= 1-3, no-0) 1,183 Frequency of loose stools per day X8 (= 1-3, no-0) 1,408 BSA X9 (= 1-3, no-0) 1,191 SKF X10 (=1-5, normally -0) 1,007 A total value of more than 4.518 is a high extraskeletal index of axSpA severity, no more than 4.518 is a low extraskeletal index of axSpA severity,

[0050] Note: SCF - glomerular filtration rate

[0051] BSA – Body Surface Area, the total area of ​​psoriatic lesions on the body

[0052] To determine VITAxS, the values ​​of the indicators are summed up using the formula:

[0053] VITax = 2.955xX1 + 1.057xX2 + 0.43xX3 + 0.838xX4 + 0.847xX5 + 0.672xX6 + 1.183xX7 + 1.408xX8 + 1.191xX9 + 1.007xX10.

[0054] If the resulting sum exceeds 4.518, it is considered a high extraskeletal axSpA severity index. If the sum is no more than 4.518, it is considered a low extraskeletal axSpA severity index.

[0055] Sensitivity and specificity analysis were performed using the ROC analysis. The area under the ROC curve was 0.929 (0.896; 0.962) (Fig. 1). The sensitivity of the model was 83%, and the specificity was 91%.

[0056] The essence of the claimed method is explained by the following examples.

[0057] Example 1

[0058] Patient L. has been observed at the V.A. Nasonova Research Institute of Rheumatology since age 20. Her medical history indicates that arthritis of the small joints of the feet, ankles, hips, and right knee first appeared at age 12, with annual exacerbations. Examination revealed an elevated ESR of 28 mm / h, an elevated C-reactive protein of 32 mg / L, and a positive HLA-B27 level. An ophthalmologist detected lens opacity and signs of band keratopathy, although there were no clinical signs of active uveitis. She was diagnosed with juvenile chronic arthritis and prescribed methotrexate at a dose of 12.5 mg per week, nonsteroidal anti-inflammatory drugs (NSAIDs), and intra-articular betamethasone. Over the next 5 years, there were 3-4 annual exacerbations of uveitis of the left eye, lasting 4-5 weeks, resulting in a persistent decrease in vision in the left eye; periodic synovitis of the right knee joint with fluid accumulation, pain in the lumbar spine of an inflammatory rhythm.Since the age of 25, the patient has been experiencing shortness of breath during physical exertion and a dry cough; pain and limited mobility in the hip joints have increased. A routine examination revealed bilateral stage 4 sacroiliitis, bilateral coxitis with severe narrowing of the hip joint spaces, and acetabular protrusion. An electrocardiogram (ECG) showed signs of right atrial overload. Echocardiography (EchoCG) revealed thickening of the aortic wall and aortomitral junction with the formation of a subaortic crest-shaped thickening up to 8 mm ("subaortic bump"), dilation of the aortic root up to 40 mm, thickening of the aortic and mitral valves, grade 3 mitral regurgitation, and grade 1 aortic regurgitation.

[0059] Ophthalmological examination data reveals an exacerbation of recurrent uveitis in the left eye, complicated by cataracts: the right eye (OD) is calm, the left eye (OS) has an edematous, subatrophic cornea, and clear anterior chamber fluid. A circular posterior synechia is present. The pupil is irregularly shaped and does not react to light. The lens is opacified under the posterior capsule. The vitreous body is destroyed. The fundus is behind the flare.

[0060] Diagnosed with: Ankylosing spondylitis, HLA-B27-associated, advanced stage, bilateral coxitis, peripheral arthritis, with extraskeletal manifestations: eye damage (recurrent uveitis of the left eye, complicated cataract, vitreous destruction); heart damage (thickening and dilation of the aortic root, grade 3 mitral regurgitation), high activity, functional class 2.

[0061] According to the severity scale for EP, this patient scores 19 points:

[0062] average number of uveitis exacerbations per year 3 or more (3 points), average duration of exacerbations 1 month or more (3 points), synechiae (1 point), band-like corneal degeneration (2 points), cataract (2 points), vitreous damage (2 points), aortic wall thickening / subaortic thickening (1 point), aortic dilation < 45 mm (1 point), aortic / mitral valve thickening (1 point), grade 3 mitral insufficiency (3 points).

[0063] Prognostic indicator values ​​for this patient:

[0064] Indicator Designation of the indicator Coefficient Significance for the patient Total VP score ≥ 10 X1 = 1 2,955 2,955 Number of uveitis exacerbations per year X2 = 3 1,057 3.171 Aortic / mitral regurgitation X5 = 3 0,847 2.541

[0065] To calculate the extraskeletal index of axSpA severity, we sum up the prognostic indicators using the formula above:

[0066] VITax = 2.955x1 + 1.057x3 + 0.43x0 + 0.838x0 + 0.847x3 + 0.672x0 + 1.183x0 + 1.408x0 + 1.191x0 + 1.007x0 = 8.667.

[0067] The obtained total value of 8.667>.4.518, which corresponds to a high value of extraskeletal severity index.

[0068] Further treatment of the patient: given the high inflammatory activity and severe course of the CP, therapy with a biological therapy (GABA) was prescribed: adalimumab 40 mg subcutaneously once every 2 weeks. This resulted in stabilization of the ocular inflammation, a decrease in the thickness of the "subaortic ridge," and a reduction in inflammatory activity in the joints and spine. Mitral valve replacement and sequential hip replacement were performed.

[0069] Example 2

[0070] Patient K., 33 years of age, began with right-sided iridocyclitis. Since then, she has experienced intermittent episodes of diarrhea. A year after the first episode of uveitis, she developed pain and stiffness in the lumbar spine, followed by pain in the upper spine. She was taking NSAIDs. While taking NSAIDs, she experienced bloody diarrhea up to 5-6 times a day, accompanied by fever and moderate abdominal pain. Upon examination (colonoscopy with histological confirmation), ulcerative colitis (UC) was diagnosed and mesalazine 3 g per day was prescribed. This resulted in a decrease in abdominal pain, but 4-5 loose stools per day persisted, as well as back pain. Two to three exacerbations of uveitis lasting 10-12 days were noted annually, as well as arthritis of the sternoclavicular, knee, and ankle joints. Upon examination at the V.A.Nasonova was diagnosed with HLA-B27, and radiological examination revealed stage 3 bilateral sacroiliitis and isolated syndesmophytes in the lumbar spine. An echocardiogram revealed thickening and consolidation of the right coronary leaflet of the aortic valve. An ophthalmologist examined her: mixed injection of the right eyeball, edematous iris, anterior synechia at the 11 o'clock position, precipitates in the vitreous and on the anterior corneal surface, and a normal fundus.

[0071] Diagnosis: “Ankylosing spondylitis, HLA-B27-associated, late stage, with damage to peripheral joints, extraskeletal manifestations: ulcerative colitis of chronic continuous course, recurrent uveitis of the right eye, heart damage (thickening of the aortic valve), high activity, FC 2.

[0072] According to the severity scale for EP, this patient scores 13 points:

[0073] average number of uveitis exacerbations per year 3 or more (3 points), average duration of exacerbations from 10 days to 1 month (2 points), synechiae (1 point), thickening of the aortic valve (1 point), abdominal pain (2 points), frequency of stool per day 4-6 times (2 points), visible blood in the stool (2 points).

[0074] Prognostic indicator values ​​for this patient:

[0075] Indicator Designation of the indicator Coefficient Significance for the patient Total VP score ≥ 10 X1 = 1 2,955 2,955 Number of uveitis exacerbations per year X2 = 3 1,057 3.171 Frequency of stool per day X8 = 2 1,408 2,816

[0076] To calculate the extraskeletal index of axSpA severity, we sum up the prognostic indicators using the formula above:

[0077] VITax = 2.955x1 + 1.057x3 + 0.43x0 + 0.838x0 + 0.847x0 + 0.672x0 + 1.183x0 + 1.408x2 + 1.191x0 + 1.007x0 = 8.942.

[0078] The obtained total value is 8.942> 4.518, which corresponds to a high value of the extraskeletal severity index.

[0079] The patient was prescribed treatment with adalimumab 40 mg subcutaneously once every 2 weeks in combination with sulfasalazine 2 g per day, which led to persistent remission of uveitis and UC, a decrease in spinal pain and stiffness, and improved mobility and posture.

[0080] Example 3

[0081] Patient Ch. has been ill since the age of 22: pain and stiffness in the spine, pain in the hip joints, periodic arthritis of the knee joints with a large amount of fluid, accompanied by a fever up to 39°C, an accelerated ESR of 45 mm / h. The diagnosis of "AS" was made after 10 years of the disease based on inflammatory back pain, the presence of bilateral sacroiliitis; HLA-B27 was detected. Treatment was prescribed with sulfasalazine, NSAIDs, pulse therapy with methylprednisolone. Betamethasone was administered intra-articularly with a short-term effect. For a year, he has noted a change in the color of urine (brown). During another exacerbation, he was hospitalized at the V.A. Nasonova Research Institute of Rheumatology. The examination revealed limited mobility of the spine with a decrease in all vertebral indices, arthritis of the knee joints, blood test results showed ESR-36 mm / h, CRP-29.5 mg / l, blood creatinine 110.0 μmol / l (normal range: 53-95 μmol / l), SCF-62 ml / min / 1.73 m 2 , other indicators are within normal limits.

[0082] Urine analysis: protein – 0.066‰, erythrocytes completely cover the field of view, leukocytes 0-2, flat epithelium – single in the field of view.

[0083] Urine analysis according to Nechiporenko: erythrocytes 8000 (normal up to 1000), leukocytes 1300 (normal up to 2000), no cylinders.

[0084] EchoCG revealed thickening of the non-coronary leaflet of the aortic valve, mitral valve prolapse with grade I insufficiency, and grade I aortic insufficiency.

[0085] Ultrasound of the kidneys: no space-occupying formations, stones / microliths were detected.

[0086] Ultrasound of the pelvic organs: areas of fibrosis in both lobes of the prostate.

[0087] The urologist diagnosed chronic nephritis as part of the underlying disease.

[0088] Diagnosis: "Ankylosing spondylitis, HLA-B27-associated, advanced stage, with peripheral joint involvement, extraskeletal manifestations: chronic nephritis, stage 1 CKD, heart damage (thickening of the aortic valve), high activity, FC 2."

[0089] According to the severity rating scale for EP, this patient scores 5 points:

[0090] thickening of the aortic valve (1 point), macrohematuria (3 points), SCF 62 ml / min / 1.73 m 2 (1 point).

[0091] Prognostic indicator values ​​for this patient:

[0092] Indicator Designation of the indicator Coefficient Significance for the patient Erythrocyturia X7 (=3) 1,183 3,549 SKF X10 (=1) 1,007 1,007

[0093] To calculate the extraskeletal index of axSpA severity, we sum up the prognostic indicators using the formula above:

[0094] VITax = 2.955x0 + 1.057x0 + 0.43x0 + 0.838x0 + 0.847x0 + 0.672x0 + 1.183x3 + 1.408x0 + 1.191x0 + 1.007x1 = 4.556.

[0095] The obtained total value is 4.556> 4.518, which corresponds to a high value of the extraskeletal severity index.

[0096] The patient was prescribed golimumab 50 mg subcutaneously once a month, which resulted in remission of arthritis, spondylitis, and nephritis. After 3 months, urine analysis showed no protein, and 3-4 red blood cells per high-power field.

[0097] Example 4

[0098] Patient S., 47 years old at the time of observation, developed inflammatory back pain at the age of 27. She had been under observation for 10 years with a diagnosis of spinal osteochondrosis. She received treatment with NSAIDs on demand, physiotherapy, and manual therapy, which resulted in a decrease in pain. Ankylosing spondylitis was diagnosed in the 11th year of the disease based on the detection of stage 3 sacroiliitis and limited mobility of the thoracic and lumbar spine. Spinal radiographs showed syndesmophytes in the cervical and lumbar spine. During the disease, she suffered three attacks of iridocyclitis with alternating eye involvement. The eye inflammation was relieved within 10-12 days with the use of anti-inflammatory drops; during the last exacerbation, betamethasone was administered subconjunctivally once. Over the past 2 years, he has been experiencing pain in the hip, knee, ankle joints, and is constantly taking NSAIDs.

[0099] During examination at the V.A. Nasonova Research Institute of Rheumatology, limited mobility of all parts of the spine and the development of cervicothoracic kyphosis were noted. Erythematous, scaly lesions up to 3 cm in diameter were found on the scalp and elbows. There was pain in the knee and ankle joints, and swelling of the right ankle. Hip abduction was fully functional. Blood tests revealed ESR -15 mm / h, CRP -16.5 mg / L, and HLA-B27 was positive. Urinalysis revealed no abnormalities.

[0100] EchoCG revealed thickening of the mitral valve cusps and developing calcification of the aortic valve cusps.

[0101] The ophthalmologist diagnosed recurrent uveitis in the stage of long-term remission.

[0102] Dermatologist diagnosed plaque psoriasis, BSA-1.5%.

[0103] Diagnosis: "Ankylosing spondylitis, HLA-B27-associated, late stage, bilateral coxitis, enthesopathies, with extraskeletal manifestations (recurrent uveitis of both eyes outside of exacerbation, post-inflammatory fibrosis of the aortic and mitral valve cusps, psoriasis), moderate activity, FC 2."

[0104] According to the severity scale for VP, this patient scores 5 points:

[0105] average number of uveitis exacerbations per year < 1 (1 point), average duration of exacerbations 10 days - up to 1 month (2 points), thickening of the aortic / mitral valve (1 point), BSA < 10% (1 point).

[0106] Prognostic indicator values ​​for this patient:

[0107] Indicator Designation of the indicator Coefficient Significance for the patient Number of uveitis exacerbations per year X2 (=1) 1,057 1,057 BSA X9 (=1) 1,191 1,191

[0108] To calculate the extraskeletal index of severity of axSpA, we sum up the prognostic indicators using the formula above:

[0109] VITax = 2.955x0 + 1.057x1 + 0.43x0 + 0.838x0 + 0.847x0 + 0.672x0 + 1.183x0 + 1.408x0 + 1.191x1 + 1.007x0 = 2.248.

[0110] The obtained total value is 2.248 < 4.518, which corresponds to a low value of the extraskeletal severity index.

[0111] The patient was prescribed treatment with sulfasalazine 2 g per day, NSAIDs, betamethasone was locally injected into the ankle joint with effect.

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