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Clinical and Epidemiological Aspects of Rheumatoid Arthritison Biological Therapy

TabarekAyadNoori1 Atta Ah Mousa Al-Sarray2

Ali Hussein Al-Hafidh3

1,2,3 Middle Technical University / Iraq

E- mail:[email protected]

Abstract:

Background: Rheumatoid arthritis is a chronic, autoimmune, inflammatory disorder that most commonly affects the joints, causing progressive, symmetric, erosive destruction of cartilage and bone, which is usually associated with autoantibody production.

Objectives: To examines female versus male perspective concerning prevalence, clinical features, complication and functional classes in rheumatoid arthritis patients on biological therapy.

Subjects and Methods: A descriptive; cross sectional study conducted at Baghdad teaching hospital in Baghdad city, (convenient sample) included 210 patients already diagnosed with rheumatoid arthritis. The data collection continued for the period starting on 1th December -2020 ending on 1st April, 2021.

Results: the majority of rheumatoid arthritis cases were females 173 (82. 4%) and 37 of them (17.6%) were males. Female to male ratio was 4.6:1. Mean of age was (50.81 ± 11 years). The majority of studied sample had primary education 38% and unemployed 80%% for both sexes. Males reported to have family history of rheumatic diseases (40%) more than females (24%); smoking also higher in males compared to females 29% vs. 6%. Clinical features were worse in women than men; morning stiffness 64% vs. 62%; fatigue 81% vs. 64%; loss of appetite 33% vs. 10%; weight loss 23% vs. 2%. Similarly complication reported to be more frequent in female patients specifically osteoporosis and sicca symptoms (45% vs. 27%; 50% vs. 32%) respectively.

Conclusion: Females to males ratio was 4.6:1. Clinical features, functional classes and complications worsen in female patients.

Recommendation:

Special attention must be given to females rheumatoid arthritis patients particularly in postmenopausal period to prevent complication and deformity of the disease; Health education regarding early diagnosis, early initiation of effective therapy and regular exercise.

Key words: Rheumatoid arthritis, Clinical and epidemiologiclaspects, Gender differences, Biological therapy.

Introduction:

RA is a common chronic systemic autoimmune disorder of unknown etiology, characterized by a synovial hyperplasia, symmetric, and progressive inflammatory

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polyarthritis.Affected patients often experience inflammatory signs in the joints of the hands, wrists, and feet, but many other joints may be involved including the temporo- mandibular joints, elbows, shoulders, hips, knees, and ankles. Its worldwide distribution affects approximately 0.5-1% of the population [1, 2].The arthritis is typically symmetrical, and usually leads, if uncontrolled, to destruction of joints due to erosion of cartilage and bone, causing joint deformities. The disease may also affect other parts of the body. This may result in a low red blood cell count, inflammation around the lungs, and inflammation around the heart. Fever and low energy may also be present [3].Patient's daily activity largely affected by rheumatoid arthritis, therefore physician tend to determine extent of physical disability that patients suffer from, this can be detected by steinbrocker functional classification; it’s four level scale range from class I to class IV: 1. Class I – Completely have ability to perform usual daily living activities. 2. Class II – Able to perform usual self-care and vocational activities but limited in avocational activities. 3. Class III – Able to perform usual self-care activities but limited in vocational and avocational activities. 4. Class IV – Limited in ability to perform usual self-care, vocational, and avocational activities [4].

The diagnosis of RA was based on the 1987 American College of Rheumatology (ACR) criteria. These criteria were based on the persistence of arthritic symptoms over time; however, this classification system failed to identify patients with early inflammatory arthritis.It is now recognized that early therapeutic intervention significantly improves clinical outcomes and reduces irreversible joint damage and disability. With this focus, the ACR and the European League Against Rheumatism (EULAR) in 2010 devised new classification criteria for early arthritis, which assess joint involvement, autoantibody status, acute-phase response, and symptom duration, as well as revised criteria for classifying RA in newly presenting patients, those with erosive disease typical of RA, and those with inactive disease with or without treatment[5].

Treatments for rheumatoid arthritis help to prevent or slow down joint damage,decrease inflammation in the joints, relieve pain, improve quality of life and reduce disability [6]. Methotrexate is the cornerstone in the management of RA.

Despite the effectiveness of these medications some patients with RA experience failure even with use of combination or triple DMARDs and need for other line of treatment. The use of biologic therapy in treatment of RA has revolutionized the management in the last two decades [7].

Objective of the Study

To examines female versus male perspective concerning prevalence, clinical features, complication and functional classes in rheumatoid arthritis patients on biological therapy.

Subjects and Methods Study Design

A cross sectional analytical study conducted in Baghdad teaching hospital – Medical City – Baghdad.

Duration of Study

The data collection continued for a period of four months starting on 1thDecember - 2020 ending on 1stApril, 2021.

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Place of Study

The place of study was in Baghdad teaching hospital in Baghdad city.

Inclusion and Exclusion Criteria of Study

Inclusion criteria: Rheumatoid patients fulfilled ACR_EULAR 2010 criteria for the diagnosis of RA; who were aged 18-75 years of either gender accepted to participate in the study.

Exclusion criteria: Patients with active infection and discontinue biological therapy and those having other types of rheumatoic diseases including psoriasis.

Statistical Analysis

Analysis of data was carried out using the available statistical package of SPSS-25 (Statistical Packages for Social Sciences version 25). Qualitative data were presented in simple measures of frequency and percentage whereas quantitative data summarized by mean, standard deviation, and range (minimum, maximum values).

The significance of different percentages (qualitative data) was tested using Pearson Chi-square test. Statisticalsignificance was considered whenever the P value was equal or less than 0.05.

Results:

The majority of studied sample were female 173 (82. 4%) and 37 of them (17.6%) were males. Female to male ratio was 4.6:1. Most female patients were in the age group 50- 59 years; 89% of female were married vs. 100% of male; highest percentages of both genders found to have primary education 39% female vs. 32% male; 83% of female patients wereunemployed vs. 64% males; family history of rheumatic disease reported in 24%, 40% females and males, respectively. Most cases in both genders found to have higher BMI, overweight more in males 37% whereas obesity higher in females 43%. Significant associations were found among gender and marital status, occupation, family history at (P-value <0.05), highly significant association was found between gender & smoking P- value = 0.0001.

Table (1): Comparison of demographic variables in both genders

Demographic variables

Gender Males

(n=37)

Females (n=173)

Total

No % No % No % P.V

Age groups < 40years 6 16.22 30 17.34 36 17.14 0.950

40-49 10 27.03 47 27.17 57 27.14

50-59 13 35.14 53 30.64 66 31.43

≥ 60years 8 21.62 43 24.86 51 24.29

Mean ± SD 50.56 ±10.73 50.86 ±10.87

Marital status Un married 0 .00 19 10.98 19 9.05 0.035*

Married 37 100.0 154 89.02 191 90.95

Educational

Illiterate 3 8.11 35 20.23 38 18.10 0.101

Primary 12 32.43 69 39.88 81 38.57

Intermediate 9 24.32 19 10.98 28 13.33

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level Secondary 5 13.51 15 8.67 20 9.52

College 8 21.62 35 20.23 43 20.48

Occupation Employed 13 35.14 29 16.76 42 20.00 0.011*

Unemployed 24 64.86 144 83.24 168 80.00 Family

history

Absent 22 59.46 131 75.72 153 72.86 0.043*

Present 15 40.54 42 24.28 57 27.14

Smoking Yes 11 29.73 11 6.36 22 10.48 0.0001*

No 26 70.27 162 93.64 188 89.52

BMI

classification

Under weight 2 5.41 5 2.89 7 3.33

0.066 Normal weight 12 32.43 29 16.76 41 19.52

Over weight 14 37.84 64 36.99 78 37.14

Obese 9 24.32 75 43.35 84 40.00

Statistically significant association was found between gender and clinical features of rheumatoid arthritis i.e. fatigue with highest percentages occur in females patients 81% compared to 64% in males. Gender significantly associated with loss of appetite

& weight (P-vale < 0.05) higher percentages of appetite loss found in female 33%

compared to 10% male the same things regarding weight loss that higher percentages occur in female compared to male 23% vs. 2%. No statistically significant association detected between genders and other clinical characteristics.

Table (2): Clinical features of rheumatoid patients in both genders

Clinical characteristic

Gender Males

(n=37)

Females (n=173)

Total

No % No % No % P.V

Morning stiffness

Present 23 62.16 112 64.73 135 64.28 0.766

Absent 14 37.83 61 35.26 75 35.71

Fever Present 19 51.35 98 56.65 117 55.71 0.556

Absent 18 48.65 75 43.35 93 44.29

Fatigue Present 24 64.86 141 81.50 165 78.57 0.025*

Absent 13 35.14 32 18.50 45 21.43

Loss of appetite Present 4 10.81 58 33.53 62 29.52 0.006*

Absent 33 89.19 115 66.47 148 70.48

Loss of weight Present 1 2.70 40 23.12 41 19.52 0.004*

Absent 36 97.30 133 76.88 169 80.48

Flare ups** Present 20 54.05 98 56.65 118 56.19 0.773

Absent 17 45.95 75 43.35 92 43.81

* P- value is significant is less than0.05.* Flare up in last 6 months.

Tender joint in patients with rheumatoid arthritis occur more frequently in females compared to males except (fingers, hips and ankles) detected more in males, with no significant association found among them.

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Table (3): Distribution of joints involvement with genders Most

commonly pain in joints

Gender

Male Female Total

No % No % No %

Fingers 6 16.22 19 10.98 25 11.90

Wrists 3 8.11 25 14.45 28 13.33

Shoulders 5 13.51 25 14.45 30 14.29

Hips 1 2.70 0 .00 1 .48

Knees 17 45.95 88 50.87 105 50.00

Ankles 2 5.41 0 .00 2 .95

Feet 3 8.11 16 9.25 19 9.05

Total 37 100.00 173 100.00 210 100.00

2 =15.858df= 6 p= 0.015

The women with rheumatoid arthritis have higher percentages than men in class III

&IV (23%, 5% in female vs. 13% and 5% in males) respectively while 81% of males categorized in class I& II compared to 71% females.

Figure (1): Clinical Disease Activity Index CDAI in rheumatoid arthritis in both genders

Osteoporosis and sicca symptoms were the most important and frequent complications in RA patients, they associated significantly with genders with higher percentage in female compared to male 45% vs. 27%; 50% vs. 32% (P-value= 0.043, 0.042) osteoporosis and sicca symptoms respectively.

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Similarly, other complications as gastrointestinal symptoms & rheumatoid nodules reported more in females than in males but with no significant association.

Table (4): Distribution of Rheumatoid arthritis patients according to complication with gender

Complications

Gender Males

(n=37)

Females (n=173)

Total

No % No % No % P.V

GIT symptoms Yes 11 29.73 63 36.42 74 35.24 0.440

No 26 70.27 110 63.58 136 64.76

Osteoporosis Yes 10 27.03 78 45.09 88 41.90 0.043*

No 27 72.97 95 54.91 122 58.10

Rheumatoid nodules

Yes 2 5.41 15 8.67 17 8.10 0.509

No 35 94.59 158 91.33 193 91.90

SICCA symptoms**

Yes 12 32.43 88 50.87 100 47.62 0.042*

No 25 67.57 85 49.13 110 52.38

*p value is significant is less than0.05.**Sicca symptoms: dry mouth and eyes.

Discussion:

Rheumatoid arthritis is a chronic, progressive, inflammatory, autoimmune disorder that involves peripheral joints mostly small and medium size but large joints involvement such as knee joints occur. It’s a worldwide disease 0.5- 1% of population.

This study was conducted on (210) patients with RA who fulfill ACR/EULAR 2010 criteria with mean age (50.56 ± 10.73 years) for males and (50.86 ±10.87 years) for females. The present study reveals that the prevalence of rheumatoid arthritis was higher in female patients with female to male ratio 4.6:1; this was comparable to that reported in Algeria (5.9:1) [8] but was lower than what reported in the Brazilian population (8:1) (Almeida Mdo et al., 2014) [9] and in in Iraq in 2019 by Faiq et al., (7.6:1)[10] and higher than study performed in Minnesota (3:1) [11]. The differences could be due to genetic, environmental and hormonal factors that have impact on females more than males.

Concerning with smoking, highest percentages of smoking reported among male compared to femaleM. Intriago in Ecuador [12] & Patricia in California [13] agree with these findings whereas (Coffey et al 2019)who reports that smoking was more in female than males [134].

Increasing body weight is public among rheumatoid patients that associated with higher clinical disease activity index CDAI the results from present study showed that females have higher percentages of obesity than males that compatible with another studies performed by (Younis et. al., 2017) in Iraq and (Linauskas et. al., 2017) in Denmark [15, 16].

Morning stiffness detected more in female patients compared to male but statistically non-significant Forslind in 2007 in Sweden found the opposite [17]. Morning stiffness of joints is a very common complaint of patients with RA and is experienced as

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tenderness and restricted movement upon awakening lasting at least 1 hour before maximal improvement for at least 6 weeks (Mackie et al., 2012) [18].

Symptoms like weight lost, appetite lost and fatigue significantly associated with genders, they diagnosed frequently in females, Intriago 2019 [12] found the same results. Most common complication of rheumatoid arthritis is osteoporosis; people with rheumatoid arthritis are at increased risk for osteoporosis for many reasons. To begin with, the glucocorticoid medications often prescribed for the treatment of rheumatoid arthritis can trigger significant bone loss. In addition, pain and loss of joint function caused by the disease can result in inactivity, further increasing osteoporosis risk. Studies also show that bone loss in rheumatoid arthritis may occur as a direct result of the disease. The bone loss is mostly diagnosed in areas immediately surrounding the affected joints [19].

Of concern is the fact that women, a group already at increased risk for osteoporosis particularly postmenopausal women. The present studies show significant association between genders and occurrence of osteoporosis with highest percentages among females; The Aurrecoechea in 2016 agree with these findings [20].

Conclusions:

1- RA more in female than in male with ratio 4.6:1.

2- Clinical features, functional classes and complications worsen in female patients.

Recommendation:

Special attention must be given to females rheumatoid arthritis patients particularly in postmenopausal period to prevent complication and deformity of the disease; Health education regarding early diagnosis, early initiation of effective therapy and regular exercise.

References:

[1] McInnes IB, Schett G (2011) The pathogenesis of rheumatoid arthritis. N Engl J Med 365:2205–

2219. doi:10.1056 /NEJMra1004965.

[2] Atzeni, F., Masala, I. F., Bagnasco, M., Lanata, L., Mantelli, F., &Sarzi-Puttini, P. (2021).

Comparison of Efficacy of Ketoprofen and Ibuprofen in Treating Pain in Patients with Rheumatoid Arthritis: A Systematic Review and Meta-Analysis. Pain and Therapy, 1-12.

[3] Turesson C, O'Fallon WM, Crowson CS, et al. Extra-articular disease manifestations in rheumatoid arthritis: incidence trends and risk factors over 46 years. Ann Rheum Dis 2003; 62:722.

[4] Hochberg, M. C., Chang, R. W., Dwosh, I., Lindsey, S., Pincus, T., & Wolfe, F. (1992). The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis & Rheumatism: Official Journal of the American College of Rheumatology, 35(5), 498-502.

[5] Aletaha, D., Neogi, T., Silman, A. J., Funovits, J., Felson, D. T., Bingham III, C. O., ... & Hawker, G. (2010). 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis &

rheumatism, 62(9), 2569-2581.

[6] Küçükdeveci, A. A. (2020). Nonpharmacological treatment in established rheumatoid arthritis. Best Practice & Research Clinical Rheumatology, 101482.

[7] Silvagni, E., Giollo, A., Sakellariou, G., Ughi, N., D’Amico, M. E., Scirè, C. A., & Huizinga, T. W.

(2020). One year in review 2020: novelties in the treatment of rheumatoid arthritis. ClinExpRheumatol, 38(2), 181-94.

[8] Slimani S, Abbas A, Ben Ammar A, et al. (2014). Characteristics of rheumatoid arthritis in Algeria:

a multicenter study. RheumatolInt, 34, 1235–1239.

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[9] Almeida Mdo S, Almeida JV, Bertolo MB. (2014). Demographic and clinical features of patients with rheumatoid arthritis in Piaui, Brazil-evaluation of 98 patients. Rev Bras Reumatol, 54, 360–

365. Al-Salem

[10] Faiq, M. K., Kadhim, D. J., &Gorial, F. I. (2019). The Belief about Medicines among a Sample of Iraqi Patients with Rheumatoid Arthritis. Iraqi Journal of Pharmaceutical Sciences (P-ISSN: 1683- 3597, E-ISSN: 2521-3512), 28(2), 134-141.

[11] E.Myasoedova, C. S. Crowson,H. M. Kremers, T. M. Therneau, and S. E. Gabriel, “Is the incidence of rheumatoid arthritis? Results from Olmsted County, Minnesota, 1955–2007,”Arthritis

& Rheumatology, vol. 62, no. 6, pp. 1576 rising–1582, 2010.

[12] Intriago, M., Maldonado, G., Cárdenas, J., & Ríos, C. (2019). Clinical characteristics in patients with rheumatoid arthritis: differences between genders. The Scientific World Journal, 2019.

[13] Katz, P. P., Yazdany, J., Trupin, L., Schmajuk, G., Margaretten, M., Barton, J., ... &Yelin, E. H.

(2013). Sex differences in assessment of obesity in rheumatoid arthritis. Arthritis care &

research, 65(1), 62-70.

[14] Coffey, C. M., Davis, J. M., &Crowson, C. S. (2019). The impact of gender on time to rheumatoid arthritis classification: a retrospective analysis of a population-based cohort. Rheumatology international, 39(12), 2025-2030.

[15] Younis, K. R., & Al-Bustany, D. A. (2017). Prevalence of obesity in rheumatoid arthritis and its association with disease activity and latex positivity in a sample of patients in Erbil. Zanco Journal of Medical Sciences (Zanco J Med Sci), 21(2), 1726-1735.

[16] Linauskas, A., Overvad, K., Symmons, D., Johansen, M. B., Stengaard‐Pedersen, K., & de Thurah, A. (2019). Body fat percentage, waist circumference, and obesity as risk factors for rheumatoid arthritis: a Danish cohort study. Arthritis care & research, 71(6), 777-786.

[17] Forslind, K., Hafström, I., Ahlmen, M., &Svensson, B. (2007). Sex: a major predictor of remission in early rheumatoid arthritis?. Annals of the rheumatic diseases, 66(1), 46-52.

[18] Mackie, S. L., Taylor, J. C., Twigg, S., Martin, S. G., Steer, S., Worthington, J., ... & Morgan, A.

W. (2012). Relationship between area-level socio-economic deprivation and autoantibody status in patients with rheumatoid arthritis: multicentre cross-sectional study. Annals of the rheumatic diseases, 71(10), 1640-1645.

[19] Hsu, C. Y., Chen, J. F., Su, Y. J., Chen, Y. C., Lai, H. M., Yu, S. F., ... & Cheng, T. T. (2020).

Time-averaged disease activity of rheumatoid arthritis associated with long-term bone mineral density changes. Therapeutic Advances in Chronic Disease, 11, 2040622320981517.

[20] Aurrecoechea, E., Díaz, J. L., Lizuain, M. D., McGwin, G., &Calvo-Alen, J. (2017). Gender- associated comorbidities in rheumatoid arthritis and their impact on outcome: data from GENIRA. Rheumatology international, 37(4), 479-485.

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