الفهرس 
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Abstract
During the past decade, the well-known disease called Ankylosing Spondylitis has come to be considered as a subset of the broader entity referred as axial spondyloarthritis (axSpA), which also includes non-radiographic axSpA. The need of this new classification was aimed to improve the sensitivity for an early diagnosis, to reduce diagnostic delay, and to allow an early treatment. Although there is improvement in the recognition, the management of patients, and the treatment strategies of axSpA, unmet needs persist, there is still a substantial gap of 5-8 years between the onset of symptoms and the diagnosis of axSpA. This study is intended to enhance awareness and understanding of Axial Spondyloarthritis and to identify and discuss the current unmet needs in axSpA. Multiple defects are still unfulfilled for axial SpA patients those defects include delayed diagnosis specially for female, failure to achieve treatment target, pain, impaired quality of life and associated comorbidities.
Up to the best of our knowledge this is the first study to highlight unmet needs for axial Spondyloarthritis patients in Egypt in general and in upper Egypt in particular.
This was an Observation cross sectional hospital-based study at Sohag University hospital, Rheumatology outpatient clinic. The study included 100 patients diagnosed as Ankylosing Spondylitis.
Summary of our results:
• The vast majority of cases were males (82%) while only 18 cases (18%) were females.
• The mean age of the study population was 33.2±9.4 years, with a very wide range from 18-57 years. However, the only minority of cases aged 50 years or more.
• Around three fifths of the cases were married, and more females were married compared to males, but with non-significant difference.
• The mean disease duration of the cases was around 10 years, with no significant difference between males and females. Regarding the mean duration between the onset of symptoms and the start of treatment of the study cases was around 5.8 years among males and 7 years among females. Although this was higher among females compared to males, the difference was non-significant.
• All of the cases (100%) had inflammatory low back pain. Regarding morning stiffness and limited spinal movement, they were found in around three quarters of the cases, with non-significant differences. As regards the deformities, around half of the cases had deformities, the most frequent was inability to extend the neck (28%), followed by loss of lumbar lordosis (12%), then exaggerated thoracic kyphosis and lastly compensatory hip flexion (2%); with no significant differences between males and females. Peripheral joint affection and enthesitis were seen in 62% and 70% of the cases; respectively.
• There are some differences in the prevalence of certain clinical manifestations between males and females. females have a higher percentage of ocular and respiratory manifestations compared to males, although these differences are not statistically significant. However, females have a significantly higher percentage of cardiac involvement compared to males (p=0.030). Similarly, there are significant differences in the prevalence of fatigue and respiratory diseases between males and females (p=0.050 and p=0.026, respectively). However, there are no statistically significant differences in the prevalence of other clinical manifestations, such as GIT disorders, renal involvement, weight loss, depression, diabetes mellitus, and hypertension.
• There are some differences in the prevalence of certain X-ray and MRI findings between males and females. females have a higher percentage of erosions and ankylosis in the sacro-iliac joints compared to males, although these differences are not statistically significant according to the p-value. Similarly, females have a higher percentage of sclerosis in the MRI sacro-iliac joints compared to males, but this difference is also not statistically significant.
• There are some differences in the mean values of the blood parameters between males and females. males have a higher mean Hb level compared to females, although this difference is not statistically significant. Similarly, there are no statistically significant differences in the mean MCV, WBCs, PLT, ESR, and CRP levels between males and females.
• There are no significant differences in the prevalence of rheumatoid factor, ANA, HLA-B27, and HCV between males and females. The only significant difference is in the percentage of cases with a negative ANA, where males have a lower percentage of negative ANA compared to females, although this difference is marginally significant (p=0.062).
• There are some differences in disease activity between males and females, with females having a higher percentage of very high disease activity and males having a higher percentage of moderate disease activity. However, these differences are not statistically significant. Additionally, the mean and standard deviation of the ASDAS (Ankylosing Spondylitis Disease Activity Score) is similar between males and females, and the difference is also not statistically significant.
• There are some differences in disease activity and functional status between males and females. Females have a lower percentage of inactive BASDAI activity compared to males, and this difference is statistically significant. The mean BASDAI, BASFI, and KATZ ADL scores are also higher for females compared to males, but these differences are not statistically significant, except for the BASFI score which is significant (p=0.056).
• There are some differences in treatment use between males and females, with females being more likely to receive rehabilitation and physiotherapy and biological/tsDMARD treatments, while males are more likely to receive non-DMARD treatments. However, some of these differences are not statistically significant, there are no significant differences between males and females in regard to the regularity of treatment use.
• There are no significant differences in the degree of pain between males and females, according to the mean VAS scores and the percentage of participants reporting mild or moderate pain. The T-test value for the mean VAS scores is marginally significant (p=0.149), suggesting that there may be some differences in pain intensity between males and females, but this difference is not statistically significant according to the p-value.
• Around half of the male cases were smokers (51.2%) compared to zero among females, with a significant difference (p value = 0.006)
• Among the 9 female cases included in the study, 2 were pregnant at time of the study.
• Males were significantly taller than females, with a mean length of males of 171.4 cm, compared to only 162.4 cm among females, p value <0.001. As weight of the both groups were comparable, the BMI showed significantly higher mean among females (28.6) compared to males (25.44); p value = 0.030.
• The vast majority of the female cases were either overweight (55.6%) or obese (33.3%), which is significantly higher compared to males (with overweight and obese ratios of 58.5% and 2.4; respectively).
Conclusions
Female patients with axSpA experience significant disease burden owing to delayed diagnosis and differences in clinical manifestations compared with male patients.
Limitations
• The study was conducted in a single hospital and may not be representative of the entire population of Egypt or other regions of the country.
• The small sample size of only 100 patients.
• The study was conducted in a cross-sectional design, which limits the ability to establish causality or examine changes in disease activity and functional status over time.
• The study did not include a control group, making it difficult to compare the results to the general population or other groups.
• The study did not assess the impact of socioeconomic status or education level on disease activity and functional status, which may be important factors to consider in developing interventions to address the unmet needs of axSpA patients in Egypt.
Recommendations
• We propose three priority areas for change: the identification of ways to increase awareness of disease occurrence among HCPs, improve understanding of gender differences in disease manifestation and outcome measures, and conduct gender-stratified clinical trials.
• In our opinion, addressing these research needs would generate important evidence to help ensure timely diagnosis and appropriate disease management for women living with axSpA.
• Greater understanding of biologic treatment during pregnancy are needed for improved quality of life in female patients with axSpA.
• Further studies into sex and gender differences in the manifestation of axSpA may result in less under-diagnosis and misdiagnosis, more optimal treatment strategies, and decreased overall disease burden in female axSpA patients.