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BACKGROUND: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. AIM: To report efficacy and infection rates in patients receiving tofacitinib induction treatment, by baseline corticosteroid status. METHODS: We evaluated efficacy and safety data from OCTAVE Induction 1&2 in patients with moderately-to-severely active ulcerative colitis who received tofacitinib 10 mg twice daily or placebo for 8 weeks, based on induction baseline oral corticosteroid use (Corticosteroid-Yes/No) and dose (< 20/ ≥ 20 mg/day). Infections of interest included serious infections, herpes zoster (HZ), and adjudicated opportunistic infections (OIs). RESULTS: At OCTAVE Induction 1&2 baseline, 478/1092 (43.8%) patients were receiving corticosteroids. Tofacitinib demonstrated significant induction efficacy versus placebo for both Corticosteroid-Yes and Corticosteroid-No. With adjustment for prior tumor necrosis factor inhibitor and immunosuppressant failure, there were no statistically significant differences in remission and clinical response rates for Corticosteroid-Yes versus Corticosteroid-No. Among tofacitinib-treated patients, HZ and OIs occurred more frequently in Corticosteroid-Yes versus Corticosteroid-No, regardless of dose (< 20 mg vs. ≥ 20 mg). Infection incidence rates (regardless of severity/seriousness) during tofacitinib induction were generally similar regardless of baseline corticosteroid use. The proportion of tofacitinib-treated patients with HZ was 0.2% for Corticosteroid-No versus 1.1% for Corticosteroid-Yes < 20 mg and 1.0% for Corticosteroid-Yes ≥ 20 mg. Two out of three patients had HZ OIs. CONCLUSIONS: Tofacitinib induction efficacy (clinical response and remission) was similar in baseline corticosteroid subgroups. Infections of interest were rare; HZ and OIs occurred more frequently among those receiving tofacitinib and corticosteroids versus those receiving tofacitinib without corticosteroids. TRIAL REGISTRATION: http://www. CLINICALTRIALS: gov (NCT01465763[21/10/2011]; NCT01458951[21/10/2011]).
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Colite Ulcerativa , Herpes Zoster , Humanos , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/induzido quimicamente , Inibidores de Proteínas Quinases/efeitos adversos , Pirróis/efeitos adversos , Herpes Zoster/induzido quimicamente , Herpes Zoster/epidemiologia , Corticosteroides/efeitos adversos , Resultado do Tratamento , Indução de RemissãoRESUMO
Alopecia areata (AA) is an autoimmune disorder that manifests as nonscarring hair loss and imposes a substantial disease burden. The current study, using an e-claims database, assesses the disease burden, comorbidities, treatment patterns, specialties involved in the diagnosis of AA, healthcare resource utilization (HCRU), and associated costs in privately insured patients with AA in Dubai, United Arab Emirates. The retrospective longitudinal secondary study was conducted using Dubai Real-World Database e-claims data during 01 January 2014 to 30 June 2022. Patients with at least one diagnosis claim of AA during the index period (01 January 2015-30 June 2021) with continuous enrollment (one or more AA/non-AA claim in the post-index period) were included in the analysis. The patients were stratified into subcohorts based on diagnosis code and treatment patterns, as mild, moderate-to-severe, and others. Demographics, comorbidities, treatment patterns, specialists visited, and HCRU were assessed. The study included 11 851 patients with AA (mean age: mild: 37 years; moderate-to-severe: 36 years), with a male predominance (mild: 77.6%; moderate-to-severe: 60.8%). The most prevalent comorbidities in the moderate-to-severe AA subcohort were autoimmune and T-helper 2-mediated immune disorders, including contact dermatitis and eczema (62.1%), atopic dermatitis (36.1%), and asthma (36.1%). Most patients consulted dermatologists for treatment advice (mild AA: 87.4%; moderate-to-severe AA: 47.7%) and, notably, within 1 day of AA diagnosis. Topical steroids were frequently prescribed across cohorts, regardless of disease severity. Analysis of comorbidities among patients with AA indicated an additional HCRU burden among these subsets of patients. The median disease-specific HCRU cost was higher for psychological comorbidities versus autoimmune and T-helper 2-mediated immune disorders (US $224.99 vs US $103.70). There is a substantial disease and economic burden in patients with AA and associated comorbid conditions; therefore, investing in novel therapies that target the underlying autoimmune pathway may address the gap in effective management of AA.
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Vitiligo is a common chronic autoimmune disorder characterized by skin and hair depigmentation that affects 0.5%-2.0% of the global population. Vitiligo is associated with diminished quality of life (QoL) and psychosocial burden. The burden of vitiligo may vary based on skin tone and cultural differences as well as geographical variations in disease awareness, societal stigma, healthcare systems and treatment options. Data on the burden and management of vitiligo in Africa, the Middle East and Latin America are scarce. Literature searches using terms covering vitiligo in Africa, the Middle East and Latin America were conducted using PubMed to identify relevant publications that focused on disease prevalence and burden, QoL and psychosocial impact and disease management between 2011 and 2021. Most of the reviewed studies were conducted in the Middle East, and most Latin American studies were from Brazil. Most studies involved small patient numbers and may not be generalizable. Reported prevalence of vitiligo ranged from 0.18% to 5.3% in Africa and the Middle East, and from 0.04% to 0.57% in Latin America. In several studies, prevalence was higher among female participants. Generally, non-segmental vitiligo was the dominant clinical variant identified and the age at onset varied widely across studies. Common comorbidities include autoimmune diseases such as Hashimoto's thyroiditis, alopecia areata and diabetes. Few treatment guidelines exist in these regions, with the exceptions of guidelines published by the Brazilian and Argentinian Societies of Dermatology. There is a clear unmet need for large epidemiological studies with uniform methodology to accurately ascertain the true prevalence of vitiligo in Africa, the Middle East and Latin America. Additional data on vitiligo burden and management in Africa and Latin America are also needed, along with local disease management guidelines that consider genetic variation, psychosocial burden and socioeconomic diversity in all 3 regions.
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BACKGROUND: Alopecia areata (AA) is an autoimmune disease characterized by non-scarring hair loss in adults and children. Clinical manifestations range from hair loss in small, well-circumscribed patches to total hair loss on the scalp or any other hair-bearing areas. Although the exact pathogenesis of AA is not fully understood, it is thought that loss of immune privilege caused by immunological dysregulation of the hair follicle is key. Genetic susceptibility also plays a role. Response to currently available treatments is widely variable, causing patient dissatisfaction and creating an unmet need. AA is frequently associated with multiple comorbidities, further affecting patient quality of life. AIMS AND FINDINGS: AA causes a significant burden on dermatologists and healthcare systems in the Middle East and Africa. There is a lack of data registries, local consensus, and treatment guidelines in the region. Limited public awareness, availability of treatments, and patient support need to be addressed to improve disease management in the region. A literature review was conducted to identify relevant publications and highlight regional data on prevalence rates, diagnosis, quality of life, treatment modalities, and unmet needs for AA in the Middle East and Africa.
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INTRODUCTION: Atopic dermatitis (AD) data are scarce in Dubai [United Arab Emirates (UAE)]. Therefore, this study aimed at understanding real-world healthcare resource utilization (HCRU) and related costs, specialties, treatment landscape, consultation-based prevalence and incidence, and patient characteristics. METHODS: This retrospective, longitudinal, insurance e-claims (Dubai Private Insurance-insured expatriates) database studied AD in Dubai between 1 January 2014 and 31 March 2020. Two cohorts of patients based on treatment status as the eligibility criteria were selected from 442,956 patients with at least two AD diagnosis claims: treated AD [mild to moderate (10,134 patients) and moderate to severe (3515 patients)] and untreated or on drugs not included in the treated AD cohort (10,806 patients). RESULTS: Across treated AD (mild to moderate and moderate to severe) and untreated AD cohorts, mean age was ~ 29 years; the majority were from dermatology (65-44%) and pediatrics (29-32%) specialty. Key HCRU cost contributors were hospitalizations and outpatient visits in both the treated AD groups. Mean annual disease-specific HCRU cost per patient was highest for the moderate-to-severe treated (531.5 USD) cohort, followed by the mild-to-moderate treated (378.4 USD) cohort, and lowest for the untreated (144.0 USD) cohort; patients with AD with any infection, asthma, or allergic rhinitis showed a similar trend. However, AD-diagnosed patients with Staphylococcus infection had the highest mean HCRU cost among the mild-to-moderate treated AD cohort, followed by the moderate-to-severe treated AD cohort. CONCLUSION: This study indicated AD to be a common skin disease with a prevalence rate of 4-5% in Dubai (UAE), with the majority of patients (about 90%) being treated by specialists. However, there is a significant underuse of newer innovative therapies (including biologics). Also, disease severity (moderate-to-severe AD) was associated with high direct medical cost, which could be controlled by early intervention. Furthermore, AD treatment choice could focus on major direct HCRU cost contributors such as hospitalizations, comorbid conditions, and infections.
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Introduction: Atopic dermatitis (AD) data are scarce in Dubai [United Arab Emirates (UAE)]. Therefore, this study aimed at understanding real-world healthcare resource utilization (HCRU) and related costs, specialties, treatment landscape, consultation-based prevalence and incidence, and patient characteristics. Methods: This retrospective, longitudinal, insurance e-claims (Dubai Private Insurance-insured expatriates) database studied AD in Dubai between 1 January 2014 and 31 March 2020. Two cohorts of patients based on treatment status as the eligibility criteria were selected from 442,956 patients with at least two AD diagnosis claims: treated AD [mild to moderate (10,134 patients) and moderate to severe (3515 patients)] and untreated or on drugs not included in the treated AD cohort (10,806 patients). Results: Across treated AD (mild to moderate and moderate to severe) and untreated AD cohorts, mean age was ~ 29 years; the majority were from dermatology (65-44%) and pediatrics (29-32%) specialty. Key HCRU cost contributors were hospitalizations and outpatient visits in both the treated AD groups. Mean annual disease-specific HCRU cost per patient was highest for the moderate-to-severe treated (531.5 USD) cohort, followed by the mild-to-moderate treated (378.4 USD) cohort, and lowest for the untreated (144.0 USD) cohort; patients with AD with any infection, asthma, or allergic rhinitis showed a similar trend. However, AD-diagnosed patients with Staphylococcus infection had the highest mean HCRU cost among the mild-to-moderate treated AD cohort, followed by the moderate-to-severe treated AD cohort. Conclusion: This study indicated AD to be a common skin disease with a prevalence rate of 4-5% in Dubai (UAE), with the majority of patients (about 90%) being treated by specialists. However, there is a significant underuse of newer innovative therapies (including biologics). Also, disease severity (moderate-to-severe AD) was associated with high direct medical cost, which could be controlled by early intervention. Furthermore, AD treatment choice could focus on major direct HCRU cost contributors such as hospitalizations, comorbid conditions, and infections. Supplementary Information: The online version contains supplementary material available at 10.1007/s13555-022-00769-z.
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Estimates of the global prevalence of rheumatoid arthritis (RA) range from 0.24 to 1%, but vary considerably around the globe. A variation in RA prevalence is also expected across Africa and the Middle East, due to ethnic, climate, and socioeconomic differences. To assess the prevalence of RA in Africa and the Middle East, we searched Medline (via PubMed) and databases of major rheumatology conferences. Seventeen journal articles and 0 abstracts met the inclusion criteria. Estimated prevalence ranged from 0.06 to 3.4%. Most studies reported values near or below 0.25%. Consistent with data from other regions, RA was more prevalent among urban than rural populations, and among women than men. The women:men prevalence ratio ranged from 1.3:1 to 12.5:1, which suggests notable differences from the global average of 2:1. Relative increases in prevalence were observed in North Africa and the Middle East (13% since 1990) and Western Sub-Saharan Africa (14%), whereas rates in Eastern, Central, and Southern Sub-Saharan Africa show decreases (4-12%). Low disease awareness, delays to visit rheumatologists, and socioeconomic factors appear to hinder early diagnosis and aggressive treatment. Few countries have developed RA-specific treatment guidelines, and many physicians and patients face limited access to even basic treatments. An improved understanding of the epidemiology and management of RA, and the related socioeconomic consequences is necessary, so that targeted attempts can be made to encourage early diagnosis and treatment.
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PURPOSE: Dermatologists practicing in African and Middle Eastern countries face numerous challenges when managing patients with plaque psoriasis, especially those with disease in a difficult-to-treat anatomic area or those who are a pediatric, geriatric, or pregnant patient. The publication of comprehensive, up-to-date, region-specific clinical guidelines may help to address some of these challenges and improve outcomes. We conducted a literature review to identify recent guidelines and other publications describing patients with plaque psoriasis in Africa and the Middle East. PATIENTS AND METHODS: An online literature search of the PubMed database was conducted to identify publications reporting clinical guidelines and research studies on plaque psoriasis. The search included all articles published from January 2008 to March 2020 inclusive. The titles and abstracts of all search results were screened by a reader to identify those that described patients in Africa or the Middle East. RESULTS: A total of 145 publications were identified by the literature search and screened by a reader. There were 10 publications that described patients in Africa or the Middle East: 4 research articles, 3 reviews, 2 guidelines, and 1 case study. The 2010 guidelines from South Africa made recommendations for treating plaque psoriasis of varying severity, although without specific recommendations for difficult-to-treat anatomic areas or pediatric, geriatric, or pregnant patients. The 2014 guideline on biologics from Saudi Arabia included recommendations for the use of these agents in patients with plaque psoriasis, including difficult-to-treat anatomic areas and pediatric patients (TNF inhibitors only), but provided no recommendations for pregnant or geriatric patients. CONCLUSION: There is an urgent unmet need for comprehensive clinical guidelines on the management of patients with plaque psoriasis in Africa and the Middle East. Region-specific studies on the epidemiology, burden of disease, and the safety and effectiveness of newer pharmacotherapies are needed to support the development of such guidelines.
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The management of axial spondyloarthritis (axSpA) is challenging worldwide, and the particular challenges shared by North Africa and the Middle East are mainly related to early diagnosis and standardized management. We believe there are several reasons for these challenges, including: (a) limited awareness of the disease manifestations and prevalence in the region among physicians; (b) the concept of nonradiographic axSpA, while accepted with some difficulty by the rheumatology community, may not be well understood by the referring primary care physicians; (c) access to, and training in magnetic resonance imaging varies greatly between countries in the North Africa and Middle East region, and this may have a large impact on early diagnosis; (d) country-specific treatment guidelines are unavailable; and (e) economic and cultural factors influence patients' attempts to seek and continue treatment. In this review, we will discuss the prevalence of axSpA in North Africa and the Middle East, as well as the challenges to diagnose and treat patients in this region. As rheumatologists practicing in North Africa and the Middle East, we also provide suggestions to assist physicians, other healthcare professionals, and researchers in facilitating early, accurate diagnosis and treatment of axSpA.
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Padrões de Prática Médica , Reumatologistas , Reumatologia , Espondilartrite/terapia , África do Norte/epidemiologia , Diagnóstico Precoce , Disparidades em Assistência à Saúde , Humanos , Imageamento por Ressonância Magnética , Oriente Médio/epidemiologia , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/normas , Valor Preditivo dos Testes , Prevalência , Reumatologistas/normas , Reumatologia/normas , Espondilartrite/diagnóstico por imagem , Espondilartrite/epidemiologia , Resultado do TratamentoRESUMO
BACKGROUND: Early diagnosis and therapeutic management of inflammatory arthritis (IA) is crucial for minimizing disease progression and improving outcomes. We recently developed the New Early Arthritis Referral Criteria to help improve the detection of suspected early IA via musculoskeletal (MSK) examination. The present study aimed to evaluate the agreement between rheumatologists and primary care physicians (PCPs) trained by rheumatologists in detecting IA when applying the standardized MSK examination techniques used to develop this criteria in a real-world setting in Jeddah, Saudi Arabia. METHODS: This quasi-experimental study was conducted in 4 primary health centers and involved 30 PCPs and 3 rheumatologists. All PCPs were trained by rheumatologists to apply the standardized MSK examination techniques used to develop the New Early Arthritis Referral Criteria. Patients were eligible if they were >18 years of age and presented with small-joint pain that persisted for >6 weeks. Patients were excluded if they had prior diagnosis of osteoarthritis, hand fractures, or rheumatic disease associated with IA. All patients were examined separately by a PCP and a rheumatologist, with the findings compared via kappa statistics and the rheumatologist's findings considered the "gold standard". RESULTS: Data from 202 of the 203 enrolled patients were analyzed. There was fair-to-moderate agreement between PCPs and rheumatologists when assessing swelling of the small joints and wrist of the right side (range of kappa: 0.14-0.41) and low-to-moderate agreement in similar examinations of the left side (range of kappa: 0.04-0.42). Assessments of joint tenderness showed fair-to-moderate agreement for both the right side (range of kappa: 0.22-0.47) and left side (range of kappa: 0.24-0.45). P-values were significant for virtually all comparisons. CONCLUSION: MSK examinations by PCPs showed a promising extent of agreement in detecting IA with those by rheumatologists following training. Refinement of the standardized training process could further improve accuracy and help PCPs to confidently identify cases of early IA, thus allowing earlier intervention than is typical in this setting.
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Atopic dermatitis (AD) is a common inflammatory skin disease characterized by intensely pruritic lesions. The prevalence of atopic dermatitis is increasing in developing regions, including Africa and the Middle East. However, these regions are underrepresented in the dermatology literature, and a better understanding of the growing burden of atopic dermatitis in Africa and the Middle East is necessary. Herein, we summarize current knowledge on atopic dermatitis epidemiology, disease burden, and treatment options in Africa and the Middle East, highlighting the unmet needs of patients in these regions. With these needs in mind, we provide clinical recommendations for appropriate management of atopic dermatitis in Africa and the Middle East. FUNDING: Pfizer Inc. Plain language summary available for this article.