Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis.

Objectives: Describe tofacitinib safety from an integrated analysis of randomized controlled trials (RCTs) in patients with ankylosing spondylitis (AS).

Method: Pooled data from Phase 2 (NCT01786668; 04/2013-03/2015)/Phase 3 (NCT03502616; 06/2018-08/2020) RCTs in AS patients were analyzed (3 overlapping cohorts): 16-week placebo-controlled (tofacitinib 5 mg twice daily [BID] [n = 185]; placebo [n = 187]); 48-week only-tofacitinib 5 mg BID (n = 316); 48-week all-tofacitinib (≥ 1 dose of tofacitinib 2, 5, or 10 mg BID; n = 420). Baseline 10-year atherosclerotic cardiovascular disease (ASCVD) risk was determined in patients without history of ASCVD (48-week cohorts).

Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials.

Introduction: We assessed tofacitinib efficacy and safety in ankylosing spondylitis (AS) by body mass index (BMI) category.

Methods: Data were pooled from phase 2/3 trials; analyses included patients with active AS randomized (1:1) to tofacitinib 5 mg twice daily or placebo, who were stratified by baseline BMI into < 25, ≥ 25 to < 30, and ≥ 30 kg/m categories. Efficacy was assessed at week 12 and safety to week 16.

The rheumatology workforce in the Arab countries: current status, challenges, opportunities, and future needs from an ArLAR cross-sectional survey.

The Arab League of Associations for Rheumatology (ArLAR) Research Group (ARCH) conducted this study to investigate the number of current practicing rheumatologists in the Arab countries, to estimate the projected number of rheumatologists in 10 years, and to evaluate the current workload, practice profile, consultation waiting time, and geographical mobilities of these rheumatologists. This cross-sectional survey study was conducted in 16 Arab countries in two parts. The first survey was addressed nominally to national societies to estimate the current and projected workforce.

What is the best referral strategy for axial spondyloarthritis? A prospective multicenter study in patients with suspicious chronic low back pain.

Objective: To assess the value of referral strategies for axial spondyloarthritis (axSpA) in patients with suspicious chronic inflammatory low back pain (LBP), to estimate the value of inflammatory back pain (IBP) for referral, and to identify the predictive factors of the final diagnosis of axSpA in Middle Eastern Arab countries.

Methods: The study was multicentric, prospective, and conducted in LBP first-line clinics (rheumatology, internal, family medicine, orthopedic surgery, neurosurgery, and neurology). Consecutive adult patients aged under 45years were included in case of LBP suspicious of inflammatory nature according to the first-line physician.

Assessing the Burden of Osteoarthritis in Africa and the Middle East: A Rapid Evidence Assessment.

Introduction/objectives: This rapid evidence assessment (REA) was conducted to assess the burden of weight-bearing joint osteoarthritis in the developing countries of Africa and the Middle East.

Methods: Our REA methodology used a standardized search strategy to identify observational studies, published between January 1, 2010, and April 23, 2020, reporting on outcomes pertaining to the epidemiology and humanistic or economic burden of weight-bearing osteoarthritis. Relevant data from the included studies were used for qualitative analysis.

Treat-to-Target in Axial Spondyloarthritis: Are we there yet?

The Treat-to-target (T2T) strategy in axial spondyloarthritis (axSpA) stipulates that treatment should reach a predefined target and if not reached, intensification of therapy is implemented aiming at best future outcomes. Clinical remission was recommended by the 2017 international task force as the treatment target using Ankylosing spondylitis disease activity score (ASDAS) inactive disease, or alternatively, ASDAS low disease activity. The results of a recent T2T trial in axSpA were negative for the chosen primary outcome.

Instrument selection for the ASAS core outcome set for axial spondyloarthritis.

Objectives: To define the instruments for the Assessment of SpondyloArthritis international Society-Outcomes Measures in Rheumatology (ASAS-OMERACT) core domain set for axial spondyloarthritis (axSpA).

Methods: An international working group representing key stakeholders selected the core outcome instruments following a predefined process: (1) identifying candidate instruments using a systematic literature review; (2) reducing the list of candidate instruments by the working group, (3) assessing the instruments' psychometric properties following OMERACT filter 2.2, (4) selection of the core instruments by the working group and (5) voting and endorsement by ASAS.

What is peripheral spondyloarthritis? Identifying proportion, phenotype and burden in post hoc analysis of the ASAS-PerSpA study.

Background: Little is known about the prevalence, phenotype, and burden of peripheral spondyloarthritis (pSpA). The objective of the study is to compare the phenotype and burden of disease of pure pSpA to that of pure psoriatic arthritis (PsA), pure axial SpA (axSpA), and combined forms of SpA.

Methods: This is a post hoc analysis of 4,185 patients from the cross-sectional ASAS-Peripheral involvement in SpA (PerSpA) study.

Axial spondyloarthritis.

Axial spondyloarthritis (axSpA) encompasses both radiographic and non-radiographic axSpA. It is a chronic inflammatory disease with a predilection for involving the axial skeleton. The most common presenting symptoms are chronic back pain and spinal stiffness but peripheral and extra-musculoskeletal manifestations occur also frequently.

Development of an environmental contextual factor item set relevant to global functioning and health in patients with axial spondyloarthritis.

Objective: To describe the development of an Environmental contextual factors (EF) Item Set (EFIS) accompanying the disease specific Assessment of SpondyloArthritis international Society Health Index (ASAS HI).

Method: First, a candidate item pool was developed by linking items from existing questionnaires to 13 EF previously selected for the International Classification of Functioning, Disability and Health (ICF) /ASAS Core Set. Second, using data from two international surveys, which contained the EF item pool as well as the items from the ASAS HI, the number of EF items was reduced based on the correlation between the item and the ASAS HI sum score combined with expert opinion.

Development of an Educational Video for Self-Assessment of Patients with RA: Steps, Challenges, and Responses.

Objectives: The primary objective was to develop an educational video to teach patients with rheumatoid arthritis (RA) self-assessment of their disease activity. Secondary objectives were to validate the video, identify the challenges in producing it, and the responses to these challenges.

Methods: Rheumatologists from 7 Middle Eastern Arab countries (MEAC) discussed unmet needs in the education of patients with RA.

Root joint involvement in spondyloarthritis: a post hoc analysis from the international ASAS-PerSpA study.

Objectives: The primary objective was to compare the clinical characteristics of SpA patients with and without root joint disease (RJD+ and RJD-). The secondary objectives were to compare the prevalence of RJD across various SpA subtypes and in different world regions, and to compare the SpA axial severity and SpA burden between RJD+ and RJD-.

Methods: This is a post hoc analysis of the Assessment of Spondyloarthritis International Society PerSpA study (PERipheral involvement in SpondyloArthritis), which included 4465 patients with SpA [axial (axSpA), peripheral (pSpA), PsA, IBD, reactive and juvenile] according to the rheumatologist's diagnosis.

Does smoking affect level of seropositivity in RA? A post-HOC global and inter-country analysis of COMORA cohort.

To study the association of smoking status and the level of seropositivity in RA patients from COMORA Cohort. A post hoc analysis of COMORA database included 3439 RA patients was performed. Current smokers or recently quitted (< 3 years) were initially compared to those who never smoked or stopped > 3 years (Group I vs.

Perceptions of patients with rheumatoid arthritis about self-assessment of disease activity after watching an educational video: a qualitative pilot study from the AUTO-DAS in Middle Eastern Arab countries project.

To evaluate the perceptions of patients with rheumatoid arthritis (RA) about self-assessment of their disease activity after watching an educational video. Consecutive patients with RA consulting their rheumatologist in six Middle Eastern Countries were invited to watch an educational video developed to teach self-assessment using Disease Activity Score (DAS-28). Then, a rheumatology nurse conducted a semi-structured interview and collected the patients' perception about the understanding of the video, feasibility, capability and confidence in performing self-assessment using Likert-type items.

Prevalence and distribution of peripheral musculoskeletal manifestations in spondyloarthritis including psoriatic arthritis: results of the worldwide, cross-sectional ASAS-PerSpA study.

Objectives: To characterise peripheral musculoskeletal involvement in patients with spondyloarthritis (SpA) including psoriatic arthritis (PsA), across the world.

Methods: Cross-sectional study with 24 participating countries. Patients with a diagnosis of axial SpA (axSpA), peripheral SpA (pSpA) or PsA according to their rheumatologist were included.

Correction to: Recommendations for the management of rheumatoid arthritis in the Eastern Mediterranean region: an adolopment of the 2015 American College of Rheumatology guidelines.

In the original version of this article the first name of the co-author was incorrectly spelled as "Khaled A. Alnaqbi". The correct spelling should have been "Khalid A.

Recommendations for the management of rheumatoid arthritis in the Eastern Mediterranean region: an adolopment of the 2015 American College of Rheumatology guidelines.

Clinical practice guidelines can assist rheumatologists in the proper prescription of newer treatment for rheumatoid arthritis (RA). The objective of this paper is to report on the recommendations for the management of patients with RA in the Eastern Mediterranean region. We adapted the 2015 American College of Rheumatology guidelines in two separate waves.

Measurement properties of the ASAS Health Index: results of a global study in patients with axial and peripheral spondyloarthritis.

Objectives: To evaluate construct validity, interpretability, reliability and responsiveness as well as determination of cut-off points for good and poor health within the original English version and the 18 translations of the disease-specific Assessment of Spondyloarthritis international Society Health Index (ASAS HI) in 23 countries worldwide in patients with spondyloarthritis (SpA).

Methods: A representative sample of patients with SpA fulfilling the ASAS classification criteria for axial (axSpA) or peripheral SpA was used. The construct validity of the ASAS HI was tested using Spearman correlation with several standard health outcomes for axSpA.

Tofacitinib 5 mg Twice Daily in Patients with Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs: A Comprehensive Review of Phase 3 Efficacy and Safety.

Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We performed a comprehensive review of phase 3 studies of tofacitinib 5 mg twice daily (BID) (approved dose in many countries) in patients with moderate to severe RA and inadequate response to prior disease-modifying antirheumatic drugs.

Methods: A search of PubMed and ClinicalTrials.

Dosing down and then discontinuing biologic therapy in rheumatoid arthritis: a review of the literature.

Aim: To review the published studies that dose down and then discontinue biologic therapy in patients with rheumatoid arthritis (RA), particularly concerning the criteria for such dosing and the impact on clinical outcomes.

Methods: Published studies conducted in patients with RA that sequentially decreased the dose and then discontinued therapy were included if one or more of the following biologic disease modifying antirheumatic drugs (bDMARDs) was evaluated: abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab or tocilizumab.

Results: Five studies qualified for inclusion.