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Hanan Al Rayes,1 Norah AlOudah,1 Roaa Alsolaimani,2,3 Abdulrahman Alharthi,4 Mohammed Attar,4 Hassan Daghasi,4 Abdurahman Albeity,2 Afnan M Afifi,2 Abdulelah AlQahtani,1 Alya Alkaff,5 Sultan M Alkhamesi,3 Basant Elnady4,6 1Department of Rheumatology, Prince Sultan Military Medical City, Riyadh, Saudi Arabia; 2Department of Medicine, King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia; 3Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia; 4Department of Rheumatology, Al Hada Armed Forces Hospital, Taif, Saudi Arabia; 5Obstetrics and Gynecology Department, King Faisal Specialist Hospital, and Research Center, Jeddah, Saudi Arabia; 6Rheumatology and Rehabilitation Department, Faculty of Medicine, Benha University, Benha, EgyptCorrespondence: Basant Elnady, Tel +966562387723, Email basantelnady@gmail.comObjective: The current study aimed to determine the pregnancy outcomes complications in patients with SLE and its association with clinical, laboratory variables, disease activity, and medication use in the Saudi population, as well as pregnancy effect on disease activity.Methods: A multicenter study included pregnant female patients with Systemic Lupus Erythematosus (SLE) from three tertiary centers in Saudi Arabia. The demographics, clinical, and laboratory variables, SLE disease activity index (SLEDAI), medication before, during, and after pregnancy, planned pregnancy, pregnancy-related outcomes, and complications in comparison to age-matched healthy female controls were noted.Results: A total of 66 pregnant patients with SLE and 93 healthy age-matched pregnant controls were included in the study. A total of 77.3% had SLEDAI-2K ≤ 4 before conception, and 84.85% of pregnancies were planned. Age of conception, cesarean section, miscarriage, and low birth weight were statistically significant (p < 0.05) higher in SLE patients than in healthy controls. Among all clinical and laboratory variables, SLEDAI-2K > 4 and active lupus nephritis during pregnancy were statistically associated with adverse outcomes (p < 0.05), history of lupus nephritis was not associated with statistically adverse pregnancy outcomes. Higher SLEDAI-2K > 4 was an independent risk at least 4.87 times higher association with adverse pregnancy outcomes. (p < 0.05).Conclusion: SLE is intricately connected with unfavorable pregnancy outcomes. The preconception of high disease activity stands as a pivotal risk factor for adverse outcomes. Despite the disease remission and meticulous planning, SLE patients frequently grapple with disease exacerbations during pregnancy, culminating in unexpected and unfavorable pregnancy-related outcomes. This underscores the intricate and multifaceted nature of managing SLE during gestation.Keywords: systemic lupus erythematosus, pregnancy, disease activity

David Callanan,1 Rahul N Khurana,2 Raj K Maturi,3,4 Sunil Patel,5 Charles C Wykoff,6 David Eichenbaum,7,8 Arshad M Khanani,9,10 Tarek Hassan,11 Hanh Badger,12 Shraddha Mehta,12 Grace Le,12 Mayssa Attar,13 Jennifer Seal,13 Xiao-Yan Li12,14 1Texas Retina Associates, Arlington, TX, USA; 2Northern California Retina Vitreous Associates, Mountain View, CA, USA; 3Midwest Eye Institute, Indianapolis, IN, USA; 4Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USA; 5West Texas Retina, Abilene, TX, USA; 6Retina Consultants of Houston, Retina Consultants of America, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA; 7Retina Vitreous Associates of Florida, St. Petersburg, FL, USA; 8Morsani College of Medicine, University of South Florida, Tampa, FL, USA; 9Sierra Eye Associates, Reno, NV, USA; 10University of Nevada, Reno School of Medicine, Reno, NV, USA; 11Associated Retinal Consultants, Royal Oak, MI, USA; 12Allergan plc, Irvine, CA, USA, at the time of this work; 13Allergan, an AbbVie company, Irvine, CA, USA; 14VivaVision Biotech, Inc, Shanghai, People’s Republic of ChinaCorrespondence: David Callanan, Texas Retina Associates, 801 West Randol Mill Road, Suite 101, Arlington, TX, USA, 76012, Tel +1 817-261-9625, Fax +1 817-261-9586, Email dcallanan@gmail.comPurpose: To evaluate the impact of modifying the abicipar pegol (abicipar) manufacturing process on the safety and treatment effect of abicipar in patients with neovascular age-related macular degeneration (nAMD).Methods: A new process for manufacturing abicipar was developed to reduce host cell impurities. In a prospective, Phase 2, multicenter, open-label, 28-week clinical trial, patients (n=123) with active nAMD received intravitreal injections of abicipar 2 mg at baseline (day 1) and weeks 4, 8, 16, and 24. Outcome measures included proportion of patients with stable vision (< 15-letter loss from baseline; primary endpoint), change from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), and adverse events.Results: Overall, 8.9% (11/123) of patients experienced intraocular inflammation (IOI) and discontinued treatment. IOI cases were assessed as mild (2.4% [3/123]), moderate (4.9% [6/123]), or severe (1.6% [2/123]) and resolved with steroid treatment. Visual acuity in most patients with IOI (8 of 11) recovered to baseline BCVA or better by study end. No cases of endophthalmitis or retinal vasculitis were reported. Stable vision was maintained for ≥ 95.9% (≥ 118/123) of patients at all study visits. At week 28, treatment-naïve patients showed a greater mean improvement from baseline in BCVA compared with previously treated patients (4.4 vs 1.8 letters) and a larger mean CRT reduction from baseline (98.5 vs 45.5 μm).Conclusion: Abicipar produced using a modified manufacturing process showed a moderately lower incidence and severity of IOI compared with Phase 3 abicipar studies. Beneficial effects of treatment were demonstrated.Keywords: abicipar, age-related macular degeneration, inflammation

Hanan Al Rayes,1 Sultana Abdulaziz,2 Asma Mohammed Alotaibi,3 Mufaddal Adil Alaithan,1 Mohammed Attar,4 Hassan Daghasi,4 Rand Melibari,2 Ali H Althagafi,4 Basant Elnady4,5 1Rheumatology Division, Department of Medicine, Prince Sultan Military Medical City, Riyadh, Saudi Arabia; 2Division of Rheumatology, Department of Medicine, King Fahad Hospital, Jeddah, Saudi Arabia; 3Department of Medicine, Prince Sultan Military Medical City, Riyadh, Saudi Arabia; 4Division of Rheumatology, Department of Medicine, Al Hada Armed Forces Hospital, Taif, Saudi Arabia; 5Rheumatology, Rehabilitation and Physical Medicine Department, Faculty of Medicine, Benha University, Benha, EgyptCorrespondence: Basant ElnadyDivision of Rheumatology, Department of Medicine, Al Hada Armed Forces Hospital, Al Hada Ring Road, Al Hada, Postal Code 1347, Taif, Zip Code 21944, Saudi ArabiaTel +966562387723Fax +966127542811Email basantelnady@gmail.comBackground: Rheumatoid arthritis (RA) is associated with adverse pregnancy outcomes and postpartum complications, especially with severe disease activity.Objective: The current study aimed to compare the pregnancy outcomes in patients with RA and healthy controls as well as to assess the impact of disease-related variables, medications and disease activity on pregnancy and neonatal-related outcomes in the Saudi population.Methods: This prospective multicenter study included pregnant female patients with RA from three tertiary centers in Saudi Arabia. The demographics, disease activity scoring (DAS28-CRP), medication before and during pregnancy, pregnancy-related outcomes, and complications in comparison to age-matched healthy female controls were noted.Results: A total of 77 pregnant patients with RA and 250 healthy age-matched pregnant controls were included in the study. A total of 67.53% were in remission before conception (DAS28CRP ≤ 2.6), and 81.8% of pregnancies were planned. Age of conception, preterm labor, neonatal intensive care unit (NICU) admission and low birth weight were statistically significant (p < 0.05) and higher in RA patients than in healthy controls. Longer disease duration (p < 0.001), and high C-reactive protein and erythrocyte sedimentation rate levels before conception (p ≤ 0.001) were statistically associated with preterm NICU admission. There was statistically significant association between mild (p = 0.015) or moderate to severe DAS28-CRP (p = 0.001) and RA patients regarding pregnancy outcomes. The classification table obtained from the logistic model showed patients with mild and moderate-severe DAS28-CRP have significantly high chances of having an adverse pregnancy outcome.Conclusion: RA has a negative impact on pregnancy-related outcomes. Higher disease activity is considered a major risk; thus, tight disease control should be aimed. Planned pregnancy follow-up is associated with better pregnancy outcomes.Keywords: rheumatoid arthritis, pregnancy, disease activity

Jie Shen,1 Margot L Goodkin,2 Warren Tong,2 Mayssa Attar3 1Clinical Pharmacology, 2Clinical Development, 3Clinical Pharmacology, Metabolism and Immunology, Allergan plc, Irvine, CA, USA Purpose: Fixed-combination medications can benefit patients requiring multiple agents to lower their intraocular pressure (IOP), but combining agents with complementary mechanisms of action is challenging if their dosing frequency differs. This study compares in vivo pharmacokinetic and ocular tolerability of bimatoprost 0.01% ophthalmic solutions dosed once or twice daily. Reports of twice-daily dosing in glaucoma patients are also reviewed.Methods: New Zealand White rabbits were administered bimatoprost 0.01% monotherapy or fixed-combination bimatoprost 0.01%/brimonidine 0.1%, once or twice daily in both eyes for 4 days. Ocular tissues were harvested and analyzed by liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters calculated included maximum observed concentration, time to maximum concentration, and area under the concentration-time curve.Results: Due to extensive metabolism, bimatoprost concentration was below the quantitation limit by 1 hour post-dose in all samples. Bimatoprost acid exposure, however, could be measured up to 6–8 hours post-dose and was similar in the aqueous humor and iris-ciliary body (pharmacological site of action) of animals treated once or twice daily with either bimatoprost 0.01% or fixed-combination bimatoprost 0.01%/brimonidine 0.1%. Increasing dosage frequency in rabbits did not raise the incidence of drug-related conjunctival hyperemia (most common adverse event associated with bimatoprost use in humans), suggesting comparable ocular tolerability of the once- and twice-daily regimens for each formulation.Conclusion: Bimatoprost 0.01% administered once or twice daily as monotherapy and in fixed-combination with brimonidine 0.1% in rabbits show similar pharmacokinetic profiles of bimatoprost acid, especially in the iris-ciliary body. Key findings from previous clinical studies suggest that by varying the concentration of benzalkonium chloride (a preservative with corneal penetration-enhancing properties), formulations of bimatoprost 0.01% can be administered once or twice daily. These findings support development of bimatoprost 0.01%-based fixed-dose combination therapies administered twice daily for patients who require multiple adjunctive medications to control their IOP. Keywords: bimatoprost, pharmacokinetics, glaucoma, intraocular pressure, hyperemia

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Lean six sigma (LSS) is an important business strategy for organisations, including small and medium-sized enterprises (SMEs). Over the years, SMEs have had a potentially significant impact on various countries’ gross domestic product (GDP). The main purpose of this research is to investigate the critical success factors (CSFs) for lean six sigma (LSS) implementation in the Kingdom of Saudi Arabia’s SMEs, and to contribute to discovering the factors that lead to business success, increase revenue, and enhanced competitive advantages. The study identified 29 factors from previous research in order to guide the successful implementation of LSS in the SME sector in Saudi Arabia in particular. The CSFs were refined, producing a consolidated list of 14 factors. A principal components analysis (PCA) identified four main factors: leadership support and management structure, technological capabilities, knowledge acquisition, and creativity and innovation. These factors could influence the success of SMEs in Saudi Arabia by adopting LSS in their business processes. [ABSTRACT FROM AUTHOR]