Qletli (adalimumab biosimilar) / Bio-Thera Solutions - LARVOL DELTA

Assessment of Safety , Clinical Efficacy With QLETLI in Non-infectious Uveitis (UV) (clinicaltrials.gov) - P4 | N=60 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting | Trial completion date: May 2024 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Ocular Inflammation • Ophthalmology • Uveitis

PISCES: Clinical Study of Stage IV Psoriasis in Children With Geleli (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Pediatrics • Psoriasis

Assessment of Safety , Clinical Efficacy With QLETLI in Non-infectious Uveitis (UV) (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting | Trial completion date: May 2023 ➔ May 2024 | Trial primary completion date: Jan 2022 ➔ Dec 2023

Enrollment open • Trial completion date • Trial primary completion date • Ocular Inflammation • Ophthalmology • Uveitis

Clinical Study of Stage IV Psoriasis in Children With Geleli (clinicaltrials.gov) - P=N/A | N=80 | Not yet recruiting | Sponsor: Bio-Thera Solutions

Metastases • New trial • Dermatology • Immunology • Pediatrics • Psoriasis

Assessment of Safety , Clinical Efficacy With QLETLI in Non-infectious Uveitis (UV) (clinicaltrials.gov) - P4; N=60; Not yet recruiting; Sponsor: Bio-Thera Solutions

Clinical • New P4 trial • Ocular Inflammation • Ophthalmology • Uveitis

Bio-Thera Solutions announces China National Drug Administration acceptance of Biologics License Application for proposed biosimilar to Humira (adalimumab) (Businesswire) - "Bio-Thera Solutions...announced that the China National Drug Administration (CNDA) has accepted for review the Biologics License Application (BLA) for BAT1406, a proposed biosimilar to Humira®1 (adalimumab), which is used to treat patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis."

Non-US regulatory

Bio-Thera Solutions launches first commercial product, Qletli (格乐立), in China (Businesswire) - "Bio-Thera Solutions, Ltd...today announced that QLETLI® (格乐立®), a biosimilar to Humira® (adalimumab), is now available in China. QLETLI® (格乐立®), the first adalimumab biosimilar approved by the China National Medical Products Administration (NMPA), is authorized for the treatment of three autoimmune diseases: rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis."

Launch non-US

"Bio-Thera Solutions Launches First Commercial Product, QLETLI® (格乐立®), in China https://t.co/QeSOkLaQ68" (@NewsFromBW)

"I guess I'll throw in Humira, which reportedly got through the negotiations. But Bio-Thera's adalimumab biosimilar was just approved last week, so I'm curious to see what is going to happen to prices." (@JChanPharma)

Drug Concentrations and Anti-drug Antibodies Influence in Response to Adalimumab: Results from the BioEfficacySpA Clinical Trial (ACR-ARHP 2019) - "Our results show that even though assays used to detect drug concentration and ADA titer may be influenced by an individual/endogenous immune profile (previous to drug administration), response to ADL does not seem to be significantly affected by ADA titers or ADL concentration."

Clinical

A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira (clinicaltrials.gov) - P3; N=554; Completed; Sponsor: Bio-Thera Solutions

Clinical • New P3 trial

Evaluation of Children with Psoriasis from the BiPe Cohort: Are Patients Using Biotherapies in Real Life Eligible for Phase III Clinical Studies? (PubMed, Paediatr Drugs) - "The majority of children treated with biotherapies in real-life practice differ from those in phase III trials, most commonly because of the clinical type of their psoriasis, the disease severity being lower than required and the use of prior or concomitant psoriasis treatment. Efficacy and safety results from phase III clinical trials in selected populations may not sufficiently reflect what is seen in real life, thus results from real-life cohort studies are necessary."

Clinical • Journal • P3 data

Late-onset rheumatoid arthritis: clinical, biological, and therapeutic features About a retrospective study. (PubMed, Geriatr Psychol Neuropsychiatr Vieil) - "The rheumatoid arthritis of the elderly remains a common condition and constitutes a diagnostic and therapeutic challenge. Because of the co-morbidities, the clinician's perception of the patient's overall condition and the inaccuracies in the use of certain molecules in these patients, under-treatment may, on the contrary, weaken a patient whose remission will be postponed. This was not the case in our series, with a methodical use of methotrexate as well as effective dose biotherapies."

Journal • Retrospective data

Update in treatment of uveitic macular edema. (PubMed, Drug Des Devel Ther) - "Immunomodulators including methotrexate, mycophenolate mofetil, tacrolimus, azathioprine, and cyclosporine, as well as biologic agents, notably the anti-tumor necrosis factor-α monoclonal antibodies adalimumab and infliximab, may accomplish the control of inflammation and associated ME in refractory cases, or enable the tapering of steroids. Newer biotherapies have demonstrated promising outcomes and may be considered in persisting cases of UME."

Journal • Review

Efficacy of adalimumab and infliximab in recalcitrant retinal vasculitis inadequately responsive to other immunomodulatory therapies. (PubMed, Clin Rheumatol) - "During the study period, a statistically significant corticosteroid-sparing effect was observed (p = 0.0002), while BCVA values did not significantly change (p = 0.950). Anti-TNF-α monoclonal antibodies have proved excellent results in patients with recalcitrant sight-threatening RV."

Clinical • Journal

QUANTIFICATION OF MINIMAL RESIDUAL DOSE ASSOCIATED WITH BIOLOGICAL THERAPEUTIC RESPONSE ANTI DRUG ANTI BODIES: ARE THEY ALL NEUTRALIZING? (EULAR 2019) - "...We did search the presence of anti-body antidrugs (ADA) and the residual dose for the following therapies: Etanercept (ETN), Infliximab (IFX), Adalimumab (Ada) or Rituximab (RTX)... The ADA assay is a revolutionary tool allowing the evaluation of treatment response but it cannot be considered without the clinical assessment of patient. The evaluation residual dose should be concomitant to valorize and guide the therapeutic decision"

FAILURE TO BIOLOGICAL THERAPY: WHEN TO EXPECT IT? (EULAR 2019) - "...We did search the presence of anti-bodyanti-drugs (ADA) and the residual dose for the following therapies: Etanercept (ETN),Infliximab (IFX), Adalimumab (Ada)or Rituximab (RTX)... Immune response induced in patients treated with biotherapy can be quantified now thanks to ADA dosage and the residual dose assessment."

The use of leukocytes' secretome to individually target biological therapy in autoimmune arthritis: a case report. (PubMed, Clin Transl Med) - "An efficient way to effectively treat patients with complex autoimmune arthropathies, and avoid irreversible disability, is to know their leukocytes' secretome to identify abnormally secreted cytokines and personalize their biotherapy, as exemplified by this case report."

Clinical • Journal

INFECTIONS WITH ANTI TNF ALPHA: PROSPECTIVE STUDY OVER 12 YEARS (EULAR 2019) - "...The molecules used were: infliximab, etanercept, adalimumab with a respective number n (%) = 29 (21), 44 (33), 61 (46)... More than a third of patients have infectious complications after TNFα treatment in our study sometimes with serious issue. Thus, with the emergence of these accidents, the physician has to be very vigilant when instituting this biotherapy, and secondly, a rigorous and prolonged monitoring of the patients."

Clinical

IMPACT OF SPONDYLOARTHRITIS ON THE MALE SEXUAL FUNCTION: LIMITING FACTORS (EULAR 2019) - "...For the treatment side: 40.5% were on NSAIDs, 70.3% on csDMARDs and 56.8% of patients were on biotherapy (33.3% on adalimumab, 52.4% on infliximab and 14.3% on Etanercept)... Our results suggest the impact of SpA on patients’ sexual function. Pain during intercourse and the limitation of the sexual desire were the most limiting factors of the sexual function."

BIOSIMILAR BAT1406 VERSUS ADALIMUMAB THERAPY ON ACTIVE ANKYLOSING SPONDYLITIS: A RANDOMIZED, DOUBLE-BLINDED, MULTICENTER, CONTROLLED PHASE 3 TRIAL (EULAR 2019) - "The study met the primary endpoint of demonstrating equivalent efficacy of BAT1406 and ADA. BAT1406 was comparable in tolerance, safety and immunogenicity with ADA in active AS patients."

Clinical • P3 data

ADULT ONSET STILL’S DISEASE: EXPERIENCE OF THE RHEUMATOLOGY DEPARTMENT OF THE UNIVERSITY HOSPITAL OF CASABLANCA (EULAR 2019) - "...Therapeutically, 100% of patients received corticosteroids; 65% methotrexate; and 29% biotherapies (tocilizumab, anakinra, infliximab, adalimumab)... Our data are consistent with those in the literature. Some peculiarities emerge concerning the articular features. From 3 series of literature and ours, totaling 135 cases, it appears that the most frequent locations are: wrist (82%), knees (70%), elbows (46%), ankles (45%), proximal interphalangeal (44%), shoulders (42%) and metacarpophalangeal (42%)."

Clinical

IMMUNOGENICITY OF TNF ALPHA ANTAGONISTS IN RHEUMATIC INFLAMMATORY DISEASES : IMPACT ON CLINICAL RESPONSE (EULAR 2019) - "...Objectives: The objective of our study was to determine the incidence of ADAb anti Infliximab (IFX) and anti Adalimumab (ADA) and to evaluate the therapeutic impact of the presence of ADAb, the rate of ADAb and trough serum concentration of the drug at the time of sampling and six months later... The presence of ADAb and low trough levels seem to not affect the therapeutic response in patients on TNF alpha antagonists. Other tracks than immunogenicity should be investigated to explain the loss of response to these biotherapies."

Clinical

Neurological adverse events induced by tumour necrosis factor alpha inhibitors in paediatric inflammatory bowel diseases: an analysis based on the French National Pharmacovigilance Database (ESPGHAN 2019) - "...Reports were selected using the medical dictionary for regulatory activities (MedDRA) on SOC finervous system disordersfl, crossed with ''infliximabfl (IFX) or fiadalimumabfl (ADA) exposure (only reports where drugs were ''suspected'' were kept), fiage between 0 to 18 years oldfl, and fiCrohn Diseasefl (CD) or fiUlcerative colitisfl (UC) or fiIBDfl... NAEs induced by anti-TNFa biologics in children with IBD are rare. However, clinical symptoms have to be known by paediatric gastroenterologists, and neurologist advices are helpful to precise diagnosis and discuss treatment. Most authors recommend discontinuation of anti- TNFatherapy in severe NAEs and switch to alternative treatments."

Adverse events

Development and application of an in vitro dendritic cell internalization assay to assess immunogenicity risk (AAI 2019) - "...The extent of Adalimumab, Traztuzumab, and Utomilumab internalization was correlated with clinical immunogenicity incidence suggesting the assay may be able to detect frame work differences. Statistical power calculation of fold change set required donor numbers at 10. The assay can be used in combination with other in vitro immunogenicity assays to support BioTx design"

Preclinical