Academic literature on the topic 'Adalimumab-behandling'

Crohns sjukdom är en kronisk inflammatorisk tarmsjukdom som kan drabba hela mag- tarmkanalen och karakteriseras av återkommande skov eller kontinuerliga besvär. Symptomen beror på lokaliseringen av sjukdomen, inflammationsgrad och komplikationer. Målen vid farmakabehandling vid Crohns sjukdom är bland annat erhållande av klinisk remission och bevarande av remission. Biologiska läkemedel för behandling av Crohns sjukdom introducerades under slutet av 1990-talet och till dem hör TNF-α-hämmare. Det proinflammatoriska cytokinet TNF-α spelar troligtvis en central roll i patogenesen vid Crohns sjukdom. När konventionell behandling som exempelvis glukokortikoider och immunmodulerande farmaka inte är tillräcklig kan behandling med TNF-α-hämmare bli aktuell. TNF-α-hämmaren adalimumab godkändes i Sverige för behandling av Crohns sjukdom i juni 2007.

Syftet med denna studie var att undersöka adalimumabs effekt avseende klinisk remission vid Crohns sjukdom, både vad beträffar att uppnå klinisk remission och bevarande av remission. Sekundär frågeställning var uppkomst av eventuella allvarliga infektiösa tillstånd vid adalimumabbehandling.

Metoden för studien har varit en litteraturstudie där fem vetenskapliga artiklar har studerats. Tre av studierna var RCT-studier och två var öppna studier.

I två studier var skillnaden signifikant högre vad gäller klinisk remission i vecka 56 i adalimumabgrupperna jämfört med placebogruppen. I en studie påvisades remission i signifikant högre grad i adalimumabgruppen än i placebogruppen vecka 4. I en annan studie visades signifikant större remissionsgrad vecka 52 jämfört med vecka 0 med adalimumabbehandling. En studie visade på erhållande av remission hos patienter med luminal sjukdom och hos patienter med fistulerande sjukdom med adalimumabbehandling. I tre av studierna hade man inga fall av allvarliga infektioner. I en studie rapporterades ett fåtal fall av allvarliga infektioner i placebogruppen men inga i adalimumabgruppen. I en studie rapporterades 7 fall av allvarliga infektioner i adalimumabgrupperna och 9 fall i placebogruppen under den blindade studien.

Sammanfattningsvis visade studierna att behandling med adalimumab kan inducera och bevara remission vid Crohns sjukdom upp till 56 veckor. Dessutom visade studierna på låg biverkningsprofil gällande allvarliga infektioner.

Ankyloserande spondylit (AS) är en kronisk inflammatorisk sjukdom som drabbar axialskelettet. Inflammationen som uppstår tros bero på ett överskott av tumörnekrosfaktor (TNF) i kroppen som gör att inflammation och smärta förekommer utan någon direkt anledning. Ungefär 0,5% av befolkningen har AS och det är mer vanligt att män drabbas. Även barn kan drabbas av AS. Adalimumab är en humaniserad monoklonal antikropp och hämmare av cytokinet TNF. Hämmas TNF minskar inflammationen och smärtan i kroppen och progressionen av AS begränsas. Adalimumab ges subkutant via injektion i dosen 40 mg varannan vecka. Syftet med detta litteraturarbete var att undersöka huruvida adalimumab är ett effektivt och säkert läkemedel att använda vid behandling av AS. Artiklarna som undersökts i detta arbete hittades via sökningar i databasen Pubmed och då användes sökorden ”ankylosing spondylitis adalimumab” och ”ankylosing spondylitis adalimumab safety”. Utav resultaten som erhölls från de fem studierna kan det konstateras att adalimumab har god effekt vid behandling av AS jämfört med placebo. De allra flesta värdena som sågs var statistiskt signifikanta. Liknande biverkningar såg från alla studier men de som förekom var av mild grad. Slutsatsen av detta litteraturarbete är att adalimumab är ett effektivt läkemedel att använda vid behandling av AS. Det minskar symtomen och bromsar upp progressionen av AS. Adalimumab är även ett säkert läkemedel då de vanligaste biverkningarna som förekommer är av mild grad.
Ankylosing spondylitis (AS) is chronic inflammatory disease that affects the axial skeleton causing pain and stiffness. The inflammation occurs due to an excess of tumor necrosis factor (TNF) in the body which causes an inflammation without any direct cause. Approximately 0.5% of the population has AS and it´s more common that men suffer from this disease. Children can also be affected by this disease. Adalimumab is a humanized monoclonal antibody and inhibitor of the TNF cytokine. If TNF is inhibited the inflammation and the pain in the body will be reduced and the progression of AS will be limited. Adalimumab is given subcutaneously via injection at a dose of 40 mg every other week.  The intention with this literature work was to investigate whether adalimumab is an effective and safe drug to use in the treatment of AS. The articles examined in this work were found through searches in the database Pubmed where the words “ankylosing spondylitis adalimumab” were used. This resulted in 32 articles and four of them were selected. Since the four articles found during the first search were very similar, the searchword “safety” was added to broaden the information about adalimumab and look more at side effects adalimumab might possibly give. By adding “safety” the fifth article was found. The results from these five articles in this literature work shows that adalimumab has god effect in the treatment of AS compared with placebo. A majority of the values seen was statistically significant. Similar side effects were seen from all studies but the reported side effects were mild. The conclusion of this literature study is that adalimumab is an effective drug to use in the treatment of AS. It reduces the symptoms and slows the progression of AS. Adalimumab is also a safe drug since the most common side effects that occurs are mild.

Reumatoid artrit (RA) är en typ av reumatisk sjukdom där uttalad inflammation uppstår i flertalet leder tillsammans med smärta och stelhet. Inflammationen uppkommer som resultat av en autoimmun reaktion. I Sverige har ungefär 1 % av befolkningen RA och sjukdomen är 2–3 gånger vanligare hos kvinnor än hos män. Adalimumab (Humiraâ) är en TNF-hämmare som används vid behandling av RA. Humira är en humaniserad monoklonal antikropp som binder till TNF och neutraliserar de effekter som TNF utövar och reducerar på så vis symtom samt bromsar progressionen av RA. Under 2018 beräknas Humira utsättas för konkurrens av biosimilarer, vilka innehåller en version av den verksamma substansen som finns i det biologiska referensläkemedlet. För att en biosimilar ska godkännas krävs det att de bland annat har jämförbar effekt och säkerhet som referensläkemedlet. Syftet med denna litteraturstudie var att undersöka om biosimilarer till adalimumab är lika effektiva och säkra vid behandling av RA som det biologiska referensläkemedlet Humira. De fem artiklar som analyserats i denna litteraturstudie hittades via sökning i databasen PubMed med sökorden “rheumatoid arthritis”, “adalimumab” och “biosimilar”. Totalt gav detta 38 träffar varav 5 artiklar valdes ut. Enligt de resultat som sågs i denna litteraturstudie kan det konstateras att de fem biosimilarer som undersökts hade likvärdig effekt som referensläkemedlet adalimumab (Humiraâ) vid behandling av RA. Fyra av fem studier visade även att immunogenicitet mellan biosimilar och Humira var likvärdig. Liknande biverkningar förekom i båda behandlingsgrupper och behandling med en biosimilar gav inte fler eller allvarligare biverkningar än behandling med Humira. Lansering av biosimilar till adalimumab kommer troligtvis leda till lägre behandlingskostnader och därmed till att fler patienter kan få möjlighet till behandling.
Rheumatoid arthritis (RA) is a type of rheumatic disease where pronounced inflammation occurs in several joints along with pain and stiffness. The inflammation occurs as a result of an autoimmune reaction. In Sweden, approximately 1% of the population has RA and the disease is 2-3 times more common among women than men. One of the proinflammatory cytokines that plays a major role in RA is tumor necrosis factor (TNF). TNF is produced primarily by macrophages in the synovial membrane and has been shown to regulate release of other cytokines like IL-1 and IL-6. TNF also contributes to the release of metalloproteases from fibroblasts, reduced synthesis of proteoglycan from chondrocytes and to monocytes differentiate into osteoclasts. In this way, TNF contributes to joint destruction. Adalimumab (Humiraâ) is a TNF-inhibitor used in the treatment of RA. Humira is a humanized monoclonal antibody that binds to TNF and neutralizes the effects that TNF exerts and thus reduces symptoms and inhibits the progression of RA. In 2018, Humira is expected to be exposed to biosimilars competition. Biosimilars contains a version of the active substance in the biological reference drug and in order for a biosimilar to be approved it is necessary that they have comparable effect and safety as the reference drug. The purpose of this literature study was to investigate whether biosimilars to adalimumab are as effective and safe in the treatment of RA as the biological reference drug Humira. The five articles analyzed in this literature study were found through a search in the PubMed database with the words "rheumatoid arthritis", "adalimumab" and "biosimilar". In total, this resulted in 38 hits, of which 5 were selected. According to the results seen in this literature study, it can be noted that the five biosimilars investigated had similar effect as the reference drug adalimumab (Humira) in the treatment of RA. Four out of five studies also showed that the immunogenicity between the biosimilar and Humira was similar. Similar side effects occurred in both treatment groups and treatment with a biosimilar did not give more or more serious side effects than treatment with Humira. The launch of biosimilar adalimumab is likely to result in lower treatment costs and cost savings, as a result of the price competition that may occur between biosimilar adalimumab and the reference drug Humira. How much the cost will fall is hard to predict, but if there is a 58% reduction previously seen with other launched biosimilars, it can result in a cost saving of SEK 635 million. However, the amount of price reduction remains to be seen.

Rheumatoid arthritis (RA) is an autoimmune disease, which causes joint inflammation. Different environmental and genetic factors such as smoking, anti-citrullinated protein antibody, rheumatoid factor, and certain MHC-alleles cause RA. It affects mostly women and it is characterised by joint swelling, pain, tiredness, and stiffness. Untreated RA can lead to disability and complications in different organs (brain, lung, heart,). The body develops tolerance against self-antigens using different mechanisms, including Tregs mediated, by increasing the expression of inhibitory receptors and through receptor modification/destruction of self-reactive cells.  Failure in the resistance development mechanism leads to autoimmune diseases. The most important cellular components of RA dependent inflammation are macrophages, T-cells, and B-cells. These cells contribute to the inflammations process by producing antibodies, cytokines, and through antigen presentation or immune cell activation. One of the cytokines, which are released by macrophages and T-cells is Tumour necrosis factor (TNF). It stimulates angiogenesis, activation of osteoclasts and the production of different cytokines by increasing the expression of NF-kB.  The diagnostic process of RA consists of serological, physical, and radiological examinations. These examinations together with other factors are utilized for calculating score (0-10), in order to decide if a patient have RA or not. The treatment of RA depends on disease activity and it is composed of NSAID, steroids, DMARDs, biological DMARDs and non-pharmacological treatment. The interventions can be given as a monotherapy or in combination. The disease activity of RA or the efficacy of a drug which is used to treat RA can be studied by ACR response, DAS-28, HAQ-DI score using joint progression score. The aim of the study was to investigate the efficacy and safety of adalimumab, as well as to compare it with other treatments, which are used to in RA. 5 scientific articles which were obtained from PubMed were used to perform the study. The keywords used to get the materials was” adalimumab rheumatoid arthritis”. It gave 172 results and 5 of the first 20 were selected. ACR 20 response and change in DAS-28 were studied as a primary efficacy endpoint. The result of the studies demonstrated that adalimumab had a moderate-god effect against RA according to the ACR/ EULAR criteria. However, adalimumab was less effective comparing to barcitinib, tocilizumab, sirukumab but it had a similar efficacy as ABP 501 as well as abatacept.   ACR response, change in DAS-28 and remission rate showed better results in patients who treated by sirukumab, tocilizumab or barcitinib. The studies have also proved that adalimumab leads to better outcomes when it is used in combination with methotrexate instead of monotherapy. Regarding safety, all the drugs showed similar patterns and nasopharyngitis as well as lung infections were the most common adverse events. More studies are required in order to find the perfect target molecule and combination therapy so that RA can be treated efficiently and at a lower cost.