In our science jobs we have to justify our use and assess what impact our work has on Society.
For Prof G is is easy. He is lead on a clinical trial of drug X and it works and is licensed and so it has impact on people with MS, but maybe drug X gets used in other autoimmunities and the impact gets bigger and it works in Cancer too a bit impact etc. Then there is impact on Society. Manufacturer of Drug X makes at load of cash and Manufacturer opens up a factory in Tyne and Weirdside employing 8,000 people and the impact gets bigger and bigger
But for a humble scientist it is much more different..Yep we were the first group to underpin the science of cannabis for use in spasticity and yes cannabis became a licensed drug and yes it has helped a certain company make loads of cash for UK PLC but as there is a time limit from the discovery to the Impact so we can’t use it so as a scientist you are stuffed:-).
Yes it is all a load of boll***cks for example Prof Brian Cox made the point for Manchester University that he made more people do physics A level and the Impact Comittee bought it,
We have to play this game, So if we are making stuff up, Do you think we could try this one?
The ocrelizumab phase II extension trial suggests the potential to improve the risk: Benefit balance in multiple sclerosis.Baker D, Pryce G, James LK, Marta M, Schmierer K.Mult Scler Relat Disord. 2020; sept; 44:102279.
What did it say?….It would be safe to delay dosing ocrelizumab when the COVID-19 pandemic.
Now you say it has a september 2021 date and the pandemic hit in feb/march….but I say I foresaw the problem and that is why I put it online at MedrXiv in Jan 2020 https://www.medrxiv.org/content/10.1101/2020.01.09.20016774v2
Did it have impact? Yes it did as it changed clinical practice
In the Netherlands
van Lierop ZY, Toorop AA, van Ballegoij WJ, Olde Dubbelink TB, Strijbis EM, de Jong BA, van Oosten BW, Moraal B, Teunissen CE, Uitdehaag BM, Killestein J, Kempen ZLV. Personalized B-cell tailored dosing of ocrelizumab in patients with multiple sclerosis during the COVID-19 pandemic. Mult Scler. 2021 Jul 9:13524585211028833. doi: 10.1177/13524585211028833.
But also is Germany
Ocrelizumab Extended Interval Dosing in Multiple Sclerosis in Times of COVID-19.Rolfes L, Pawlitzki M, Pfeuffer S, Nelke C, Lux A, Pul R, Kleinschnitz C, Kleinschnitz K, Rogall R, Pape K, Bittner S, Zipp F, Warnke C, Goereci Y, Schroeter M, Ingwersen J, Aktas O, Klotz L, Ruck T, Wiendl H, Meuth SG.Neurol Neuroimmunol Neuroinflamm. 2021 Jul 14;8(5):e1035. doi: 10.1212/NXI.0000000000001035.
Objective: To evaluate the clinical consequences of extended interval dosing (EID) of ocrelizumab in relapsing-remitting multiple sclerosis (RRMS) during the coronavirus disease 2019 (COVID-19) pandemic.
Methods: In our retrospective, multicenter cohort study, we compared patients with RRMS on EID (defined as ≥4-week delay of dose interval) with a control group on standard interval dosing (SID) at the same period (January to December 2020).
Results: Three hundred eighteen patients with RRMS were longitudinally evaluated in 5 German centers. One hundred sixteen patients received ocrelizumab on EID (median delay [interquartile range 8.68 [5.09-13.07] weeks). Three months after the last ocrelizumab infusion, 182 (90.1%) patients following SID and 105 (90.5%) EID patients remained relapse free (p = 0.903). Three-month confirmed progression of disability was observed in 18 SID patients (8.9%) and 11 EID patients (9.5%, p = 0.433). MRI progression was documented in 9 SID patients (4.5%) and 8 EID patients (6.9%) at 3-month follow-up (p = 0.232). Multivariate logistic regression showed no association between treatment regimen and no evidence of disease activity status at follow-up (OR: 1.266 [95% CI: 0.695-2.305]; p = 0.441). Clinical stability was accompanied by persistent peripheral CD19+ B-cell depletion in both groups (SID vs EID: 82.6% vs 83.3%, p = 0.463). Disease activity in our cohort was not associated with CD19+ B-cell repopulation.
Conclusion: Our data support EID of ocrelizumab as potential risk mitigation strategy in times of the COVID-19 pandemic.
Using standard 6 monthly dosing the people with more ten cells or more per microlitre were 26/176 (17.6%) at six months and 17/102 (15.7%) if it was delayed by more than a month. So if we say that people with B cells can make a COVID-19 vaccine responses it suggests that at least 1/5 people will make an antibody response after COVID vaccination and delaying by a month would make much difference.
It also shows you can relapse whilst you have no peripheral B cells
So if we delayed by 3 months (I can’t answer this) or 6 months (I can answer this) how many more people would have B cell counts above 10 cells/microlitre and could make an antibody response following COVID-19. However, would this work? and would it be safe? and importantly would it matter? We need data for this.
Did this cause this change? Well it is reference number 13…..So why not claim it….now that’s Impact Isn’t it:-(
Yep what a pile:-)
Next issue covid19 vaccination